Change to basic company dossier

What is the procedure for submitting changes to the basic company dossier and what deadlines/fees apply?

In order to submit an application for authorisation of a medicinal product in the notification procedure, an approved basic company dossier must be available, based on Art. 37 and Art. 38 of the Complementary and Phytopharmaceutical Products Ordinance (KPAV)-in German only. An amendment to the basic company dossier, e.g. the new authorisation of an additional active substance manufacturer, must be applied for using the form New Authorisation variation in Notification Procedure KPTPO HMV4. The amendment of a basic company dossier is assigned to type IB as Variation Y.2 in accordance with the Medicines Licensing Ordinance (AMZV) Annex 7 (Art. 22a) List of amendments to medicinal products for human use in accordance with Articles 21-24 VAM (Chapter 1.5) – in German only. The deadlines thus correspond to those for type IB variations (see Guidance document Time limits for authorization applications HMV4, Annex 1). The fee for a Type IB variation is CHF 750 in accordance with Annex 1 No. 1 No. 6.1 Ordinance of the Swiss Agency for Therapeutic Products on its Fees (GebV-Swissmedic)-in German only.

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Dr. Katharina Oehler
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