In connection with the entry into force of the Resolution of the Cabinet of Ministers of Ukraine of 27 March 2019 No. 296 "On Amendments to the Resolution of the Cabinet of Ministers of Ukraine of 26 May 2005 No. 376 "On Approval of the Procedure for State Registration (Re-registration) of Medicinal Products and the Amounts of the Fee for Their State Registration (Re-registration)" and amendments to the Order of the Ministry of Health of Ukraine of 29 July 2003 No. 358 "On Approval of the Form and Description of the Registration Certificate for a Medicinal Product", to help ensure the supply of medicinal products to the population of Ukraine, the State Expert Center of the Ministry of Health of Ukraine (hereinafter – the Center) recommends that applicants/applicants' representatives submit a letter in free form indicating the following information on medicinal products registered in accordance with the Procedure for Conducting Expert Evaluation of the Authenticity of Registration Materials for a Medicinal Product Submitted for State Registration for the Purpose of Its Procurement by a Specialized Organization, approved by the Order of the Ministry of Health of Ukraine of 03.11.2015 No. 721: trade name of the medicinal product, dosage form, packaging, applicant/manufacturer(s), MoH of Ukraine order "On State Registration of a Medicinal Product".
In accordance with the letters provided, the Center will prepare an invoice for payment for the procedure of issuing a registration certificate with an extended validity period. According to the Center's order of 11.04.2019 No. 76, the cost of 1 copy of the registration certificate is UAH 630.
The preparation and issuance of registration certificates will be carried out in accordance with paragraph 9 of Section VIII of the Procedure for conducting expert evaluation of registration materials for medicinal products submitted for state registration (re-registration), as well as expert evaluation of materials on amendments to registration materials during the validity of the registration certificate, approved by MoH order of 26.08.2005 No. 426 (as amended by MoH order of 23.07.2015 No. 460).
