In recent months, several legislative acts have been adopted that significantly affect the regulation of medicinal products, specifically: A ban on advertising information on the labeling and information about persons other than the Manufacturer and MAH (marketing authorization holder), which comes into effect on January 18, 2025; Parallel import of medicines purchased by an authority […]
Newsletter on cosmetics, food products and biocides in Ukraine (Sep’22)
We highlight the most important regulatory news regarding cosmetics, food products and disinfectants (biocides).
Since February 24, Ukraine has been defending itself from the russian invasion, the country is under martial law. Every day the aggressor’s troops launch rockets on civilian infrastructure. On September 4, 2022, the Office of the UN High Commissioner for Human Rights reported 13,917 civilian casualties in Ukraine, of which 5,718 were killed and 8,199 were injured. It is noted that the real numbers are much higher, as each case is confirmed, and obtaining information is significantly complicated.
Cratia fully resumed work in mid-March, as of today we perform absolutely all types of regulatory activities.
We are grateful to the international community for its support, thanks to which we can defend ourselves and believe in a bright future. We are grateful to our many partners who provide the humanitarian aid that is so necessary in today’s healthcare system. We are grateful to everyone in the world who has empathy and helps Ukrainians. We are endlessly grateful to the Armed Forces and Regional Defence, doctors and medical workers, infrastructure workers, volunteers and many others.
State Service of Ukraine on Food Safety and Consumer Protection
From May 13, 2022, the State Service of Ukraine on Food Safety and Consumer Protection, the central competent authority responsible for certification and market surveillance of most consumer products, resumed accepting Applications for state sanitary-epidemiological assessment. At the same time, the assessment procedure was changed – a requirement was introduced to receive from the State Service of Ukraine on Food Safety and Consumer Protection a referral for conducting an examination to the relevant expert commission.
Changes in the regulation of baby foods
We remind you that on May 13, 2022, the Law of Ukraine “On Amendments to Certain Legislative Acts of Ukraine on Bringing the Legislation of Ukraine in the Field of Baby Foods into Compliance with the requirements of the European Union Legislation” entered into force.
The law made significant changes to the requirements for the production, circulation, and advertising of baby food, the main of which are:
- Change in the procedure for placing baby food on the market – the state registration of baby food and the requirement to obtain a sanitary-epidemiological examination opinion have been canceled; instead, mandatory notification to market the product has been introduced.
- Changes in the requirements for the composition of baby food (a ban on the use of certain ingredients) and labeling (mandatory information has changed, banning the use of certain phrases, etc.) have been introduced.
- Prohibition of advertising of infant formula and follow-on formula with clearly defined exceptions.
- Extension of the list of violations of the requirements of the food legislation, for which it is envisaged to impose fines on the market operator (violation of the requirements to send a notification of the intention to put into circulation, offer for sale, or sale of baby food, in which the content or number of ingredients does not meet the requirements of the law, or contains prohibited substances/ingredients) and legislation in the field of advertising.
Cratia offers an analysis of the composition and development of national labeling under the requirements of the updated legislation, as well as a voluntary service for obtaining a document from expert organizations confirming the compliance of baby food with the safety requirements. This document can be added to the Notice of Intention to be put into circulation in addition to the list of mandatory documents.
Technical regulations for cosmetic products
We remind you that the “Technical Regulations for Cosmetic Products” was approved by Resolution No. 65 dated January 20, 2021, which was supposed to enter into force on August 3, 2022.
However, the date of entry into force of the Technical regulations on cosmetic products was postponed to August 3, 2024. An additional two years transition period is provided till August 3, 2026, that allows the placing of cosmetic products on the market under the “old” sanitary-hygienic conclusions and “new” Technical regulations.
The transition period allows cosmetic product market operators to prepare for new requirements. Market operators are encouraged to start preparations early, including but not limited to implementing Good Manufacturing Practices (GMP) in production, developing a product information file (PIF) and preparing a cosmetic product safety report (CPSR), review of product composition and updating the labeling.
Ukrainian Technical regulation on cosmetic products was developed based on Regulation (EC) No. 1223/2009 of November 30, 2009 on cosmetic products. For national manufacturers complying with the requirements of the Technical regulation means complying with most of the requirements of the European act, that provides a route to enter the European Union market.
Cancellation of the list of critical imports
On July 7, the amendments to Resolution No. 153 of February 24, 2022 canceled the list of critical imported goods. This means the ability for local operators to make payments in foreign currency to non-residents for any products.
Labeling in the state language
By letter No. 15.1.4-10/6024 dated June 2, 2022, the State Service of Ukraine for Food Safety and Consumer Protection reports that labeling exceptions were applied to avoid a critical situation and artificial shortage at the beginning of martial law, but in connection with gradual adaptation to new conditions, the competent authority requires strict compliance of consumer rights legislation.
Moratorium on state market supervision and product control
By Resolution No. 303 of March 13, 2022, planned and unplanned activities of state supervision (control) and state market supervision have been temporarily suspended. As of August 31, 2022, this resolution was amended by Resolution No. 955 which clarifies that during the period of martial law, unplanned state supervision (control) is allowed in certain areas.
In addition, the Resolution of the CMU dated May 3, 2022 No. 550 suspended the state control of non-food products by customs authorities. The moratorium is valid until the termination or abolition of martial law in Ukraine.
Prohibition of russian products
Resolution of the CMU dated April 9, 2022 No. 426 prohibits the import of goods from the Russian Federation into the territory of Ukraine.
Ukraine is a candidate state for EU membership
On June 23, Ukraine obtained the status of a candidate state for joining the European Union. The candidate status legally determines Ukraine’s movement towards full membership in the EU. This movement envisages the further approximation of the legislative system, infrastructure, principles and practices of Ukraine to the European Union.
Have any questions or want to know more? Contact us:
+38 044 364 33 55
+38 044 361 48 28
17-21 Baggovutivska str., 6th floor, 04107, Kyiv, Ukraine
info@cratia.ua