Eudralex Volume 3 Draft Guideline (Radiopharmaceuticals)

Title:
Eudralex Volume 3 Draft Guideline (Radiopharmaceuticals)
Short Title:
EMEA/CHMP/QWP/306970/2007

https://www.gmp-compliance.org/files/guidemgr/EMA_WC500003549_radio_draft.pdf

Origin/Publisher:

EMEA 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel (44-20-7) 418 8400, Fay (44-20-7) 418 85 95

Content:
This guideline describes the additional information that needs to be submitted in relation to radiopharmaceuticals, in the context of applications for marketing authorisations or variations to authorised medicinal products.

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