The European Commission recently sent a letter to EU pharmaceutical trade associations requesting information on how the pharmaceutical industry will adapt to the new EU import rules for Active Pharmaceutical Ingredients (“API”) that will apply as of 2 July 2013.
Under the new rules, introduced following the adoption of the EU Falsified Medicines Directive (2011/62/EU) in June 2011, active substances for medicinal products for human use may only be imported into the EU if:
accompanied by a written confirmation of the country of manufacture’s competent authority, confirming, inter alia, the existence of EU-equivalent Good Manufacturing Practice (GMP) standards and enforcement;
the country of manufacture is included on an official list of countries whose regulatory and enforcement framework has been assessed and is deemed EU-equivalent by the European Commission; or
an EU Member State exceptionally waives the requirement, in strictly defined circumstances, in order to ensure the continued availability of medicinal products.
Several EU Member States, including in particular the United Kingdom, have expressed concerns regarding the implications of the new rules on the availability of medicinal products on the EU market. However, in the letter, the European Commission stated that it has “put everything in place […] to ensure that the new rules […] are well known, understood and implementable”, and that “[c]learly, it is up to industry to ensure compliance with the incoming rules […]”. The European Commission asked the trade associations to:
ensure that member companies “do now obtain” the written confirmation from the relevant third countries, since there is “no reason to wait any longer […]”;
provide the European Commission with “precise information about the number of manufacturing sites located in third countries and actively supplying active substances to medicinal products (human) manufacturers in the EU”; and
inform the European Commission about “risk-mitigation measures […] put in place to ensure supply of active substances in cases where a third country may not issue ‘written confirmations’, while not being ‘listed’ by the European Commission”.
The European Commission provided 19 October 2012 as the deadline for submitting this information to the responsible DG SANCO unit via the following e-mail address: email@example.com. The responsible unit intends to plan a meeting with the trade associations to discuss this issue further on the basis of the submitted information.
Pharmaceutical companies and active substance manufacturers should prepare for the application of the new rules, and seek the required written confirmation from the relevant competent authorities.