The State Service for Medicines and Drugs Control is considering an issue whether it is lawful for a foreign company representative office to carry functions of an authorized representative of a foreign manufacturer of medical products.
The issue, first of all, is related to different definitions of “authorized representative” in different regulatory acts.
Thus, in accordance with Article 1(1) of the Law of Ukraine “On Technical Regulations and Conformity Assessment”, an authorized representative is any individual or legal entity resident of Ukraine, which has got a written instruction from a manufacturer to act on its behalf with regard to tasks specified in the instruction.
Article 1(3) of the Law of Ukraine “On Technical Regulations and Conformity Assessment” provides that technical regulations and conformity assessment procedures, the application of which is prescribed by technical regulations, and terms and definitions specified in Article 1(1) of this Law can be supplemented and/or clarified.
The Technical Regulations on Medical Products, Medical Products for In Vitro Diagnosis and Active Medical Products for Implantation approved by Resolution of the Cabinet of Ministers of Ukraine No. 753 as of November 2nd,2013 and Resolution of the Cabinet of Ministers of Ukraine No. 754 as of November 2nd,2013, defines an authorized representative as any legal entity or individual entrepreneur resident of Ukraine or registered under the laws of Ukraine, and also a representative office of a foreign commercial entity which is duly authorized by a manufacturer to take legal actions on its behalf with respect to the manufacturer’s responsibilities laid down in the corresponding Technical Regulation.
The issue of correlation between the mentioned terms and possible consequences for the market in case of alternative approaches of the State Service on Medicines and Drugs Control are now being considered by Legal Alliance Company.
Contact the author: Lidiya Sangarovskaya, senior associate at Legal Alliance Company, sangarovskaya@l-a.com.ua
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