Guideline Knowledge Base
Search versions, compare publication history, and download source files from a single client-ready portal.
Available Guidelines
116 matches
-
Imported from European Medicines Agency (https://www.ema.europa.eu/en/regulatory-and-procedural-guideline.xml).
-
Imported from European Medicines Agency (https://www.ema.europa.eu/en/regulatory-and-procedural-guideline.xml).
-
Imported from European Medicines Agency (https://www.ema.europa.eu/en/regulatory-and-procedural-guideline.xml).
-
Imported from European Medicines Agency (https://www.ema.europa.eu/en/regulatory-and-procedural-guideline.xml).
-
Imported from European Medicines Agency (https://www.ema.europa.eu/en/regulatory-and-procedural-guideline.xml).
-
Imported from European Medicines Agency (https://www.ema.europa.eu/en/regulatory-and-procedural-guideline.xml).
-
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
Imported from European Medicines Agency (https://www.ema.europa.eu/en/regulatory-and-procedural-guideline.xml).
-
Imported from European Medicines Agency (https://www.ema.europa.eu/en/regulatory-and-procedural-guideline.xml).
-
Imported from European Medicines Agency (https://www.ema.europa.eu/en/regulatory-and-procedural-guideline.xml).
-
This Annex to the Guide to Good Manufacturing Practice for Medicinal Products (“the GMP Guide”) gives guidance on the taking and holding of reference samples of starting materials, packaging materials or finished products and retention samples of finished products.
Get Guideline Updates in Your Mailbox
Subscribe for major GMP/GDP guideline changes, new publications and timeline updates.