The API industry faces a challenge in meeting the EU FMD deadline

Changes to the EU rules governing the importation of APIs will come into effect in July 2013. The new regulations are part of the implementation of the EU Falsified Medicines Directive and they are causing the industry a huge headache. Susan Birks reports.

Following the adoption of Directive 2011/62/EU on Falsified Medicines, as of 2 July 2013 the EU will outlaw the production of medicines for human use containing active substances imported from third countries whose authorities have not signed a statement attesting that these substances comply with EU standards for good manufacturing practices (GMP). The principles of the Falsified Medicines Directive¹ (FMD) are designed to protect patients from counterfeit medicines and while they were broadly welcomed by the industry, the actual implementation of the Directive is causing some concern.

According to a recent position paper put out by the European Fine Chemicals Group (EFCG), the Directive stipulates rules for the importation of APIs that require ‘a written confirmation from the national competent authority of the exporting country that the APIs manufactured there are compliant with GMP at least equivalent to EU standards’. Exceptions to this will be made ‘if the exporting country is on an approved list of non-EU countries that have been assessed by the EU to ensure they meet EU manufacturing standards (Article 111)’, or ‘exceptionally, and where necessary, to ensure the availability of key medicinal products, in the instance that a non-EU API factory manufacturing for export has been inspected by an EU Member State and was found to be compliant with EU manufacturing standards’.

In short, from 2 January 2013 all active substances, or APIs, imported into the EU are required to be manufactured in compliance with good manufacturing practices equivalent to those of the EU. Written confirmation of compliance with this requirement, which will be issued by an authority in the exporting country, will need to accompany all active substances imported into the EU as of 2 July 2013.