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Document 31991L0507R(01)

Corrigendum to 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 (OJ No L 270 of 26. 9. 1991)

PB L 299 van 30.10.1991, p. 52–52 (EN)

ELI: http://data.europa.eu/eli/dir/1991/507/corrigendum/1991-10-30/oj

31991L0507R(01)

Corrigendum to 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 (OJ No L 270 of 26. 9. 1991)

Official Journal L 299 , 30/10/1991 P. 0052 - 0052


Corrigendum to 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 (Official Journal of the European Communities No L 270 of 26 September 1991)

On page 40, in the Annex, Part 2, section D,1., the second subparagraph is replaced by the following:

'These tests are essential for checking the conformity of the medicinal product with the formula when, exceptionally, an applicant proposes an analytical method for testing the finished product which does not include the assay of all the active ingredients (or of all the excipient constituents subject to the same requirements as the active ingredients).`

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