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Procedural advice on CHMP/CAT/PRAC Rapporteur/Co-Rapporteur appointment principles, objective criteria and methodology in accordance with Article 62 (1) of Regulation (EC) No 726/2004

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance).

GMP EMA

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Pilot phase for CHMP early contact with patient / consumer organisations

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance).

GMP EMA

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Pilot on early dialogue with patient organisations for orphan marketing authorisation applications: Outcome Report

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance).

GMP EMA

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Note for guidance on the inclusion of appendices to clinical study reports in marketing authorisation applications

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance).

GMP EMA

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Mandate of the European Medicines Agency Innovation Task Force (ITF)

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory-overview/research-development).

GMP EMA

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Member states contact points for translations review

Imported from European Medicines Agency (https://www.ema.europa.eu/en/regulatory-and-procedural-guideline.xml).

Gepubliceerd: 8 sep 2026 GMP EMA

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Basic requirements for active substances used as starting materials

Imported from European Commission — EudraLex (https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en).

GMP EC

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Aide-Memoire for GMP Inspections

Imported from European Commission — EudraLex (https://health.ec.europa.eu/medicinal-products/falsified-medicines_en).

GMP EC

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Detailed Commission guideline of 8 December 2017 on the good manufacturing practice for investigational medicinal products pursuant to the second paragraph of the Article 63(1) of Regulation (EU) No 536/2014

Imported from European Commission — EudraLex (https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en).

Gepubliceerd: 8 dec 2017 GMP EC

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The linguistic review process of product information in the centralised procedure - Human

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance).

GMP EMA

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Richtlijnen Kennisbank

Beschikbare richtlijnen

Procedural advice on CHMP/CAT/PRAC Rapporteur/Co-Rapporteur appointment principles, objective criteria and methodology in accordance with Article 62 (1) of Regulation (EC) No 726/2004

Pilot phase for CHMP early contact with patient / consumer organisations

Pilot on early dialogue with patient organisations for orphan marketing authorisation applications: Outcome Report

Note for guidance on the inclusion of appendices to clinical study reports in marketing authorisation applications

Mandate of the European Medicines Agency Innovation Task Force (ITF)

Member states contact points for translations review

Basic requirements for active substances used as starting materials

Aide-Memoire for GMP Inspections

Detailed Commission guideline of 8 December 2017 on the good manufacturing practice for investigational medicinal products pursuant to the second paragraph of the Article 63(1) of Regulation (EU) No 536/2014

The linguistic review process of product information in the centralised procedure - Human

Ontvang richtlijnupdates in uw mailbox