The European Commission set out its rules on the importation of active pharmaceutical ingredients (API) in Directive 2011/62/EU - published last June - as part of a wider effort to ensure that fake and substandard ingredients do not enter the supply chain.
A central requirement of these rules is that exporters in countries outside the European Union (EU) provide written confirmation from local regulators that production sites meet with appropriate standards regardless of whether they have been inspected by the EDQM or by regulators from an EU member State.
However, ‘third countries’ – those outside the EU - can ask for exemption from this requirement if they can prove that manufacturing and inspection standards are the same as those applied in Europe.
According to a Q&A document posted yesterday to date only Switzerland and Israel have made such requests and both countries are still undergoing assessment to determine if good manufacturing practice (GMP) and control regulations are equivalent to those in the European Union and that they are properly enforced.
If the regulators do make the grade API manufacturers in Switzerland and Israel will not need to provide written assurances that their facilities are up to standard when shipping to EU countries.
The new document also reiterates that it is the importer is responsible for checking that a supplier has provided the necessary documentation and that regulators in individual member States are required to verify that such assessments take place.
Whether countries like China and India - whose manufacturers supply most of the APIs used in Europe - will apply for written confirmation exemption remains to be seen.
In related news the Commission has also published the final template for written confirmation letters. The document is available here.