Report on the Member States’ transposition of Article 118a of Directive 2001/83/EC on the Community code relating to medicinal products for human use

Background and further information:

The falsification of medicines is a serious threat to public health. Falsification affects a wide range of medicines, such as cancer, sexual dysfunction and Hepatitis C treatments. Falsified medicines can and do penetrate the legal supply chain, as seen with the discovery in 2014 of falsified vials of the cancer treatment Herceptin in multiple EU markets.

In 2011, the European Parliament and the Council adopted Directive 2011/62/EU (the Falsified Medicines Directive) to amend Directive 2001/83/EC and address increasing concerns regarding falsified medicines in the legal supply chain.

The Falsified Medicines Directive introduces mandatory safety features on prescription medicines from February 2019 (unless explicitly exempted), strengthens good distribution practices and requirements for wholesale distributors, reinforces rules on importation, controls and inspections of active substances and their manufacturers, and establishes an EU-wide logo to allow the identification of legal online retailers of medicines (applicable from 1 July 2015).

In order to ensure effective enforcement of these provisions, Article 118a of Directive 2001/83/EC requires Member States to 'lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and [to] take all necessary measures to ensure that those penalties are implemented'. Member States were to notify the Commission of their measures by 2 January 2013.

This report provides an overview of the Member States’ transposition measures and a qualitative assessment of their effectiveness.

European Commission: DG Health and Food Safety: Medicinal products: Falsified medicines https://ec.europa.eu/health/human-use/falsified_medicines_en

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