The State Service of Ukraine on Medicinal Products (the Service) informed by its letter dated 02.12.2011 that the Regulation CT-H МОЗУ 42-4.4:2011 “Medicinal Products. International harmonized requirements for series certification” establishes requirements regarding the contents of series certificates on medicinal product, intermediate products, unpackaged or partially packaged products, as well as on active pharmaceutical ingredients and studied medicinal products that are used for approved clinical trials. The Regulation is mandatory for use by all domestic business entities manufacturing medicinal products.

In addition, the Service recommends applying the requirements of the Regulation СТ-Н МОЗУ 42-4.4:2011 to the products that are imported to Ukraine as well.

On December 7, 2011 the President of Ukraine signed the Law of Ukraine “On Amendments to Article 17 of the Law of Ukraine “On Medicinal Products” No. 4056-VI dated 17.11.2011 to ensure the implementation of pharmaceutical development of medicinal products and research study (the Law). The Law comes into force on the day following the day of its publication. According to the Law, unregistered medicinal products may be imported to the territory of Ukraine for preclinical and clinical studies; for registration in Ukraine (samples in dosage forms); exhibiting at trade shows, fairs, conferences, etc. without the right to sell them; individual use, as it was before, as well as for pharmaceutical development and research study. Read more »

On January 10, 2012 the President of Ukraine signed the Law of Ukraine No. 4196-VI “On Amendments to Some Laws of Ukraine in the Healthcare Sector on Strengthening Control over the Circulation of Medicines, Food Products for Special Dietary Use, Functional Foods and Dietary Supplements” providing, among other things, for the possibility to restrict advertising of certain OTC, if such are included in the list of medicinal products prohibited for advertising (the List). The provisions that prohibit advertising the above medicinal products will take effect in 6 months after the date of their publication. Read more »

On December 10, 2011 Kyoto Protocol member states reached a basis agreement called Durban Platform.

Kyoto Protocol is an international agreement on reduction of greenhouse emissions into atmosphere main goal of which is to achieve stabilization of greenhouse gas concentrations in the atmosphere at a level that would prevent dangerous anthropogenic interference with the climate. Within the framework of the first protocol’s implementation stage (till 2012) 37 industrialized countries committed themselves to reduce greenhouse emissions for 5% in average based on their 1990 emission quantities. Read more »

In its letter No. 01-06/1642/2011 dd. 24.11.2011 the Supreme Economic Court of Ukraine laid down legal position of the Supreme Court of Ukraine as to the practice of application of certain legislative provisions concerning, in particular, corporate relations. In general, it shall be noted that expressed positions are obvious in many respects. Read more »

On November 23, 2011 the Cabinet of Ministers of Ukraine adopted Resolution No. 1234 “On Amendments to the Procedure for Granting Subsidies to Employers by the Fund of Social Protection of Disabled Persons in Creating Special Jobs for Disabled Persons Registered with the State Employment Service”. The Resolution outlines the above Procedure as of December 27, 2006 as amended. Read more »