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Eudralex Volume 3 PRODUCTION AND QUALITY CONTROL OF CYTOKINE PRODUCTS DERIVED BY BIOTECHNOLOGICAL PROCESSES
Origin/Publisher:
European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium), http://ec.europa.eu/enterprise/
Document Type:
Guideline
Content:
This note for guidance is intended to facilitate the
collection and submission of data to support applications
for marketing authorisation for cytokine products derived
from biotechnological processes, particularly with
respect to Part 2, sections A-E of the Annex to Directive
75/318/EEC as amended.
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