From 28 January 2022, new regulations will come into force for manufacturers, importers and distributors of medicines for human and veterinary use. The National Competent Authorities (FAMHP / Farmatec) 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).
As part of the new regulations for veterinary medicines (regulation 2019/6 and 2021/16), the following changes will enter into force:
- Integration of the EudraGMDP database with the Organisation Management Service (OMS) database.
- Expansion of two modules of EudraGMDP to include veterinary medicines:
- Wholesale Distributor Authorisation (WDA);
- Registration of Active Pharmaceutical Ingredient (API-Reg).
From 28 January 2022, National Competent Authorities (NCA) 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 (OMS). The NCA will only be able to issue certificates and licenses if the relevant data is available in the EMA database (OMS), when issuing a new Manufacturing and Importation Authorisation (MIA), but also when renewing or varying an MIA, or issuing a new certificate after an inspection.
All manufacturers, importers and distributors of medicines or active substances must enter their details into the Organisation Management Service database. (Note: The EMA has already completed the database based on existing data in EudraGMPD.) The NCA 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 NCA for new or updated licences or certificates.
To consult data in the OMS, no specific account is required. 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, no action is required.
If any amendments are needed to your data, 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.