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).
- 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.
From 28 January 2022, the FAMHP will only issue certificates and licences if the relevant data is available in the EMA database. For example, when issuing a new Manufacturing and Importation Authorisation (MIA), but also when renewing or varying an MIA, or a new certificate after inspection.
All manufacturers, importers and distributors of medicines or active substances must enter their details into the Organisation Management Service database. The EMA has already completed the database based on existing data in EudraGMPD.
The FAMHP is asking stakeholders to check from 28 January 2022 onwards whether all the data have been correctly entered into the EMA database before applying to the FAMHP for new or updated licences or certificates.
No specific account is required to consult data in the Organisation Management Service. If you wish to have the data amended, your organisation must be registered with the EMA and a data management role must be designated for Substances, Products, Organisations and References (SPOR).
- If your organisation and its addresses have been correctly registered, you do not need to do anything.
- If any amendments are needed to your information, you must request a change request.
- If you are a manufacturer within the EEA that uses production sites outside the EEA, we ask you to contact these sites so that they can check that their details are correct in the Organisation Management Service and request a correction if necessary (via change request).
More information on the EMA website