What is eu Directive 2001 83 EC?
From Wikipedia, the free encyclopedia. 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.
What is Regulation EC No 726 2004?
The purpose of this Regulation is to lay down Community procedures for the authorisation, supervision and pharmacovigilance of medicinal products for human and veterinary use, and to establish a European Medicines Agency (hereinafter referred to as ‘the Agency’).
How many volumes are there in EudraLex?
10 volumes
EudraLex consists of 10 volumes: Concerning Medicinal Products for Human use: Volume 1 – Pharmaceutical Legislation.
What is CMDh?
The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh), was set up in Directive 2004/27/ EC for the examination of any question relating to marketing authorisations of a medicinal product in two or more Member States in accordance with the mutual recognition procedure or the …
Is EudraLex legally binding?
It is not legally binding and, in case of doubt, reference should be made to the appropriate EU Directives and Regulations. Notice to applicants documents are publicly available under: EudraLex – Volume 2 – Pharmaceutical Legislation Notice to Applicants and regulatory guidelines medicinal products for human use.
What is pharmacovigilance commonly called?
Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
What is a Type 1a variation?
A minor change to a marketing authorisation that has a minimal or no impact on the quality, safety or efficacy of the medicine and does not require prior approval before implementation by the marketing authorisation holder. For more information, see type IA variations: questions and answers.
How do EU directives work?
An EU directive is a legal act which requires member states to accomplish a particular set of goals without dictating the means to do it. In other words, it outlines certain rules which must be met, but each member state decides how to ensure compliance through national laws.
What is the difference between directives regulations and decisions?
Directives lay down certain results that must be achieved but each Member State is free to decide how to transpose directives into national laws. Decisions are EU laws relating to specific cases and directed to individual or several Member States, companies or private individuals.
For what pharmacovigilance is required?
The role of pharmacovigilance is to determine which adverse events cross the line of a drug’s efficacy. In other words, analysing which side effects are worth the risk to patients compared with how effective they are at treating a disease.
What are the types of pharmacovigilance?
1.1 Defining pharmacovigilance They may vary in presentation and occurrence and are commonly divided into type A (augmented pharmaceutical response) and type B (bizarre or hypersensitivity) adverse drug reactions (3). throughout a drug’s market life. Pre-marketing safety assessment is generally limited for children.
What was the name of the EU Directive 2001 / 83?
Directive 2001/83/EC of the European Parliament and of the Council Show full title Directives originating from the EU 2001 No. 83
What was the community code of 2001 / 83 / EC?
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. THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
What was the first EU Medicinal Products Directive?
Beginning with Directive 65/65/EEC the European Community adopted a highly sophisticated system of legal provisions dealing with medicinal products. The system mainly was formed by a conglomeration of Directives, each dealing with aspects of the law on medicinal products.
When did the community code directive come into effect?
In November 2001, European Parliament and the Council adopted Directive 2001/83/EC on the Community Code relating to medicinal products for human use. The so-called “Community Code Directive” combined in one legal act nearly all aspects of European law on medicinal products.