Dear сolleagues, In this digest, you will find the most important news on the registration, pharmacovigilance and quality control of medicines in Armenia, Azerbaijan, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan, Ukraine, Uzbekistan, and the Eurasian Economic Union (EAEU) which came into effect at the end of 2023 and the first half of 2024. In brief: […]
Important: SI units on the package labeling in UA
The transition period for placing of products into circulation with measuring information in SI units on the labeling will come to an end in 11 months, on 01.01.2021. The requirements of the Order of the Ministry of Economic Development No. 914 of 04.08.2015 apply to all products that will be placed on the market of Ukraine, including:
- medicinal products;
- medical devices;
- food products;
- cosmetics.
For the implementation of SI units in the labeling of medicines registered in Ukraine, it is required to submit an Application for variations, follow the assessment procedure, and grant approval. Artworks of the primary and secondary package in color with SI units must be submitted for registration at the database of the State Service of Ukraine on Medicines and Drugs Control. We recommend starting the process immediately, as the state expert examination and approval procedure takes several calendar months.
Changes in the labeling of medical devices and cosmetics do not require approval or registration, but in some cases, notification of changes may be necessary. We recommend bringing the labeling under the requirements of Order No. 914 in advance to avoid problems with placing and providing products on the Ukrainian market.
For dietary supplements, medical nutrition, or food products for weight control, one may need to make changes to the report Annex. For baby food and functional baby food, it is necessary to go through the procedure for making changes to the Annex to the Conclusion of the State Sanitary and Epidemiological Examination.
The purpose of Order No. 914 is the practical implementation of the provisions of the Law of Ukraine “On Metrology and Metrological Activities” in terms of the uniformity of measurement units. Although the rules apply specifically to labeling, we also recommend reviewing the information in the instructions for use (user manuals) to maintain the unified approach.
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