The European Union (EU) pharmaceutical industry has been asked how closely non-EU countries need to work with EU medicine safety controls to access member country markets.
In a formal consultation, the European Commission is asking whether exporting countries should participate in the EU’s pharmaceutical ‘Community information and rapid alert system’, and/or directly alert the EU of any local suspension or withdrawal of a medicine’s marketing authorisation.
The EU is also asking pharma companies to assess a checklist of standards that non-EU medicine inspection agencies need to follow, if their countries are allowed to sell pharmaceuticals to the EU.
The consultation – which ends on 23 March – has been sparked by the agreement of EU directive 2011/62/EU ‘relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products’. It says active substances shall only be imported accompanied by written confirmation of good manufacturing practice from a competent authority.