About us

The National Institute of Pharmacy was formed from the Technical Development Section of The Ministry of Health in 1962. In 1968 NIP merged with the Chemical Section of the National Institute of Public Health in order to produce a unified drug control agency with general responsibility for marketing authorization and supervision of manufacturing, wholesale and retail trade of the medicinal products.

In 1998 the Ministry of Welfare issued the new deed of foundation of NIP. That defines the NIP as a controlling auhtority of GMP, GDP and as a licensing authority for the marketing authorization of the most medicinal products. NIP is also responsible for licensing the individual medicine import, authorisation of duty-free donations of medicines in and out of Hungary.

Activities defined by the legislation

· Evaluation and marketing authorization of human medicinal products

· Registration of paramedicines

· Authorization of clinical trials

· Issuing GCP licenses, inspections

· Issuing GLP licenses, inspections

· Issuing GMP licenses, inspections

· Issuing GDP licenses, inspections

· Licensing parallel medicine import

· Licensing individual medicine import

· Authorisation of duty-free donations of medicines

· Supervision of medicine supply

· Control of drug information and drug advertisment

· Editing and amending of Hungarian Pharmacopoeia

· Editing and amending of Formualea Normales

· Qualifying of the electronical information-system on medicinal products used by non-pharmacies

Activities defined by the Foundation Deed

· Preparatory and advisory contribution for request in the legislation of human medicines

· Contribution for request in the harmonization of EU legistlation

· Developing and providing the public information systems regarding the data in its competency

· Establishing and maintaining international relations regarding its competency

· Contribution with WHO

· Pharmaceutical organizational-methodological, training and research institute of the Ministy of Health, in co-operation with the National Health Service and the professional colleges

· Analizing the data of utilization, developing the pharmaceutical science, methodology, encourage the practical use of new sientific achievements

· Issuing pharmaceutical methodological letters

· Maintaining an independent network of Medicine Reviewers

· Maintaining a direct information service on drug affairs

· Contribution with universities in the training of pharmacists

Undertaking activities

· Teaching activities

· Organizing scientific, specialists tranings

· Publishing pharmaceutical publications

· Scientific expert report for request

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About us Quality Policy System Transparency Organisational structure Links FAQ Events Contact Contact points RSS Sitemap Laws and regulations Finance Forms	About us The National Institute of Pharmacy was formed from the Technical Development Section of The Ministry of Health in 1962. In 1968 NIP merged with the Chemical Section of the National Institute of Public Health in order to produce a unified drug control agency with general responsibility for marketing authorization and supervision of manufacturing, wholesale and retail trade of the medicinal products. In 1998 the Ministry of Welfare issued the new deed of foundation of NIP. That defines the NIP as a controlling auhtority of GMP, GDP and as a licensing authority for the marketing authorization of the most medicinal products. NIP is also responsible for licensing the individual medicine import, authorisation of duty-free donations of medicines in and out of Hungary. Activities defined by the legislation · Evaluation and marketing authorization of human medicinal products · Registration of paramedicines · Authorization of clinical trials · Issuing GCP licenses, inspections · Issuing GLP licenses, inspections · Issuing GMP licenses, inspections · Issuing GDP licenses, inspections · Licensing parallel medicine import · Licensing individual medicine import · Authorisation of duty-free donations of medicines · Supervision of medicine supply · Control of drug information and drug advertisment · Editing and amending of Hungarian Pharmacopoeia · Editing and amending of Formualea Normales · Qualifying of the electronical information-system on medicinal products used by non-pharmacies Activities defined by the Foundation Deed · Preparatory and advisory contribution for request in the legislation of human medicines · Contribution for request in the harmonization of EU legistlation · Developing and providing the public information systems regarding the data in its competency · Establishing and maintaining international relations regarding its competency · Contribution with WHO · Pharmaceutical organizational-methodological, training and research institute of the Ministy of Health, in co-operation with the National Health Service and the professional colleges · Analizing the data of utilization, developing the pharmaceutical science, methodology, encourage the practical use of new sientific achievements · Issuing pharmaceutical methodological letters · Maintaining an independent network of Medicine Reviewers · Maintaining a direct information service on drug affairs · Contribution with universities in the training of pharmacists Undertaking activities · Teaching activities · Organizing scientific, specialists tranings · Publishing pharmaceutical publications · Scientific expert report for request Last updated: 2008.08.25 16:22 printer version
National Institute of Pharmacy \| H-1051 Budapest, Zrínyi u. 3. \| Mail: 1372 P.O. Box: 450. Tel: +36 1 88 69 -300 \| Fax: +36 1 88 69-460 \| Impressum \| Copyright Opening hours for docketing: Monday to Thursday: 8.30-12.00, Friday: 8.30-11.00