Guidance document Formal requirements

1 Introduction

1.1 Terms, definitions, abbreviations

1.1.1 Abbreviations

AAA Accelerated Application Hearing ASMF Active Substance Master File CCDS Company Core Data Sheet CDS Core Data Sheet CEP Certificate of Product CHM Complementary and Herbal Medicines CL Checklist Common Technical Document: format for authorisation applications, divided into Modules 1-5 DMF Drug Master File DMF/ASMF Holder Holder of the Drug Master File / Active Substance Master File Doc Documents eCTD electronic Common Technical Document eDok Swissmedic application submission format, paper version + electronic version (see Swissmedic website) FTP Fast-Track authorisation Procedure GMO Genetically Modified Organisms HMP Human medicinal products HPC Healthcare Professional Communication ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use IHP Information for Healthcare Professionals KAS Known Active Substance LoA Letter of Access LoQ List of Questions MAH Marketing Authorisation Holder MDR Regulation (EU) 2017/745 on medical devices (EU-MDR) MedD Medical device MUMS Minor Use and Minor Species NAS New Active Substance NTA Notice to Applicants, format for authorisation applications, divided into Parts I-IV ODS Orphan Drug Status PBRER Periodic Benefit-Risk Evaluation Report PDP Pediatric Development Plan, FDA PI Patient Information PIP Paediatric Investigation Plan PL Package Leaflet (of veterinary medicinal products) PMF Plasma Master File PPN Procedure with Prior Notification

PSUR/PBRER Periodic Safety Update Report/Periodic Benefit Risk Evaluation Report PVP Pharmacovigilance Plan RMP Risk Management Plan SAP number Identification number in the Swissmedic's SAP business case application, e.g. for medicinal products, applications, products SmPC Summary of Product Characteristics temp. Temporary new authorisation tempAI Temporarily authorised additional indication TPA Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (Therapeutic Products Act, SR 812.21) TV Technical Validation (of applications in eCTD format) VMP Veterinary Medicinal Products VMPI Veterinary Medicinal Product Information = Information for healthcare professionals + package leaflet WL Guidance Document

1.1.2 Definitions

Data carrier CD, DVD, blu-ray disc Binder A4 rigid ring binder with two sets of holes, 50mm or 80mm spine Loose-leaf binder Plastic folder for hole-punched documents, A4, two sets of holes Dividers Set of dividers with light cardboard or plastic tabs Cover sheets The cover sheets made available online by Swissmedic, with the titles and the bar codes for separating the individual sections within the authorisation documentation, Modules 1-5 (CTD) and Parts I-IV (NTA) respectively.

1.1.3 Description of the requirements

The requirements are described in tabular form, and are numbered. No. Subject Requirement C/O Exceptions

1.1.3.1 Description of the Explanation of the requirement C=compulsory Descriptions of special

subject O=optional cases and requirements objections) … … … … …

1.1.4 Symbols used and their meaning

This symbol means: “Please note!” Information marked with this symbol is explanatory and provides additional information.

3 This symbol means: "Example / Summary". Examples and summaries are intended to help clarify the requirements, and serve as additional information. Purpose of this guidance document

1.2 Objective of this guidance document

Since this guidance document is an Administrative Ordinance document aimed at the administrative bodies, it does not directly specify the rights and obligations of private individuals. Swissmedic uses this guidance document first and foremost as a resource for applying the legal provisions in a uniform and equitable manner. The publication of this document provides transparency concerning how applications should be structured so that they can be processed efficiently and completed in accordance with Swissmedic's practices and systems. This document also takes into account all publications on this subject in the Swissmedic Journal in recent years. In the case of divergences between the formal requirements specified in previous documents and those specified in the guidance document Formal requirements, the present document takes precedence.

1.3 Scope

This guidance document applies to all submissions to Swissmedic. It specifically does not apply to:

• Requirements related to the content of applications

• Medical devices

• Market monitoring cases other than those explicitly mentioned

• Legal cases

• Inspections

• Certificates

• Clinical trials

• Notifications for narcotics

• Submission of laboratory orders The requirements of the directory Overview of documents to be submitted must be taken into account in addition to the requirements described in this guidance document. Requirements specific to certain types of application that cannot be found here are described in the relevant guidance documents.

2 General requirements

Documentation submission

In principle, all documentation on the application being submitted must be submitted by the applicant, because as the (future) marketing authorisation holder, the applicant bears legal responsibility for the authorised medicinal product and accordingly must have the full documentation and information. Submissions by third parties are only accepted for DMF/ASMF (see short instruction Submission for DMF/ASMF holder) and compositions of flavouring agents (see form Full declaration).

2.1 Submission formats

No. Subject Requirement C/O Exceptions

2.1.1 Paper submission There are two options: C

in CTD format Entirely paper-based submission: Module 1-5: One original as hard copy The individual sections of Modules 2-5 of the paper original must be marked by dividers/tabs.

No. Subject Requirement C/O Exceptions In addition, the paper original must be subdivided using the cover sheets provided electronically by Swissmedic. Furthermore, the IHP / PI / VMPI / packaging must be submitted electronically on a data carrier. Paper submission with eDok copy: One paper original for Modules 1-5 plus an identical electronic copy on a data carrier The individual sections must be submitted as an eDok copy on the data carrier in accordance with the instructions (see WL Guidance eDok) The paper original (with the modules submitted separately) must not contain dividers or cover sheets. In addition, the IHP / PI / VMPI / packaging must be submitted on a data carrier.

2.1.2 Paper submission There are two options: C

in NTA format (veterinary Entirely paper-based submission: medicinal One original as hard copy products only) The individual sections of the paper original (Parts Ic-IV) must be marked by dividers/tabs. In addition, the paper original must be subdivided using the cover sheets provided electronically by Swissmedic. In addition, the veterinary medicinal product information / packaging must be submitted electronically on a data carrier. Paper submission with eDok copy: One paper original for Parts I-IV plus an identical electronic copy on a data carrier. The individual sections must be submitted as an eDok copy on the data carrier in accordance with the instructions (see WL Guidance eDok). The paper original (with the parts submitted separately) must not contain dividers or cover sheets. In addition, the veterinary medicinal product information / packaging must be submitted electronically on a data carrier.

2.1.3 Binding of the Paper documents for Modules 1-5 (or Parts I-IV C

paper documents respectively) must be submitted in binders or folders, divided by module

2.1.4 Cover sheets Swissmedic provides cover sheets with the section titles C The cover

and barcodes for separating the individual sections of paper sheets are not submissions in the CTD or NTA structure (these cover required for the sheets are available for download on the Swissmedic submission of website). an eDok copy. These cover sheets must be printed out by the applicant and placed in the authorisation documents in front of the corresponding section. All sections must also be separated by dividers. If a section exceeds the volume of a (standard Swiss) ring binder, a cover sheet for the relevant section must be inserted as the first sheet of each new binder.

2.1.5 Numbering The official structure (CTD, NTA) for the numbering of the C

system CTD / individual sections must remain unchanged. NTA 2.1.6 eCTD The special requirements for an eCTD submission are C published on the Swissmedic website. The following documents should be taken into consideration:

• Guidance for Industry on Providing Regulatory Information in eCTD Format

• Questions and answers by Swissmedic on eCTD implementation

No. Subject Requirement C/O Exceptions

• Swiss Module 1 Specification for eCTD

• Swiss eCTD Validation Criteria

• Guidance on applications according to paragraph 13, TPA for eCTD applications

2.1.7 Additional Word or Companies that do not work with Swissmedic’s eGov Portal C

PDF documents must submit Word versions of the information for healthcare professionals and patients / veterinary medicinal product information and PDF versions of packaging (or manuscripts in Word format) on an electronic data carrier.

Other requirements applicable to documents to be submitted can be found in the “Overview of documents to be submitted”. Details of the requirements relating to content can be found in the guidance documents published on the Swissmedic website.

Entirely paper-based submissions: Staples must not be used for entirely paper-based submissions. Staples may still be used for paper documents submitted with eCTD or eDok.

No transparent folders may be used.

PDF documents must be machine-readable, i.e. generated using OCR (Optical Character Recognition). PDF documents with more than 20 pages must include a document structure with useful bookmarks (HMP). A list of contents with active links within a document with more than 20 pages is desirable. The entries in the list of contents should be short and meaningful. Scanned documents, including cover letter and forms, must comply with the OCR standard before they are submitted, i.e. the text must be searchable as text. The size of a PDF file should not exceed 200 MB. Larger files should be split into smaller parts.

When using the cover sheets, please note:

Paper applications, submission of publications: In connection with the submission of documentation, the reference documents do not need to be submitted in paper form if they are publicly available, free of charge, at all times. In this case electronic submission of the published data alone is sufficient. The applicant should clearly state what references can be found on the CD and specify the corresponding versions and dates. Life cycle following the transfer of authorisation: After the authorisation of a medicinal product has been transferred, it is preferable to continue using the existing submission format (particularly in the case of eCTD).Option 1:The existing MAH transfers the eCTD life cycle to the new MAH. The new MAH continues using the existing eCTD life cycle.Option 2: The existing MAH does not transfer the eCTD life cycle to the new MAH. The new MAH submits the authorisation transfer on paper and continues using the life cycle as eCTD after the transfer. The transfer is consolidated in the new life cycle. However, a baseline will be required for certain sections of the dossier (e.g.

module 3). Option 3: The existing MAH does not transfer the eCTD life cycle to the new MAH. The new MAH submits the transfer on paper and continues using the life cycle on paper after the transfer of the medicinal product.

3 Summary of submission formats

eGov Portal eCTD Paper

Paper original Entirely paperwith eDok based submission copy

Cover letter, forms, --- 1 copy 1 copy 1 copy etc. of each

Draft healthcare --- Module 1 professional / patient / information / --- 1 copy 1 copy Parts Ia/Ib in veterinary product paper form information

Packaging --- --- 1 copy 1 copy

Staples --- Permitted Permitted Not permitted

Paper documentation --- - 1 copy 1 copy (Modules 2-5 / Parts 1c to IV )

Electronic documentation on CD/DVD --- 1 copy 1 copy - (Modules 1-5 / Parts I to IV)

Electronic documentation by eGov 1 copy Portal(Modules 1-5 / Parts I to IV )

Cover sheets --- 1 cover sheet per - - (Modules 1-5 / Parts I to IV ) section

Dividers --- 1 set of dividers per - - (Modules 2-5 / Parts 1c to IV ) section

Additional Word documents Contained in the On data carrier On eCTD Packaging (also accepted as PDF) electronic with electronic On data carrier data carrier and or IHP/PI/VMPI submission. documentation

2.2 Time limits

No. Subject Requirement C/O Exceptions

2.2.1 General The time limits are those stipulated in the guidance C

document Time limits for authorisation applications.

2.2.2 Time limits for In the event of formal objections, applicants will be C

resolving given a maximum of 60 days to rectify the shortcomings shortcoming. regarding formal Extensions cannot be granted. requirements

2.3 Signatures / Signatory authority

No. Subject Requirement C/O Exceptions

2.3.1 Signatory Applicants may delegate third parties to submit C

authorised to applications and notifications on their behalf. In commit the firm such cases, the corresponding power of attorney must be submitted with the application.

