EC releases rules on assessing non-EU medicine controls
Brussels officials to assess inspection resources of countries
The European Commission has laid down fresh rules on how the European Union (EU) should decide whether a non-EU country’s medicine controls are sufficiently robust to allow its checks to be recognised within the EU. They are supposed to complement EU directive 2001/83/EC, which allows member states to avoid the pointless duplication of best practice assessments by trusted non-EU countries.
The new Commission decision says these controls can only be accepted after Brussels officials assess a country’s inspection resources; the qualification and training of inspectors; inspection procedures; strategies addressing conflicts of interest; inspection performance standards; enforcement powers, alert and crisis mechanisms; and analytical capacity.
It adds that Commission officials must also assess the non-EU country’s ability to provide the EU with ‘regular and rapid…information…[on] non-compliant producers of active substances’.