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Commission Directive on the testing of medicinal products

Commission Directive 91/507/EEC 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 prod...

Commission Directive 91/507/EEC 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, replaces the above Annex with a new text. Making reference to recent Directives in this field, its intent is to adapt to technical progress the requirements for testing and documentation of medicinal products in the context of applications for marketing authorization. Requirements for all categories of medicinal products are set out, and are supplemented by special rules applicable to radiopharmaceuticals and biological medicinal products. With exceptions in stated fields, Member States are to comply with the Directive no later than 1 January 1992.