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Imported from European Medicines Agency (https://www.ema.europa.eu/en/regulatory-and-procedural-guideline.xml).
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Imported from European Medicines Agency (https://www.ema.europa.eu/en/regulatory-and-procedural-guideline.xml).
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Imported from European Medicines Agency (https://www.ema.europa.eu/en/regulatory-and-procedural-guideline.xml).
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Imported from European Medicines Agency (https://www.ema.europa.eu/en/regulatory-and-procedural-guideline.xml).
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Imported from European Medicines Agency (https://www.ema.europa.eu/en/regulatory-and-procedural-guideline.xml).
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Imported from European Medicines Agency (https://www.ema.europa.eu/en/regulatory-and-procedural-guideline.xml).
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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).
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Imported from European Medicines Agency (https://www.ema.europa.eu/en/regulatory-and-procedural-guideline.xml).
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Imported from European Medicines Agency (https://www.ema.europa.eu/en/regulatory-and-procedural-guideline.xml).
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Annex 19 - Reference and Retention Samples
GepubliceerdThis 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.
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