EMA develops new guidance for importing medicines into Europe

The European Medicines Agency (EMA) is seeking help from European Union (EU) pharma companies to design new guidance for importers shipping medicinal products into the EU. With the growth in counterfeit medicines, the availability of pharmaceuticals online, and the increasing complexity of legitimate global supply chains, EMA thinks the time is right for clarified guidance. It has released a concept paper on the issue and wants comments by August. Draft guidance will then be released in September, for comments by next April (2016); a final draft will come in November.

At present, said the concept paper, EMA has sought to extend quality controls by designating importers as EU manufacturers. This means that importers have to comply with good manufacturing practice (GMP), such as establishing a pharmaceutical quality system, have adequate personnel and premises, and arrangements for receiving complaints and making recalls. However, said EMA’s paper: 'Involved stakeholders may benefit from a clarification of expectations,' and hence it is developing specific guidance for importers.

This will include how tests on imported medicines are undertaken where the EU does not have a mutual recognition agreement with a jurisdiction where an exporting manufacturer is based. It will also seek to clarify under what circumstances a medicine is regarded as an import: 'This can be particularly complex in the context of global commercial activities and there may be little-known implications…even when the physical location of medicinal products remains within the EU,' said the Agency.

An associated EMA note stressed: 'In recent years, the manufacture of medicinal products for the EU market increasingly occurs outside of the EU…particularly…for the manufacture of active substances…'