Eudralex Volume 3 Radiopharmaceuticals (3AQ20A)

Title:
Eudralex Volume 3 Radiopharmaceuticals (3AQ20A)

https://www.gmp-compliance.org/files/guidemgr/3aq20aen.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 info@ema.europa.eu; http://www.emaea.europa.eu

Document Type:
Guideline
Content:
This guide describes the specific additional information needed in the submission in relation to radiopharmaceuticals (toxicol./pharmacol. data; clinical documentation, dosimetry, labelling).

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