Directive 2001/83/EC of the
European Parliament
The European Parliament (EP) is one of the Legislature, legislative bodies of the European Union and one of its seven Institutions of the European Union, institutions. Together with the Council of the European Union (known as the Council and in ...
and of the Council of 6 November 2001 on the Community code relates to medicinal products for human use in mainly countries that are part of the
European Union
The European Union (EU) is a supranational union, supranational political union, political and economic union of Member state of the European Union, member states that are located primarily in Europe, Europe. The union has a total area of ...
.
The Directive dealt with the disparities between certain national provisions, in particular between provisions relating to medicinal products, which directly affected the functioning of the internal market of the European Union.
See also
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EudraLex
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Directive 65/65/EEC1, requires prior approval for marketing of proprietary medicinal products
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Directive 75/318/EEC Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products. This directive of ...
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Directive 75/319/EEC Directive 75/319/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products. This directive of ...
, requires marketing authorization requests to be drawn up only by qualified experts
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Directive 93/41/EEC Council of the European Communities Directive 93/41/EEC of 14 June 1993 repealed Directive 87/22/EEC on the approximation of national measures relating to the marketing of high-technology medicinal products, as this directive had been superseded by ...
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Directive 2001/20/EC
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Regulation of therapeutic goods
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European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or Eur ...
References
{{DEFAULTSORT:Directive 2001 83 EC
Health and the European Union
Pharmaceuticals policy
2001 82
2001 in law
2001 in the European Union