In 2014, an Association Agreement between Ukraine on the one hand, and the European Union, the European Atomic Energy Community and their Member States, on the other (hereinafter referred to as the Association Agreement) has been concluded. Ukraine was granted the status of a candidate for membership in the European Union (hereinafter the EU) in 2022. To date, despite russia’s full-scale war, Ukraine is confidently moving towards European integration in all sectors, in including the pharmaceutical industry.
The approval of new Law of Ukraine No.2469-IX "On medicinal products" of July 28, 2022 (hereinafter referred to as the Law) was a major action for the harmonization of legislation regulating the circulation of medicinal products with the EU's legislation. The Law shall be put into effect 2.5 years after the lifting of martial law, imposed by Decree of the President of Ukraine No. 64/2022 "On the imposition of martial law in Ukraine" of February 24, 2022, with certain exceptions.
In particular, the following Law's provisions shall be brought into force from January 1, 2028:
This "transition stage" will enable the government authorities to develop the relevant statutory and regulatory enactments and allow business to prepare for new rules. For this reason, it is essential even now to monitor and participate in public agencies' activities aimed at implementing the new Law's provisions.
It is worth noting that the pharmaceutical industry concept may comprise the development, manufacture and distribution of medicinal products, medical devices. Since through the prism of European integration this concept is extremely wide, we suggest to dwell on the issues of circulation of medicinal products, on which the Ukrainian business is most focused today.
It is necessary to distinguish a number of acts from EU legislation, since it is mainly on them that the new Law is based:
1. Directive 2001/83/EC of the European Parliament and of the Council of November 6, 2001 on the Community Code relating to medicinal products for human use;
2. Regulation (EC) No.1901/2006 of the European Parliament and of the Council of December 12, 2006 on medicinal products for paediatric use. The Regulation lays down rules for the development of medicinal products for human use to meet the specific therapeutic needs of the paediatric population without subjecting the paediatric population to unnecessary clinical or other trials; and in accordance with Directive 2001/20/EC;
3. Directive 2001/20/EC of the European Parliament and of the Council of April 4, 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use;
4. Regulation (EC) No.726/2004 of the European Parliament and of the Council of March 31, 2004 laying down Community procedures for the authorization and supervision of medicinal products for human use and veterinary use and establishing a European Medicines Agency;
5. Regulation (EC) No.141/2000 of the European Parliament and of the Council of December 16, 1999 on orphan medicinal products.
On industrial visa-free and mutual recognition of GMP certificates
Let us recall that the GMP (Good Manufacturing Practice) certificate confirms compliance of the conditions of manufacture of medicinal products with the requirements of good manufacturing practice in line with international standards, which cover requirements to staff, equipment, premises, control, storage, packaging, labelling, shipment and distribution of medicinal products.
Foreign pharmaceutical manufacturers have to reaffirm in Ukraine GMP certificates issued by the competent authorities of their countries. The solution is the direct application of GMP documents of EU member states without the need for another procedure of their recognition in Ukraine.
Another obstacle to the competitiveness of Ukrainian manufacturers is the need to confirm the GMP certificate issued in Ukraine, in order to enter the European market. The Ministry of Health of Ukraine (hereinafter referred to as MOH) stated that the recognition of Ukrainian GMP certificates in Europe will give an impetus to the development of pharmaceutical manufacturing in Ukraine, namely, will allow the export of the product to the EU market with lower regulatory barriers.
According to the Ministry of Economy of Ukraine, playing a key role in the introduction of industrial visa-free by Ukraine, the process of preparing for the conclusion of the Agreement on conformity assessment and acceptance of industrial products (ACAA) has been activated.
Pursuant to Article 57 of the Association Agreements, the ACAA Agreement may be concluded in respect of the sectors or products specified in Annex III to the Association Agreement. It is Annex III that approves the List of legislation for adaptation with time frames for its implementation. Although it includes medical devices, active implantable medical devices; in vitro diagnostic medical devices, the pharmaceutical sector is not included in the list of products for which an industrial visa-free may be concluded.
It is therefore necessary to amend the Association Agreement and extend Annex III. Recognition of Ukrainian GMP certificates in Europe will also require appropriate additional training of inspectors and direct inspection of the manufacture of medicinal products.
Marketing authorization
In addition to other innovations of marketing authorization, from August 18, 2025, documents for marketing authorization (amending, reauthorization, etc.) should be submitted in electronic form under the standard of the Electronic Common Technical Document (eCTD). The business community pays particular attention to the introduction of the standard functioning in the EU and the timeliness of its implementation.
Verification of medicinal products (2D code)
Article 57 of the Law introduces a new and the most effective tool against medicine counterfeiting – the National Medicines Verification System, taking into account the requirements of the Commission Delegated Regulation (EC) 2016/161 of October 2, 2015 supplementing Directive 2001/83/EC.