2.3.2 Signatures Cover letters, forms and other documents C Users of the

requiring an original signature must be submitted Swissmedic eGov in paper form and bear the original signature of an portal are subject to authorised signatory. the applicable The signature does not have to be that of a contractual person recorded in the Commercial Register as conditions. having signatory authority. It may also be that of a person duly authorised by the applicant to sign documents for the corresponding operation.

2.3.3 Signatures for The documentation required for a DMF/ASMF C

DMF/ASMF (Form Part B and Letter of Access) must bear the applications original signature of the DMF/ASMF holder for each new application.

Swissmedic does not accept scanned, electronic or printed out signatures on paper submissions.

2.4 Confirmation of receipt

No. Subject Requirement C/O Exceptions

2.4.1 Confirmation of Swissmedic does not send confirmations of receipt C Swissmedic

receipt by post. confirms receipt of type IA, IAIN and IB (HMP) variations, and variations that do not require assessment (VMP; if the applicant is not a portal user), applications for advertising permits and licence applications. Confirmation of receipt always sent for fast-track requests.

Authorisation holders may consult the status of their application online on the Swissmedic eGov Portal. For details, see the Swissmedic website and the Guidance for the Swissmedic eGov Portal.

2.5 Module 1

2.5.1 Cover letter

Requirements applicable to the cover letters of certain types of application can be found in the section on the application in question. No. Subject Requirement C/O Exceptions 2.5.1.1 General ▪ Medicinal product name plus appropriate details C Variation types IA, if other designations have been used for the IAIN and IB (HMP), medicinal product in the documentation (e.g. as well as variations without assessment

No. Subject Requirement C/O Exceptions other product names, chemical name, and variations with development code no.) assessment with a

• Name of the active substance time limit “Reduced”

• If known: Authorisation number (VMP) can be submitted without

• If known: Application ID cover letters

• Application type (for applications for variation, provided no further including the type of variation) and short information or scientific justification reasons need to be

• List of all administrative documents and other stated. documentation submitted (for each Module/Part, with number of binders)

• For eCTD submissions: number of data carriers.

2.5.1.2 Dispatch of Authorisation documents will only be sent if O Users of the

authorisation specifically requested by the applicant applicant Swissmedic eGov documents and is subject to a fee. If an authorisation document portal can download is required, this must be expressly stated in the an up-to-date cover letter for all submission types. authorisation document themselves by logging into the Portal.

2.5.1.3 Documents not If documents required by Swissmedic are not C

submitted submitted, the reasons for omitting them must be explained in the cover letter.

2.5.1.4 Additional ▪ Pharmaceutical form, authorisation holder in C

information for out Switzerland of stock situations ▪ Details of the medicinal product to be imported (foreign authorisation no., medicinal product designation, pharmaceutical form, authorisation holder)

• Name and address of the firm in the country of export from which the medicinal product to be imported will be obtained

• Name and address of the repackaging company

• Contact details of the Responsible Person for the authorisation holder

• 24-hour emergency number

2.5.2 Forms

No. Subject Requirement C/O Exceptions

2.5.2.1 Forms New An original of the form must be submitted for each C

authorisation of authorisation number and for each application type. human medicinal Dosage strength number: state the various dosage products / New strengths. authorisation of veterinary medicinal products

2.5.2.2 Form Variations The forms consist of an administrative part with C

and extensions sections 1 (Basic information) to 7 (Signature) and HMP / Form section 8 with the list of variations. In the form for Variations VMP HMP, a template starting on a new page exists for every variation. In the form Variations VMP, all changes are separated into individual templates by variations without assessment and variations with assessment. Each template begins on a new page. A form can also be used for a variation application, a multiple application, a collective application or a collective-multiple application. Further information can be found in Chapter 3.12 of this guidance document: "Variations and extensions".

No. Subject Requirement C/O Exceptions

2.5.2.3 Full declaration The complete qualitative and quantitative C

form composition of the medicinal products must be stated.

2.5.2.4 Form For medicinal products with herbal active C

Manufacturer substances, the requirements set out in the information Guidance document Details required regarding manufacturers of herbal active substances must be met. The requirements set out in the Guidance document Authorisation of homeopathics, anthroposophics and other complementary medicinal products must be observed on the form Manufacturer information when authorising homeopathic and anthroposophic medicinal products without an indication and with a reduced dossier. Furthermore, the requirements of the guidance document Simplified information requirements on the form manufacturer information for the reduced dossier must be applied to applications for authorisation with a reduced dossier.

2.5.2.5 Form If the status changes while an application is in C If no submission /

Status of progress, the form containing the response to the authorisation for the authorisation List of Questions or the response to the preliminary relevant medicinal applications decision must be resubmitted. product exists in abroad other countries, there is no need to submit the form Status of authorisation applications abroad. The reasons for omitting the form should be set out in the cover letter.

2.5.2.6 Form Confirmation This form must always be submitted if it is possible C

regarding that the medicinal product may contain substances substances from derived from GMO. This applies irrespective of GMO whether substances have to be declared in accordance with the Guidance document Product information for human medicinal products. If the medicinal product contains GMO, the declaration is to be made according to Art. 27 para. 3 TPO and the form does not need to be submitted.

Form Manufacturer information should only be submitted if it is required for the application type in question. If the form is submitted for other application types, Swissmedic will neither check it nor approve it.

The currently valid versions of the forms are available on the Swissmedic website. The use of forms that are no longer valid after the transitional period stipulated by Swissmedic (usually three months) has expired will result in Swissmedic issuing a formal objection. Unless otherwise explicitly stated by Swissmedic, the default transitional period for forms is 3 months. If additional application requirements are associated with a new version of a form, a default transitional period of 3 months likewise applies to these new requirements.

Incomplete forms may also result in a formal objection.

For VMP (if applicable according to Art. 28 RO) the form Information on GMO-containing veterinary medicinal products must be submitted.

2.5.3 Medicinal product information

2.5.3.1 Mandatory submission

No. Subject Requirement C/O Exceptions 2.5.3.1.1 Submission is Information for C Dosage forms in accordance with Art. 14, para. 2, mandatory for healthcare TPLRO that are only administered by doctors or human medicinal professionals and dentists (e.g. products for injection or infusion) do products patients must both not require patient information. For these medicinal indispensing be submitted. products, the information for healthcare categories A and B professionals should be inserted in the packaging. Complementary medicinal products: Information for healthcare professionals is not required for homeopathic and anthroposophic medicinal products according to Art. 24, Art. 25 para. 2 KPTPO, medicinal products for gemmotherapy according to Art. 35 para. 2 KPTPO and Asian medicinal products without an indication according to Art. 30 et seq. KPTPO. Medicinal product information is not required for homeopathic and anthroposophic medicinal products without an indication according to Art. 25 para. 1 KPTPO, homeopathic and anthroposophic medicines without an indication and medicinal products for gemmotherapy without an indication according to Art. 27 KPTPO and Schüssler salts without an indication according to Art. 28 KPTPO.

2.5.3.1.2 Submission is Information for O Medicinal products according to Art. 14 para. 1

mandatory for healthcare let. ater-quater TPA human medicinal professionals and Information for healthcare professionals is not products in patients must both required. dispensing be submitted. category D Herbal medicinal products Information for healthcare professionals is mandatory for certain active substance groups (e.g. anthraquinone laxatives, medicinal products containing St. John's wort, ginkgo and echinacea). If a product contains other active substances, Swissmedic can waive the requirement for information for healthcare professionals in response to an application to this effect. Complementary medicinal products: For Asian medicinal products according to Art. 29 KPTPO, the Agency can waive the requirement for information for healthcare professionals in response to an application to this effect. Information for healthcare professionals is not required for homeopathic and anthroposophic medicinal products according to Art. 24, Art. 25 para. 2 KPTPO, medicinal products for gemmotherapy according to Art. 35 para. 2 KPTPO and Asian medicinal products without an indication according to Art. 30 et seq. KPTPO. Medicinal product information is not required for homeopathic and anthroposophic medicinal products without an indication according to Art. 25 para. 1 KPTPO, homeopathic and anthroposophic medicines without an indication and medicinal products for gemmotherapy without an indication according to Art. 27 KPTPO and Schüssler salts without an indication according to Art. 28 KPTPO.

The requirement to provide information for healthcare professionals is waived for the

No. Subject Requirement C/O Exceptions following categories of medicinal products, provided that appropriate reasons are given: Baby foods, bath additives and compresses (healing clay, poultices), disinfectants, dietary supplements, intimate hygiene products, products for sensitive skin, Tear substitutes, nasal products (with secretolytic and moistening effect), laxatives (only bulking and filling agents), vitamin products (only those with water-soluble vitamins), dental products (products for the gingiva and the other oral mucosa, products with fluoride, products to prevent tooth decay, tooth surface and to desensitise the dentine).

2.5.3.1.3 Submission is Information for C

mandatory for healthcare human medicinal professionals or products in patients is not dispensing required categoryE

2.5.3.1.4 Submission is Information for C Information for healthcare professionals does not

mandatory for healthcare have to be prepared for veterinary medicinal veterinary product professionals and products in dispensing category E, veterinary information package leaflet are medicinal products that can be dispensed in pet and compulsory. bee-keeping shops, or homeopathic preparations without an indication. Product information is not required (Art. 14, paras. 1 and 3, TPLRO) if Swissmedic has given its consent and if all the required information is placed on the container used for dispensing. The requirements for the information and texts on containers and packaging material must comply with Art. 13 and 14, in conjunction with Annex 6, TPLRO)

2.5.3.2 Requirements

No. Subject Requirement C/O Exceptions

2.5.3.2.1 Cover letter(in State version on which the text submitted is based

addition to the (i.e. the latest version approved by Swissmedic) requirements in section 2.5.1 “Cover letter”) For safety-relevant changes:

• In the subject line: "Safety-relevant change to the product information"

• Discussion regarding enhanced measures (e.g. HPC)

• State reasons for the safety relevance in the text

• If the safety-relevant changes are in connection with a national or international safety signal, mention this in the cover letter

2.5.3.2.2 Templates for The templates for information for healthcare C

medicinal product professionals and patient information available on information the Swissmedic website must be used to submit manuscripts of medicinal product information for human medicinal products.

2.5.3.2.3 Templates for Applicants should use the templates for information O

veterinary for healthcare professionals for VMP and medicinal product immunological VMP and the template for a package information leaflet for VMP, all available on the Swissmedic website, to submit manuscripts of veterinary medicinal product information.

2.5.3.2.4 References in the Statements made in the medicinal product C Veterinary

medicinal product information must be scientifically justified and medicinal products: information proved. Suitable references are study reports, Reference to EUpublications, or other scientific documentation. SmPC is possible in exceptional cases

No. Subject Requirement C/O Exceptions References to study reports, publications, other scientific documentation, a summary or an overview must always cite the corresponding page number. Example: Study xyz, binder 3, page 736. Or Binder 2, Reference 38: Müller et al, title etc., page 13 A simple reference to the firm's internal Core Data Sheet (CDS) or the Company CDS (CCDS) or the Summary of Product Characteristics (SmPC) is not permitted, since this is not a scientific reference. References must not be removed while the application is in progress.

