Legal framework governing medicinal products for human use in the EU

Gavel with scales and book in the background © khz -

The EU legal framework for medicinal products for human use is intended to ensure a high level of public health protection and to promote the functioning of the internal market, with measures which moreover encourage innovation. It is based on the principle that the placing on the market of medicinal products is made subject to the granting of a marketing authorisation by the competent authorities.

A large body of legislation has developed around this principle, with the progressive harmonisation of requirements for the granting of marketing authorisations since the 1960s, implemented across the EEA.

Community authorisation procedures (centralised, mutual recognition) are in place since the mid-90s and in addition the system is supported by a Community regulatory agency in charge of providing the EU institutions with scientific advice on medicinal products: the European Medicines Agency (EMA).

The requirements and procedures for the marketing authorisation for medicinal products for human use, as well as the rules for the constant supervision of products after they have been authorised, are primarily laid down in Directive 2001/83/ECpdf(2 MB) and in Regulation (EC) No 726/2004pdf . These texts additionally lay down harmonised provisions in related areas such as the manufacturing, wholesaling or advertising of medicinal products for human use.

Community legislation also provides for common rules for the conduct of clinical trials (the investigations in humans intended to discover or verify the effects of medicinal products before their authorisation) in the EU.

In addition, various rules have been adopted to address the particularities of certain types of medicinal products and promote research in specific areas: orphan medicinal products ( Regulation (EC) No 141/2000pdf ), medicinal products for children ( Regulation (EC) No 1901/2006pdf ) and advanced therapy medicinal products ( Regulation (EC) No 1394/2007pdf ).

All Community legislation in the area of medicinal products for human use is contained in volume 1 of "The Rules Governing Medicinal Products in the European Union".

To facilitate the interpretation of the legislation and its uniform application across the EU, numerous guidelines of regulatory and scientific nature have additionally been adopted:

A detailed explanation of the marketing authorisation procedures and other regulatory guidance intended for applicants is contained in volume 2 (Notice to Applicants).

Scientific guidance on the quality, safety and efficacy of medicinal products is provided in volume 3.

Specific guidance on the legal requirements concerning good manufacturing practices, pharmacovigilance and clinical trials is laid down in volumes 4, 9 and 10, respectively.

  • For access to EU pharmaceutical legislation consult EUDRALEX
  • For a summary of EU pharmaceutical legislation consult SCADPlus