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Beschikbare richtlijnen

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Guidance to applicants /marketing authorisation holders on oral explanations at EMA

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

GMP EMA

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Guidance on the format of the risk management plan (RMP) in the EU - in integrated format (Rev. 2.0.1)

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

GMP EMA

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Guidance on the anonymisation of protected personal data and assessment of commercially confidential information during the preparation of RMPs (main body and annexes 4 and 6)

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

GMP EMA

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Guidance on parallel EMA / EUnetHTA 21 Joint Scientific Consultation

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

GMP EMA

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Guidance on meetings with applicants on the responses to questions received from European Medicines Agency scientific Committees during the evaluation within the centralised procedure

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

GMP EMA

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Guidance for sponsors: Procedural advice for post-orphan medicinal product designation activities

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

GMP EMA

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General principles: European Medicines Agency-Food and Drug Administration parallel scientific advice

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

GMP EMA

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GVP Module XVI – Risk minimisation measures (Rev 3)

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

GMP EMA

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GLP compliance: Non-clinical studies GLP compliance (annex to the cover letter)

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

GMP EMA

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Follow-up and non-urgent information for quality defects

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/compliance-post-authorisation/good-distribution-practice).

GDP EMA

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GMP voor het Middenkader in de Farmaceutische Industrie

Training GMP voor het Middenkader – Farmaceutische Industrie (België)

Richtlijnen Kennisbank

Beschikbare richtlijnen

Guidance to applicants /marketing authorisation holders on oral explanations at EMA

Guidance on the format of the risk management plan (RMP) in the EU - in integrated format (Rev. 2.0.1)

Guidance on the anonymisation of protected personal data and assessment of commercially confidential information during the preparation of RMPs (main body and annexes 4 and 6)

Guidance on parallel EMA / EUnetHTA 21 Joint Scientific Consultation

Guidance on meetings with applicants on the responses to questions received from European Medicines Agency scientific Committees during the evaluation within the centralised procedure

Guidance for sponsors: Procedural advice for post-orphan medicinal product designation activities

General principles: European Medicines Agency-Food and Drug Administration parallel scientific advice

GVP Module XVI – Risk minimisation measures (Rev 3)

GLP compliance: Non-clinical studies GLP compliance (annex to the cover letter)

Follow-up and non-urgent information for quality defects

Ontvang richtlijnupdates in uw mailbox