2.5.3.2.5 Marking of All changes compared to the last approved version C Veterinary

changes must be clearly marked as such. medicinal products: The marking must be shown in the manuscripts As of the answer to throughout the entire application process. the preliminary Changes must be marked/highlighted using Word’s decision, only those “Track Changes” function. No other forms of changes that do not marking/highlighting will be accepted. correspond to the proposed If a manuscript contains changes affecting several corrections by pending applications, it must be apparent which Swissmedic must changes were requested with which application, be marked. e.g.by using different editor IDs. If an application for a variation contains changes to texts inserted during several rounds of text corrections, and if the text has not yet been approved, confirmation must be given that the corrections suggested by Swissmedic in the previous version have been made. Corrections by Swissmedic that have not yet been agreed upon must be clearly marked as corrections made to the text by Swissmedic, e.g. by inserting a comment.

2.5.3.2.6 Safety-relevant The application requires either a Direct Healthcare C Veterinary

changes to the Professional Communication (DHPC) or a medicinal medicinal product justification for not submitting a DHPC. products:Only information Within the framework of an application concerning changes concerning safety-relevant changes, no further changes to the serious and lifelast approved text may be made in addition to the threatening justified, safety-related changes. Other changes reactions or must be applied for separately. irreversible damage The content of safety-relevant changes concerns are considered to new, more restrictive statements in the sections be safety-relevant "Dosage / use", "Contraindications", "Warnings and precautionary measures", “Interactions”, "Pregnancy / breast feeding" and "adverse reactions". If the patient information is also concerned, the corresponding changes must be submitted at the same time as those concerning the information for healthcare professionals.

2.5.3.2.7 Information for For EU-SmPCs: the last version approved in the O

healthcare EU, stating the date on which the approval was professionals from granted, should be submitted. other countries, For medicinal products or changes that have not EU-SmPCs yet been approved: the applicant's proposal for the EU-SmPC must be clearly marked as the applicant's draft. For Access Worksharing applications, the Information for healthcare professionals should additionally be submitted in English.

2.5.3.2.8 Resubmission: of Changes to the text that were rejected by C

rejected changes Swissmedic for a first authorisation or earlier

No. Subject Requirement C/O Exceptions applications can be requested again only if they are documented by new data.

For human medicinal products that are authorised exclusively for export, a manuscript for the basic information is checked and approved. Depending on the requirements (according to dispensing category), this basic information can be for healthcare professionals or patients, or can be information on the outer packaging. For veterinary medicinal products that are authorised exclusively for export, a manuscript of the medicinal product information (information for healthcare professionals and/or package leaflet) is checked and approved. For requirements relating to the information elements to be produced (information for healthcare professionals and/or package leaflet), please refer to the guidance document Product information for veterinary medicinal products. The information for healthcare professionals and patients for human medicinal products and the information for healthcare professionals and package leaflet for veterinary medicinal products must be submitted in an official Swiss language for approval.

2.5.4 Packaging

No. Subject Requirement C/O Exceptions

2.5.4.1 Submission The format and number of C Paper copies are not required when

methods for copies to be submitted are making a submission in eCTD format. packaging (folding as specified in the cartons, labels, "Submission formats" table Users of the Swissmedic eGov portal do sachets, etc.) in section 2.1. not need to submit an additional electronic data carrier for the packaging. Colour laser print-outs in original format (‘mock-ups’) Packaging does not have to be submitted can be submitted instead of for homeopathic and anthroposophic original prints of packaging medicinal products without an indication (folding cartons, labels, according to Art. 25 para. 1 KPTPO, sachets, etc.) homeopathic and anthroposophic medicines without an indication and In addition, packaging medicinal products for gemmotherapy should be submitted on a without an indication according to Art. 27 data carrier as a single file KPTPO, Schüssler salts without an with searchable text (OCR). indication according to Art. 28 KPTPO and Asian medicinal products without an indication according to Art. 30 et seq. KPTPO.

2.5.5 Curriculum vitae of the experts

No. Subject Requirement C/O Exceptions

2.5.5.1 Dated and signed Required for: C

curriculum vitae of ▪ The overview (CTD: Module 2.3, 2.4, 2.5) the experts ▪ Statement by an expert The original of the document is not required

2.5.6 Documentation of Environmental Risk Assessment

No. Subject Requirement C/O Exceptions

2.5.6.1 Environmental risk Human medicinal products C

assessment (incl. ▪ Applications for new active substances the related reports)

• Biosimilar applications

• KAS and extensions only if an elevated environmental impact is anticipated.

• Applications for additional indications (type II variations) that are likely to have a substantial environmental impact.

• For Art. 13 TPA applications, an ERA is only required if the authorisation was granted in a non-EU country.

No. Subject Requirement C/O Exceptions

• Non-submissions must be substantiated. Veterinary medicinal products

• An ERA (at least a Phase I assessment) is part of every new authorisation.

• Non-submissions must be substantiated.

2.5.7 Decisions by foreign authorities

No. Subject Requirement C/O Exceptions

2.5.7.1 Cover letter(in If final Assessment Reports by foreign authorities C

addition to the with comparable medicinal product control systems requirements in section 2.5.1 “Cover letter”) exist (in accordance with the list published on the Swissmedic website), but are not enclosed with the application, the reasons for omitting them must be stated in the cover letter.

2.5.7.2 Final Assessment Final Assessment Reports by foreign authorities O

Reports by foreign with comparable medicinal product control systems authorities exist (in accordance with the list published on the Swissmedic website).

2.5.8 PVP / RMP / Pharmacovigilance planning documents (human medicinal products

only)

No. Subject Requirement C/O Exceptions

2.5.8.1 General Documentation on pharmacovigilance planning C

should be submitted in accordance with Annex 3 TPO (ICH Guideline E2E and EU Guideline on good pharmacovigilance practices (GVP) – Modules V.A and V.B). Swissmedic prefers that if an EU RMP is available, it should be submitted. To be submitted:

• for all new authorisation applications for medicinal products with at least one new active substance (incl. orphan drugs) and their indication extensions

• for applications for the authorisation of medicinal products that are not eligible for a simplified authorisation procedure (Art. 12, para. 5 let a-e TPLO), namely vaccines, sera and toxins, blood products, biotechnological medicinal products and advanced therapy medicinal products (ATMP)

The US REMS format (Risk Evaluation and Mitigation Strategy) is not accepted as implementation of the ICH Guideline.

• The following do not require an RMP:

• Applications for authorisation of a biosimilar.

• Applications for authorisation of a KAS.

• Applications for authorisation of medicinal products under Art. 14 para. 1 let. a bis-quarter TPA. If an RMP is submitted for an application that does not require one, this will usually not be assessed or approved by Swissmedic.

2.5.9 Paediatric Investigation Plan

No. Subject Requirement C/O Exceptions

2.5.9.1 PIP The requirements are based on the guidance C

document Paediatric Investigation Plan.

2.5.10 Information on the bioequivalence trial / reference product

No. Subject Requirement C/O Exceptions

2.5.10.1 Information on the If the proof of the transferability of the test results C

bioequivalence for the reference product is based on trial pharmacokinetic bioequivalence trials, information (human medicinal according to EMA/CHMP/600958/2010/Corr* products only) "Appendix IV of the Guideline on the Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1)" should be submitted. Information on Criteria for proving the comparability of a foreign C pharmaceutical comparator medicinal product with the Swiss bridging reference product should be submitted in accordance with the guidance document Authorisation of human medicinal product with known active substance, section 6.3.6

2.5.10.2 Veterinary If the proof of the transferability of the test results C

medicinal for the reference medicinal product is based on products: pharmacokinetic bioequivalence trials, confirmation Information on the must be provided that the test medicinal product bioequivalence used in the bioavailability trial is identical to the trial and reference product submitted to Swissmedic for authorisation. product

2.5.11 Information on GCP inspections

No. Subject Requirement C/O Exceptions

2.5.11.1 Information on A completed EMA GCP inspections template must C

GCP inspections be submitted for all application types whose documentation includes clinical trials (including bioequivalence trials).

2.5.12 GMP/Certificates/Establishment licences

No. Subject Requirement C/O Exceptions

2.5.12.1 Proof of GMP For foreign manufacturers, to be submitted in C

compliance, accordance with: Guidance document GMP certificates and compliance by foreign manufacturers establishment licences

For veterinary medicinal products: The documents cited must be submitted under Part 1a6 manuf.

2.5.13 Manufacturing information: flow chart for vaccines and blood products

No. Subject Requirement C/O Exceptions

2.5.13.1 Presentation of the Clear, summarised presentation of the C

manufacturing manufacturing steps and sites as a flow chart steps for vaccines and blood products

Für For TAM: VMP: Flowcharts Applicants zur Herstellung should submit flowcharts onder sind von Gesuchstellerin manufacturing under partPart unter docdoc 1a41a4 prodprod quality quality. einzureichen.

2.5.14 Evidence that the obligation to notify pursuant to the Nagoya Ordinance is satisfied

No. Subject Requirement C/O Exceptions

2.5.14.1 Evidence that the According to Art. 3 para. 2 TPO, a new application C Access to the

obligation to notify for authorisation of a medicinal product whose genetic resource or pursuant to the development is based on the utilisation of genetic related traditional Nagoya Ordinance resources or related traditional knowledge must knowledge took is satisfied include the registration number pursuant to Art. 4 place prior to 12 para. 3 or Art. 8 para. 5 NagO. The registration October 2014. number is issued by the Federal Office for the Environment (FOEN) and provides the applicant with proof of compliance with the obligation to notify according to Articles 4, 5 or 8 NagO, and is a prerequisite for authorisation under Art. 9 paragraph 2 TPO. The requirements of NagO as well as Arts. 2 and 9 TPO must be satisfied for all new authorisation applications that involve substances (active substances or excipients) whose development is based on a genetic resource, if access to the genetic resource was gained after 12 October 2014 (see Art. 25d NCHA). If the utilisation of traditional knowledge relating to genetic resources pursuant to

Article 23p NCHA is involved, the obligation to

notify according to Article 4 is similarly applicable. If the use of a genetic resource from Switzerland pursuant to Art. 8 NagO is involved, evidence that the obligation to notify has been met is to be provided once Art. 8 NagO has taken effect from 1 January 2017. Further information on the Nagoya Protocol and its implementation in Switzerland can be found on the website of the responsible authority and the National Focal Point for the Nagoya protocol at the FOEN.

