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Published on 23 November 2012

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Legislation on falsified medicines applicable 2 January 2013

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An excerpt from Council Directive 2011/62/EU
Directive 2011/62/EU of 8 June 2011 has amended 2001/83/EC relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products. This tightening was necessary in the face of overwhelming evidence that the 2001 Directive was failing to stem the flow of counterfeit medicines into the EU, up from just over 560,000 articles in 2005 to over 4 million in 2007, with up to 90% of medicines bought online being fake.
Here we reproduce the summary of amendments and insertions to Articles of 2001/83/EC. Member States are required to bring into force the laws, regulations and administrative procedures necessary to comply with the Directive by 2 January 2013. These focus on (i) an obligatory authenticity feature on the outer packaging of the medicines, (ii) a common, EU-wide logo to identify legal online pharmacies, (ii) tougher rules controlling the producers of active pharmaceutical ingredients, and (iv) more rigorous documentation on the part of wholesale distributors.
  1. Directive 2001/83/EC of the European Parliament and of the Council lays down the rules for, inter alia, manu­facturing, importing, placing on the market, and the wholesale distribution of medicinal products in the Union as well as rules relating to active substances.
  2. There is an alarming increase of medicinal products detected in the Union which are falsified in relation to their identity, history or source. Those products usually contain sub-standard or falsified ingredients, or no ingredients or ingredients, including active substances, in the wrong dosage thus posing an important threat to public health.
  3. Past experience shows that such falsified medicinal products do not reach patients only through illegal means, but via the legal supply chain as well. This poses a particular threat to human health and may lead to a lack of trust of the patient also in the legal supply chain. Directive 2001/83/EC should be amended in order to respond to this increasing threat.
  4. The threat to public health is also recognised by the World Health Organisation (WHO), which set up the International Medical Products Anti-Counterfeiting Taskforce (‘IMPACT’). IMPACT developed Principles and Elements for National Legislation against Counterfeit Medical Products, which were endorsed by the IMPACT General Meeting in Lisbon on 12 December 2007. The Union participated actively in IMPACT.
  5. A definition of ‘falsified medicinal product’ should be introduced in order to clearly distinguish falsified medicinal products from other illegal medicinal products, as well as from products infringing intellectual property rights. Furthermore, medicinal products with uninten­tional quality defects resulting from manufacturing or distribution errors should not be confused with falsified medicinal products. To ensure uniform application of this Directive, the terms ‘active substance’ and ‘excipient’ should also be defined.
  6. Persons procuring, holding, storing, supplying or exporting medicinal products are only entitled to pursue their activities if they meet the requirements for obtaining a wholesale distribution authorisation in accordance with Directive 2001/83/EC. However, today’s distribution network for medicinal products is increasingly complex and involves many players who are not necessarily wholesale distributors as referred to in that Directive. In order to ensure the reliability of the supply chain, legislation in relation to medicinal products should address all actors in the supply chain. This includes not only wholesale distributors, whether or not they physically handle the medicinal products, but also brokers who are involved in the sale or purchase of medicinal products without selling or purchasing those products themselves, and without owning and physically handling the medicinal products.
  7. Falsified active substances and active substances that do not comply with applicable requirements of Directive 2001/83/EC pose serious risks to public health. Those risks should be addressed by strengthening the verifi­cation requirements applicable to the manufacturer of the medicinal product.
  8. There is a range of different good manufacturing practices that are suitable for being applied to the manu­facturing of excipients. In order to provide for a high level of protection of public health, the manufacturer of the medicinal product should assess the suitability of excipients on the basis of appropriate good manufac­turing practices for excipients.
  9. In order to facilitate enforcement of and control of compliance with Union rules relating to active substances, the manufacturers, importers or distributors of those substances should notify the competent authorities concerned of their activities.
  10. Medicinal products may be introduced into the Union while not being intended to be imported, i.e. not intended to be released for free circulation. If those medicinal products are falsified they present a risk to public health within the Union. In addition, those falsified medicinal products may reach patients in third countries. Member States should take measures to prevent these falsified medicinal products, if introduced into the Union, from entering into circulation. When adopting provisions supplementing this obligation on Member States to take those measures, the Commission should take account of the administrative resources available and the practical implications, as well as the need to maintain swift trade flows for legitimate medicinal products. Those provisions should be without prejudice to customs legislation, to the distribution of competences between the Union and the Member States and to the distribution of responsibilities within Member States.
  11. Safety features for medicinal products should be harmonised within


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