On 1 July 2011 the European Commission published (external link) in the Official Journal of the European Union. introduces a number of amendments to Directive 2001/83/EC (“the 2001 Directive”) aimed at dealing with the increasing incidence of falsified medicinal products penetrating the legitimate supply chain. The UK government is required to implement these changes in law, and has just completed its public consultation :
The 2011 Directive lays down the rules for manufacturing, importing, placing on the market, and the wholesale distribution of medicinal products in the European Union as well as rules relating to active substances and certain excipients.
Falsified Medicines Directive amongst other measures makes a number of significant changes to the controls on active substances and excipients intended for use in the manufacture of a medicinal product for human use, and in particular introduces two new definitions for Active substances and Excipients.
The manufacture of active substances should be subject to good manufacturing practice regardless of whether those active substances are manufactured in the Union or imported. Where active substances are manufactured in third countries it should be ensured that such substances have been manufactured to the relevant European standards of good manufacturing practice, so as to provide a level of protection of public health equivalent to that provided for by EU law.
Where API is imported into the UK, and is intended for use either in an authorised medicinal product or for export to a third country, the importer should obtain confirmation that the API has been manufactured in accordance with the relevant requirements of EU GMP by one of two means:
- by obtaining a written confirmation from the Competent Authority of the exporting third country, with such confirmation to accompany the shipment, that the API has been:
- manufactured to GMP standards at least equivalent to those laid down in the European Union,
- the third country manufacturing plant is subject to regular, strict and transparent inspections, and effective enforcement of GMP,
- in the event of non-conformance of the manufacturing site on inspection, such findings will be communicated to the European Union without delay.
- by reference to a “white list”, prepared by the European Medicines Agency, of third countries assessed as providing equivalent regulatory controls over API manufacture and distribution as those applied in the EU. This assessment would follow a request for assessment from the exporting third country Competent Authority, and consider the regulatory framework for API manufacture and control and its equivalence to EU standards.
Exceptionally, Member States can waive the requirement for a written confirmation in relation to a specific API manufacturing site which has been inspected by an EU Competent Authority and issued with a GMP Certificate. Such a waiver should only be used where necessary to ensure the availability of medicinal products, and is only valid as long as the GMP Certificate is valid. Member States using this waiver should communicate this fact to the European Commission.
The collection of Q&As taken from the MHRA’s engagement with industry stakeholders on the 15 November 2012 to review their arrangements to ensure the security of supply of active substances and their compliance with the importation provisions of the Falsified Medicines Directive is now available.
Q&As from the Falsified Medicines Directive MHRA/industry meeting