2.5.15 Information on combination products (medicinal products with a medical device

component)

No. Subject Requirement C/O Exceptions

2.5.15.1 Requirements In general, a distinction is made between C Does not apply to

pertaining to the combination products with non-separable MedD veterinary medicinal documentation on components according to Art. 2 para. 1 let. f MedDo products the medical device (SR 812.213) and those with a separate MedD (MedD) component. component of a Here the non-separable combination is understood combination to be a physically inseparable unit (described in the product EMA Guideline Quality documentation for medicinal products when used with a medical device, EMA/CHMP/QWP/BWP/259165/2019 as integral) or as having use-specific non-separability (described in the EMA Guideline as co-packaged). In the case of separable combinations (described in the EMA Guideline as referenced), the MedD component is not co-packaged with the human medicinal product. However, the medicinal product refers to a specific MedD for combined use. It must be indicated using check boxes in section 6.7 of the form New authorisation of human medicinal products and section 5.6 of the form Variations and Extensions HMP whether the product is a combination product, and if so, what type of combination it is. Depending on the type of combination, the following requirements apply:

No. Subject Requirement C/O Exceptions a) Non-separable, physical unit, integral:MedD with CE marking:If the MedD component has a CE mark showing it meets the conformity requirements, the corresponding declaration of conformity from the medical device manufacturer must be provided in module 3.2.R.For MedD components with a CE mark in the higher risk classes Im, Is, Irsi, IIa, IIb and III, a certification from one of the designated conformity assessment bodies (EC certificate, CE mark with 4-digit identification number from the conformity assessment body) must also be provided in module 3.2.R.MedD without CE marking:If the MedD component does not have a CE mark, it must be demonstrated in module 3.2.R that it satisfies the applicable basic safety and performance requirements in Annex I of the new MDR. For MedD components without a CE mark in the higher risk classes Im, Is, IIa, IIb and III, in keeping with Art. 117 MDR a Notified Body Opinion must also be provided in module 3.2.R. b) Non-separable combination, use-specific non-separability, co-packagedIn line with the EMA requirements, additional proof of meeting the MedD requirements, its proposed purpose, use and the associated risks are required to assess combinations with use-specific nonseparability (co-packaged). Combinations with use-specific non-separability (co-packaged) must therefore be CE marked. However, the details of the manufacturer, authorised representative and importer of the MedD do not need to be included on the labelling as the authorisation holder bears full responsibility for the combination product approved under medicinal product legislation. The suitability of the MedD components with the specific human medicinal product must also subsequently be demonstrated for both types of non-separable combination (integral and copackaged). The requirements in this regard (data and dossier file storage) can be found in the EMA guideline on combination products (Quality documentation for medicinal products when use with a medical device, EMA/CHMP/QWP/BWP/259165/2019). c) Separable combination, referenced:MedD components of separable combinations must meet the conformity requirements according to Art. 1 para. 3 let. b MedDO (“CE labelling”). In addition, the corresponding declaration of conformity from the medical device manufacturer must be provided in module

3.2.R.For medical device components in the higher risk classes Im, Is, Irsi, IIa, IIb and III, a certification from one of the designated conformity assessment bodies (EC certificate, CE mark with 4-digit identification number from the conformity assessment body) must also be provided in module 3.2.R. The suitability of the medical device component in this combination with the specific medicinal product must also be demonstrated. The requirements in this regard (data and dossier file storage) can be found in the EMA guideline on combination products (Quality documentation for medicinal

No. Subject Requirement C/O Exceptions products when used with a medical device, EMA/CHMP/QWP/BWP/259165/2019).

Please note: All documents required for the MedD components of a non-separable combination product (with a MedD component Im, Is, Ir; IIa, IIb or III; NBOp or certificate of conformity to be issued by the notified body) should always be present when submitting the application. Due to expected bottlenecks at the certification bodies, the applicant can agree a later submission date with Swissmedic, but this should not delay the approval process for a new authorisation or variation (with the exception of type IB or type IA/IAIN variation applications to be approved in advance or after the fact). This later submission date must be set out in the cover letter, stating the binding timescale, and substantiated with corresponding documentation from the certification body. Since products submitted to Swissmedic for approval that have received the official decision which concludes the approval process are directly marketable, all documents relevant to the approval must be present and can be checked before this official decision is issued.

2.5.16 Risk assessment for nitrosamines in active substance and/or finished medicinal

products

No. Subject Requirement C/O Exceptions

2.5.16.1 Risk assessment • For all new authorisations with C Does not apply to

for nitrosamines in chemical/synthetic active ▪ Veterinary medicinal products active substance substances or active

• Co-marketing MP substances with synthetic components ▪ MP for parallel import

• Non-submissions must be ▪ Radiopharmaceuticals substantiated.

2.5.16.2 Risk assessment • For all new authorisations C Does not apply to

for nitrosamines in • Non-submissions must be ▪ Veterinary medicinal products finished medicinal substantiated. ▪ Co-marketing MP products

• MP for parallel import

• Radiopharmaceuticals

• Complementary medicinal products with no indication (notification procedure)

• Teas and lozenges under the notification procedure

2.6 Modules 2-5

2.6.1 List of contents and labelling of binders for paper submissions

No. Subject Requirement C/O Exceptions

2.6.1.1 Contents To be submitted for all paper submissions, for the C

documentation supplied (Modules 2-5) The Overall CTD Table of Contents (Section 2.1) is the table of contents for the entire CTD (Modules 2–5) Each module has its own list of contents The level of detail of the list of contents is defined in the Granularity Document (Annex to the ICH document Organisation of The Common Technical Document for the Registration of Pharmaceuticals for Human Use M4)

2.6.1.2 Labelling of the Labelling on the binder spines: C

binders ▪ Name of the medicinal product

• If available: Authorisation no.

• Module concerned by the documentation

• Separate numbering of all volumes per module or for all volumes within the entire documentation (always stating the total number of binders)

No. Subject Requirement C/O Exceptions

• If appropriate, reference numbers and / or page numbers

• Applicant

2.6.1.3 List of contents of The individual studies must be separated using the C

the binders cover sheets provided by Swissmedic. If there are several binders for a single study, the cover sheet for the first binder must be placed at the top of every subsequent binder. Every binder must contain a list of contents. An overall list of contents of the studies must be submitted. It must show exactly which pages are contained in each binder, e.g. Study xyz, binder 3, pages 632 to 895. Voluminous annexes should be given their own list of contents. Cover sheets must be included in every binder, as described above.

Documentation sent to Swissmedic spontaneously that does not fall within the framework of an application will be returned to the authorisation holder, at the expense of the latter (e.g. update to Module 3).

2.6.2 References

No. Subject Requirement C/O Exceptions

2.6.2.1 Extent of cross- A fundamental concept regarding the CTD is to C

referencing avoid repeating information that is presented in Modules 3, 4 and 5 in the summaries and overviews of Module 2. For that reason, comprehensive cross-referencing of the documents in Module 2 to the other parts of the CTD, in accordance with the ICH guidelines, is mandatory

2.6.2.2 Type of cross- The use of the CTD/NTA chapter numbers ("cross O

referencing strings" according to the ICH) serves as the basis for the cross referencing Chapter numbers should be expanded in line with the ICH guidelines by the insertion of a short additional text, e.g. stating the volume, the page numbers or "see study xyz"

2.6.2.3 Referencing in ▪ The references must be numbered consecutively

Modules 3.3; 4.3; ▪ A list of contents must be submitted, and must 5.4 (references to state the exact binder for each reference and its literature) number, e.g. Binder 2, references 38 to 89 Reference 38: Müller et al, title, etc. (pages within this reference 1 to 13) reference 39: Wang et al, title, etc. (pages within this reference 1 to 45).

• If several binders are used for the references, the cover sheet for the first binder must also be inserted at the top of each binder.

• Every binder must also contain a list of contents for the references that are contained in it.

• In the information for healthcare professionals / patients, reference must be made to the corresponding module, the reference number, the 5.4, reference 22, page 5, binder 2)

2.6.2.4 References to The references contained in the overviews

literature in the (Modules 2.3–2.5) constitute an integral part of the overviews for submission and must be submitted in the Module 2 corresponding modules. For eCTD applications, the

No. Subject Requirement C/O Exceptions references must be linked either from the body text or from the list of references in the overviews.

A formal objection will be issued for referencing that cannot be found, that is incorrect or that is not sufficiently comprehensive. Furthermore, referencing must not be based on a complex cascade structure with various lists of contents (more than two intermediate steps).

2.7 Answers to communications from Swissmedic during the ongoing application

process

No. Subject Requirement C/O Exceptions

2.7.1 Cover letter Must always be included. C

2.7.2 Complete Missing documents will be requested by C

submission Swissmedic. The processing of the application will only continue once Swissmedic has received all the documents it has requested, plus any test samples it may have requested. Replies to the List of Questions: If no complete answer or no justified written application for the time limit to be extended is received by the date stated in the List of Questions, the corresponding questions are considered to be unanswered. Under certain circumstances, this may lead to a negative preliminary decision or a negative official decision, and costs will be applied.

2.7.3 Statement / The conditions imposed in the preliminary decision C

Answer to the must be fulfilled within the time limit specified and preliminary submitted collectively. decision

3 Special requirements

3.1 Company meetings

The requirements set out in the form Company meetings and the guidance document Meetings for applicants held with the Authorisation sector must be observed.

3.2 Recognition of important medicinal product status

3.2.1 Recognition of orphan drug status (ODS) for human medicinal products

No. Subject Requirement C/O Exceptions

3.2.1.1 General The applicant must at least have a delivery and an C

invoice address in Switzerland. A separate application for ODS recognition must be submitted for each individual orphan indication.

3.2.2 Recognition of MUMS status for veterinary medicines

No. Subject Requirement C/O Exceptions

3.2.2.1 General The applicant must at least have a delivery and an C

invoice address in Switzerland. Minor use: a separate application for recognition must be submitted for each individual indication.

No. Subject Requirement C/O Exceptions Minor species: for the treatment of animal species or categories other than cattle, pigs, horses, dogs, cats, sheep (not including milk ewes) and poultry (not including laying hens)

3.3 Application for temporary authorisation (tempA/tempAI HAM)

No. Subject Requirement C/O Exceptions

3.3.1 Cover letter(in Mandatory as of 1 Apr. 2021: “Application for an C

addition to the AAA for an authorisation procedure in connection requirements in section 2.5.1 “Cover letter”) with a temporary authorisation (tempA/tempAI)”.Mention authorisation applications or any questions or decisions on the part of other authorities, if applicable. see also:VZ Overview of documents to be submitted and guidance document Temporary authorisation of human medicinal products. The decision minutes on the AAA should be submitted as a Word file.

3.4 Request for fast-track procedure for human medicinal products

No. Subject Requirement C/O Exceptions

3.4.1 Cover letter(in “Application for an AAA for a fast-track procedure C

addition to the (FTP)” requirements in section 2.5.1 “Cover letter”) Mention authorisation applications or any questions or decisions on the part of other authorities, if applicable see also:VZ Overview of documents to be submitted and guidance document Fast-track authorisation procedure. The decision minutes on the AAA should be submitted as a Word file.

