The April/May issue of the Life Sciences and Healthcare Newsletter prepared by Arzinger about the most important legal acts adopted in Ukraine related to the pharmaceutical industry and the most important pharmaceutical market regulation news in English.

Arzinger Pharma Newsletter -April-May2015_eng

In this issue:

MEDICINAL PRODUCTS

CLINICAL TRIALS

– MOH explained application of reduced VAT rates for import of materials intended for clinical trials

– Rules for interaction between MOH and the State Expert Centre on clinical trial issues have been approved

STATE REGISTRATION OF MEDICINAL PRODUCTS

– Amendments to the Procedure of registration (re-registration) of medicinal products

– Rules for interaction between MOH and the State Expert Centre on clinical trial issues have been approved

– Draft changes to the procedure of the state expert examination of registration materials on medicinal products

IMPORT OF MEDICINAL PRODUCTS

– Changes to the customs clearance procedure

MANUFACTURE OF MEDICINAL PRODUCTS

– MOH’s recommendations to conduct microbiological control during manufacture of non-sterile medicinal products have been abolished

MEDICINAL PRODUCT RETAIL

– Mandatory accreditation for pharmacies has been abolished

STATE PRICE CONTROLS

– A bill on limiting maximum sales mark-up for medicinal products and medical devices

– MOH’s drafts amendments to the State Price Controls rules regarding medicinal products and medical devices

PUBLIC PROCUREMENT 

– Explanations of the Ministry of Economic Development as to the anticorruption program

ADVERTISING

– Amendments to the advertising law

TAXES, FEES AND OTHER MANDATORY PAYMENTS

– Taxes for expired medicinal products

– Bills on import duties abolishment and exemption from import duty for medicinal products and medical devices

COSMETICS

– Elaboration of Technical Regulations on cosmetics is planned for IV quarter 2015

SCREENING OF OFFICIALS

– A register of officials to be screened for corruption practices commenced its work

Kind regards and best wishes,

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