EU legislation

Community legal regulations.         

Please note: regulations are directly effective, while directives have to be transposed to national legislation.

1) EU legal regulations governing pharmaceuticals:

A) Directives:

  • Commission Directive 2006/17/EC (32006L0017), implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells
  • Commission Directive 2005/62/EC (32005L0062), implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments
  • Commission Directive 2005/61/EC (32005L0061), implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events 
  • Commission Directive 2005/28/EC (32005L0028), laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products
  • Commission Directive 2004/33/EC (32004L0033), implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components
  • Directive 2004/23/EC (32004L0023), of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells
  • Directive 2004/9/EC (32004L0009), of the European Parliament and of the Council on the inspection and verification of good laboratory practice (GLP)
  • Directive 2004/10/EC (32004L0010), of the European Parliament and of the Council on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (codified version)
  • Commission Directive 2003/94/EC (32003L0094), laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use 
  • Directive 2002/98/EC (32002L0098), of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC
  • Directive 2001/83/EC ( 32001L0083) of the European Parliament and of the Council on the Community code relating to medicinal products for human use 
  • Directive 2001/20/EC ( 32001L0020)  of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use 
  • Directive 2001/18/EC ( 32001L0018) of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC 
  • Council Directive 93/41/EEC (31993L0041), repealing Directive 87/22/EEC on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology
  • Council Directive 90/219/EEC (31990L0219), on the contained use of genetically modified micro-organisms
  • Council Directive 78/25/EEC ( 31978L0025), on the approximation of the laws of the Member States relating to the colouring matters which may be added to medicinal products

B) Regulations:

  • Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004  
  • Commission Regulation (EC) No 658/2007 (32007R0658), of 14 June 2007 concerning financial penalties for infringement of certain obligations in connection with marketingauthorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council 
  • Regulation (EC) No 850/2004 (32004R0850), of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC
  • Regulation (EC) No 1901/2006 (32006R1901), of the European Parliament and of the Council on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004
  • Regulation (EC) No 726/2004 (32004R0726), of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency 
  • Commission Regulation (EC) No 1084/2003 (32003R1084),  concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State 
  • Commission Regulation (EC) No 1085/2003 (32003R1085), concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products falling within the scope of Council Regulation (EEC) No 2309/93 
  • Council Regulation (EC) No 953/2003 (32003R0953), to avoid trade diversion into the European Union of certain key medicines
  • Commission Regulation (EC) No 847/2000 (32000R0847), laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts 'similar medicinal product' and 'clinical superiority'
  • Regulation (EC) No 141/2000 (32000R0141), of the European Parliament and of the Council on orphan medicinal products 
  • Commission Regulation (EC) No 2141/96 (31996R2141), concerning the examination of an application for the transfer of a marketing authorization for a medicinal product falling within the scope of Council Regulation (EC) No 2309/93 
  • Commission Regulation (EC) No 1662/95 (31995R1662), laying down certain detailed arrangements for implementing the Community decision-making procedures in respect of marketing authorizations for products for human or veterinary use
  • Commission Regulation (EC) No 540/95 (31995R0540), laying down the arrangements for reporting suspected unexpected adverse reactions which are not serious, whether arising in the Community or in a third country, to medicinal products for human or veterinary use authorised in accordance with the provisions of Council Regulation (EEC) No 2309/93 
  • Council Regulation (EC) No 297/95 (31995R0297), on fees payable to the European Agency for the Evaluation of Medicinal Products
  • Council Regulation (EEC) No 1768/92 (31992R1768), concerning the creation of a supplementary protection certificate for medicinal products

C) Council Decisions:

  • 94/358/EC: Council Decision  (31994D0358), accepting, on behalf of the European Community, the Convention on the elaboration of a European Pharmacopoeia
  • 75/320/EEC: Council Decision (31975D0320), setting up a pharmaceutical committee 
  • 2001/571/EC: Commission Decision on the national provisions notified by Germany in the field of pharmacovigilance

2) EC legal regulations governing prices and reimbursements:

  • Council Directive 89/105/EEC (31989L0105), relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems

3) EC legal regulations governing medical devices:

  • Directive 2007/47/EC of the European Parliament and of the Council (32007L0047),  amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market