Review of pharmaceutical legislation
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use
Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products
Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use
New Annex I to 2001/83 and new variation regulations
The new Annex I to Directive 2001/83/EC as well as the two new regulations on variations (Regulations (EC) No 1084/2003 and No 1085/2003) have been published in the Official Journal L 159 of 27.6.2003.
COMMISSION DIRECTIVE 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use
COMMISSION REGULATION (EC) No 1084/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State
COMMISSION REGULATION (EC) No 1085/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products falling within the scope of Council Regulation (EEC) No 2309/93
On the 2nd of June 2003, the Health Council adopted a political agreement on the proposal for Regulation modifying Council Regulation 2309/93 on the centralised procedure and the EMEA and on the proposal modifying Directive 2001/83/EC establishing a Community code on medicinal products for human use.
Amended proposal for a Regulation of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products
Amended proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use
Modified proposals for the Directives adopted by the CommissionAfter the first reading of the European Parliament, the Commission has adopted on 3 april 2003 the Modified Proposal of the Directive amending Directive 2001/83/EC on the Community Code relating to medicinal products for human use and of the Directive amending Directive 2001/82/EC on the Community Code relating to veterinary medicinal products
The modified proposals are available in all linguistic versions below:
After the first reading of the European Parliament, the Commission has adopted the modified proposal of the "regulation of the European Parliament and the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products".
Review of Pharmaceutical Legislation
Today the commission has officially transmitted to the European Parliament and the Council the three legislative proposals concerning the review of the Community Pharmaceutical Legislation
- Proposal for a Regulation of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products
- Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use
- Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products
Report on the operation of the authorisation procedures for medicinal products adopted and available in all languages of the European Community
Today, the Commission adopted the report on the experience acquired as a result of the operation of the procedures for granting marketing authorisations for medicinal products laid down in Regulation (EEC) N° 2309/93, in chapter III of directive 75/319/EEC and chapter IV of directive 81/851/EEC. This report is based on Article 71 of Regulation (EEC) No 2309/93
Press conference
Member of the European Commission, responsible for Enterprise and the Information Society
Commission's proposal to review EU pharmaceutical legislation
Press conference
Brussels, 18 July 2001
Memo
Press Release
Other documents
Review of the pharmaceutical legislation: Commission modified proposal for the Regulation
After the first reading of the European Parliament, the Commission has adopted the modified proposal of the "regulation of the European Parliament and the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products".
Discussion document (Final version)
Summary record of the Special Meeting on the "Review" 27th November 2000
European Commission - Enterprise and Industry Directorate General - Consumer goods - Pharmaceuticals - Last update :