Ключевое слово фармацевтическое законодательство


Директивы Европейского союза

Директивы на русском языке (неофоциальные переводы)

Директивы на английском языке

  1. Council Directive 89/105/EEC of 21 December 1988 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
  2. Council Directive 89/342/EEC of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional provisions for immunological medicinal products consisting of vaccines, toxins or serums and allergens
  3. Council Directive 89/381/EEC of 14 June 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products and laying down special provisions for medicinal products derived from human blood or human plasma
  4. Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use
  5. Council Directive 92/25/EEC of 31 March 1992 on the wholesale distribution of medicinal products for human use
  6. Council Directive 92/26/EEC of 31 March 1992 concerning the classification for the supply of medicinal products for human use
  7. Council Directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets
  8. Council Directive 92/28/EEC of 31 March 1992 on the advertising of medicinal products for human use
  9. Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products
  10. Council Directive 93/40/EEC of 14 June 1993 amending Directives 81/851/EEC and 81/852/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products
  11. Commission Directive 96/68/EC of 21 October 1996 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance)
  12. Commission Directive 1999/104/EC of 22 December 1999 amending the Annex to Council Directive 81/852/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (Text with EEA relevance)
  13. Commission Directive 1999/73/EC of 19 July 1999 including an active substance (spiroxamine) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance)
  14. Commission Directive 2000/37/EC of 5 June 2000 amending Chapter VIa 'Pharmacovigilance' of Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products (Text with EEA relevance)
  15. Commission Directive 2000/38/EC of 5 June 2000 amending Chapter Va (Pharmacovigilance) of Council Directive 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (Text with EEA relevance)
  16. Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma
  17. Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products
  18. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
  19. Commission Directive 2003/94/EC of 8 October 2003 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 (Text with EEA relevance)
  20. Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use
  21. Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance)
  22. Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products (Text with EEA relevance)
  23. Commission Directive 2005/28/EC of 8 April 2005 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 (Text with EEA relevance)
  24. Commission Directive 2006/130/EC of 11 December 2006 implementing Directive 2001/82/EC of the European Parliament and of the Council as regards the establishment of criteria for exempting certain veterinary medicinal products for food-producing animals from the requirement of a veterinary prescription (Text with EEA relevance)
  25. Directive 2008/29/EC of the European Parliament and of the Council of 11 March 2008 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the implementing powers conferred on the Commission
  26. Commission Directive 2009/115/EC of 31 August 2009 amending Council Directive 91/414/EEC to include methomyl as active substance (Text with EEA relevance)
  27. Commission Directive 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products (Text with EEA relevance)
  28. Directive 2009/35/EC of the European Parliament and of the Council of 23 April 2009 on the colouring matters which may be added to medicinal products (recast) (Text with EEA relevance)
  29. Commission Directive 2009/87/EC of 29 July 2009 amending Directive 98/8/EC of the European Parliament and of the Council to include indoxacarb as an active substance in Annex I thereto (Text with EEA relevance)
  30. Commission Directive 2009/9/EC of 10 February 2009 amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use (Text with EEA relevance)
  31. Commission Directive 2009/98/EC of 4 August 2009 amending Directive 98/8/EC of the European Parliament and of the Council to include boric oxide as an active substance in Annex I thereto (Text with EEA relevance)
  32. Commission Directive 2009/99/EC of 4 August 2009 amending Directive 98/8/EC of the European Parliament and of the Council to include chlorophacinone as an active substance in Annex I thereto (Text with EEA relevance)
  33. Commission Directive 2011/14/EU of 24 February 2011 amending Council Directive 91/414/EEC to include profoxydim as active substance Text with EEA relevance
  34. Commission Directive 2011/22/EU of 3 March 2011 amending Council Directive 91/414/EEC to include bispyribac as active substance Text with EEA relevance
  35. Commission Directive 2011/23/EU of 3 March 2011 amending Council Directive 91/414/EEC to include triflumuron as active substance Text with EEA relevance
  36. Commission Directive (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use (Text with EEA relevance. )

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