Ministry of Healthcare of Ukraine Calls for Discussion on State Registration of Medicines Purchased through Specialized Organizations

On May 18, 2005 the Draft Resolution of the Cabinet of Ministers of Ukraine, proposing to amend the Procedure of State Registration (Reregistration) of Medicinal Products and Fees for Their State Registration (Reregistration), approved by the Resolution of the Cabinet of Ministers of Ukraine of 26.05.2005 No 376 was published on the official website of the Ministry of Healthcare of Ukraine for public discussion.

The Draft Resolution proposes to set forth the peculiarities of state registration of medicinal products, purchased for funds of state budget through specialized organizations for the execution of agreements with the Ministry of Healthcare of Ukraine.

In accordance with the Draft Resolution provisions, likewise other medicinal products, indicated category of medicines will be registered by the Ministry of Healthcare of Ukraine further to submission of an application for registration and an affirmative conclusion of State Expert Center, drawn up after passing an expert evaluation.

However, for such medicinal products a specific list of obligatory for submission documents is prescribed. Thus, together with an application for the state registration the following shall be submitted to the State Expert Center:

• a document, confirming that a medicinal product is liable for purchase following the results of procurement procedure, conducted by the specialized organization for the execution of an agreement with the Ministry of Healthcare of Ukraine;
• files of registration dossiers, submitted for registration of medicinal product to regulatory authority of the country, where the medicinal product is registered, or for pre-qualification of medicinal product by the World Health Organization;
• an valuation report of the medicinal product, prepared by regulatory authority of the country, where the medicinal product is registered, or formed by the World Health Organization, if medicinal product is pre-qualified;
• medicinal product quality control methods;
• an instruction for use of medicinal product or information for use of medicinal product;
• a sample of original pharmaceutical package;
• translations of marking text of medicinal product packing and instruction for use of medicinal product or information for use of medicinal product.

It should be noted, that the Draft Resolution envisages limited validity of marketing authorization of medicinal products, purchased for state budget funds through specialized organizations. Accordingly, marketing authorizations may be issued before the end of the term of the Law of Ukraine “On Amendments to Certain Laws of Ukraine concerning Timely Access of Patients to Essential Pharmaceuticals and Medicinal Products through Public Procurement, Assisted by Specialized Procurement Organizations” of 19.03.2015 No 269-VIII, which is currently set at March 31, 2019.

The Draft Resolution also determines separate grounds for rejection in registration of an indicated category of medicines. They particularly include not submitting relevant documents, indicated above, regarding such medicinal product, or submitting not in its entirety, detecting in indicated documents invalid or incomplete information, detecting inauthenticity of translation of marking text of such medicinal product packing or instruction for use of such medicinal product.

Provided that, the Draft Resolution envisages short term for notification of rejection in registration. Thus, in comparison with 10 days, provisioned for conventional medicinal products, rejection in registration of medicinal products, purchased for state budget funds through specialized organizations shall be communicated to an applicant within three business days.

It should be noted, that according to the Draft Resolution it has been proposed to release applicants for state registration of indicated category of medicinal products from payment of fees for state registration of medicinal products.

Please note, that the necessity of adopting this Draft Regulation is defined by the adoption of the Law of Ukraine “On Amendments to Certain Laws of Ukraine concerning Timely Access of Patients to Essential Pharmaceuticals and Medicinal Products through Public Procurement, Assisted by Specialized Procurement Organizations” of 19.03.2015 No 269-VIII, effective April 25, 2015, which introduced a separate procedure of purchasing medicinal products for state budget funds though international specialized organizations that carry out procurements on the grounds of agreements concluded with the Ministry of Healthcare of Ukraine.