On October 20, 2016, the website of the Ministry of Health of Ukraine published an explanation regarding the mechanism of exchange of registration certificates for medicinal products that have undergone re-registration, as a result of which their validity period became indefinite.

In order to fulfill the requirements of Part Eighteen, Article 9 of the Law of Ukraine “On Medicinal Products” and the Procedure for State Registration (Re-registration) of Medicinal Products, approved by Resolution No. 376 of the Cabinet of Ministers of Ukraine of May 26, 2005 (as amended), which defines that “on registered medicinal product, the applicant is issued a certificate specifying the period of validity during which the medicinal product is allowed to be used in Ukraine”, approved the order of the Ministry of Health of Ukraine dated 27.07.2016 No. 773 “On Amendments to the Order of the Ministry of Health of July 29, 2003 No. 358”, registered in the Ministry of Justice of Ukraine on August 18, 2016 under No. 1149/29279 (hereinafter – Order of the Ministry of Health No. 773), which entered into force on September 16, 2016.

The specified order approved the updated form of the registration certificate for medicinal products, including medical immunobiological preparations, in particular, it provides for the indication of the period during which the use of the registered and/or re-registered medicinal product is allowed and the corresponding validity period of the registration certificate, namely:

– for 5 years – in case of registration and individual cases of re-registration of the medicinal product;

– indefinitely – in the case of re-registration of a medicinal product, except for cases when the Ministry of Health decides on additional re-registration after 5 years for justified reasons related to pharmacovigilance;

– until March 31, 2019 – in the case of registration of a medicinal product, which is subject to procurement with the participation of international specialized organizations in order to ensure state targeted programs.

The updated form of the registration certificate of the medicinal product contains information about certain obligations (if any), taking into account which the registration certificate was issued, in accordance with Clause 7 of Section IV of the Procedure for conducting an examination of registration materials for medicinal products submitted for state registration (re-registration) , as well as examinations of materials on making changes to registration materials during the validity of the registration certificate, approved by the order of the Ministry of Health of Ukraine dated 26.08.2005 No. 426 with changes, as well as the periodicity of submitting a regularly updated safety report in accordance with the Procedure for monitoring adverse reactions of authorized medicinal products for medical use, approved by the order of the Ministry of Health of Ukraine dated 12.27.2006 No. 898.

Given that the procedure for approving changes to the order of the Ministry of Health of Ukraine dated July 29, 2003 No. 358 “On approval of the form and description of the registration certificate for a medicinal product” in the Center for Medicines and the subsequent state registration of the order of the Ministry of Health of Ukraine No. 773 as a normative legal act in the Ministry of Justice of Ukraine, as well as the order of forms of registration certificates according to the new form took a considerable time, in order to ensure the continuity of the treatment process, to avoid the risk of reducing the access of patients to the necessary medicinal products, for medicinal products that have been re-registered and are allowed to be used for an unlimited period, registration certificates of the old model were temporarily issued for a period valid for 5 years, with subsequent replacement of registration certificates of a new form after approval of changes to Order No. 358.

The exchange of temporarily issued registration certificates of the old model for registration certificates in the form approved by the order of the Ministry of Health No. 773 will be carried out free of charge upon the written request of the applicant to the SE “State Expert Center of the Ministry of Health” (hereinafter – the Center), which will be considered a basis for the Center to prepare and provide the applicant with a draft registration certificate of the new form for approval.

After agreement with the applicant on the draft registration certificate of the new form, the original of the updated registration certificate will be sent to the Ministry of Health of Ukraine for signature within 3 working days. If there is confirmation of the applicant’s authority, the original of the temporarily issued registration certificate of the old model is exchanged at the Center for a properly executed registration certificate of the new approved form.

Please note that the temporarily issued registration certificate of the old model is valid for the period specified in it (5 years), its exchange for a registration certificate of the new form can be carried out at the request of the applicant during the specified period.

According to the materials of moz.gov.ua