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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.