3.5 Request for procedure with prior notification for human medicinal products

No. Subject Requirement C/O Exceptions

3.5.1 Cover letter(in Possible date for the Meeting before application C

addition to the submission or reason why this is not considered requirements in section 2.5.1 “Cover letter”) necessary. Planned submission date for the test eCTD sequence (if applicable) Planned date of the actual submission of the application (state within a time frame of +/- 2 calendar weeks)

3.5.2 Timing of request To be submitted in writing, at the earliest 6 months C

and at the latest 3 months prior to the planned submission of the application.

A procedure with prior notification can only be carried out if the authorisation application is subsequently submitted in the CTD format, via Portal, as an eCTD application or as a paper version with an eDok copy.

If a submission in eCTD format is planned, it is strongly recommended that applicants with no or limited experience of eCTD submit a test sequence at least 3 weeks prior to submitting their application. In that way, it is possible to avoid the risk of exceeding time limits as a result of technical shortcomings.

3.6 Authorisation of new active substances

No. Subject Requirement C/O Exceptions

3.6.1 Cover letter(in Short presentation of the clinical trials conducted

addition to the and, if applicable, of the pharmaceutical requirements in section 2.5.1 “Cover letter”) characteristics and the manufacturing processes.

3.6.2 Modules 2-5/ See the Guidance document Authorisation of C

Parts Ic to IV human medicinal product with new active substance and Guidance document Authorisation of veterinary medicinal products If an application for submission to the US FDA is also planned or the submission has already been made, the relevant SEND datasets must be provided in accordance with the current requirements in the FDA Data Standards Catalog.

3.7 New authorisation KAS

No. Subject Requirement C/O Exceptions

3.7.1 Cover letter(in Short presentation of the clinical trials conducted C

addition to the and, if applicable, of the pharmaceutical requirements in section 2.5.1 “Cover letter”) characteristics and the manufacturing processes.

3.7.2 Timing of The application may not be submitted more than C

submission two years before document protection expires.

3.7.3 Modules 2-5/ See the Guidance document Authorisation of C

Parts Ic-IV human medicinal product with known active pharmaceutical substance and Guidance document Authorisation of veterinary medicinal product with known API

3.8 Similar biological medicinal products (biosimilars) – human medicinal

products only

No. Subject Requirement C/O Exceptions

3.8.1 Cover letter(in ▪ Justification for requesting an authorisation C

addition to the process in accordance with Guidance document requirements in section 2.5.1 “Cover letter”) Authorisation biosimilar.

• Short presentation of the clinical trials conducted and, if applicable, of the pharmaceutical characteristics and the manufacturing processes.

• State where the comparability studies between the biosimilar and the comparator product can be found in the documentation

• Justification of the divergence if the dosage form, dosage strength and / or the excipients of the biosimilar are different from those for the reference product

• Demonstrate the suitability of foreign comparator products according to section 5.4 of the Guidance document Authorisation Biosimilar.

3.8.2 Modules 2-5 ▪ See the Guidance document Authorisation C

Biosimilar

3.9 Applications under Article 13 TPA

No. Subject Requirement C/O Exceptions

3.9.1 Cover letter(in Note if specific requirements are foreseen for C

addition to the implementing the spontaneous recording of requirements in section 2.5.1 “Cover letter”) suspected adverse drug reactions in Switzerland (e.g. special questionnaires within the framework of enhanced pharmacovigilance)

No. Subject Requirement C/O Exceptions

3.9.2 Documentation to The complete documentation in CTD format C

be submitted for (Modules 2-5 plus the country-specific Module 1) or human medicinal NTA format (Parts I-IV), as it was submitted to the products reference authority. Results of the assessment by the reference authority, including additional documentation (final assessment report and additional test results). RMP: In the Switzerland-specific module 1.8.2, the current RMP must be submitted for first applications for authorisation of medicinal products with at least one new active substance (NAS) and applications for authorisation of a new indication for such medicinal products. This also applies to medicinal products that cannot be authorised under the simplified procedure according to Art. 12 para. 5 let. a-e TPLO. Biosimilars are not required to include an RMP.

3.9.3 Documentation to The complete documentation (Parts I-IV), as it was C

be submitted for submitted to the reference authority. veterinary All documents and assessment results issued while medicinal products the procedure abroad was in progress (List of Questions plus responses, assessment reports, decisions etc.) must be submitted under Part 1a3. Documents relating to post-approval variations (if any) should also be submitted under Part 1a3.

3.10 Submissions according to Art. 14 para. 1 let. abis-quater TPA

No. Subject Requirement C/O Exceptions

3.10.1 Documents to be ▪ See guidance document Authorisation in C

submitted accordance with Art. 14 para. 1 let. abis-quater TPA and the Overview of documents to be submitted

3.11 Co-marketing medicinal products

No. Subject Requirement C/O Exceptions

3.11.1 Cover letter(in Name and authorisation of the basic preparation C

addition to the and any admissible differences compared to the requirements in section 2.5.1 “Cover letter”) basic preparation

3.11.2 Conversion of a ▪ Submission of a complete and identical set of C

co-marketing documentation, i.e. the entire life cycle of the authorisation into basic product must be submitted in chronological a stand-alone order including labelling/designation of the authorisation – previous submission date and module. Variation E.106 Alternatively, if there is a relevant declaration of (HMP) or E.103 consent from the authorisation holder of the basic (VMP) product, only the actually approved documentation (Module 2-5) and any forms to be amended from Module 1 can be submitted. Confirmation from the authorisation holder for the co-marketing medicinal product that no changes have been made to the previous version – except the forms to be updated – should then also be submitted for Module 1. If the authorisation holder for the existing basic medicinal product dispenses with authorisation, its documentation can also be transferred to the existing co-marketing medicinal product.

• If the authorisation documentation exists in eCTD format, the affected modules must always be submitted as a new eCTD sequence.

• Confirmation that the documentation submitted is identical to that for the basic product (including

No. Subject Requirement C/O Exceptions any additional material that was approved in the meantime). Alternatively: Submission of a declaration of consent from the authorisation holder of the basic product to Swissmedic, stating that the latter will include the scientific documentation for the files in the procedure concerning conversion of the co-marketing medicinal product to a separate authorisation. ▪ Confirmation that the authorisation holder has at its disposal all the documents it requires to fulfil its healthcare-related responsibilities, and accepts all the obligations associated with the authorisation of a stand-alone medicinal product.

3.11.3 Conversion of a Declaration of consent to the status change from

stand-alone both the holder of authorisation for the co-marketing authorisation into medicinal product and the holder of authorisation a co-marketing for the basic product (see form Authorisation for coauthorisation and marketing of medicinal product). vice versa Concerning the new basic product: (status change) – ▪ The holder of authorisation for the current basic Variation E.107 product can give its written consent to the (HMP) or E.104 documentation in Swissmedic’s possession (VMP) being formally transferred to the current comarketing medicinal product.

• If the authorisation documentation exists in eCTD format, the affected modules must always be submitted as a new eCTD sequence. Concerning the new co-marketing medicinal product:

• Module 1, as for new submission for a comarketing medicinal product. An application for the conversion of a stand-alone authorisation into a co-marketing authorisation (E.107 or E.104) may only be submitted if a simultaneous application for the conversion of the existing comarketing MP into a stand-alone authorisation is also submitted (E.106 or E.103). The basic medicinal product thus switches its status with that of the co-marketing MP ("role reversal"). Concerns section 3.11.2 where a complete and identical document set is submitted as an eDOK. All the documentation should be submitted in a single eDOK. The marketing authorisation holder should create the folders for the “historic” documents at the lowest level of the eDOK structure..The folder names should include the year, month and type of submission as follows::

• Definition of date format: YYYY_MM_DD

• Definition of type of submission: Free text, the marketing authorisation holder decides how the variation is described

• Example: 2021_03_01_var-type1b The documents can then be filed in this folder.

• Note: Paths should not be too long (maximum 180 characters)

Concerns section 3.11.2 where an identical document set is submitted as an eCTD. The current eCTD of the basic medicinal product should be submitted as a separate eCTD to act as a “reference dossier”. Please also see the relevant information sheets. - When submitting via the Portal, option “Art. 13” is selected. A “reference dossier” can then be submitted in accordance with the requirements for Portal use. Please also see the relevant information sheets.

3.12 Variations and extensions

No. Subject Requirement C/O Exceptions

3.12.1 Submission of Submission of a variation application: C If type IA/IAIN

the form A form consisting of the administrative part (sections 1-7) variations (HMP) Variations and plus the corresponding variation template. e.g. HMP: are part of a extensions Q.II.b.1 with the requested variation (Q.II.b.1.a "Secondary multiple application HMP / packaging site"). e.g. VMP: B.21 (Variation of secondary that includes type IB

No. Subject Requirement C/O Exceptions Submission of packaging site without assessment) or F.II.b.1 a-z or II variations the form (Variation of manufacturing site with assessment). and/or authorisation Variations extensions (HMP), VMP Submission of a multiple application: there is no need to provide an A form consisting of the administrative part (sections 1-7) implementation date plus the corresponding variation templates. e.g. HMP:. and the variations twice Q.II.b.1 with the requested variations (Q.II.b.1.a do not have to be "Secondary packaging site" and Q.II.b.1.b "Primary already packaging site"). VMP: as for HMP. implemented.

Submission of a collective application: A form consisting of the administrative part (sections 1-7) plus the corresponding variation template. e.g. HMP: Q.II.b.1 with the requested variation (e.g. Q.II.b.1.a "Secondary packaging site"). In the administrative part, the table under section 1 (Basic information) must be reproduced and completed according to the number of authorisation numbers/medicinal products concerned. If additional forms have to be submitted (e.g. form Manufacturer information), the forms listed in section 4 (Additional forms to be submitted) should be submitted for each medicinal product concerned. Extensions cannot be submitted as a collective application. VMP: as for HMP.

Submission of a collective-multiple application: A form consisting of the administrative part (sections 1-7), where the table under section 1 (Basic information) was reproduced and completed according to the number of authorisation numbers/medicinal products concerned, plus the corresponding variation templates. (e.g. HMP: Q.I.b.1 and Q.I.b.2 with the requested variations (e.g. Q.I.b.1.b "Change within the specification acceptance criteria" and Q.I.b.2.a "Minor change to an analytical procedure for the active substance").). If additional forms have to be submitted, the forms listed in section 4 (Additional forms to be submitted) should be submitted for each medicinal product concerned. VMP: as for HMP

3.12.2 Completion of The conditions to be fulfilled and documentation to be C If variations without

the form submitted for the requested variation must be confirmed by assessment (VMP) Variations and ticking the checkbox. are part of a extensions / An implementation date must always be given for type IA multiple application Submission of and IAIN variations (HMP) and variations without that includes the form assessment (VMP). This date must be in the past and must variations with Variations be provided in the format “DD.MM.YYYY”. assessment (VMP), VMP there is no need to provide an The text fields "Scope / justification for the change" and implementation date "Present / Proposed" must be completed. It is not sufficient and the variations simply to refer to the documentation or the company's do not have to be internal codes. If needed, a table can also be copied into already the text fields. implemented.

Variation templates that are not required should be omitted.

