RESUMO
OBJECTIVE: Introduction: medicinal products are special goods which the quality of life and health of the population directly depends on. Therefore, ensuring the quality of medicinal products is central to state policy of developed countries in the conditions of free movement of goods and services. High quality of medicinal products should be supported in the context of pharmaceutical market globalization by using exclusively a modern quality control system such as serialization. The aim: the rationale for the need to use the serialization system of medicinal products by European countries which are not a part of the EU is the goal of our research. PATIENTS AND METHODS: Materials and methods: the research is based on EU law (Directive 2001/83/EC, Directive 2011/62/EU, Delegated Regulation (EU) 2016/161), Ukrainian legislation, statistics of WHO, General Prosecutor's Office, European Union Intellectual Property Office, Court judgment of the Ukrainian courts, legal doctrine in the field of medical law. The research is also based on general and special scientific research methods. CONCLUSION: Conclusions: existing quality control mechanisms do not cope with the task of providing the people with access to high quality and safe medicinal products. The serialization of medicinal products provides an opportunity to raise the quality control of medicinal products to a new level in the process of globalization. Serialization of medicinal products is important for Ukraine and other country's not in EU, it will fill the internal pharmaceutical market with a qualitative product and will allow the export of medicinal products.
