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.