On April 25, 2012 Arzinger held a business breakfast “Narcotic Drugs, Psychotropic Substances and Precursors: Regulatory Aspects” as part of the Arzinger Academy Legal Days project to continue its workshop series for pharmaceutical companies.

Speakers at the workshop were Arzinger’s Senior Associate Natalia Martynyuk, Associates Nazar Polyvka and Nadia Karlash. Igor Stasyuk, Head of the Ukrainian State Service for Drug Control Department for Licensing Drug Trade Activities was a special guest at the workshop.

Nazar Polyvka, Associate of Arzinger’s Life Science Practice, highlighted the issues of legal regulation of narcotic and psychotropic substances and precursors turnover. Thus, the Cabinet of Ministers’ Decree No. 770 as of May 6, 2000 determines the List of narcotic drugs, psychotropic substances and precursors (hereinafter the List) including four main categories of narcotic drugs:  (1) especially dangerous narcotic drugs, turnover of which is prohibited; (2) narcotic drugs, turnover of which is limited; (3) narcotic drugs, turnover of which is limited, with some control measure exceptions permitted (in case a preparation contains an insufficient amount of narcotic substance which cannot be isolated); and (4) precursors with a limited turnover and control measures set with respect to them.

The concept “turnover” of drugs, psychotropic substances and precursors comprises the following activities: cultivation of the plants included in the List; development, production and manufacture; storage; transportation and shipping; purchase, sale, import into the territory of Ukraine; export from the territory of Ukraine; transit through the territory of Ukraine; use, destruction of narcotic drugs, psychotropic substances and precursors included in the List.

The second part of the report dealt with the issue of licensing the activities related to narcotic drugs, psychotropic substances and precursors turnover (products and materials relating to Tables II and III, and List 1 of Table IV of the List, in excess of permissible limits). A necessary condition for licensing such activities is the availability of an appropriate material and technical base, in particular for the recording and preservation of drugs, psychotropic substances and precursors, as well as technical standards and trained personnel (License Terms – Order of the Ministry of Healthcare No. 66 as of 02.02.2010). A license shall be issued to a business entity for one or more activities for a period of five years.

Nadia Karlash spoke further on the regulation of activities related to narcotic drugs, psychotropic substances and precursors turnover. She told about the procedure for the import of narcotic drugs, psychotropic substances and precursors to Ukraine and the conditions for their transportation across the country. The mandatory requirements for the import of such substances to Ukraine include a license and an appropriate permit. In addition, the import shall be carried out exclusively within the quota yearly determined by the Cabinet of Ministers of Ukraine and only through the state border checkpoints approved by Order of the Cabinet of Ministers of Ukraine No. 1950 as of 25.12.2002.

Nadia dwelt on the issue of prescriptions for narcotic (psychotropic) drugs, which are regulated by Order of the Ministry of Healthcare No. 360 as of 19.07.2005. She also drew the participants’ attention to the procedure for destruction and disposal of narcotic drugs, psychotropic substances and precursors. Thus, the Order of the Cabinet of Ministers No. 589 as of 03.06.2009 regulates the destruction of products containing narcotic drugs in excess of permissible limits, in the event that such preparations are deemed unsuitable for further use. Destruction must be carried out by a business entity having an appropriate license. Besides, on order of the entity’s director a special commission should be set up, which should be headed by the director or his deputy and include a representative of the territorial body of the Ministry of Internal Affairs, whose presence is required at the time of destruction. Destruction must be carried out based on the procedure determined by the State Commission on Drug Control.

Natalia Martynyuk, Senior Associate, concluded the workshop with her report “Narcotic Drugs, Psychotropic Substances and Precursors: State Control”. She reminded the listeners about the competences and rights of law enforcement and regulatory agencies in respect of drug turnover. In particular, the law enforcement agencies (State Security Service, Department for the Fight against Drug Trafficking of the Ministry of Internal Affairs of Ukraine and General Prosecutor’s Office) have the right to conduct the full range of operational and search measures, pre-investigation checks and investigative actions (search, seizure, interrogation, interrogation, etc.), to enter the premises of enterprises, to make personal inspections, examination and seizure of objects and documents.

Regulatory agencies are the State Service for Drug Control, Customs, Border Protection Service and the Ministry of Healthcare of Ukraine. The function of the State Service for Drug Control is the control of drug turnover and of compliance with the license terms for business related to narcotic drugs. Thus, the Service has the right to take samples of drugs, plants, products, substances for examination, as well as to obtain information from enterprises, including from their automated information and referral systems and databases, documents, materials and other data about narcotic drugs that are in the turnover (including illegal) in Ukraine.

At the end of the workshop Arzinger’s lawyers gave legal advice to representatives of pharmaceutical companies in terms of activities related to narcotic drugs, psychotropic substances and precursors turnover.

After the speaker’s presentations the business breakfast participants were given an opportunity to ask questions to the experts and to share their experience with colleagues.