EudraLex is the collection of rules and regulations governing
medicinal products in 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 ...
.
Volumes
EudraLex consists of 10 volumes:
*Concerning Medicinal Products for Human use:
**Volume 1 - Pharmaceutical Legislation.
**Volume 2 - Notice to Applicants.
***Volume 2A deals with procedures for marketing authorisation.
***Volume 2B deals with the presentation and content of the application dossier.
***Volume 2C deals with Guidelines.
**Volume 3 - Guidelines.
*Concerning Medicinal Products for human use in
clinical trial
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, diet ...
s (investigational medicinal products).
**Volume 10 - Clinical trials.
*Concerning Veterinary Medicinal Products:
**Volume 5 - Pharmaceutical Legislation.
**Volume 6 - Notice to Applicants.
**Volume 7 - Guidelines.
**Volume 8 - Maximum residue limits.
*Concerning Medicinal Products for Human and Veterinary use:
**Volume 4 -
Good Manufacturing Practice
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceut ...
s.
**Volume 9 -
Pharmacovigilance.
*Miscellaneous:
**Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)
Directives
*
Directive 65/65/EEC1, requires prior approval for marketing of proprietary medicinal products
*
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 ...
, clarifies requirements of 65/65/EEC1 and requires member states to enforce them
*
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
*
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 ...
, establishes the European Agency for the Evaluation of Medicinal Products
*
Directive 2001/20/EC
The Clinical Trials Directive (Officially Directive 2001/20/EC of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to implementati ...
, defines rules for the conduct of
clinical trials
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dieta ...
*
Directive 2001/83/EC
Directive 2001/83/EC of the European Parliament 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 Directive dealt with the disparitie ...
*
Directive 2005/28/EC
{{Use dmy dates, date=July 2018
The Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005 of the European Parliament and of the Council) lays down principles and detailed guidelines for good clinical practice as regards conducting ...
, defines Good Clinical Practice for design and conduct of clinical trials
See also
*
European Union law
European Union law is a system of rules operating within the member states of the European Union (EU). Since the founding of the European Coal and Steel Community following World War II, the EU has developed the aim to "promote peace, its valu ...
*
European Union directive
A directive is a legal act of the European Union that requires member states to achieve a particular result without dictating the means of achieving that result. Directives first have to be enacted into national law by member states before thei ...
*
European Commission
The European Commission (EC) is the executive of the European Union (EU). It operates as a cabinet government, with 27 members of the Commission (informally known as "Commissioners") headed by a President. It includes an administrative body ...
*
Directorate-General
Within the European Union, Directorates-General are departments with specific zones of responsibility, the equivalent of ministries at a national level. Most are headed by a European Commissioner, responsible for the general direction of the Dir ...
*
EUR-Lex
Eur-Lex (stylized EUR-Lex) is an official website of European Union law and other public documents of the European Union (EU), published in 24 official languages of the EU. The Official Journal (OJ) of the European Union is also published on EU ...
*
Regulation of therapeutic goods
*
*
Good clinical practice Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements ...
*
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 ...
*
EUDRANET EUDRANET, the European Telecommunication Network in Pharmaceuticals (European Union Drug Regulating Authorities Network), is an IT platform to facilitate the exchange of information between regulatory partners and industry during submission and eval ...
*
EudraVigilance
EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is the European data processing network and management system for reporting and evaluation of suspected adverse reactions to medicines which have been authorised or bein ...
*
Title 21 of the Code of Federal Regulations
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (O ...
(USA)
*
Drug development
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for re ...
References
* Eudralex,The Rules Governing Medicinal Products in the European Union, European Communities Commission. Directorate-General for Industry, Pharmaceuticals and Cosmetics.
** Vol. 1: Pharmaceutical legislation: medicinal products for human use.
** Vol. 2: Notice to applicants: medicinal products for human use.
** Vol. 3: Guidelines: medicinal products for human use.
** Vol. 4: Good manufacturing practices: medicinal products for human and veterinary use.
** Vol. 5: Pharmaceutical legislation: veterinary medicinal products.
** Vol. 6: Notice to applicants: veterinary medical products.
** Vol. 7. Guidelines: Veterinary medicinal products.
* Markus Hartmann and Florence Hartmann-Vareilles, ''The Clinical Trials Directive: How Is It Affecting Europe's Noncommercial Research?'', PLoS Clin Trials. 2006 June; 1(2): e13
External links
News on Pharmaceuticals (European Union)
(EU DG Enterprise and Industry)
(European Commission)
{{drug control laws
Health and the European Union
European Union law
Pharmaceuticals policy
National agencies for drug regulation
de:Arzneimittelzulassung#Europäische Union