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Eudralex Volume 3 PRODUCTION AND QUALITY CONTROL OF MEDICINAL PRODUCTS DERIVED BY RECOMBINANT DNA TECHNOLOGY

Origin/Publisher:

European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium), http://ec.europa.eu/enterprise/

Document Type:
Note for guidance
Content:
This note for guidance is intended to facilitate the collection and submission of data to support applications for marketing authorisation within the EEC for polypeptide based products derived by rDNA technology and intended for medicinal use in man. It concerns the application of Part 2, sections A-E of the Annex to Directive 75/318/EEC as amended, with a view to the granting of a marketing authorisation for a new medicinal product derived by rDNA technology.

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