How manufacturing of veterinary medicines is regulated
Manufacture of medicines for clinical trials and for veterinary use includes the following activities:
- Processing of a dosage form,
- Processing of an intermediate medicinal product,
- Manufacture of biological active substance where it continues without storage through to the manufacture of the dosage form,
- Primary packaging,
- Secondary packaging, including relabelling and serialisation,
- Contract testing laboratories for medicines for veterinary use,
- Physical importation of medicinal products from countries outside the EU/EEA,
- Batch certification of products intended for EEA markets.
How are manufacturers of medicines regulated?
Manufacturers:
- Need to obtain a manfacturer's / importer's authorisation (MIA) from the HPRA before they can certify or release any products processed or imported.
- Must comply with Good Manufacturing Practice (GMP) Guidelines and EU and national legislation.
- Must have a valid GMP certificate. This certificate is issued by the HPRA after each GMP inspection if there is a satisfactory level of compliance.
The HPRA inspects manufacturers to verify compliance with GMP and relevant legislation, as part of the authorisation process and routinely thereafter using risk based criteria.
An authorised manufacturer must apply for HPRA approval for specified changes to its activities prior to certification or release of products concerned. An MIA variation application describing the change should be submitted with supporting documentation.
How are contract laboratories that test medicines regulated?
Contract laboratories that test medicines for veterinary use are required to hold MIA under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6).
You can find a list of authorised manufacturers of medicines on the EudraGMDP website.