For applicants – State Expert Center of the Ministry of Health of Ukraine

Professional development Vacancies

For applicants

Documents, services and offerings of the Center for applicants

Most frequently opened

Registration: lists and orders10 materials eCTD4 materials Pharmacovigilance2 materials

Sections

UA M1 eCTD 2

ICH eCTD Specification v3.2.2 2

Cost and conclusion of the contract 3

Standard contract forms 14

Contracts for expert evaluation of materials on medicinal products, including MIBP
Contracts for review of registration materials on medicinal products (simplified procedure)
Contracts for expert evaluation of the authenticity of registration materials for medicinal products
Contracts for the provision of services for expert assessment of registration materials for medicinal products, vaccines or other medical immunobiological preparations for the treatment and/or specific prophylaxis of acute respiratory disease COVID-19, caused by the SARS-COV-2 coronavirus, under an obligation for emergency medical use
Contracts for laboratory testing of medicinal products at the Pharmaceutical Analysis Laboratory
Contracts for expert evaluation of clinical trial materials
Contracts for the provision of expert services for state health technology assessment of medicinal products
Contracts for the provision of consulting services on methodological issues of preparing a dossier for state HTA
Contracts for expert evaluation of materials on medicinal products submitted for inclusion in the State Formulary
Contracts for the provision of services for paid access to the adverse reaction database
Contracts for the provision of services for expert assessment of dossier materials of the plasma master file for medicinal products manufactured from human blood or blood plasma
Agreement on the review of medicinal product dossier materials for parallel import
Agreements on conducting human health impact assessment of vitamins, minerals and other substances, as well as maximum permissible doses (amounts) in food products intended to be placed on the market as dietary supplements and/or services for providing consultations on risk assessment
Agreement on the provision of services for expert evaluation of registration materials of medicinal products, vaccines or other medical immunobiological preparations for the treatment and/or specific prophylaxis of acute respiratory disease COVID-19, caused by coronavirus SARS-COV-2, under an obligation for emergency medical use

Advance payment (clinical trials) 3

Samples of documents: expert evaluation of medicinal products 2

Sample documents: clinical trials 2