15 November 2017
In 2010, Ukraine ratified the Council of Europe Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data 1981 (“the Data Protection Convention”). Further to such ratification, in 2011 the Law of 1 June 2010 No. 2997-VI on Personal Data Protection (“the Personal Data Protection Law”) was enacted to become the cornerstone of national data protection legislation.
26 May 2017
In March 2017, Ukrainian Government approved the new National Essential Medicines List for Ukraine (the “NEML”), which is to become a single basis for the procurement and reimbursement of medicines in the public sector, as well as price controls.
29 March 2017
Over March 2017, Ukrainian Government and Ministry of Health (“MOH”) approved a number of regulations to finalize the framework for reimbursement of several groups of medicinal products. “Available Medicines” pharmacy reimbursement program (the “Program”) is scheduled to be launched from 1 April 2017, with its cornerstones being as follows:
26 September 2016
In September 2016, the Antimonopoly Committee of Ukraine (the “AMC”) handed down a significant decision holding a major global pharmaceutical company and its four Ukrainian distributors liable for uncompetitive conduct that resulted in overcharging for drugs in Ukrainian public tenders.
5 September 2016
Egorov Puginsky Afanasiev & Partners Ukraine team successfully defended interests of one of the world’s largest pharmaceutical companies in a dispute with the State Intellectual Property Service of Ukraine (Patent office) on extension of patent term for medical product for of additional three years over standard 20 years’ term.
14 July 2016
On 31 May 2016, Ukrainian Parliament passed a law to significantly simplify the market access for certain categories of medicinal products. In particular, the law introduces a streamlined registration (marketing authorization) process for any drugs already authorized by competent authorities of (i) the U.S., Switzerland, Japan, Australia, Canada and (ii) the EU under centralized authorization procedure, in each case for use in relevant countries. Such registration is to be performed within 17 business days and involve a limited documentation check, without a full-scale local review of the registration dossier. The law entered into effect on 19 June 2016. However, bringing it to life still requires approval of a number of by-laws that are being developed by the Ministry of Health of Ukraine. When implemented, simplified registration procedures are expected to reduce the market entry barriers for international pharmaceutical business.
25 February 2016
On February 11, 2016 the Federal Law “On Ratifying the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Goods and Medical Equipment) Within the Framework of the Eurasian Economic Union” and Federal Law “On Ratifying the Agreement on Common Principles and Rules for the Circulation of Pharmaceuticals within the Framework of the Eurasian Economic Union” (Agreements) came into force.
9 November 2015
With effect from 30 October 2015, a new order of the Ministry of Healthcare of Ukraine (the “Order”) introduced a number of significant changes to Ukrainian drug review and authorization process.
16 September 2014
Egorov Puginsky Afanasiev & Partners publish an update on Pharmacy and Pharmaceuticals Market Regulation News.