Guidance document Time limits for authorization applications
6.1 New layout, no content adjustments to the previous version. tsj
6.0 Due to expansion of scope of temporary authorisations: New inclusion of time stb
limits for temporary additional indications in Annex 1
5.0 Correction in Annex 1: Deletion of application type conversion of temporary to stb/lm
regular authorisation
4.0 Adaptation of guidance document due to new structure for VMP variations (early fg/ps
revision of VMP regulations) Details of FTP application procedure / temporary authorisation deadlines
3.2 Correction of the footnote in annex 1 stb
3.1 Formal adjustments to the header and footer dei
No content adjustments to the previous version.
3.0 Annex 1 – Overview of time limits: Explanation that companies have 30 calendar stb
days to respond if the PD is a rejection.
2.1 Annex 1 – Overview of time limits: Explanation regarding the six-day submission dts
window for responses to the LoQ in fast-track and temporary authorisation procedures.
2.0 Correction of Time limit categories / Application types, Variation Type IB, stb
Correction of documents subject to formal objection: 30 CD. Correction of the footnote 3 on page 11.