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 […]
Updated procedure for notification of information on cosmetic products
By the Order of the Ministry of Health of Ukraine dated July 19, 2024, No. 1264, amendments to the Procedure for notification (submission) of information on cosmetic products (hereinafter referred to as the Procedure), approved by the Ministry of Health of Ukraine on December 18, 2023, No. 2147, were approved.
The Procedure defines the mechanism for notifying (submitting) information on cosmetic products that meet the requirements of the Technical regulation on cosmetic products, as well as the procedure for forming and maintaining the System of electronic notification (provision) of information on cosmetic products notification portal.
The amendments clarify and expand both the general provisions and the requirements for notifying information on cosmetic products under the Procedure.
The changes define the legal relationship between the System administrator and the System owner (service agreement regarding the functioning of the system) and impose a number of obligations on the System administrator.
Regarding the data to be notified for single-component and multi-component products:
- The requirement to provide information about the product’s status has been removed;
- The provisions of the Procedure regarding CMR substances have been aligned with the Technical Regulation on Cosmetic Products, specifically concerning the absence of CMR substances in the cosmetic product, except in cases where use is permitted or restricted by Annexes 3–6 to the Technical Regulation on Cosmetic Products;
The provisions of the Procedure have been aligned with the Technical Regulation on Cosmetic Products concerning the graphical file of the labeling.
The approved changes are an important step in improving legislation, ensuring clearer regulation, and aligning with European legislation norms.
Our services
Cratia provides comprehensive regulatory support and accompanies at all stages of regulatory compliance of cosmetic products in Ukraine:
- outsourcing of a Responsible Person (RP) in Ukraine;
- assessment of the composition of the product;
- filling of the Product Information File;
- Cosmetic Product Safety Report (CPSR);
- verification/development of labeling, instructions, and advertising materials;
- product notification;
- development and implementation of Good Manufacturing Practice in accordance with ISO 22716 (GMP);
- legal and consulting support of the manufacturer, Responsible person or distributor (importer).
We possess deep knowledge and experience, speak and write fluent English. We will take over the organization of the process, assist in filling of the set of documents and perform the required procedures in a short time.
We provide preliminary consultations free of charge, call us by phone +38 (068) 064-78-31, +38 (044) 223-61-67, or write to info@cratia.ua, or come to the meeting directly to our office.
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