Related information, State Institute for Drug Control

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Voluntary Harmonization Procedure (VHP)

Important information for Applicants for Clinical Trials via VHP procedure
Important Information for Applicants for Clinical Trials through the Voluntary Harmonisation Procedure on the Possibility of Involvement of Multicentric Ethics Committees, So Called VHP Plus (HMA CTFG website refers)

BREXIT – Important Notice to Sponsors of Clinical Trials on Pharmaceuticals

Important Information for Applicants for Clinical Trials through the Voluntary Harmonisation Procedure on the Possibility of Involvement of Multicentric Ethics Committees, So Called VHP Plus (HMA CTFG website refers)

Genetically Modified Organism (GMO) aspects for investigational medicinal products

Information for sponsors of clinical trials/submitters of Development Safety Update Reports (DSURs)

Amendments to protocol and updates to clinical trial dossier following the issuance of authorisation/approval of the conduct of the clinical trial

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