New MHRA Q & A Document on the Import of Active Pharmaceutical Ingredients

The Directive 2011/62/EU on the prevention of the entry of falsified medicinal products was published on 1 July 2011. In article 46 b it lays down strict rules for the import of active ingredients in the EU. Each import from countries outside of the EU must be accompanied by a written confirmation. Only the countries whose control of the manufacturing and distribution of active ingredients is considered as being equivalent to the EU standard and which consequently are in the White List maintained by the European Medicines Agency are exempted from this requirement. A further exemption is made for manufacturing sites in non-EU-countries that possess a certificate of Good Manufacturing Practice after having been inspected successfully by the authorities. In this case the exemption is only made for a period not exceeding the validity of the certificate of Good Manufacturing Practice. Afterwards the written confirmation is required again.

The United Kingdom is in the process of transposing the Directive into national law. The MHRA has already published some interesting consultation documents with regard to the effects and consequences of the Directive's requirements. As part of the consultation process a meeting between MHRA and representatives of industry was held on 15 November 2012. From this meeting resulted a questions- and-answers-document. This document contains 17 questions and opinions - partly with sensitive content - that underline the problems of the new import rules. The following is a selection of some of the issues:

  • India is to set up a 'written confirmation' process that is founded on only a brief site visit by the authorities. Will this truly add assurance to the supply chain?
    Currently the situation with India remains unclear. Until more information is made available this position should not be relied upon. 
  • Does the MHRA have inspection resource that could be used to inspect active ingredients producers in third countries?
    Currently the MHRA does not have sufficient resource for this.
  • What are the differences between manufacture, import and distribution?
    No difference is made between import and distribution activities. For both a GDP certificate is required. A GMP certificate is mandatory for the manufacturer of an active ingredient.
  • If an active ingredient has been imported for an investigational medicinal product and stocks of the active ingredient remain, can these be used for the manufacture of early commercial batches of medicinal products?
    Unless the active ingredient is covered by a written confirmation, it cannot be used for this purpose.

The answers given in the Q & A document show how the United Kingdom deals with the new situation. The different EU member states surely take different approaches to the implementation of the requirements of Directive 2011/62/EU as regards the import of active ingredients.  But one problem will be the same in all EU member states: the lacking human resources of the authorities to inspect active ingredient producers in third countries. But the pharmaceutical companies won't have much time to prepare for the new situation - especially as concerns the prevention of supply shortages (see our news dated 27 June 2012) - since the new import rules will be valid as of 2 July 2013!

Please also see the MHRA Medicines Regulatory News with the announcement of the Q & A document as well as the Q&A document itself.

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