Content

  • Government extends the list of pharmaceuticals the prices of which are subject to state regulation
  • Draft amendments to the License Provisions for Performing Pharmaceutical Import are submitted for public comment
  • New fees for veterinary services, plant protection and protection of plant variety rights are approved
  • New list of pharmaceuticals approved for non-prescription use in Ukraine is adopted

Government extends the list of pharmaceuticals the prices of which are subject to state regulation

As you may know, in 2012 Ukraine started integrating European experience with using reference prices in state regulation of pharmaceutical prices. The government established a working group on the issue and then decided to launch a pilot project on regulating pharmaceutical prices for hypertension patients.

Currently the government is considering an analogous project for diabetes patients. We assume that there will soon be similar projects in other areas of the pharmaceutical sector. As a result, more pharmaceuticals could be subject to state price regulation in Ukraine (and reference prices could be used).

As regards European experience in applying reference prices for diabetes treatment, the Cabinet of Ministers developed the draft Resolution “On the Realization of a Pilot Project for Implementation of State Regulation of Insulin Prices.” It was posted on the official Ministry of Health website for public discussion.

The draft Resolution introduces state regulation of insulin prices by establishing an overall wholesale price level, using a mechanism for determining comparative (reference) prices.

According to the project the overall wholesale insulin price level should be calculated on the basis of comparative (reference) prices for such pharmaceuticals as established in Moldova, Greece, Georgia, Turkey, Kazakhstan, Russia, Albania, Romania and Bulgaria.

In cases when there are no comparable pharmaceuticals on a given country’s market, the comparative (reference) price should be formed on the basis of the prices for such products in Hungary, Lithuania, Latvia, the Czech Republic, Slovakia and Poland; declared changes in wholesale prices in Ukraine should be taken into account.

The project envisages that the appropriate procedure for calculating the overall wholesale insulin price level should be approved by the Ministry of Health by 1 June 2013 and that the wholesale insulin price level should be established and published by 1 July 2013.

Draft amendments to the License Provisions for Performing Pharmaceutical Import are submitted for public comment

The draft Order of the Ministry of Health amending the License Provisions for Performing Pharmaceutical Import has been published for public comment on the Ministry’s official website.

The draft anticipates that the License Provisions approved by Order No. 143 of the Ministry of Health of 20 February 2013 should be supplemented with Annex No. 10 indicating the information that the importer’s dossier must contain. Among other things the importer’s dossier must contain the following:
• Brief information about the importer and its subdivisions;
• A description of the importer’s pharmaceutical quality system and references to the standards that have been applied;
• Information about the importer’s use of services related to pharmaceutical import in particular those related to storage, quality control and transportation;
• A description of the QRM methodology used by the importer (where applicable);
• Information on the qualifications, professional experience and responsibilities of the relevant employees;
• A description of the company, information on the size of the relevant areas, a list of company buildings, etc.

The dossier should be supported with the relevant attachments, namely with organizational schemes, layouts of the importer’s buildings, plans for the warehouses that indicate special storage areas (where applicable) and a list of key control laboratory equipment (if the company has its own laboratory).

The draft Order also supplements the License Provisions with the requirement that imported pharmaceuticals should be produced according to proper manufacturing practices that harmonize with EU legislation. This should be confirmed in accordance with the Procedure for Conformity Conditions in Pharmaceutical Manufacturing approved by the Order of the Ministry of Health of Ukraine No. 1130 dated 27 December 2012.
Please recall that according to Order No. 1130 confirmation of the conformity of working conditions with GMP requirements is overseen by the State Service of Ukraine on Pharmaceuticals (hereinafter – the State Service). The State Service examines the relevant documents and inspects production processes (in some cases). If it comes to a positive decision, the State Service provides the applicant with a formal Conclusion.

State quality control of pharmaceuticals imported into Ukraine should be carried out according to the procedures approved by Order of the Cabinet of Ministers No. 902dated 14 September 2005 (in the edition approved by Order No. 793 of the Cabinet of Ministers dated 8 August 2012).

If adopted, the Order will take force on 1 December 2013.

New fees for veterinary services, plant protection and protection of plant variety rights are approved

On 26 March 2013 Order No. 96 of the Ministry of Agricultural Policy and Food (hereafter – the Ministry) dated 13 February 2013 "On Approving Fees for Services Related to Veterinary Medicine Issues, Plant Protection and Rights Protection for Plant Varieties Provided by the Authorities and Institutions Managed by the State Veterinary and Phytosanitary Service” took force.

Order No. 96 voids Ministry order No. 666 dated 31 October 2012 of the same name and establishes the new fees for the services related to veterinary medicine issues, plant protection and rights protection for plant varieties provided by the authorities and institutions managed by the State Veterinary and Phytosanitary Service.

The fees established by Order No. 96 for certain services are lower than those foreseen by Order No. 666.

The fees for some services have been cancelled.New list of pharmaceuticals approved for non-prescription use in Ukraine is adopted

In February 2013 Order of the Ministry of Health No. 166 dated 26 February 2013 was adopted. The Order approves the list of pharmaceuticals that can be used without prescription in Ukraine and cancels the Order of the Ministry of Health No. 78 dated 3 February 2012. Order No. 166 will take effect on the day it is officially published. To the best of our knowledge this publication will take place on 5 April 2013.

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We will continue to monitor developments and will be happy to discuss with you any questions you may have.