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)
Brokers of finished medicinal products
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.