Guidance document Mobile technologies
1 Terms, definitions, abbreviations
1.1 Terms and definitions
A two-dimensional (2D) barcode comprises lines or dots of different widths with varying gaps in between, with the maximum possible contrast between lines/dots and gaps. These codes can be read optoelectronically. The 2D barcodes most frequently used for medicinal products are the data matrix code and the quick response (QR) code. QR code: A QR code is a 2D barcode that complies with the ISO/IEC 18004 standard. Data matrix code: A data matrix code is a 2D code consisting of black and white cells, generally arranged in a square or rectangular pattern. The number of rows and columns increases with the quantity of
information stored in the code, up to a maximum of 2,335 alphanumeric characters. See the Packaging guidance document for data matrix specifications. URL: A Uniform Resource Locator (URL) identifies and localises a website by means of the access method to be used (e.g. the appropriate network protocol such as HTTP or HTTPS) and the site address (e.g. www.swissmedic.ch). Accessibility: Threshold-free or low-threshold access to the content that ensures full access and unrestricted opportunity of use for all. Integrity: Immutability of information, i.e. protection against manipulation or unauthorised modification of the content. Providing information security by ensuring the content is complete and intact.
1.2 Abbreviations
TPLRO Ordinance of the Swiss Agency for Therapeutic Products of 9 November 2001 on the Licensing Requirements for Therapeutic Products (SR 812.212.22) EMA European Medicines Agency IHP Information for Healthcare Professionals TPA Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (SR 812.21) PL Package leaflet of veterinary medicinal products PI Patient information PM Packaging materials (primary and secondary packaging) RMP Risk management plan for human medicinal products TPO Therapeutic Products Ordinance of 21 September 2018 (SR 812.212.21) TPLO Ordinance of the Swiss Agency for Therapeutic Products of 22 June 2006 on the Simplified Licensing of Therapeutic Products and the Licensing of Therapeutic Products by the Notification Procedure (SR 812.212.23) WL Wegleitung = guidance document
2 Introduction
Mobile technologies can be used to simplify access to information associated with the use of medicinal products and provide support to people with disabilities in particular. This guidance document describes the use of mobile technologies using the example of QR codes for human and veterinary medicinal products. It is geared to the requirements of the European Medicines Agency (EMA) (EMA/493897/2015 and EMA/364980/2017_rev.1). Given the rapid pace of technological progress, this guidance document will apply by analogy to other mobile technologies in addition to QR codes.
2.1 Legal framework
The legal framework is provided by TPA, TPO, TPLRO and KPTPO. In particular, the requirements are based on the following legal provisions:
TPA
Art. 11 para. 2 let. a, no. 4 Application for a marketing authorisation
Art. 67 para. 1bis Informing the general public
TPO
Art. 26 Language
Art. 28 Updating the medicinal product information
Art. 29 Time of publication of the medicinal product information
TPLRO
Art. 5a RMP documentation
Art. 12 Information and text on containers and packaging materials
Art. 13 Information for healthcare professionals
Art. 14 Package leaflet
Art. 16 Exceptions
Ann. 1 Information and text on containers and packaging materials
Ann. 3 Requirements for the declaration of active substances and pharmaceutical excipients in human medicinal products
Ann. 4 Requirements for the Information for healthcare professionals for human medicinal products
Ann. 5.1 – 5.3 Requirements for the package leaflet / Patient information
Ann. 6 Labelling and medicinal product information for veterinary medicinal products
KPTPO ▪ Art. 26 Labelling and medicinal product information
3 Objective
As this is a guidance document aimed at administrative bodies, it does not directly specify the rights and obligations of private individuals. Swissmedic uses this document first and foremost as a resource for applying the legal provisions on authorisation in a uniform and equitable manner. The publication of the guidance document is designed to make it clear to third parties what requirements must be fulfilled according to the practice of Swissmedic.
4 Scope
This guidance document applies to the authorisation of human and veterinary medicinal products and is not applicable to complementary medicinal products without indication and veterinary medicinal products in the notification procedure under Art. 39 TPLO.
5 Assessment principles
5.1 General principles
QR codes must only link to information that does not violate therapeutic products legislation and which is useful, medically necessary, clear and not misleading. QR codes and the information to which they link must not jeopardise medicinal product safety or deceive users. Marketing authorisation holders must ensure integrity and accessibility. Accordingly, they must put in place mechanisms to protect against attempted manipulation, and use appropriate devices and software to ensure the information to which the code links is fully accessible. QR codes must not impair the legibility of the mandatory information required by TPLRO. QR codes can be requested as part of the new authorisation procedure or for medicinal products that have already been authorised.
5.2 Language
The information to which QR codes link must be provided in the languages required by therapeutic products legislation. It is also permissible to link to other language versions of the information. However, Swissmedic will only check the versions in the correspondence language; it is the responsibility of the marketing authorisation holder to ensure that translations in all other languages are correct. If a human medicinal product is intended solely for use in hospitals in accordance with Art. 26 para. 4 TPO and is labelled accordingly, texts accessible via QR code may only be in an official language or English. The authorisation holder must ensure that additional information can be provided in the official language requested by users.
