Manufacturers, importers and distributors of human and veterinary medicines must check their data in the Organisation Management Service database of the EMA
January 20, 2022
From 28 January 2022, new regulations will come into force for manufacturers, importers and distributors of medicines for human and veterinary use. The FAMHP is asking them to check from 28 January 2022 onwards whether their organisation's data are correctly registered in the Organisation Management Service of the European Medicines Agency (EMA).
Source: FAMHP
As part of the new regulations for veterinary medicines (regulation 2019/6(link is external) and 2021/16(link is external)), the following changes will enter into force.
- Integration of the EudraGMDP database with the Organisation Management Service database.
- Expansion of two modules of EudraGMDP to include veterinary medicines:
- Wholesale Distributor Authorisation (WDA);
- Registration of Active Pharmaceutical Ingredient (API-Reg).
The FAMHP will no longer enter a company's data (such as name and address) into EudraGMDP, but will use the details in the EMA's central database.