The State Service of Ukraine on Medicines and Drugs Control informs on the exercise of State control over compliance with the requirements of the legislation on quality and safety of medicines (regarding Si labeling of  medicines)

The State Service of Ukraine on Medicines and Drugs Control (hereinafter – SMDC) has received many requests from manufactures and/or medicines’ applicants, professional non-governmental organizations, business entities engaged in economic activity in the production of medicines, wholesale and retail traders of medicines, importers of medicinal products (except for API) on clarification of the Order of the Ministry of Economic Development and Trade of Ukraine of 04.08.2015 № 914 “Approval of definitions of the basic Si units, names and definitions of the derived SI units, decimal multiples and fractions of the Si units, authorized off-grid units as well as their symbols and Rules for the use of units of measure and spelling the names and symbols of the units of measure and the symbols of values” (registered by the Ministry of Justice of Ukraine of 25.08.2015 No.1022/27467) (https://zakon.rada.gov.ua/laws/show/z1022-15#Text), (hereinafter –  Order of the Ministry No.914) and informs on the following.

Note that labeling of medicines is approved by the Ministry of Health of Ukraine during the State registration of medicines and is regulated by the Law of Ukraine “On Medicines”.

In accordance with the Law of Ukraine “On Medicines”, medicines are allowed to use in Ukraine after their State registration, except in the cases provided for by this Law.

Labelling requirements for the packaging of a finished product are defined by the Procedure for the examination of drug registration materials, which is submitted for State registration (re-registration) as well as the examination of materials on changes in the registration materials during the validity of registration certificate approved by the Order of the Ministry of Health of Ukraine of 26.08.2005 No. 426 (as amended in the Order of the Ministry of Health of Ukraine of 23.07.2015 No. 460)

According to the Ministry of Health of Ukraine (letter dated 22.07.2019 No. 24-04/35878/2-19) it is considered advisable (if it is decided by the manufacturer/applicant of medicines) in any of the registration procedures of the applicant regarding the changes to the registration materials into the Text of the labeling to the registration certificate in part of 17 “CLAUSES” to declare use of spelling of names on the packages of medicines the names and symbols of the units of measure and the symbols of the value after writing in Ukrainian the application of the Latin in accordance with the Order of the Ministry No.914, e.g.: 30 mg.

Medicinal products released into circulation during the term when it is allowed to be used in Ukraine can be used until expiry date, specified by the manufacturer and indicated on the package.

At the same time we inform that in accordance with the Regulation on the State Service of Ukraine on Medicines and Drugs Control, approved by the Cabinet of Ministers of Ukraine of 12.08.2020 No. 647, the SMDC exercises State monitoring over compliance with legislation with respect to quality and safety of medicinal products and medical devices in all stages of circulation, including GxP compliance (GMP, GDP, GSP, GVP).

We should also like to state that all medicinal products imported into the customs territory of Ukraine for further distribution (trade) are subject to State quality control. The Procedure for State control of the quality of medicines imported into Ukraine is approved by the resolution of the Cabinet of Ministers of Ukraine of 14.09.2005 No. 902 (hereinafter – Procedure). In accordance with paragraph 3 of the Procedure, registered medicines can be imported into Ukraine only when the manufacturer issued a quality certificate – certificate of analysis or a batch certificate, which certifies conformity of medicinal products with quality control specifications, including indicators “Labeling, Packaging” approved for State registration (re-registration) of medicines at the time of release of the medicinal product. The grounds for sending drug batches for laboratory analysis according to SMDC indicators of the quality specification of methods of quality control of drugs or in accordance with the general requirements established by the State Pharmacopoeia of Ukraine are defined in paragraph 9 and 10 of the Procedure.

State quality control of medicinal products in circulation .

In accordance with the requirements of paragraph 2 of the Procedure for State quality control of medicinal products, approved by the Cabinet of Ministers of Ukraine of 03.02.2010 No. 260 “Some issues of State quality control of medicinal products” for State quality control of medicinal products, SMDC officials, among other things, perform random visual monitoring of conformity of medicinal products with quality control specifications approved for State registration (re-registration) of medicines at the time of release of the medicinal product.

In view of the above, medicinal products in circulation must comply with the approved registration documents, including with regard to packaging and labeling.

In order to obtain additional clarifications on the implementation of the requirements of Order of the Ministry No.914 regarding the application of Si units on packages of medicinal products, we propose to contact the Ministry of Health of Ukraine, since the issues of state registration (re-registration) of medicinal products fall within the competence of the Ministry of Health of Ukraine and the Ministry of Economic Development and Trade of Ukraine, as the developer of the relevant order.

At the same time, we note that the letters of the State Service of Ukraine on Medicines and Drugs Control are not normative legal acts, they have information only and do not establish legal norms.