The President returned the document with his signature. We looked into what the law is about, how it will affect the work of pharmacists and when it will come into effect. Legislative Bill No. 5547 has been on the agenda of the Verkhovna Rada for a long time, but for various reasons the document was not considered.
“We thoroughly discussed draft law No. 5547 with all stakeholders of the industry, took into account proposals from pharmaceutical associations, people’s deputies and international partners. Therefore, the entire pharmaceutical industry was waiting for the approval of the new version of the law “On Medicines”,” the relevant committee commented.
When will it go into effect?
The fact that the law has been signed and its text is already on the website of the Verkhovna Rada does not mean that the document will work in the coming days. According to the document, its provisions should come into force in 2.5 years from the date of adoption by the Parliament. During this time, Ukrainian pharma should restructure its production to European standards. But it is difficult to predict when the war will end. Therefore, it was decided that the bill would come into effect 2.5 years after the end of martial law.
What’s in the law?
The draft Law “On Medicines” plans to implement the state policy on efficiency, quality and safety of medicines based on the principles:
- regulation in the sphere of circulation of medicines for public health purposes;
- creation of conditions for the development of a competitive environment in the sphere of circulation of medicines to stimulate improvement of their quality, safety and effectiveness, prioritization of economic accessibility of medicines for the patient and orientation towards ensuring efficiency and accessibility of the treatment process;
- creating conditions for the development of the pharmaceutical industry;
- formation of a favorable investment climate, overcoming technical barriers in international trade in medicines by adapting regulations and industry standards with the legislation of the European Union;
- ensuring proper implementation of pharmacovigilance and quality control of medicines, including those imported to Ukraine;
- preventing low-quality and falsified medicines from entering the Ukrainian market and ensuring their withdrawal from circulation;
- state registration and circulation of a medicinal product based on the results of a comprehensive assessment of its quality, efficacy and safety, benefit/risk ratio;
- unambiguous and clearly defined grounds for not requiring the submission of the results of preclinical and clinical trials in order to obtain state registration of a medicinal product for a generic medicinal product;
- protection by the state of the rights and legitimate interests of participants in the drug market;
- prioritizing Ukraine’s self-sufficiency in medicines, including blood and human plasma products, and encouraging voluntary and free blood and plasma donation;
- observance of moral principles when trading in therapeutic substances of human origin by all participants in legal relations;
- licensing of production, import of medicines, wholesale and retail trade in medicines in the interest of protecting public health;
- realization of the right to full, reliable information about the medicinal product and accessibility of its receipt;
- Establishing reasonable restrictions on advertising and promotion of medicines;
- recognizing the important role of medical sales representatives in the promotion of medicines;
- continuous improvement of the pharmacovigilance system through harmonization of terminology, introduction of good pharmacovigilance practices adapted to the standards adopted in the European Union, achievements of scientific and technical progress, technological developments, electronic exchange of information, including reporting of adverse drug reactions;
- personal responsibility of registrants for continuous pharmacovigilance of medicinal products registered and in circulation in Ukraine.
- Ensuring accessibility of medicines and places of sale.
The implementation of the norms proposed by the draft law will ensure:
- elimination of terminological inconsistencies contained in the Ukrainian legislation and adaptation of terminology in this area to the acts of the EU legislation;
- establishing rules for the placement of medicinal products intended for human use, taking into account special requirements for reference and generic medicinal products, homeopathic medicinal products, traditional herbal medicinal products, pediatric, high-tech and orphan medicinal products;
- regulation at the level of law of procedures concerning state registration of medicines;
- fixing special provisions on licensing in the sphere of production, wholesale trade, import of medicines (except for active pharmaceutical ingredients);
- determination of the content of the labeling of the package of a medicinal product and requirements for safety characteristics;
- Classification of medicines;
- Establishing rules for distance selling of medicinal products of the population;
- defining the specifics of advertising and detailing the provisions of the information policy on medicines;
- an integrated approach in the normative regulation of the pharmacovigilance system;
- consolidation of general requirements for medicinal products derived from human blood and blood plasma;
- effectiveness of the mechanism of supervision and control in the sphere of circulation of medicines and liability for violation of legislation on medicines, based on the need to ensure the rights of consumers in this sphere.
The full text of the law can be found here
