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Inspections - Counterfeit Medicines

Warning about the possibility of fake medicines, for the treatment of influenza, being sold on the Internet:

The EMEA and National Competent Authorities in the Member States warn that criminal groups may take advantage of the current outbreak of  novel influenza virus A/H1N1 ('swine flu') ,  to sell fake, adulterated  or unauthorised antiviral medication or vaccines, via the Internet.  Members of the public who buy counterfeit or illicit copies of  these medicines may be putting their own health, or that of their families, at risk. 

Counterfeiters try to bypass the foreseen regulatory pathways of licensing and supervision by competent authorities. Such illegal trade often occurs through the internet. Counterfeits may include fakes which do not contain any of the medicine or contain the wrong medicine.

The EU has a strong legal framework for the licensing, manufacturing and distribution of medicines. At the end of the distribution chain, only licensed pharmacies and approved retailers are allowed to offer medicines for sale, including the legitimate sale over the Internet.  The EMEA, the European Commission and the Member States cooperate closely to combat fake medicines.  This cooperation also inlcudes the Council of Europe (in particular EDQM) and WHO (IMPACT).

Counterfeit medicines are part of the broader phenomenon of substandard pharmaceuticals - medicines manufactured below established standards of safety, quality and efficacy. They are deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit medicines may include products with the correct ingredients but fake packaging, with the wrong ingredients, without active ingredients or with insufficient active ingredients. This definition is provided by the World Health Organisation (WHO) in their Fact sheet on counterfeits.

Until recently, the most frequently counterfeited medicines in wealthy countries were new, expensive lifestyle medicines, such as hormones, steroids and antihistamines. In developing countries the most counterfeited medicines have been those used to treat life-threatening conditions such as malaria, tuberculosis and HIV/AIDS. As the phenomenon spreads, more and more medicines are counterfeited, including expensive ones, such as anti-cancer drugs, and those highly in demand, such as antivirals.

Regulators and industry are equally concerned about the rise in counterfeits. End of 2008 the European Commission made a legal proposal to combat counterfeits.
The Heads of Medicines Agencies (HMA) in their Strategy Paper, Section 7, stresses that although enforcement of medicines legislation is the competency of Member States, coordination between various national and international bodies involved in fighting counterfeits is necessary.

EMEA seeks to support anti-counterfeiting activities in close cooperation with the Commission and national medicines agencies by facilitating information sharing and coordinating actions (including recalls and testing) in the case of centrally authorised product counterfeits.

Documents under consultation

 

 

 

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