European falsified meds directive: implications for manufacturers

pharmafile | June 7, 2011 | News story | Manufacturing and Production APIs, GDP, GMP, excipients, pharma manufacturing 

The Council of the European Union gave its backing to the new Directive on Falsified Medicines on May 27, setting the wheels in motion for its transposition into EU national law.

In addition to headline elements such as adding safety features to medicine packs and tackling the internet trade in counterfeit drugs, the Directive contains a number of clauses with implications for the day-to-day business of pharmaceutical manufacturing.

In particular, it introduces a number of changes to good manufacturing and distribution practices (GMP/GDP) for active pharmaceutical ingredients and excipients.

Once the Directive comes into force (via the EU’s new delegated acts process which makes the European Commission responsible for developing much of the technical and practical detail of the legislation), GMP requirements will be much more harmonised, and manufacturers will have to demonstrate greater oversight of the upstream supply chain.

For example they will have to obtain documented confirmation of compliance with EU GMP rules for imported APIs, issued by the regulatory authority of the exporting country, unless that country is on a list of countries recognised as having ‘equivalent’ regulatory standards, based on GMP rules, inspection and enforcement activity and communication with the EU authorities. A manufacturer should also declare in writing that API suppliers have been audited and comply with EU GMP.

In the area of APIs, registration of players in the supply chain – currently mandatory for manufacturers, distributors and importers of APIs – will be extended to include brokers which are involved in the sale or purchase of APIs indirectly, without owning and physically handling the products.

Registrations will be held in national databases held by the competent authority in each EU member state, and must be updated yearly, or when a change occurs in the business which could impact API safety or quality.

The Qualified Person (QP) at the pharmaceutical manufacturer has responsibility to verify API registrations and the safety, quality and authenticity of APIs, and also to inform the regulatory authority promptly if falsified medicines or starting materials are suspected.

API manufacturers, importers or distributors located within the EU will be inspected at a risk-based frequency, while those outside the EU may be inspected where there are grounds to suspect non-compliance, or at the request of an EU member state, competent authority or the API manufacturer itself.

For excipients, the Directive re-introduces the subject of GMP, even though a specific EU directive on GMP for excipients was shelved in 2009 on the grounds that it would be too costly to implement given the expected benefits.

Now, the Risk-assessment guidance for excipients should be developed by the Commission, which will be used by drugmakers to assess excipient supplies by looking at measures such as “source, intended use and previous instances of quality defects”.

The Directive as adopted will be published in the Official Journal of the European Union into all official languages of the EU. Once published, it will enter into force 20 days following publication. Member States will have 18 months to transpose the directive into their national law.

Phil Taylor

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