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Procedural advice on publication of information on withdrawals of applications related to the marketing authorisation of human medicinal products

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

GMP EMA

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Procedural advice on appointment and responsibilities of the CVMP rapporteur and co-rapporteur (according to Article 62 (1) of Regulation (EC) No 726/2004)

Imported from European Medicines Agency (https://www.ema.europa.eu/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines).

GMP EMA

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Points to consider for assessors, inspectors and EMA inspection coordinators on the identification of triggers for the selection of applications for “routine” and/or “for cause” inspections, their investigation and scope of such inspections

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

GMP EMA

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Operational procedure on handling of consultation with target patient groups on package leaflets for centrally authorised products for human use

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 manufacture of the finished dosage form - First version

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers).

GDP EMA

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Mobile scanning and other technologies in the labelling and/or package leaflet of centrally authorised medicinal products

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

GMP EMA

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Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products

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

GMP EMA

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Innovative drug development approaches Final report from the EMEA/CHMP-think-tank group on innovative drug development

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

GMP EMA

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Information required for identification of a need for pre-authorisation GCP inspections

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

GMP EMA

Laatste versie Tijdlijn bekijken
Information required for early identification of a need for pre-authorisation GMP inspections

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 publication of information on withdrawals of applications related to the marketing authorisation of human medicinal products

Procedural advice on appointment and responsibilities of the CVMP rapporteur and co-rapporteur (according to Article 62 (1) of Regulation (EC) No 726/2004)

Points to consider for assessors, inspectors and EMA inspection coordinators on the identification of triggers for the selection of applications for “routine” and/or “for cause” inspections, their investigation and scope of such inspections

Operational procedure on handling of consultation with target patient groups on package leaflets for centrally authorised products for human use

Note for guidance on manufacture of the finished dosage form - First version

Mobile scanning and other technologies in the labelling and/or package leaflet of centrally authorised medicinal products

Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products

Innovative drug development approaches Final report from the EMEA/CHMP-think-tank group on innovative drug development

Information required for identification of a need for pre-authorisation GCP inspections

Information required for early identification of a need for pre-authorisation GMP inspections

Ontvang richtlijnupdates in uw mailbox