Further information can be found in the guidance document Variations and extensions HMP or guidance document Variations VMP 3.12.3 "Other The templates for "Other variation" can be found in the C variation" Variations and extensions HMP form under the individual variations (e.g. Q.I.a.1.z) and at the end of section E Regulatory changes (E.z Other regulatory change), at the end of section Q. Quality changes (Q.z. Other quality change) or at the end of section C. Safety, efficacy and pharmacovigilance changes (C.z Other change relating to

No. Subject Requirement C/O Exceptions safety, efficacy and pharmacovigilance). The form Variations VMP includes, where relevant, the template “Other variation time limit’ “Reduced” in the individual variation templates and at the end of the individual sections E, F and G. Templates with time limit “Standard” are also included at the end of each section. The templates for "Other variation" may be used only if the requested variation is not included in the list of variations.

3.12.4 Updating the Updates to the documentation (e.g. Module 3/Part II) may C

documentation be submitted only in connection with one or more variation applications. Every variation should be identified and submitted as a type IA/IAIN, type IB and/or type II variation (HMP) or as a variation with or without assessment (VMP). Documents submitted spontaneously or updates without an application for a variation will be returned to the applicant at the latter's expense.

3.12.5 Editorial Editorial changes to Module 3/Part II (incl. additions such C

changes as adding validation documents without changes to the test method, updated stability results or change to the shelf life or retest period) are not variations. Therefore, proceed as follows: If an updated Module 3/Part II comprises a type II (HMP) variation or a variation with assessment (VMP) and several independent editorial changes, for example, the variation must be submitted with the form Variations and extensions HMP or form Variations VMP, and the editorial changes must be indicated under "Present / Proposed".

If an updated Module 3/Part II consists purely of editorial changes, these changes can be submitted as “Other changes” Q.z, type IA (HMP) or variation without assessment (VMP).

3.12.6 Documentatio ▪ The documentation for collective applications in paper C

n for Collective format does not need to be submitted separately for each applications authorisation, but only once (1 original/1 copy). For collective applications in eCTD format, the documentation should be submitted individually for each medicinal product. ▪ Hybrid collective applications comprising both human and veterinary medicinal products are not admissible. If both human and veterinary medicinal products are affected, two separate (collective) applications must be submitted

3.12.7 Number of Attention must be paid to the precise wording (i.e. singular C

variations per or plural) of a variation in the forms Variations and variation no.: extensions HMP and Variation VMP. For example: the variation Q.I.b.2.a (Minor change to an analytical procedure for the active substance (for an HMP)) or B.12.a) (Minor change to an approved test procedure (for a VMP) applies to the variations to one test procedure only. If, for example, the test procedures for (1) identification using mass spectrometry, (2) impurities using HPLC and (3) bacterial endotoxins using the kinetic-turbidimetric method undergo minor changes, variation Q.I.b.2.a) (HMP) or V.12 a) (VMP) must be submitted three times.

3.12.8 Multiple Multiple variations relating to the same quality variation O Excepted from this

variations template may be submitted as a single type II variation rule is a change of relating to the (HMP: z – change in the respective variation template, active substance same quality VMP: z – change, time limit “Standard”). The precondition manufacturer variation is that all changed parameters be set out in detail in the (template Q.I.a.1). template “Present” / "Proposed” list. For VMP variations, the number (HMP: section of the variation template to which all variations relate Q; VMP: should also be listed under Description of/justification for section F, the variation. Quality changes Example HMP: Several specifications for the finished requiring product have to be changed (variation template Q.II.d.1): assessment)

No. Subject Requirement C/O Exceptions three changes within the specification acceptance criteria (3x type IA), an addition of a new specification attribute (1x type IA), and two changes outside the specification acceptance criteria (2x type II). In this case it is permissible to submit a single type II variation Q.II.d.1.z, though all changed parameters and specification limit values must be set out in detail in the “Present” / "Proposed” list. VMP: Submission as described for HMP, but under template “F.z Other quality variation”, with reference to the variation template (see above) to which the variations relate (e.g. “F.II.d.1 Variation of specification parameters and/or limits of the finished product”).

Pages with variation templates that are not the subject of the application must be deleted prior to submission to Swissmedic. If this is not done, Swissmedic will raise a formal objection to the application.

If several variations involving the same variation template are requested in a multiple application, the template should be reproduced by the applicant on the Variations and extensions form according to the number of variations. Example: a secondary packaging site (Q.II.b.1.a), a primary packaging site (Q.II.b.1.b), and a new manufacturing site (Q.II.b.1.e) are requested. A separate template Q.II.b.1 must be completed for each variation (3 copies of template Q.II.b.1). The form therefore includes the same variation template three times, with one of the requested variations checked on each separate template. The three variations may not be checked on a single template.

In the case of type IA variations, there must be a gap of no more than 12 months between the implementation date and date of notification to Swissmedic. In the case of type IAIN variations (HMP), there must be a gap of no more than one month, and in the case of variations without assessment (VMP), there must be a gap of no more than 60 calendar days between the implementation date and date of notification to Swissmedic.

3.13 Conditions imposed by Quality Assessment, Nonclinical Assessment and

Clinical Assessment

No. Subject Requirement C/O Exceptions

3.13.1 Cover letter Indication of which type of condition is required -

(condition imposed by Quality Assessment, Nonclinical Assessment or Clinical Assessment). Wording of the condition imposed by the official decision. ID of the application for which the condition was imposed.

The fulfilment of a condition imposed in respect of a collective application can be requested as a collective application.

The fulfilment of conditions should always be submitted separately and not together with other applications, e.g. variations in quality.

Swissmedic will assess whether conditions have been fulfilled in accordance with the decision letter separately and invoice them separately.

3.14 Renewal, non-renewal, no marketing and interruption to distribution

3.14.1 Renewal and non-renewal

No. Subject Requirement C/O Exceptions

3.14.1.1 Regular renewal In accordance with the regulatory time limit C Does not apply to

specified in Art. 12 para. 1 TPO, the application the renewal of a must be received by Swissmedic at the latest 6 temporary months before the authorisation expires. authorisation. Renewal applications submitted too late will not be admitted. Furthermore, the application must not be submitted sooner than one year before the authorisation expires.

3.14.1.2 Application for Submission of the administrative documents for C

renewed Module 1 in accordance with the Directory authorisation Overview Documents to be submitted with the confirmation that all the information is in line with that for the product concerned

If no application for renewal is submitted to Swissmedic before six months prior to the expiry of the authorisation, an official decision is issued to cancel the authorisation for the medicinal product once the current authorisation period expires. The deletion will be published automatically in the Swissmedic Journal. If the authorisation holder has missed the deadline for submitting the application for renewal, it may apply for renewed authorisation of the medicinal product provided the authorisation has not yet expired. The renewed authorisation will be published in the Swissmedic Journal the month after the authorisation decision has been issued, accompanied by the comment "Renewed authorisation following expiry of the authorisation". Even application for renewed authorisation will not always prevent an interruption in the marketable status of the medicinal product concerned. This will only be possible if Swissmedic has sufficient time to review the above-mentioned documents.

Renewals cannot be submitted as a collective application.

3.14.2 Discontinuation of authorised medicinal products

No. Subject Requirement C/O Exceptions

3.14.2.1 Discontinuation of If eCTD: new eCTD sequence C

medicinal product (notification)

3.14.2.2 Discontinuation of Only for medicinal products distributed in C

medicinal product with Switzerland, i.e. not possible for "export deferred withdrawal authorisations". (application) Maximum deferral period that can be applied for: 1 year (not beyond the expiry date of the authorisation certificate). If eCTD: new eCTD sequence

3.14.2.3 Cover letter for Justification for discontinuation with deferred C

discontinuation of withdrawal medicinal product with deferred withdrawal(in addition to the requirements in section 2.5.1 “Cover letter”)

In the case of collective medicinal product information texts, a type IB C.7.a) (HMP) minor variation requiring notification in advance or a variation without assessment B.3 v) (VMP) must be submitted for the medicinal product not concerned by the discontinuation at the same time.

3.14.3 Discontinuation of dosage strength number

No. Subject Requirement C/O Exceptions (None) - -

If the entire dosage strength number is being deleted as part of the discontinuation of the pack size, this is not a nAE IA discontinuation of pack size E.103 application type, but must be submitted as an AE IB deletion of dosage strength C.7 b) (HMP).

If the cover letter concerns the discontinuation of several dosage strength numbers at once, this must be considered as an application

3.14.4 Notification in accordance with Art. 11 TPO: No marketing / interruption to marketing

and Placing on the market / Renewed placing on the market

Subject Requirement C/O Exceptions (None)

3.15 Complementary medicinal products: Reduced dossiers

No. Subject Requirement C/O Exceptions

3.15.1 Renewal of the ▪ See the Guidance document Renewal and C

authorisation discontinuation of authorisation on change of status(main authorisation/export licence) ▪ Additional documents: Form Full declaration.

See the Guidance document Simplified information requirements on the Manufacturer Information form for the reduced dossier

See the Guidance document Authorisation of Homeopathics, anthroposophics and other complementary medicinal products

3.16 Complementary medicinal products: notification procedure HOMANT

No. Subject Requirement C/O Exceptions

3.16.1 Criteria for See the Guidance document Authorisation for C

application of the homeopathic and anthroposophic medicinal notification products and medicinal products for procedure gemmotherapy without indication in the notification procedure

3.16.2 Entering of data See the HOMANT user manual Offline C

and labelling the CD-ROM

3.16.3 Modification of See the Guidance document Variations and

basic company extensions and Guidance document Authorisation dossiers and for homeopathic and anthroposophic medicinal master dossiers products and medicinal products for gemmotherapy without indication in the notification procedure.

3.16.4 Extension and no ▪ See the Guidance document Renewal and C

extension discontinuation of authorisation on change of status (main authorisation/export licence)

• Applications must be submitted at the earliest 1 year and at the latest 6 months prior to the expiry of the authorisation

• Completed form Renewal of authorisation by notification procedure homeopathic and

No. Subject Requirement C/O Exceptions anthroposophic medicinal products incl. number of the products to be extended and the number of products to be discontinued. ▪ Additional documents: A copy of the official authorisation decision with a list of the authorised medicinal products (as an annex) must be submitted with each application. The applicant should delete from this list those medicinal products for which authorisation renewal is not required (discontinuation of the renewal). The deletions should additionally be highlighted using coloured markings to make them easier to find. All documents should be stamped by the marketing authorisation holder.

3.16.5 Discontinuation of ▪ See the Guidance document Renewal and C

medicinal product discontinuation of authorisation on change of (notification) status (main authorisation/export licence) ▪ Additional documents: A copy of the official authorisation decision with a list of the authorised medicinal products (as an annex) must be submitted with each application. The applicant should delete from this list those medicinal products for which authorisation renewal is not required (discontinuation of the renewal). The deletions should additionally be highlighted using coloured markings to make them easier to find. All documents should be stamped by the marketing authorisation holder.

