Development of the new edition of the Law of Ukraine “On medicinal products” is continuing

The team of Legal Alliance' associates including Mr. Alexander Yanev and Ms. Nataliia Spivak, under general guidance of Mr. Dmytro Aleshko, Partner of Legal Alliance Company is continuing to carry out the project on development of the new edition of the Law of Ukraine “On medicinal products” .

It is to be recalled that earlier Mr. Aleshko was involved for legal support of certain process within the framework of working group under the Committee of Ukrainian parliament on healthcare issues.

Since the working group established it has already held four meetings of its small circle, which included representatives of professional associations, practitioners in the field of medicine and pharmaceuticals, as well as lawyers. During the meetings the indicative framework of the new law was approved and most of its sections were drafted.

Considering the European integration vector of Ukraine, the new law on medicinal products developed in line with provisions of Directive 2001/83/EU. Development of chapters regulating, in particular, quality control of medicines, retail, preclinical study and clinical research, based on the experience of some EU countries (Poland, Czech Republic, Denmark), taking in account special aspects of the Ukrainian pharmaceutical market.

Today a number of issues requiring conceptual approving at Whole Working Group were executed. Such issues require significant changes to the existing model of regulation of the Ukrainian pharmaceutical market. Among them:

• the introduction of mandatory compliance of the market participants with good distribution practices, good pharmacy practice, good clinical laboratory practices, the introduction of mandatory certification for their compliance;
• implementation of the European model of medicines registration, which does not provide their reregistration for every five years, but single extension of the registration certificate indefinitely;
• cancellation of state registration of the API, which are made by national manufacturers and are used solely for the production of finished drugs, etc.

Today there are two working groups involved in the process of development of the Law of Ukraine "On medicines" – the above mentioned one and the working group under the Ministry of Health of Ukraine. Representatives of both working groups are discussed the possiility of merging their efforts with the aim to avoid uncoordinated actions. Joint rulemaking of working groups should results in equal quality document.