On 21 August 2024, the Parliament of Ukraine adopted amendments to the Law on Medicinal Products as a part of an effort to align Ukrainian legislation with EU regulations, particularly Article 54 of Directive 2001/83/EC. These Amendments, however, introduce stricter rules than the EU legislation.
Key provisions of the Amendments:
1. Prohibition on non-compliant labelling:
- The Amendments strictly prohibit the inclusion of any advertising information or references to entities other than the Marketing Authorisation Holder (MAH) or the manufacturer on the packaging of medicinal products.
- Unlike Directive 2001/83/EC, which allows labels of medicines to include information on other entities (e.g. distributors) if the MAH’s information is clearly distinguishable, the Amendments do not permit such labelling practices in Ukraine.
- Exceptions to these labelling requirements include medicinal products brought in as humanitarian aid and unauthorised medicinal products whose import is permitted under specific exceptions of Article 17 of the Law (e.g. investigational medicinal products, medicines for individual use, orphan medicines under specific rules). Specific procurement procedures are also exempted.
2. Penalties for non-compliance:
- The Ministry of Health of Ukraine (MOH) is authorised to temporarily suspend the registration of any medicinal product that does not comply with the new labelling requirements until the labelling is corrected through appropriate variations and the suspension is lifted.
3. Restrictions on trade and importation:
- The Amendments prohibit the importation, retail and wholesale trade of medicinal products if the labelling includes any advertising information or information about entities other than the MAH or manufacturer.
- Exceptions include certain imported medicinal products, including those brought in as humanitarian aid and unauthorised medicinal products whose import is permitted. Specific procurement procedures, such as those conducted by the Centralised Procurement Agency (Medical Procurement of Ukraine), are also exempted, provided the procured medicines meet the other prescribed labelling criteria.
Impact of the Amendments
We expect that the Amendments will affect companies in Ukraine commercialising medicines of other manufacturers and MAHs, operating under marketing, promotion, and similar agreements, that involve branding using the marketing or promoting entity's logo. This practice is permitted in Ukraine, where foreign companies can be MAHs for medicines authorised in the country.
Implementation timeline:
- The Amendments will come into force the day after their official publication, following the Ukrainian President’s signature, and will be enacted four months after the date of coming into force.
- The Ukrainian Cabinet is required to update its regulation on registration of medicinal products within three months after the law goes into effect.
- The Amendments recommend that the Ministry of Health of Ukraine and the State Service of Ukraine on Medicines and Drugs Control ensure compliance within three months of the law's enactment, including suspending the registration of non-compliant products.
For more information on pharmaceutical sector regulations, including parallel import of medicines in Ukraine, contact your CMS advisor or our local experts: Borys Danevych, Maria Orlyk.
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