3.16.6 Discontinuation of ▪ See the Guidance document Renewal and C

medicinal product discontinuation of authorisation on change of with deferred status (main authorisation/export licence) withdrawal ▪ Cover letter with justification (application) ▪ Additional documents: A copy of the official authorisation decision with a list of the authorised medicinal products (as an annex) must be submitted with each application. The applicant should delete from this list those medicinal products for which authorisation renewal is not required (discontinuation of the renewal). The deletions should additionally be highlighted using coloured markings to make them easier to find. All documents should be stamped by the marketing authorisation holder. ▪ Maximum deferral period that can be applied for: 1 year (not beyond the expiry date of the product). The delay must be the same for all medicinal products in the application.

Authorisation holders are responsible for submitting applications for renewal within the time limit. Swissmedic does not issue reminders.

Renewals cannot be submitted as a collective application.

If no application for renewal is submitted to Swissmedic before six months prior to the expiry of the authorisation, an official decision is issued to cancel the authorisation for the medicinal product once the current authorisation period expires. Deletion appears in the list “Homeopathic and anthroposophic medicinal products and medicinal products for gemmotherapy without an indication for which authorisation has been discontinued by the notification procedure in accordance with the KPTPO”. If the authorisation holder has missed the deadline for submitting the application for renewal, it may apply for renewed authorisation of the medicinal product provided the authorisation has not yet expired.

Once the official decision has been issued, the renewed authorisation is published in the list “Homeopathic and anthroposophic medicinal products and medicinal products for gemmotherapy without an indication authorised by the notification procedure in accordance with the KPTPO” . Even application for renewed authorisation will not always prevent an interruption in the marketable status of the medicinal product concerned. This will only be possible if Swissmedic has sufficient time to review the above-mentioned documents.

3.17 Complementary medicinal products: Asian medicinal products

No. Subject Requirement C/O Exceptions (None) - -

See the Guidance document Authorisation of Asian medicinal products

3.18 Authorisation of individual teas, cough and throat lozenges and pastilles in

dispensing category E by the notification procedure (human medicinal products only)

No. Subject Requirement C/O Exceptions

3.18.1 Cover letter for The shelf life must be stated in the cover letter as well C

notifications(in as the storage instruction, including reasons. addition to the requirements in section Where applicable, for cough and throat lozenges and 2.5.1 “Cover letter”) pastilles the maximum content of essential oils specified per unit must be justified in each case (see Annex 5 KPTPO, section 1.3).

3.18.2 Module 1 for teas Administrative documents must be submitted, see C

Overview of documents to be submitted

3.18.3 Module 1 for Administrative documents must be submitted, see C

sweets Overview of documents to be submitted In addition, the flavour manufacturer must submit a detailed, qualitative list of ingredients for the flavours used. Alternatively, the applicant may confirm the absence of substances subject to declaration according to Annex 3 TPLRO. If the medicinal product is promoted as “kind to teeth / tooth-friendly” an expert report by a recognised dental institute must be submitted.

3.18.4 Basic company An approved basic company dossier is required for a

dossier new authorisation in the notification procedure. The documents to be submitted are listed in the Overview of documents to be submitted. For changes that affect the basic company dossier, a cover letter listing the requested change must be submitted together with the documents specified in the Overview of documents to be submitted.

3.18.5 Cover letter for For changes that affect the basic company dossier, the

basic company reason for the requested change must be given in the dossier cover letter.

3.19 Authorisation / variations, veterinary medicinal products by the notification

procedure in accordance with Art. 39, TPLO / Art. 22, TPO

No. Subject Requirement C/O Exceptions (None) ▪ - - ▪

The time limits are those stipulated in the guidance document Notification procedure for veterinary medicinal products.

Note the form New authorisation by notification procedure veterinary medicinal products

3.20 Market surveillance

3.20.1 PSUR/PBRER:

No. Subject Requirement C/O Exceptions (None) - - In connection with PSUR/PBRER submissions, RMP updates may be submitted. An RMP update is called for if new findings require changes to the safety concerns, to pharmacovigilance activities or to riskmitigation measures (see Guidance document “RMP ICH E2E Information submission” HMP). If an RMP update is submitted, the appropriate box must be checked in the PSUR/PBRE form.

For veterinary medicinal products, no PSUR/PBRER form is required.

3.20.2 Advertising permit

No. Subject Requirement C/O Exceptions (None) - -

One copy in paper form must be submitted with the advertising (e.g. advertisements or storyboards, etc.).

The definitive version of electronic media should always be submitted on a CD/DVD.

3.21 DMF/ASMF and Plasma Master Files

3.21.1 DMF/ASMF

No. Subject Requirement C/O Exceptions

3.21.1.1 General The Applicant's Part of the DMF/ASMF must be C

submitted in Module 3 of the CTD format for human medicinal products and Part II of the NTA format for veterinary medicinal products. The entire DMF (Applicant's and Restricted Part) must also be submitted separately by the DMF/ASMF Holder. The authorisation holder is responsible for ensuring that the manufacturer of the active substance submits the currently valid version of the DMF / ASMF (Applicant's Part and Restricted Part) synchronously with the authorisation application (see instructions). The formal control of authorisation documentation can only be completed if the full DMF/ASMF (Applicant's Part and Restricted Part) and the Letter

No. Subject Requirement C/O Exceptions of Access and the fully completed form DMF are submitted.

For variation applications: a table of the changes (summary of changes) must be submitted.

3.21.1.2 Form DMF Swissmedic will not confirm receipt of the DMF. C

The form consists of parts A and B. The authorisation holder completes part A and sends a copy of the entire form (parts A and B) to the DMF / ASMF holder. The original, signed by the authorisation holder, is submitted together with each application for first authorisation or variation. The DMF / ASMF holder completes part B. The fully completed, signed form (copy of part A and the part B signed by the DMF/ASMF holder) is submitted directly together with the cover letter, Letter of Access, and the Applicant's Part and Restricted Part of the DMF holder. For applications according to Art. 13 TPA, the final Assessment Report of the Restricted Part, the LoQ and the answers of the DMF holder relating to the Restricted Part should also be submitted.

3.21.1.3 Letter of Access The DMF/ASMF must always be accompanied by a C

Letter of Access from the manufacturer in accordance with Annex 2 of the EU Guideline on Active Substance Master File Procedure. The Letter of Access must contain the name of the medicinal products and the name of the authorisation holder. The Letter of Access must be submitted by both the DMF/ASFM holder (original) and the applicant (copy).

3.21.1.4 CTD The Applicant's Part should be integrated into part C

3.2.S of the authorisation documentation. The authorisation holder’s specifications should be inserted in part 3.2.S.4.1. If the active substance is sourced from several manufacturers, the instructions in section 6 of the EU “Guideline on Active Substance Master File Procedure” must be observed. If additional specifications (e.g. particle size) are added to the active substance specification, the test procedure in question must be documented under 3.2.S.4.2. Part 3.2.S.4.4 must document three batch analyses containing the results of any additional testing.

DMF/ASMF may only be submitted in connection with an application for authorisation or variation, an extension or as part of a periodic review procedure.

Swissmedic must receive the DMF/ASMF – including the form DMF (parts A and B), Letter of Access and cover letter –before and no later than three calendar days after it has received the application for first authorisation or application for a variation. If there is no application for a DMF/ASMF, a reminder will be sent to the authorisation holder. If no application is received within 60 calendar days of the reminder being sent to the authorisation holder, Swissmedic will return the DMF/ASMF at the sender's cost if the DMF/ASMF was sent from Switzerland. If the DMF/ASMF was sent from abroad, it will be disposed of in a controlled manner at the end of the 120 days.

It is only possible to omit the paper copy of the DMF/ASMF documentation if the DMF/ASMF is submitted in eCTD format.

For veterinary medicinal products: Applicants should submit the cover letter and Letter of Access for the DMF under Part 1a4 doc prod quality. The same applies to flow charts on manufacturing (and also to the storage of CEP). The form DMF must be stored in Part 1a5 forms /footer, as must the form Declaration by the Responsible Person for foreign manufacturers

3.21.2 Plasma Master Files (PMF; human medicinal products only)

No. Subject Requirement C/O Exceptions

3.21.2.1 Annual updates Annual updates to PMF (for the purpose of C

and variations satisfying conditions of authorisation) should be submitted with an appropriate cover letter for each PMF. Variations to the Plasma Master File (e.g. additional donation centres, change in plasma country of origin, changes in test kits, etc.) must be submitted as the appropriate variation type using the form Variations and extensions. For each PMF, the variation application is submitted for one or more PMF variations according to the highest category (type II, IB, IA/IAIN) according to the classification in the European Guideline under point "Q.V.a.1 PMF / VAMF" or "M. PMF / VAMF" (Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No. 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and on the documentation to be submitted pursuant to those procedures).

The submission of a PMF annual update is considered to represent compliance with the conditions imposed on an authorisation.

3.22 Special medicinal product types and the corresponding submission

3.22.1 Radiopharmaceuticals

No. Subject Requirement C/O Exceptions

3.22.1.1 Cover letter(in Name of the active substance or the radionuclide (if

addition to the possible, use the INN) requirements in section 2.5.1 “Cover letter”) Area(s) of use in diagnostics and / or treatment. For kits, the marker nuclide must also be stated. Dosage form(s)

3.22.1.2 Establishment Permit from the Federal Office of Public Health to C

licences handle radioactive substances: Copy of the original or the application (see Radiological Protection Ordinance, RPO)

3.22.1.3 Other Guidance document Authorisation

requirements radiopharmaceutical

3.22.2 Allergen products (human medicinal products only)

No. Subject Requirement C/O Exceptions

3.22.2.1 Cover letter and If an application concerns more than five allergen C

forms if more than products, a list of the allergens – grouped into five allergen allergen groups if expedient – must be included. products are All the necessary forms and the cover letter must concerned. be submitted in one copy in this case. The cover letter must mention the list that has additionally been submitted.

3.22.2.2 Modules 2-5 See the Guidance document Authorisation of

allergen product

3.22.3 Antidotes

No. Subject Requirement C/O Exceptions

3.22.3.1 Module 1 Draft of the information for healthcare professionals and, C

if appropriate, of the patient information (e.g. for use outside the hospital) Medicinal products manufactured in Switzerland: Drafts texts in accordance with Swiss requirements Medicinal products manufactured abroad: the texts approved abroad (in a national language of Switzerland or in English) Packaging texts Medicinal products manufactured in Switzerland: Drafts texts in accordance with Swiss requirements Medicinal products manufactured abroad: Copies of the texts approved abroad and drafts of the additional adhesive labels (in German and French) that will be placed on the foreign packaging and that show the authorisation number and packaging code, plus the approval mark A, the area of application (short form), the contact data for Tox Info Suisse and the note: "ANTIDOTE: only use in emergencies and with medical supervision. The indication is defined by the professional prescribing this product". Confirmation from Tox Info Suisse stating the average annual figure for cases of intoxication in Switzerland Confirmation from the Military Pharmacy of the Swiss Confederation stating the estimated number of critical cases

3.22.3.2 Module 3 See the Guidance document Authorisation of antidote C

3.22.4 Medicinal gases

No. Subject Requirement C/O Exceptions

3.22.4.1 Application See the Guidance document Authorisation of -

documentation medicinal gas

3.22.5 Antivenins

No. Subject Requirement C/O Exceptions

3.22.5.1 Application See the Guidance document Authorisation of C

documentation antivenin

3.22.6 Parallel import

No. Subject Requirement C/O Exceptions

3.22.6.1 Application ▪ GMP/GDP compliance: official licences, C

documentation GMP/GDP certificates no more than three years old

• Wholesaler: ➢ domiciled in the country of export, GDP certificate from the authority in the country of export. ➢ domiciled in a third country with comparable control of human medicinal products and licence to source the medicinal product from the country of export from the foreign authority in the third country.

