On July 28, 2022, the Parliament of Ukraine adopted a new version of the Law “On Medicinal Products”.
The goal of the new law is the harmonization of Ukrainian legislation regulating relations in the field of medicinal products with the regulatory legal acts of the European Union, the introduction of uniform terminology, and uniform rules for regulating the pharmaceutical market.
In particular, the law defines new rules regarding:
– conditions for creation, pharmaceutical development, preclinical research, clinical trials (research), state registration of medicinal products;
– conditions of production, production (manufacturing) in the conditions of a pharmacy, appointment, application, import, wholesale and retail trade, distance trade, quality control;
– the rights and obligations of legal entities and individuals, as well as the powers of state authorities and officials in the relevant field;
The adopted draft law will enable, in particular:
– eliminate terminological inconsistencies contained in the legislation of Ukraine and adapt the terminology in this area to the acts of the EU legislation;
– establish rules for the placement of medicinal products intended for human use, taking into account special requirements for reference and generic medicinal products, homeopathic, traditional herbal medicinal products, pediatric, high-tech, and orphan medicinal products, etc.;
– to regulate at the legal level the procedures related to the state registration of medicinal products;
– to ensure an effective mechanism of supervision and control in the field of circulation of medicinal products and the responsibility of persons for violations of the legislation on medicinal products, etc.
The law also provides for the creation of a single state body that will control the circulation of drugs at all stages.