Directive 2001/83 / EC (Community code for medicinal products for human use)

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Directive 2001/83 / EC

Title: Directive 2001/83 / EC of the European Parliament and of the Council of 6 November 2001 on the creation of a Community code for medicinal products for human use
Designation:
(not official) 		Community code for medicinal products for human use
Scope: EEA
Legal matter: Pharmaceutical law
Basis: Treaty of Amsterdam , in particular Art. 95 , Art. 251
Procedure overview: European Commission
European Parliament
IPEX Wiki
Date of issue: November 6, 2001
Release date: November 28, 2001
Come into effect: December 18, 2001
Replaces: Directive 65/65 / EEC Directive 75/318 / EEC Directive 75/319 / EEC Directive 89/342 / EEC Directive 89/343 / EEC Directive 89/381 / EEC Directive 92/25 / EEC Directive 92/26 / EEC Directive 92 / 27 / EEC Directive 92/28 / EEC Directive 92/73 / EEC
Last change by: Regulation (EU) 2019/1243
Implemented by: Medicines Act (Germany) ,
Medicines Act (Austria)
Reference: OJ No. L 311/67, November 28, 2001, pp. 67-128
Full text Consolidated version (not official)
basic version
The regulation must have been implemented in national law.
Please note the information on the current version of legal acts of the European Union !

The Directive 2001/83 / EC is a Directive of the European Union in which the directives adopted since 1965, the human drug- relate, were combined into a Community Code. A number of directives have largely harmonized pharmaceutical law in the European Union over the past few decades . As a directive of the European Parliament and the Council, Directive 2001/83 / EC has an indirect effect in that it obliges the member states of the European Union to implement the directive in national laws. The scope of the directive was extended to the whole of the EEA in 2002 .

meaning

Directive 2001/83 / EC codifies principles for the manufacture, authorization , marketing and monitoring of medicinal products for human use. This means that technical and scientific hurdles have been removed in order to achieve the European internal market for pharmaceuticals. Among other things, the directive defines the non-centralized procedures for EU-wide drug approval. Arbitration procedures are foreseen if individual Member States have concerns about a serious public health hazard. The harmonization does not affect aspects of social law such as the pricing and reimbursement of pharmaceuticals.

Analogous to Directive 2001/83 / EC, all directives relating to medicinal products for use in animals have been combined in Directive 2001/82 / EC to form a Community code for veterinary medicinal products .

The centralized EU approval procedure is not determined by the directive, but by Regulation (EC) No. 726/2004 .

Implementation in national law

EC directives have to be implemented in national law by the member states. In Germany this happened with the Medicines Act of 1976 and various amendments to it. Parts of the guideline have also been implemented with the drug and active ingredient manufacturing ordinance and the drug testing guidelines . The drug testing guidelines , an administrative regulation , adopts the extensive Annex I of the guideline into national law.

In Austria, the directive has been implemented with the Medicines Act and the Medicines Works Regulations.

structure

The guideline is divided into fifteen titles and three annexes. Title I contains definitions, Title II defines the field of application. Title III regulates the placing on the market , Title IV the manufacture and import of medicinal products. Title V deals with the labeling and the package insert , Title VI with the classification of medicinal products, including the prescription requirement . Title VII regulates the wholesale , Title VIIa selling at a distance, Title VIII, the advertising of medicinal products , the title VIIIa again drug information and advertising. Title IX contains regulations on pharmacovigilance , Title X on blood products . Title XI deals with surveillance and sanctions. Title XII is the legal basis for the Standing Committee, in which representatives of the member states support the European Commission in adapting the directives, but also in decisions on drug approvals. Finally, Title XIII contains general provisions and Title XIV final provisions.

In the extensive Appendix I, the authorization requirements for medicinal products for human use are listed in detail. Part I contains the standard requirements, including evidence of pharmaceutical quality, non-clinical pharmacology and toxicity determination, and clinical testing . Part I also contains information on the Common Technical Document , the format in which the approval documents are to be submitted. Part II contains information on specific authorization applications, for example for generics and biosimilars . Part III prescribes the information to be provided on specific medicinal products, including biological (e.g. vaccines ), radiopharmaceutical , homeopathic and phytotherapeutic medicinal products . Finally, Part IV describes the information required on advanced therapy medicinal products, which include medicinal products for gene therapy and somatic cell therapy .

Annex II lists the directives repealed by Directive 2001/83 / EC, along with the deadlines with which they were to be implemented in national law in the member states. Annex III contains a correspondence table between the new directive and the repealed directives.

history

The guideline was adopted in 2001 with the aim of bringing together the existing guidelines in the European Union in the area of ​​medicinal products law dealing with medicinal products for human use, in order to obtain a better overview and clarity in this area. Since 1965, starting with Directive 65/65 / EEC, a whole series of directives had been passed, some of which were changed several times. In Directive 2001/83 / EC, a total of eleven old directives have been combined and repealed.

The directive has been further developed since it came into force. Since 2001, six directives have been passed that essentially supplemented or amended Directive 2001/83 / EC: Directive 2002/98 / EC, which regulates blood products, Directive 2003/63 / EC on biological medicinal products, Directive 2004/24 / EC on traditional herbal medicinal products and Directive 2004/27 / EC, with which the original Directive 2001/83 / EC was substantially revised.

In recent years the directive has also been supplemented and amended by the regulation on medicinal products for children and by the regulation on advanced therapy medicinal products . Directive 2008/29 / EC made technical adjustments to the committee procedures in which the standing committee is involved, Directive 2009/53 / EC changed the conditions for marketing authorizations for medicinal products, while Directive 2009/120 / EC based on scientific and technical progress in advanced therapies has adapted Annex I of Directive 2001/83 / EC.

Web links

Individual evidence

  1. ↑ Decision of the Joint EEA Committee No. 82/2002 of June 25, 2002 amending Annex II (Technical Regulations, Standards, Testing and Certification) of the EEA Agreement
  2. ↑ Directive 2001/82 / EC
  3. ↑ Directive 65/65 / EEC
  4. ↑ Directive 2002/98 / EC
  5. ↑ Directive 2003/63 / EC
  6. ↑ Directive 2004/24 / EC
  7. ↑ Directive 2004/27 / EC
  8. ↑ Regulation (EC) No. 1901/2006
  9. ↑ Regulation (EC) No. 1394/2007
  10. ↑ Directive 2008/29 / EC
  11. ↑ Directive 2009/53 / EC
  12. ↑ Directive 2009/120 / EC