IPEC e-newsletter - Excipients Insight May 2011 - 01-06-11


Inside this issue


Word of the Chair

Breaking news: Council of the European Union adopts falsified medicines directive

The Council of the European Union gave a green light to the Directive on Falsified Medicines on May 27, which was adopted by the European Parliament in February.

The new directive includes a number of provisions to address falsified medicines, including the addition of safety features for prescription medicines, stricter controls for imported active pharmaceutical ingredients, harmonisation of GMP requirements and inspections and measures to protect the public from rogue Internet pharmacies selling fake drugs.

The Directive also has implications for suppliers and user of excipients, which it defines as "any constituent of a medicinal product other than the active substance and packaging material."

It calls for the development of formalised risk-assessment guidance by the Commission, which will be used by medicinal product manufacturers to gauge excipient supplies by looking at measures such as "source, intended use and previous instances of quality defects."

There are also changes regarding inspections, specifically that "manufacturers, located in the EU or in third countries, and wholesale distributors of medicinal products shall be subject to repeated inspections."

"The competent authority shall have a system of supervision including by inspections at an appropriate frequency based on risk, at the premises of the manufacturers, importers, or distributors of active substances, located on their territory, and effective follow up thereof," according to the Directive

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.

The Directive also breaks new ground in the way it will be implemented by Member States, as it departs from the traditional comitology procedure in favour of one based on 'delegated acts' and 'implementing measures'.

The Commission will prepare a report giving an overview of the transposition measures to be submitted to the Parliament and the Council six years and six months after publication of the Directive.




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