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
- No longer in force
- CELEX number: 31975L0319
- Official Journal: JOL_1975_147_R_0013_010
- Form: Directive
- Procedure number: --
- Languages:
- da
- de
- el
- en
- fi
- fr
- it
- nl
- pt
- es
- sv
Dates
Date of document: - May 20, 1975
- June 9, 1975
- May 21, 1975
- Entry into force - Date notif.
- November 21, 1976
- See Art 38
- December 17, 2001
- Repealed by 32001L0083
Modified by
Corrected by:
- August 15, 1986 - 31975L0319R(01)
Modified by:
- Council Directive 89/341/EEC of 3 May 1989 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products - detail
- Commission Directive 2000/38/EC of 5 June 2000 amending Chapter Va (Pharmacovigilance) of Council Directive 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (Text with EEA relevance) - detail
- Council Directive 83/570/EEC of 26 October 1983 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products - detail
- Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products - detail
- Council Directive 78/420/EEC of 2 May 1978 amending Second Directive 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products - detail
All documents based on this document:
- Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use
- Commission Regulation (EC) No 541/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorization granted by a competent authority of a Member State
- Commission Regulation (EC) No 1146/98 of 2 June 1998 amending Regulation (EC) No 541/95 concerning the examination of variations in the terms of a marketing authorisation granted by a competent authority of a Member State
- Commission Directive 2000/38/EC of 5 June 2000 amending Chapter Va (Pharmacovigilance) of Council Directive 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (Text with EEA relevance)
Derogated in:
- Council Directive 89/343/EEC of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional provisions for radiopharmaceuticals
- Council Directive 89/381/EEC of 14 June 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products and laying down special provisions for medicinal products derived from human blood or human plasma
- Council Directive 89/342/EEC of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional provisions for immunological medicinal products consisting of vaccines, toxins or serums and allergens
Affected by case
- Judgment of the Court (Fifth Chamber) of 21 January 1999. Upjohn Ltd v The Licensing Authority established by the Medicines Act 1968 and Others. Reference for a preliminary ruling: Court of Appeal (England) - United Kingdom. Proprietary medicinal products - Revocation of a marketing authorisation - Judicial review. Case C-120/97.
- Judgment of the Court of 7 February 1984. Duphar BV and others v The Netherlands State. Reference for a preliminary ruling: Arrondissementsrechtbank 's-Gravenhage - Netherlands. Health-care scheme - Compatibility with the Treaty of restrictions on access to certain medicinal preparations. Case 238/82.
Legal basis
- TREATY ESTABLISHING THE EUROPEAN ECONOMIC COMMUNITY, PART THREE - POLICY OF THE COMMUNITY, TITLE I - COMMON RULES, CHAPTER 3: APPROXIMATION OF LAWS, ARTICLE 100
EuroVoc Vocabulary
- Public health
- Comitology
- Free movement of goods
- Medical research
- Approximation of laws
- Technical barriers
- Preparation for market
- Marketing
- Approximation of laws
- Proprietary medicinal products
- Pharmaceutical product