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National Regulatory Authorities in the EU (competent authority)

National Regulatory Authorities in the EU (competent authority)
1.

What is a Competent Authority in the European Union?

Competent Authorities

The European Medicines Agency works closely with the national competent authorities of the Member States of the European Union (EU) and the European Economic Area (EEA) responsible for human medicines.

The national competent authorities are primarily responsible for the authorisation of medicines available in the EU that do not pass through the centralised procedure.

For a list of all competent authorities in the European Union, follow this link.

Competent Authority in the Netherlands

While most countries have one entity for licensing and inspections of pharmaceutical manufacturers, importers and distribution, the Netherlands has opted to split the responsibility of licensing and inspecting between two government agencies; the IGJ and Farmatec.

Farmatec - CIBG
Farmatec - CIBG

Farmatec - Receives input from the IGJ on the approval or removal of pharmaceutical licenses. Part of the CIBG.

IGJ - Ministry of Health
IGJ - Ministry of Health

IGJ - Assessment of compliance with GxP guidelines, provides input to Farmatec on the outcome of inspections.

Jaap Koster
Jaap Koster
pcs-nl.com

Jaap Koster has 39 years of experience in the pharmaceutical industry in North- and South America, Asia, Africa and Europe. Jaap is the CEO of PCS.

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