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EU Commission Concept Paper on API imports

Tuesday the 17th January 2012

Dear All,

The European Commission published a further Concept Paper regarding the implementation of Directive 20011/62/EU in December 2012. This Concept Paper was published to initiate public consultation regarding the implementation of the requirements for importing APIs from outside of the EU. According to Article 46b(2) of Directive 2001/83/EC, active substances shall only be imported if, inter alia, the active substances are accompanied by a written confirmation from the competent authority of the exporting third country which, as regards the plant manufacturing the exported active substance, confirms that the standards of good manufacturing practice and control of the plant are equivalent to those in the Union. The requirement of a written confirmation is waived for third countries listed by the Commission in accordance with Article 111b of Directive 2001/83/EC. Article 111b(2) of Directive 2001/83/EC provides that the Commission adopts an implementing measure to apply these requirements.

This Concept Paper is much harder to read than the one published in November 2011 regarding the possibilities for the implementation of the Safety Features requirements; it appears to have been written by a lawyer rather than a quality professional. It lists five consultation items that it would like input on:-

1. That the GMP standard to be applied should be that given in Part II of the EU GMP (i.e. ICH Q7). This seems to be a strange question, as what other possible standard could the EU apply?
2. This provides an audit checklist for the EU to apply when assessing a third country’s GMP inspection and enforcement systems.
3. Suggests that, to ensure that equivalence is maintained, the third country should participate in the EU’s ‘rapid alert’ system for reporting quality incidents that may impact on product quality.
4. Proposes that the verification of a third country’s GMP inspection and enforcement processes should take the form of:
a. A review of relevant documentation
b. an on-site review of the third country’s regulatory system, unless MRA is in place that covers the manufacturing of APIs; and
c. if necessary, an observed inspection of one or more of the third country’s manufacturing sites for active substances
It is also proposed that the first verification should take place no later than three years after the country has been included in the list. (This timeframe seems to be a problematic proposal as a company could legitimately use API from a country on the Commission’s approved list but could subsequently be in a very difficult position if up to three years later they were removed because they failed to meet the required standard during a verification audit. It would be far better if they were not added to the approved list until after the verification had successfully been concluded.)

5. Any other comments are requested.

Best regards,
Peter Gough, Partner

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