L 174/74 Official Journal of the European Union 1.7.2011 DIRECTIVE 2011/62/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114, and point (c) of Article 168(4), thereof, Having regard to the proposal from the European Commission, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) () Directive 2001/83/EC of the European Parliament and of the Council (* lays down the rules for, inter alia, manu- facturing, importing, placing on the market, and the wholesale distribution of medicinal products in the Union as well as rules relating to active substances. 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. 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. 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. A definition of ‘falsified medicinal product’ should be introduced in order to clearly distinguish falsified () O] C 317, 23.12.2009, p. 62. () O] C 79, 27.3.2010, p. 50. (®) Position of the European Parliament of 16 February 2011 (not yet published in the Official Journal) and decision of the Council of 27 May 2011. (* OJ L 311, 28.11.2001, p. 67. (10) medicinal products from other illegal medicinal products, as well as from products infringing intellectual property rights. Furthermore, medicinal products with uninten- tional 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. 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. 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 verifi- cation requirements applicable to the manufacturer of the medicinal product. There is a range of different good manufacturing practices that are suitable for being applied to the manu- facturing 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 manufac- turing practices for excipients. 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. Medicinal products may be introduced into the Union while not being intended to be imported, ie. 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