The Falsified Medicines Directive

The Falsified Medicines Directive came into force in Europe in January 2013. The new directive introduces measures to prevent the entry of falsified medicines into the legal supply chain. The directive substantially changes the European framework around the supply of medicines and covers businesses that have traditionally not been directly regulated through medicines regulation.

European Directive 2011/62/EU of the European Parliament and of the Council (the Falsified Medicines Directive) amends Directive 2001/83/EC on the Community code relating to medicinal products for human use.

The Falsified Medicines Directive is transposed through The Human Medicines (Amendment) Regulations 2013 [SI 2013/1855] which came into force on 20 August 2013.

Directive 2011/62/EU (external link)

Directive 2001/83/EC (external link)


Background

The page gives a background to the Falsified Medicines Directive.
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Brokers of finished medicinal products

To ensure the reliability of the supply chain, the Falsified Medicines Directive extends medicine legislation to the entire supply chain.
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Legislation

This page gives information on the legislative background which underpins the Falsified Medicines Directive.
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Importation of active substances

New requirements for active substances imported into the European Economic Area for use in the manufacture of authorised medicinal products have been introduced under the Falsified Medicines Directive.

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Importing medicinal products for export (introduced medicines)

The Falsified Medicines Directive establishes a new definition of 'introduced' medicines, regarding medicines that are imported into a Member State of the EU solely for the purpose of export to a third country, with no intention that the medicine will be placed on the market in the EU.

Registration of manufacturers, importers and distributors of active substances

The Falsified Medicines Directive lays down the rules for the manufacture, import, marketing and supply of medicinal products.

Safety features

The Falsified Medicines Directive introduces the requirements for the outer packaging of certain medicines to include unspecified safety features.

Sales of medicines at a distance to the public

The illegal sale of medicinal products to the public via the internet is an important threat to public health as falsified medicinal products may reach the public in this way.
Page last modified: 23 August 2013