On January 18, 2025, amendments to the Law of Ukraine “On Medicinal Products” (No. 3910-IX dated August 21, 2024) came into force.
It is now prohibited to place any advertising information or details about third parties who are not the manufacturer or the marketing authorization holder on the inner and outer packaging of medicinal products.
Violation of labelling requirements may result in the temporary suspension of the marketing authorization until compliance is restored.
Restrictions on retail and wholesale trade, as well as import, apply to medicinal products with improper labelling, except for:
– Products imported under government procurement programs.
– Medicinal products supplied as humanitarian aid.
– Unregistered medicinal products whose importation is permitted by law.
The purpose of this law is to harmonize national legislation on medicinal product labelling with the requirements of Directive 2001/83/EC of the European Parliament and the Council. According to Article 62, Chapter V of the Directive, outer packaging and package leaflets may contain symbols or pictograms to clarify certain information specified in Articles 54 and 59(1) and other details equivalent to a summary of product characteristics that are useful for the patient, excluding any advertising elements.
These new rules aim to enhance market transparency, protect consumer rights, and align Ukrainian legislation with European standards.