• Importer: Licence to import ready-to-use medicinal products or wholesale trading licence.

• Creating packaging for Switzerland: For the foreign repackaging company, GMP certificate for the repackaging process or official document confirming that the manufacturer satisfies the PIC/S GMP requirements (inspection report with details of the last inspection). If the repackaging company is Swiss, a GMP certificate does not have to be submitted.

• Photos of the folding carton and primary container of the sample pack per dosage strength as a PDF file (if not in an official Swiss language or English, with translation)

• Information for healthcare professionals and patients in the country of export: in the corresponding language of the country of export (with translation if not in an official Swiss language or English)

• Information for healthcare professionals and patients for Switzerland: in an official Swiss language, as a Word file

• Packaging texts: Swiss packaging or label per dosage strength as a mock-up in a single file with searchable text (OCR)

3.22.6.2 Sample packs ▪ One sample pack per dosage strength and/or C

flavour must be submitted directly to the Swissmedic laboratory (OMCL; delivery conditions: see Guidance document Import of a human medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import); address: see form Import of a human medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import)).

Should there be a change to the wholesaler or supplier of the medicinal product imported according to Art. 14 para. 2 and 3 TPA, an updated version of the form “Import of a medicinal product according to Art. 14 para 2 and 3 TPA (parallel import)” must be submitted.

3.22.7 Herbal medicinal product with traditional use

No. Subject Requirement C/O Exceptions

3.22.7.1 Cover letter(in addition Brief description of the proof of traditional use

to the requirements in section 2.5.1 “Cover Information on the directly comparable herbal letter”) medicine

3.22.7.2 Modules 2-5 Additional requirements, see the Guidance C

document Authorisation of herbal medicinal products (in addition to Module 2.5, the clinical documentation must also include Module 2.7.4 (Summary of Clinical Safety) and Module 5.4 with literature references, and the preclinical documentation must include Module 2.4 (Non Clinical Overview) and Module 4.3 with literature references).

3.22.8 Herbal medicinal product with well-established use

No. Subject Requirement C/O Exceptions

3.22.8.1 Cover letter(in addition Brief description of the proof of well-established

to the requirements in use. section 2.5.1 “Cover letter”)

3.22.8.2 Modules 2-5 Additional requirements, see the guidance C

document Authorisation of herbal medicinal products (in addition to Module 2.5, the clinical documentation must also include Module 2.7.4 (Summary of Clinical Safety) and Module 5.4 with literature references, and the preclinical documentation must include Module 2.4 (Non Clinical Overview) and Module 4.3 with literature references).

Change history Version Change sig

21.0 Section 3.6 – mandatory submission of SEND datasets cho, sab, ber

20.0 Section 3.22.6 – Submission of translation of foreign packaging if not in an official nma, vit, tay

Swiss language or English.

19.0 New Swissmedic telephone number on page 1 of the guidance document stb, wer, vy

Adaptation due to revised list of variations (Annex 7 TPLRO)

18.0 Section 2.1 Submission formats – Documents (PDF) are machine-readable (OCR) stb, wer

and include a list of contents with active links. Section 2.5.3.2 Requirements – VMP: Requirements changed concerning the lac, has information elements to be produced (information for healthcare professionals and/or package leaflet) for export licences vit, tay, nma Section 3.22.6 – Clarifications regarding parallel import

17.0 Section 2.5.3.2 Medicinal product information - Addition stating that, for Access bic, stb

applications, the Information for healthcare professionals should also be submitted in EN.

16.0 Section 2.5.16 Risk assessment for nitrosamines in active substance and/or finished rin, stb

medicinal products – new nma, vit Section 3.22.6 Parallel imports – Change to application documentation re wholesalers and number of sample packs to be submitted

15.0 TAM requirement (2.5.2.6) form Information on GMO-containing veterinary medicinal zai, fg

products added

14.0 New section Documentation submission added to General requirements (section 2) stb, zsa, lem, dts

to clarify that all documentation – exceptions: DMF, ASMF and composition of flavouring agents – must be submitted by the applicant. Addition in section 2.5.13 – new “Please note” for VMP

13.6 Clarifications in section 2.5.3 regarding language requirements ski, nma, hv

Changes in section 2.5.15 regarding the submission of the documents required for cho the MedD components Changes in section 3.22.6 due to revision of Art. 14 para. 3 TPA

13.5 Sections 2.5.8, 3.8 and 3.9 revised due to RMP changes. stb

13.4 HMV4 suffixes removed ski/dsc/vy/mra/stb

3.11 Co-marketing: Clarifications regarding eDOK and eCTD.

3.12 Variations and authorisation extensions (end of section): Correction to the

submissions deadline for variations without assessment (VMP) following implementation: previously max. 1 month, now max. 60 calendar days.

13.3 New layout, no content adjustments to the previous version. dei

13.2 Section 3.11 – Co-marketing: Clarification of documentation to be submitted ski/vy/dsc/stb

Section 3.1.3 – Under the revised FeeO-Swissmedic, conditions can now be the subject of collective applications Section 3.21.1.4 – Correction: section 6 instead of section 4

13.1 Section 2.5.15 – Combination products: Clarification of concepts. stb/spb/na

Section 1.1.1 – Abbreviations added/updated accordingly

13.0 Section 3.9 – Amendment of a note that no RMP has to be submitted for a KAS cho/stb/fg

without innovation. Section 2.5.5 – Clarification that expert CVs should be dated and signed. Section 2.5.8.1 – Clarification on mandatory submission and addition of a note on RMP for KAS without innovation.

12.0 For applications requesting an FTP or temporary authorisation, the decision minutes stb/nma

must also be submitted as a Word file. This is specified accordingly in sections 3.3 and 3.4 of this guidance document. section 3.21.1 at “Please note!” – Deletion of the fix defined submission period for DMF/ASMF before submission of the application (previously 11 CD)

11.0 Adaptation of guidance document due to new structure of VMP variations (early fg/ps

revision of VMP regulations)

10.0 Section 2.5.15: Insertion of sub-heading to improve clarity (explanatory addition) stb/hv/mik/ski

Section 3.22.6: Information regarding change of a wholesaler

9.0 Modification regarding combination products due to new EU MDR and revised stb

MedDO in section 2.5.15

8.0 Section 2.1 – Submission formats: Note added on continuing the submission format vy

when authorisation is transferred. Section 3.3 – Further details concerning applications for temporary authorisation (tempA HMP) Section 3.4 – Further details concerning FTP applications (HMP) Section 3.11 – Co-marketing medicinal products: further details Section 3.13 – Review replaced by assessment

7.0 Change in section 3.3 / 3.4 "AAA". fg/wer/stb

Change below 3.12.5: Editorial changes may also be submitted as an “Other change” B.z, type IA”. Section 2.5.8.1: New reference to guidance document (formerly to information sheet) from Safety of Medicines division. Section 2.5.6.1: Explanation of Environmental Risk Assessment specifications

6.2 Change in section 2.5.4.1 “Submission methods for packaging”: jst

Addition of the term ‘mock-up’ for non-original printouts.

6.1 Section 2.5.2 «Forms»: replacement of the section number 3.11 with 3.12 “Variations tsj

and extensions”.

6.0 Section 3.3.: Addition of requirement for applications for temporary authorisation stb/buj/anm

Section 3.18: Detailed information regarding authorisation of individual teas, cough and throat lozenges and pastilles in dispensing category E by the notification procedure Section 3.21: DMF/ASMF documents can now be submitted via the Portal. 5.1 ▪ Section 3.12: Further details on the requirements concerning the submission of dts/stb documents to fulfil conditions.

• 2.5.3.2.8: Changes to the product information that were rejected by Swissmedic for a first authorisation or earlier applications can be requested again only if they are documented by new data (SMJ 03/2009).

• Chapter 2.4 Confirmation of receipt: The receipt of type IA, IAIN and IB variations is confirmed if the applicant is not a portal user. A confirmation of receipt is always issued for fast-track requests.

• Section 2.5.2 Forms: Unless otherwise explicitly stated by Swissmedic, the default transitional period for forms is 3 months. If additional application requirements are associated with a new version of a form, a default transitional period of 3 months likewise applies to these new requirements. Various corrections to the chapter numbers (incl. deletion of A at the start of the numbers and intervening 0.

5.0 Chapter 3.11 “Variations and extensions”: Inclusion of no. A.3.11.0.8 wer

Chapter 2.5.6 Explanations regarding the documentation of Environmental Risk Assessments (ERA) for biosimilar applications and additional indications that are likely to have a substantial environmental impact.

4.0 Section 3.12 “Conditions imposed by Quality Review, Preclinical Review and Clinical dts

Review”: The fulfilment of a condition imposed in respect of a collective application must entail a separate request for each medicinal product concerned. Collective applications are not permitted in relation to the fulfilment of conditions.

3.1 Point A.2.5.2.6: Further details on the mandatory submission of the form dts/stb

Confirmation regarding substances from GVO HMV4 Chapter 3.11 "Variations and extensions": Further details on the format for specifying the implementation date: “DD.MM.YYYY” (A.3.11.0.2).

3.0 Supplement to Chapter 3.14 “Complementary medicinal products: Reduced spm

dossiers”.

2.0 Chapter 3.11 "Variations and extensions": inclusion of no. A.3.11.0.7 - Number of wer/nma/gf

variations per variation no. Chapter 3.20 “DMF/ASMF and Plasma Master Files” Explanation re no A.3.20.1.2 Chapter 3.2.1 “Recognition of orphan drug status (ODS) for human medicinal products” and Chapter 3.2.2 “Recognition of MUMS status for veterinary medicines”: Swissmedic will cancel the advance payment.

1.1 Chapter 2.4 "Confirmation of receipt" dts

Explanation re no. A.2.5.1.2: Dispatch of the authorisation document is subject to a fee. Explanation re no. A.2.5.1.1: Variation types IA, IAIN and IB can be submitted without cover letters. Chapter 3.9 "Submissions according to Art. 14 para. 1 let. abis-quater TPA": The additional requirements regarding the cover letter have been deleted. Chapter 3.11 "Variations and extensions":

• Inclusion of new requirement: "Hybrid collective applications comprising both human and veterinary medicinal products are not admissible."

• Clarification concerning the submission and completion of the form Variations and extensions HMV4. Further details on the procedure for dealing with editorial changes and/or updates to documentation.

1.0 Implementation of TPO4 dts