January 21
Anjum Shabbir
11th January 2021
Consumer, Health & Environment Internal Market

Operating rules for EU database on medicinal products used by vets published

The EU Database was established by the European Medicines Agency (under Regulation 2019/6), and the now published Commission Implementing Regulation (2021/16) sets out rules on how the database should operate.

To feed the database, information must be provided by the competent authorities of Member States on veterinary medicinal products within 30 days of a positive outcome of the procedure for marketing authorisation.

The nature of the information required is further specified in the Implementing Regulation (Section 4), along with technical specifications, and rules on the means of submission - including how to exchange information in a secure manner. The format of data and documents that must be provided however has yet t


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