State Pharmacological Center of the MOH of Ukraine

Scope of activities of the SPhC of MOH of Ukraine:

•  Expertise of the documents for State registration of medicinal products;

•  Expertise of the documents for State registration of substances;

•  Expertise of the documents for conduction of the clinical studies in Ukraine ;

•  Organization and control of the clinical studies;

•  Expertise of the advertising materials of medicines;

•  Pharmacoviligance;

•  Development and analysis of the legislation for improvement of the system of the creation, clinical studies and marketing approval of the medicinal products, including GMP and GCP practices;

Director: Mr. Viktor Timofeyevich CHUMAK

Address: Chihoryna str. 18, 01042, Kiev , Ukraine

Tel.: +38 044 286-70-44

Fax: +38 044 286-77-59

Web: http://www.pharma-center.kiev.ua/

E-mail: public@pharma-center.kiev.ua

State Authority of medicinal products and medical devices of MOH of Ukraine

Scope of activities of State Authority of medicinal products and medical devices of MOH of Ukraine:

•  State registration of medicinal products, substances (actually performed by State Pharmacological Center );

•  State registration of medical devices;

•  State registration of biological and immunological products;

•  GMP recognition of foreign manufacturing sites, GMP certification;

•  Issue of the manufacturing licenses; retail (pharmacies) and wholesaler (distributors) permissions;

•  Accreditation of the quality assurance laboratories;

•  Preparation and issue of the legal acts and documents;

Head of the Authority: Mr. Yuriy Borysovich KONSTANTINOV

First deputy of the Head of the authority: Ms. Inna Bosrysovna DEMCHENKO

Web: http://www.dslz.gov.ua/

Address: Pobedy ave. 120, 03115, Kiev , Ukraine

Tel .: +38 044 424-72-60

Fax: +38   044 424-15-06

State Sanitary-epidemiological authority of MOH of Ukraine

Scope of activities of State Sanitary-epidemiological authority of MOH of Ukraine:

• State sanitary-epidemiological Authority of Ukraine is responsible for sanitary-epidemiological control:
• State registration of food products;
• State registration of food supplements (nutrition, parapharmaceutical);
• State registration of cosmetics;
• Sanitary-epidemiological expertise of manufacturing sites etc.;
• Other responsibilities in the field of sanitary, hygienical, epidemiological and toxicological control;

Chief state sanitary doctor of Ukraine : Mr. Sergey Petrovitch BEREZHNOV

Address: Nekrasovskaya str. 10/8, Kiev , Ukraine

Tel.: +38 044 486-54-86

Fax: +38 044 486-40-27

Web: http://www.ses.gov.ua/

E-mail: city@ses.gov.ua

State Inspection on medicinal products of the quality of medicinal products of the MOH of Ukraine

Scope of activities of State Inspection on medicinal products of the quality of medicinal products of the MOH of Ukraine :

Chief State Inspector of Ukraine : Mr. Vladislav Valentinovitch ONISHENKO

Deputy of the chief State inspector: Mr. Valeriy Vladimirovich STETSEV

Deputy of the chief State inspector: Mr. Andrey Dmitrievich ZAHARASH

Address: Pobedy ave. 120, 03115, Kiev , Ukraine

Tel.: +38 044 450-12-66

Fax: +38 044 450-03-67

Web: http://www.dimoz.kiev.ua/

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