Commission Directive 1999/82/EC of 8 September 1999 amending the Annex to Council Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products (Text with EEA relevance)

• Published date: 15 September 1999
• Subject Matter: Internal market - Principles,Technical barriers,Industry,Approximation of laws,Health and safety
• Official Gazette Publication: Official Journal of the European Communities, L 243, 15 September 1999

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Commission Directive 1999/82/EC of 8 September 1999 amending the Annex to Council Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products (Text with EEA relevance)

Official Journal L 243 , 15/09/1999 P. 0007 - 0008

COMMISSION DIRECTIVE 1999/82/EC

of 8 September 1999

amending the Annex to Council Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the 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 93/39/EEC(2), and in particular Article 2(a)(1) thereof,

(1) Whereas Commission Decision 97/534/EC of 30 July 1997 on the prohibition of the use of material presenting risks as regards transmissible spongiform encephalopathies(3) defines specified risk materials, provides for their elimination at source and prohibits their import into the Community;

(2) Whereas, prior to being marketed, all medicinal products, whether they originate in the Community or are imported from third countries, are subject to an approval procedure in the context of which the treatment process of any raw material is evaluated, in conformity with the provisions of the Annex to Directive 75/318/EEC;

(3) Whereas this approval procedure applies to all medicinal products to be placed on the market in the Community, notwithstanding the origin of the product or the raw materials contained therein; whereas, thereby, the compliance with Community law of medicinal products, starting materials and intermediate products which are imported into the Community to be used in the manufacture of medicinal products is systematically controlled and checked;

(4) Whereas on 21 April 1999, the Committee for Proprietary Medicinal Products of the European Agency for the Evaluation of Medicinal Products adopted an updated Note for Guidance on Minimising the Risk...