Implications for APIs in the European Falsified Medicines Directive - Pharmaceutical Technology

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Implications for APIs in the European Falsified Medicines Directive
Two industry groups offer perspectives on The European Falsified Medicines Directive.


Pharmaceutical Technology
pp. s44-s49


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Ensuring the quality of the pharmaceutical supply chain is of utmost importance to the pharmaceutical industry. The European Falsified Medicines Directive (FMD), which was adopted in July 2011, contains measures, which became effective in July 2013, requiring that all active substances manufactured outside the European Union (EU) be accompanied by a written confirmation from the regulatory authority of the exporting country. These statements are to be issued per manufacturing site and per active substance to ensure that standards of good manufacturing practice (GMP) equivalent to those in force in the EU are upheld. To gain insight on these provisions, two key industry groups, the Active Pharmaceuticals Ingredient Committee (APIC) and the European Fine Chemicals Group (EFCG), both sector groups of the European Chemical Industry Council (CEFIC), offered their perspectives on the strengths and weaknesses of the FMD.

The European Falsified Medicines Directive (FMD) seeks to prevent falsified medicines entering the legal supply chain in the European Union (EU). The directive was adopted in July 2011, and EU member states began applying provisions in January 2013. The purpose of the directive is to harmonize and strengthen safety and control measures across Europe in four main areas: safety features of medicines, the supply chain and good distribution practices (GDPs), active substances and excipients, and Internet sales (1-3).

From July 2, 2013, all active substances manufactured outside of the EU and imported into the EU must be accompanied by a written confirmation from the competent authority of the exporting country that confirms that the standards of good manufacturing practice (GMP) and control of the manufacturing plant are equivalent to those in the EU (4). These requirements constitute one of the main areas of change of the new FMD to provide a clear legal basis for the concept of international cooperation on active substances, which is based on sharing responsibilities with local regulators (4). The written confirmation is required per manufacturing site and per active substance and should provide the following assurances:

  • Standards of GMP applicable at the plant are at least equivalent to those in force in the EU.
  • The plant is subject to regular and strict controls and effective enforcement of GMP, including inspections.
  • Information on findings relating to noncompliance is supplied by the exporting third country without delay to the authorities in the importing country in the EU.

The duration of validity of the written confirmation is established by the exporting non-EU country (4). As noted by the European Medicines Agency (EMA), these new requirements reinforce the need for pharmaceutical companies to ensure that the active substance manufacturers they are working with are registered with their respective local authorities and subject to adequate regulatory oversight (4).

Additionally, the directive specifies that exporting countries with a regulatory framework equivalent to that of the EU will not need to issue written confirmations subject to approval.


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