EudraLex
Encyclopedia
EudraLex is the collection of rules and regulations governing medicinal products
in the European Union
.
Medication
A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease.- Classification :...
in the European Union
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
.
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 trialClinical trialClinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
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 PracticeGood Manufacturing Practice"Good manufacturing practice" or "GMP" are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients, diagnostics, foods,...
s. - Volume 9 - PharmacovigilancePharmacovigilancePharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines...
.
- Volume 4 - Good Manufacturing Practice
- Miscellaneous:
- Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)
Directives
- Directive 65/65/EEC1Directive 65/65/EEC1Directive 65/65/EEC1 was the first European pharmaceutical directive. -Intention:The directive was a reaction to the Thalidomide tragedy in the early 1960s, when thousands of babies were born with deformities as a result of their mothers taking the drug during pregnancy...
, requires prior approval for marketing of proprietary medicinal products - Directive 75/318/EECDirective 75/318/EECDirective 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...
, clarifies requirements of 65/65/EEC1 and requires member states to enforce them - Directive 75/319/EECDirective 75/319/EECDirective 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...
, requires marketing authorization requests to be drawn up only by qualified experts - Directive 93/41/EECDirective 93/41/EECCouncil 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 Council Regulation No 2309/93 of 22 July 1993...
, establishes the European Agency for the Evaluation of Medicinal Products - Directive 2001/20/ECDirective 2001/20/ECThe Clinical Trials Directive is a European Union directive that aimed at...
, defines rules for the conduct of clinical trials - Directive 2001/83/ECDirective 2001/83/ECDirective 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...
- Directive 2005/28/ECDirective 2005/28/ECThe Good Clinical Practice Directive lays down principles and detailed guidelines for good clinical practice as regards conducting clinical trials of medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.The directive...
, defines Good Clinical Practice for design and conduct of clinical trials
See also
- European Union lawEuropean Union lawEuropean Union law is a body of treaties and legislation, such as Regulations and Directives, which have direct effect or indirect effect on the laws of European Union member states. The three sources of European Union law are primary law, secondary law and supplementary law...
- European Union directiveEuropean Union directiveA directive is a legislative act of the European Union, which requires member states to achieve a particular result without dictating the means of achieving that result. It can be distinguished from regulations which are self-executing and do not require any implementing measures. Directives...
- European CommissionEuropean CommissionThe European Commission is the executive body of the European Union. The body is responsible for proposing legislation, implementing decisions, upholding the Union's treaties and the general day-to-day running of the Union....
- Directorate-GeneralDirectorate-GeneralA Directorate-General is a branch of an administration dedicated to a specific field of expertise.* The European Commission: Commission Directorates-General are each headed by a European Commissioner;* The European Patent Office: EPO Directorates-General;...
- EUR-LexEUR-LexEUR-Lex is a service providing legal texts of the European Union on its official website europa.eu. Replacing the earlier service CELEX, EUR-Lex provides direct free access to European Union law. The system makes it possible to consult the Official Journal of the European Union and it includes...
- Regulatory requirementRegulatory requirementRegulatory requirements are part of the process of drug discovery and drug development. Regulatory requirements describe what is necessary for a new drug to be approved for marketing in any particular country. In the US, it is the function of the Food and Drug Administration to establish these...
- Regulation of therapeutic goodsRegulation of therapeutic goodsThe regulation of therapeutic goods, that is drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency...
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
- Good clinical practiceGood clinical practiceGood Clinical Practice is an international quality standard that is provided by International Conference on Harmonisation , an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.Good Clinical Practice guidelines...
- European Medicines AgencyEuropean Medicines AgencyThe European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
- EUDRANETEUDRANETEUDRANET, the European Telecommunication Network in Pharmaceuticals , is an IT platform to facilitate the exchange of information between regulatory partners and industry during submission and evaluation of applications...
- EudraVigilanceEudraVigilanceEudraVigilance is the European data processing network and management system for reporting and evaluation of suspected adverse reactions during the development of new drugs and for following the marketing authorisation of medicinal products in the European Economic Area .The European...
- Title 21 of the Code of Federal RegulationsTitle 21 of the Code of Federal RegulationsTitle 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 , the Drug Enforcement Administration , and the Office of National Drug Control Policy ....
(USA) - Drug developmentDrug developmentDrug development is a blanket term used to define the process of bringing a new drug to the market once a lead compound has been identified through the process of drug discovery...
External links
- News on Pharmaceuticals, (European Union)
- EudraLex
- EUR-Lex
- Review of pharmaceutical legislation (EU DG Enterprise and Industry)
- Directorate General Enterprise and Industry (European Commission)