Medicinal products

Law of Ukraine No. 3910 "On Amendments to the Law of Ukraine "On Medicinal Products" on Labelling of Medicinal Products" of 21 August 2024; (2 page(s), in Ukrainian)

The Law aligns the requirements of national legislation on the labelling of medicinal products with the provisions of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.

The Law stipulates that the packaging of medicinal products shall not contain any advertising information, as well as any information about other legal entities or individuals who are not the manufacturer or applicant (holder) of the registration certificate for the medicinal product. The Law also provides that wholesale and retail trade, and import of medicinal products that do not comply with the labelling requirements set out in this Law are not allowed.

The established requirements do not apply to medicinal products imported into Ukraine with labelling and instructions for use/brief description of the medicinal product in the original language (a language other than the state language), based on the results of procurement conducted by a person authorized to carry out procurement in the healthcare sector, or procurement conducted with the involvement of a person authorized to carry out procurement in the healthcare sector, at the funds of local budgets, and/or based on the results of the procurement procedure conducted by a specialized procurement organization to fulfil the procurement agreement between the central executive body of Ukraine responsible for healthcare policy and the relevant specialized procurement organization. Additionally, this exemption covers medicinal products imported as humanitarian aid and unregistered medicinal products, import of which into Ukraine is permitted under conditions specified in Article 17 of the Law of Ukraine No. 123/96-ВР "On Medicines" of 4 April 1996 (amended).