New Rules for the Importation of APIs - a European Commission Leaflet provides Information

The rules for importing active substances for medicinal products for human use from third countries into the EU have been reformed (see our news from 11 July 2012). As of 2 January 2013, all imported active substances must have been manufactured in compliance with GMP and as of 2 July 2013 each consignment of such an active substance must be accompanied by a written confirmation stating that it has been manufactured in compliance with standards of good manufacturing practices or at least with equivalent standards. This written confirmation must be issued by an authority of the third country. This requirement is not valid for the manufacture of veterinary medicinal products.

In order to clarify the details of these rules, the European Commission has already published a document setting out 32 obvious and frequently-asked questions and answers. Recently, the document "New rules on importing active pharmaceutical ingredients into the European Union" by the European Commission was published. It explains the most important facts of the new rules in short form. For this information leaflet the Commission has chosen the six most important questions and answers from the collection of the questions and answers document. The following fundamental points are dealt with:

  • Who issues the written confirmation? 
  • Does written confirmation need to be issued for each batch/consignment? 
  • Does each imported consignment have to be accompanied by a written confirmation? 
  • Are there exceptions from the written confirmation requirement?
  • Is a written confirmation needed, even though the manufacturing site has recently been inspected by an authority of an EU Member State or by the EDQM?
  • Is a written confirmation also required where there is a 'mutual recognition agreement' between the exporting country and the EU?

The information leaflet also contains the template "Written Confirmation" that must be used for the importation of active substances.

Pharmaceutical companies are short of time to adjust to these new rules. This represents a major challenge in the light of the fact that the written confirmations have to be obtained from the authorities of the exporting countries until 2 July 2013. In this confirmation the authority of the exporting third country commits itself to inform the EMA about serious findings of non-compliance with GMP without delay. This will not really encourage the authorities' willingness to issue the written confirmation. Because of the short period until the rules' entry into force, the MHRA has already pointed out in a letter addressed to the European Commission Unit SANCO that the EU authorities need, urgently, to engage with third country regulators to inform them about the changes in the legislation. We reported on this in our news from 27 June 2012.

You can find further information in the European Commission leaflet "New rules on importing active pharmaceutical ingredients into the European Union" which includes the template for the written confirmation.

In this context also read the European Commission document "Importation of Active Substances for Medicinal Products for Human Use" with 32 questions and answers concerning the written confirmation.


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

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