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Community legislation and guidance documents
Directives
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.
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Commission Directive 2003/63/EC of 25 June 2003 amending Directive
2001/83/EC of the European Parliament and of the Council on the Community
code relating to medicinal products for human use.
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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.
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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.
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Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use.
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Directive 2001/20/EC of the European Parliament and
of the Council of 4 April 2001 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.
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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.
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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.
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Further compilation of Community Pharmaceutical Legislation may be found at: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/index.htm
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Last update: Friday, 31 May 2013. |
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