EMA gives more clarification on new EU regs for importing APIs


A new Q&A document (Version 3) has been published by the European Medicines Agency

A new Question and Answer (Q&A) document has been published by the European Medicines Agency (EMA) with regard to the GMP confirmation for active pharmaceutical ingredients (APIs) imported into the EU.

Under the Falsified Medicines Directive there are new import requirements for APIs coming into the EU, which are to be effective from July 2, 2013. All APIs imported into the EU will be required to be manufactured in compliance with good manufacturing practices (GMP) equivalent to those of the EU by 2 January 2013.

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. Exporting countries may apply for an exemption to these rules; five countries have applied, but only Switzerland has been granted an exemption to date.

Back in October, the EMA published Version 2 of its Q&A document with regard to implementation of the new APIs import requirements. Version 3 offers updates in interpretation and clarifies details and therefore replaces Version 2.

According to the pharmaceutical trade consortium Rx360, changes in the document are:

The amended response to question 18A clarifies that where a non-EU country issues a confirmation statement based relative to “equivalent GMP standards” on an inspection by another regulatory authority, that inspecting authority should be identified.

Two new questions and answers are included, 11A and 19A. The response to question 11A addresses the situation where API is imported into the EU and the dosage form is for export only. In this case, written confirmation for the API is required upon import into the EU. The response to 19A clarifies that unannounced inspections by the regulatory authority are not a requirement but should be an option available to the regulatory authority that would be consistent with requirements in the EU.

The UK MHRA also presented a Q&A document at an industry meeting held on November 15, 2012. It addresses 17 questions including administrative issues specific to the UK, including Customs and Excise processes. It includes several questions with regard to the need for manufacturers, importers and distributors to register along with information regarding forms required and the length of time it takes to complete registration. The Q&A clarifies that veterinary products are out of scope.

Additional revision to both documents may be published as interpretations are refined and additional detail on the implementation requirements are finalised.

The documents are available at the following links

EMA Q&A http://ec.europa.eu/health/files/gmp/2013_01_28_qa_en.pdf

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MHRA Q&A http://www.mhra.gov.uk/home/groups/es-policy/documents/websiteresources/con213169.pdf