COMMISSION DIRECTIVE of 19 July 1991 modifying the Annex to Council Directive 75/318/EEC on the approximation of the laws of Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products (91/507/EEC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products (1), as last amended by Directive 89/341/EEC (2),
Having regard to 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 (3), and in particular Article 5 thereof,
Having regard to 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 (4), and in particular Article 7 thereof,
Having regard to 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, regulations or administrative action relating to proprietary medicinal products and laying down special provisions for medicinal products derived from human blood or human plasma (5), and in particular Article 6 thereof,
Whereas following the adoption of Directives 89/342/EEC, 89/343/EEC and 89/381/EEC, it is necessary to amend the Annex to Directive 75/318/EEC in order to lay down special requirements for the testing of immunological medicinal products, radiopharmaceuticals and medicinal products derived from human blood or human plasma;
Whereas it is further necessary to adapt to technical progress the existing requirements laid down in the Annex to Directive 75/318/EEC, in particular with regard to the special nature of medicinal products obtained through processes mentioned in list A and in the first indent of list B of the Annex of Council Directive 87/22/EEC (6);
Whereas the provisions of this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Medicinal Products Sector established pursuant to
Article 2b of Directive 75/318/EEC,
HAS ADOPTED THIS DIRECTIVE:
Article 1
The text of the Annex to Directive 75/318/EEC is hereby replaced by the text of the Annex to this Directive.
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive, save Part 2, paragraph A, point 3.3 of the Annex, no later than 1 January 1992; they shall bring into force the provisions necessary to comply with Part 2, paragraph A, point 3.3 of the Annex no later than 1 January 1995. They shall forthwith inform the Commission thereof.
2. When the Member States adopt these provisions, the provisions shall contain a reference to this Directive or shall be accompanied by such a reference when they are published in official form. The arrangements for this reference shall be decided by the Member States.
Article 3
This Directive is addressed to Member States. Done at Brussels, 19 July 1991.