About the regulation of manufacturing of human medicines in Ireland
Manufacture of medicines for clinical trials and for human 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,
- Physical importation of medicinal products from countries outside the EU/EEA,
- Batch certification of products intended for EEA markets.
You can find a list of authorised manufacturers of medicines on the EudraGMDP website.