|Marketing authorisation - general information|
|Written by Daniel Dušek|
ISCVBM grants a marketing authorisation if requirements for the marketing authorisation specified in the Act on Pharmaceuticals and the Regulation No 228/2008 which are in compliance with the EU legislation (Directive 2004/28/EC) are fulfilled. A marketing authorisation is granted for a period of 5 years and is renewable upon application three months before expiry.Once renewed, the marketing authorisation shall normally be valid for an unlimited period oftime. However, on justified grounds relating to pharmacovigilance, the ISCVBM may decide to proceed with one additional five-year renewal, after which the authorisationwill become valid for unlimited period of time.
USKVBL Information on the Impact of "Brexit" on the Marketing Authorisation of Veterinary Medicinal Products
The United Kingdom submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union. This means that unless the withdrawal agreement establishes another date or the period is extended by the European Council in accordance with Article 50(3) of the Treaty on European Union, all Union primary and secondary law ceases to apply to the United Kingdom from 30 March 2019, 00:00h (CET). The United Kingdom will then become a 'third country'.
In this context, the USKVBL informs the applicant / MAH of nationally authorised veterinary medicinal products (including via MRP / DCP authorised products) on the certain legal repercussions of this step which need to be considered:
We recommend that marketing authorisation holders affected by the situation consider as soon as possible measures and necessary changes to the terms of marketing authorisations to ensure a validity of the marketing authorisations. once the UK leaves the Union (transfer of the MA to another holder, change of the MA holder's address, manufacturing and pharmacovigilance, generic and hybrid application issues, etc ...).
Practical information, including a document containing questions and answers on the issue, can be found on the CMDv Coordination Group website.
|Last Updated on Friday, 08 June 2018 09:35|