Historical legislation until 28 January 2022 & transitional arrangements
Since 28 January 2022 a new legislation with regard to veterinary medicinal products has been applied. Here you will find details of former legislation that was applied until 28 January 2022 as well as important transitional arrangements.
The English website on Veterinary medicines is under construction. Please refer to the German website in case desired information cannot be found here.
An overview
Renewals
Marketing authorisations were initially limited to 5 years according to Section 31 of Medicinal Products Act (AMG). Veterinary medicinal product authorisation expired 5 years after it was granted, unless renewal application was submitted.
"Nachzulassung"
Veterinary medicinal products that were already on the market before the Medicinal Products Act (AMG) came into force in 1978 had to undergo a post-marketing procedure called “Nachzulassung” until 2005.
PSURs (Periodic Safety Update Reports)
Until the application of Regulation (EU) 2019/6 from 28 January 2022 onwards, the marketing authorisation holder for a veterinary medicinal product was obliged to submit periodic safety update reports to the national competent authority.
Sunset Clause
In the context of the Medicinal Products Act (AMG), it was legally stipulated that marketing authorisations could expire due to the Sunset Clause if a marketing authorisation holder had not placed the product on the market for a period of three years.
"Stufenplan"
This procedure according to Section 63 of the Medicinal Products Act (AMG) was an instrument for prevention, elimination and minimisation of risks associated with veterinary medicinal products.
Standard marketing authorisations
In the case of a standard marketing authorisation, certain medicinal products were exempt from the obligation to obtain an individual marketing authorisation. Standard marketing authorisations were issued by the Federal Ministry of Health by ordinance.