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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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