Council Decision of 20 May 1975 setting up a pharmaceutical committee (75/320/EEC)
Grade B
mapped from publisher markup. A grade says how a document's structure was obtained, not how reliable the law is.
Address https://gelex.eu/eli/EU/decision/1975/320@1975-05-20/en
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community;
Having regard to the proposal from the Commission;
Whereas the implementation of the measures adopted by the Council as regards the approximation of the laws relating to proprietary medicinal products for human use may raise problems which should be jointly examined;
Whereas, to this end, a Committee should be set up, chaired by a representative of the Commission and composed of representatives of the Member States from those States' administrations,
HAS DECIDED AS FOLLOWS:
Article 1
A Committee called the Pharmaceutical Committee shall be set up and attached to the Commission.
Article 2
Without prejudice to the tasks of the Committee for Proprietary Medicinal Products referred to in Article 8 of the Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, the task of this Committee shall be to examine: The Commission shall consult the Committee when preparing proposals for Directives in the field of proprietary medicinal products, and in particular when it considers any amendments to Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products which it might have occasion to propose.
any question relating to the application of Directives on proprietary medicinal products which are brought up by its Chairman — either on his initiative or at the request of the representative of a Member State;
any other question in the field of proprietary medicinal products brought up by its Chairman — either on his initiative or at the request of the representative of a Member State.
Article 3
1. The Committee shall consist of senior experts in public health matters from the Member States' administrations and each Member State shall have one representative.
2. There shall be one deputy for each representative. This deputy shall be entitled to participate in meetings of the Committee.
3. A representative of the Commission shall chair the Committee.
Article 4
The Committee shall adopt its rules of procedure.
Done at Brussels, 20 May 1975. For the Council The President R. Ryan
Versions
Cited by
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The tasks of the expert group shall not comprise issues covered by Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products and issues that fall under the tasks of the Committee of Orphan Medicinal Products (COMP), set up by Article 4 of that Regulation, nor issues that fall under the tasks of the Pharmaceutical Committee, set up by Council Decision 75/320/EEC.
- Commission Decision of 30 November 2009 establishing a European Union Committee of Experts on Rare Diseases (2009/872/EC) Decision · Grade B
The tasks of the Committee shall not comprise issues covered by Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products and issues that fall under the tasks of the Committee of Orphan Medicinal Products (COMP), set up by Article 4 of that Regulation, nor issues that fall under the tasks of the Pharmaceutical Committee, set up by Council Decision 75/320/EEC.
- Commission Decision of 3 June 2014 establishing a Commission expert group on Cancer Control and repealing Decision 96/469/EC 2014/C 167/05 Decision · Grade B
The tasks of the expert group shall not overlap with issues covered by the Advisory Committee on safety and health at work (ACSH) set up by Council Decision 2003/C 218/01 by the Scientific Committee on Occupational Exposure Limits for Chemical Agents set up by Commission Decision 2014/113/EU or under Directive 2004/37/EC on the protection of workers from the risks related to carcinogens and mutagens at work, nor issues that fall under the tasks of the Pharmaceutical Committee, set up by Council Decision 75/320/EEC.
- Decision of the Council and the Commission of 13 December 1993 on the conclusion of the Agreement on the European Economic Area between the European Communities, their Member States and the Republic of Austria, the Republic of Finland, the Republic of Iceland, the Principality of Liechtenstein, the Kingdom of Norway, the Kingdom of Sweden and the Swiss Confederation (94/1/ECSC, EC) Decision · Grade B
Scientific Committee for Food (Commission Decision 74/234/EEC) Pharmaceutical Committee (Council Decision 75/320/EEC) Scientific Veterinary Committee (Commission Decision 81/651/EEC) Committee on Transport Infrastructure (Council Decision 78/174/EEC) Administrative Commission on Social Security for Migrant Workers (Council Regulation (EEC) 1408/71) Contact Committee on Money Laundering, (Council Directive 91/308/EEC) Advisory Committee on Restrictive Practices and Dominant Positions (Council Regulation (EEC) 17/62) Advisory Committee on Concentrations (Council Regulation (EEC) 4064/89)
- Decision of the Council and the Commission of 13 December 1993 on the conclusion of the Agreement on the European Economic Area between the European Communities, their Member States and the Republic of Austria, the Republic of Finland, the Republic of Iceland, the Principality of Liechtenstein, the Kingdom of Norway, the Kingdom of Sweden and the Swiss Confederation (94/1/ECSC, EC) Decision · Grade B
MEDICINAL PRODUCTS The EFTA Surveillance Authority may designate, according to its working procedures, two observers entitled to participate in the tasks of the Committee which are described in Article 2, first indent of the Council Decision 75/320/EEC of 20 May 1975 setting up a pharmaceutical committee. Notwithstanding Article 101 of the Agreement, the EC Commission shall invite experts from the EFTA States according to Article 99 of the Agreement, to participate in the tasks which are described in Article 2, second indent of the Council Decision 75/320/EEC. The EC Commission shall, in due t
- P9_TA(2024)0220 Union code relating to medicinal products for human use European Parliament legislative resolution of 10 April 2024 on the proposal for a directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC (COM(2023)0192 – C9-0143/2023 – 2023/0132(COD)) (Ordinary legislative procedure: first reading) C/2025/1328 Notice · Grade B
Member States representatives may request the Commission to discuss issues related to the practical application of this Article in the Committee established by Council Decision 75/320/EEC (Pharmaceutical Committee). The Commission may invite bodies responsible for health technology assessment as referred to in Regulation (EU) 2021/2282 or national bodies responsible for pricing and reimbursement, as required, to participate in the deliberations of the Pharmaceutical Committee.