In order to prevent and counteract the circulation of counterfeit medicinal products, their manufacturers place the following safety features on the packaging of certain medicinal product as approved by the Cabinet of Ministers of Ukraine (CMU):
1. A unique identifier or, in cases defined by law, an equivalent unique identifier to verify the authenticity and identify the packaging of the medical product;
2. Аn anti-tampering device to ensure that the package has not been opened.
It is also envisaged that a non-governmental national verification organization, a central data repository with data on unique identifiers and medicine operations would be established; as well as drafting of CMU resolution to regulate the operation of the system and the procedure for the application of safety features; determination by MOH of medicinal products, for which the placing of safety features is mandatory.
One of the important functions is the common search with the European Commission of mechanisms to enable Ukraine to fully join the European Medicines Verification Organization (EMVO); connect to the European hub, data warehouse, containing information on medicines in all EU countries and some other European states, – until EU membership status.
The Law's provisions on verification shall be effective from January 1, 2028, but not earlier than 60 months after lifting of martial law, unless a decision is taken otherwise, in particular to amend the Law on implementation of verification system.
Good practices
It has been established that MOH should approve sectoral guides adapted to the EU legislation, defining a set of organizational and technical measures and rules for related activities, namely in the form of guidelines:
This already requires business entities to review their processes.
Regulatory authority
Clause 6 of Part 1 of Article 2 of the Law shall define the regulatory authority as a central executive agency with a special status, implementing the government policy in development, admission to the market, quality control, safety and efficacy of medicinal products. The authority has a range of powers, as follows:
These powers include competence of the State Service of Ukraine on Medicines and Drugs Control and SOE "State Expert Centre of the Ministry of Health of Ukraine."
MOH reported that preliminary work on the timely launch of the regulatory authority is under way. The establishment of a single national regulatory authority meets the EU and WHO recommendations and is another step towards bringing the system on circulation of medicines in Ukraine into the EU legislation. At MOH meeting, the ministry decided that the best option would be to establish an agency within the State Service of Ukraine on Medicines and Drugs Control.
Updated EU legislation
On November 25, 2020, the Pharmaceutical Strategy for Europe has been adopted with the aim of creating a future legal and regulatory framework and supporting the industry in promoting research and technology that reach patients to fulfil their therapeutic needs, while addressing market failures. It will also consider the weaknesses exposed by the coronavirus pandemic and take appropriate actions to strengthen the system.
Thus, the pharmaceutical industry in the EU may expect dramatic but gradual changes. Dialogue with manufacturers, marketing authorization holders, wholesalers, and others should be an integral part of the development of the pharmaceutical industry at the level of the European Union and Ukraine.
Most recently, in April 2023, proposals were made for acts that revise and replace existing pharmaceutical legislation, including legislation on rare diseases, and on children. In particular:
1. Roadmap/initial impact assessment for the revision of general pharmaceutical legislation;
2. Structured dialogue on safety of supply of medicinal products;
3. Pilot project "Market launch of centrally authorized medicinal products;"
4. Study on medicine shortage;
5. Studies on optimizing public procurement of medicinal products.
The principles of the European pharmaceutical market, laid down in the new Law of Ukraine "On medicinal products" and their implementation process will probably require strategic changes.
Conclusion
To sum up, the following key issues should be highlighted:
1. The issue of industrial visa-free with the EU remains relevant, including for medicinal products and medical devices.
2. The harmonization of Ukraine's legislation with the European Union's documents is a fundamental step towards early accession to the EU.
3. The approximation of legislation, as well as European integration actions, create new opportunities for manufacturers of medicinal products and other business entities engaged in economic activities in this sector, and most importantly – entry to the European market with its own products.
4. Human health should be at the centre of the pharmaceutical industry. All innovations will contribute to a sharp increase in access to quality, efficient and safe medicinal products for Ukraine's population.
5. The gradual transition to European models, taking into account the martial law in Ukraine and the new EU sectoral legislation, poses a lot of challenges. Therefore, the active stance of citizens in the process of European integration is fundamental, while cooperation of the government, stakeholders and patients on the principle of equality is crucial for proper and full implementation of requirements to the pharmaceutical industry.
Yulia Vykhrovska
Associate at Legal Alliance
The event focused on the transformation of Ukraine's intellectual property sector on its path toward European integration.
Improving access to safe and affordable medicines for the Ukrainian population is one of the Government of Ukraine's top priorities. SAFEMed Activity (2017-2025) has supported this effort by appIying health system strengthening best practices.
The Ministry of Health website has posted a notice about the release of a revised draft order of the Ministry of Health ‘On Approval of Amendments to Certain Re
On 25 September, a webinar was held on the topic: ‘180 days of new drug price regulation. Results, prospects and practical advice.’ The event was organized by LA Law Firm in partnership with Proxima Research International.