5.3 Requirements for QR codes
The authorisation holder must ensure:
compliance with current data protection regulations.
communication between the hosting platform and end user is encrypted to current standards.
guaranteed legibility and accessibility of the linked data.
guaranteed integrity and availability of the linked data.
the hosting platform is valid and accessible from all browsers widely used in Switzerland.
the electronic version of the texts provided is identical to the most recently approved texts (IHP/PI/PL/PM).
information on using the medicinal product (e.g. videos) is based on the most recently approved texts (IHP/PI/PL/PM/RMP).
no legal provisions governing therapeutic products advertising have been violated.
the printed QR code is legible.
5.4 Information accessible via QR code
The QR code can point to information required by therapeutic products legislation and/or to additional information.
5.4.1 Information required by therapeutic products legislation
The information required by therapeutic products legislation comprises
the most recently approved medicinal product information (IHP/PI or PL)
the most recently approved packaging materials
the officially ordered information materials (defined in the guidance document RMP ICH E2E Information for submission HMP)
5.4.2 Additional information
Additional information is information that goes beyond that required by therapeutic products legislation (e.g. an instructional video on handling the medicinal product or other training documents not defined in section 5.4.1) and which relates to the safety, efficacy and/or quality of the medicinal product. This additional information must carry a description (e.g. script of an instructional video) and be consistent with the information in the most recently approved version of the medicinal product information texts. It must be justified on medical grounds and beneficial to users.
5.5 Adding or modifying QR codes
Adding refers to the first-time use of a QR code. Modifying refers to changes to the information accessible via a QR code. To add, modify or remove a QR code, please submit the Mobile technologies form.
5.5.1 Adding QR codes as part of a new authorisation procedure
A separate application is not required if the QR code is added as part of a new authorisation procedure.
5.5.2 Adding QR codes after a new authorisation procedure
To add a QR code that refers solely to information required by therapeutic products legislation, an application for a type IB E.z. variation Other regulatory change must be submitted. For veterinary medicinal products, an application for an A.z. variation Other administrative change that does not require assessment must be submitted. To add a QR code that also or only links to additional information, an application for a type II C.z. variation Other changes relating to safety, efficacy or pharmacovigilance must be submitted. For veterinary medicinal products, an application for a G.I.z.a) variation Other changes relating to safety, efficacy or pharmacovigilance that requires assessment must be submitted.
5.5.3 Modifying QR codes
Once Swissmedic has approved updates to information required by therapeutic products legislation and which is accessible via a QR code, the authorisation holder must implement the updates itself and make them accessible concurrently with official publication. For changes to additional information accessible via a QR code, an application for a type II C.z. variation Other change relating to safety, efficacy or pharmacovigilance must be submitted. For
veterinary medicinal products, an application for a G.I.z.a) variation Other change relating to safety, efficacy or pharmacovigilance that requires assessment must be submitted. Changes to additional information must be implemented promptly after the application has been completed. Removal of a QR code must be reported as a type IA/IAIN E.z variation Other regulatory change. For veterinary medicinal products, an application for an A.z. variation Other administrative change that does not require assessment must be submitted.
5.6 Recommendations on placement of and captions for QR codes
The QR code can be printed on the medicinal product information (IHP and/or PI/PL) and/or the packaging. To improve user friendliness, voluntary implementation of the following information is recommended: – Provision of a (short) URL in addition to the QR code; – Labelling of the QR code with a short, meaningful caption (e.g. “Medicinal product information”). For veterinary medicinal products with an "eLeaflet" (i.e. without medicinal product information in the pack), the note "See electronic medicinal product information (QR code)." should be included on the packaging. In this case, no further caption needs to be added to the QR code.
5.7 Timelines
The timelines are set out in the guidance document Time limits for authorisation applications.
5.8 Fees
Fees are subject to the Ordinance of 14 September 2018 on the Fees charged by the Swiss Agency for Therapeutic Products (FeeO-Swissmedic; SR 812.214.5)
Change history Version Change sig
1.5 Clarification of the recommendations on placement of and captions for QR codes thg, zsa, sab 1.4 New recommendations added concerning a caption accompanying QR codes on the zsa, vy, packaging, including specific instructions for veterinary medicinal products with eLeaflet. stb, thg New Swissmedic telephone number on page 1 of the Guidance document Adaptation due to revised list of variations for human medicinal products (Annex 7 TPLRO)
1.3 Section 5.4.1 "Training materials" are now known as "officially ordered information ski, dst
materials"
1.2 New therapeutic products information: training material according to RMP ski, sab
1.1 New layout, no content adjustments to the previous version. dei
1.0 New document ski, sab, zsa, ber, lac, iom, jua, er