Anti-Counterfeiting Directive requires Import Certificate for the Import of APIs from Third Countries into the EU

The new Directive 2011/62/EU includes an entire set of measures for protecting consumers against counterfeited medicinal products. Among them is Article 46b(2) in the Directive 2011/83/EC which will be revised that way, that APIs can only be imported into the EU if they are accompanied by a written statement from the exporting country's competent authority confirming that the following requirements are fulfilled:

  • The GMP regulations in the exporting country are at least equivalent to those in the EU
  • The manufacturer is inspected regularly and rigorously. The inspections are conducted unannounced. Measures are taken in the case of GMP violations.
  • In the case of GMP violations the EU (i.e. the authorities of the member states) are informed immediately.

This written statement may only be waived if the exporting country is accepted on a list maintained by the EU Commission. This list comprises countries the EU Commission evaluates positively with regard to their level of adherence to GMP regulations (see above mentioned requirements). This implies a local evaluation of the Commission which is only conducted upon request of the third country, though.

For starting this procedure a so called "Implementing Act" is necessary. As a first step in preparing this implementing order the EU Commission has issued a concept paper for consultation on 7 December 2011. This paper describes the procedure of the equivalence assessment of the third country and comprises an audit checklist with items that are reviewed as part of the evaluation. The items are categorised as "very important" and "critical". Part of the critical items reviewed locally by the Commission are for instance

  • How the competent authority deals with GMP violations in API manufacturing sites,
  • Related to that the effectiveness of the nationwide alert mechanism
  • The official QM system
  • The quality and accessibility of state examination offices resp. laboratory facilities

The third countries with a Mutual Recognition Agreement (MRA) are of course excepted from the evaluation assessment if the MRA also covers APIs.

The concept paper can be commented for three months, the consultation period ends on 23 March 2012. Please also see the concept paper "Implementing Act on the Requirements for the Assessment of the regulatory Framework applicable to the Manufacturing of Active Substances of Medicinal Products for Human Use".

Note: In the ICH Q7 Compliance Courses for APIs of chemical and biotechnological origin in Prague, Czech Republic, from 23-27 January 2012 the GMP requirements with regard to APIs will be discussed in detail. You can find further information at

Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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