The State Service of Ukraine on Medicines and Drugs Control started accepting applications for licensing of medicines e-retail

Опубліковано 06.01.2022 о 12:31

On December 24, 2021, in accordance with the amendments introduced into the Licensing conditions of the economic activity in the manufacture, wholesale and retail trade, import of medicines (except for active pharmaceutical ngredients), hereinafter – Licensing Conditions, the State Service of Ukraine on Medicines and Drugs Control began accepting  applications for licensing electronic retail trade in medicines.

Licensees who have a license to conduct out a retail trade in medicines may apply to the State  Service of Ukraine on Medicines and Drugs Control for the right to conduct business in electronic retail trade in medicines.

For this purpose it is necessary to submit the completed application on the form established by Annex 1 to the Licensing Conditions, which indicate that the applicant is applying for the application to expand the economic activity on electronic retail of medicines.

An application must be attached:

  • information on the availability of physical infrastructure and skilled staff required to conduct economic activity in electronic retail of medicinal products, in accordance with the form of Annex 24 to the Licensing Conditions as well as thea copy of the approved written standard working methods (standard operating procedures), which describe the work on acceptance, registration, batching, storage, delivery of order for medicines, provide consultation as well as delivery of medicines to the end-user (stitched and verified by the licensee);
  • a copy of the agreement with the postal operator on delivery of medicines to the end-user, certified by the licensee (in case of involvement on contractual basis of postal operators);
  • an applicant`s copy passport with the mark of the relevant supervisory authority about refusal due to their religious beliefs to accept the registration number of the taxpayer`s account card (submitted only by individuals – entrepreneurs who due to their religious beliefs  refuse to accept the taxpayer`s registration number and notified the supervisor authority);
  • confirmation of the lack of control over activities of the economic entities in the sense listed in the Article 1 of the Law of Ukraine “On Protection of Economic Competition”, residents of the state, carrying out an armed aggression against Ukraine, within the meaning given in Article 1 of the Law of Ukraine “On Defense”. Such information is provided in any form in compliance with the requirements of paragraph 9 of the License Terms;
  • description of the documents issued for obtaining a license in two copies in the form set out in Annex 8 to the Licensing Conditions.

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