6/7 September 2022
The Directive on the prevention of the entry of falsified medicines into the legal supply chain, 2011/62/EU, (also called "Falsified Medicines Directive") came into force at the beginning of 2013. This regulation contains a range of provisions with significant influence on Europe's pharmaceutical industry, API manufacturers outside the EU as well as brokers, importers and distributors. An important part of this Directive regarding the obligation for API deliveries from Third Countries to be accompanied by a "Written Confirmation" came into effect on 2nd July 2013 and already caused furor in advance. Like all the directives elaborated by the European Commission, this one must be transferred into national law by the EU Member States.
The UK implemented it in August 2013 into national law. For this, the MHRA extended its website with an own page including a clear overview of all important information about Directive 2011/62/EU. The page provides background information to the regulation as well as data about the provisions for the import of APIs, particularly about the "Written Confirmation". Further interesting material about specific aspects of the guideline is also available. The section "Importation of active substances" contains - among other things - a specific passage about "Imports transiting Germany" which provides recommendations for Germany based Importers (with regard to the import permit and the certificates required according to § 72a of the German Drugs Act). All important forms and fees information relevant for importation can be found under "Registration of manufacturers, importers and distributors of active substances".
You can access MHRA's "Falsified Medicines Directive" page here.