FAQ

March 25, 2020 09:00

Where can I see the State Service of Ukraine on Medicines and Drugs Control’ annual implementation plan of state supervision (control) for 2020?

The annual implementation plan of state supervision (control) for 2020, has been approved by the SMDC Order No. 1472 dated November 28, 2019 and available on the website www: http://dls.gov.ua/.

Can I be consulted if an application for a license left without consideration or was refused?

Consultation on licensing issues can be obtained at the following address: 120-A Victory Ave., Kyiv, and +380 (44) 422-55-83.

Is it possible for non-governmental organization to obtain enterprise’s licensing documents? 

Pursuant to Article 17 of the Law of Ukraine “Licensing of Different Types of Economic Activities” the extraction of licensing documents is carried out based on court decision.

However, based on the requirements of Article 10 of the Law of Ukraine “On Access to Public Information”, a licensee can apply to the State Service on Medicines and Drugs Control for obtaining copies of documents stored in his licensing case.

What to do if the pharmacy at the consumer’s request refused to provide a receipt?

According to the Regulation on the State Service of Ukraine for Food Safety and Consumer Protection, approved by the Order of the Cabinet of Ministers of Ukraine of September 2, 2015 No. 667, the State Service of Ukraine for Food Safety and Consumer Protection, within the scope of its functions, monitors the implementation of the consumer protection law.

Which drugs are sold online? Are there any medicinal products that sold online only?

In accordance with paragraph 27 of the Licensing Provisions for Conducting Economic Activity in Manufacturing, Wholesale and Retail Trade, Import of Medicinal Products (except for Active Pharmaceutical Ingredients) which was approved by the Cabinet of Ministers of Ukraine of November 30, 2016 No. 929, the trade is carried out exclusively through pharmacies and cannot be provided remotely and through e-commerce, as well as by mail and through any facilities other than pharmacies.

The requirements of paragraph 27 of the License Provisions applies only to finished medicinal products and do not extend to drugs that are not registered as medicinal products, such as BAA, food supplements, etc.

What documents need to be submitted for Retail Drug License?

In accordance with the resolution of the Cabinet of Ministers of Ukraine of November 30, 2016 No.929 “On approval of the Licensing conditions for conducting business activities in the production of medicinal products, wholesale and retail trade of medicinal products, import of medicinal products (except active pharmaceutical ingredients)” the following documents shall be submitted to the licensing authority:

  • License application in the Form given in Annex 1 to the License Terms;
  • Information confirming availability of logistic and physical infrastructure, qualified personnel that are necessary for conducting business activity in the retail trade of medicinal products, in the Form given in Annex 5 to the License Terms;
  • Copy of applicant’s passport with the mark of the relevant controlling authority for refusing, due to their religious beliefs, from the taxpayer’s registration number (to be submitted only by individuals – entrepreneurs who, due to their religious beliefs, refuse to accept the taxpayer’s registration number of the account card and informed the appropriate controlling authority);
  • Information on the absence of supervision (in the meaning given in Article 1 of the Law of Ukraine “On Protection of Economic Competition”) over applicant’s activity by residents of other states, undertaking armed aggression against Ukraine (in the meaning given in Article 1 of the Law of Ukraine “On the defense of Ukraine”) and/or which actions create the conditions for a military conflict and the use of military force against Ukraine. Such information shall be provided in an arbitrary form;
  • Two copies of the inventory of documents using the form in Annex 8 to the License Terms.

Is it possible to obtain a paper license?

No. According to the Law of Ukraine “On Licensing of Economic Activities”, a license is a record in the Unified State Register of legal entities, individuals – entrepreneurs and civil society associations of the decision of the licensing authority on whether the entity has the right to pursue the type of economic activity to be licensed.

Is it possible to open a pharmacy in a shopping center not on the ground floor?

In the premises of shopping center it is allowed to open the pharmacy in an isolated room on any floor and without arranging a separate exit to outside, on condition when shopping center equipped with passenger elevators and/or lifts (inclined or vertical lifting platforms, etc.) in good technical condition, and to comply with paragraph 165 of these License Terms.

 Is it necessary to renew license in case of changing the last name of an individual entrepreneur?

No. The Law of Ukraine “On Licensing of Economic Activities” contains no provision for license renewal in case of changing the last name of an individual entrepreneur.

However, the licensee is obliged to notify the licensing authority of any changes to the data that were specified in its documents, which were attached to the license application, within the period set by the license terms, but not later than one month after the date of such changes.

Is it possible to obtain a written confirmation that the responsible person has been entered in the Register of persons responsible for introduction of medical devices?

In accordance with paragraph 14 of the Procedure for maintaining the Register of persons, responsible for the introduction into circulation of medical devices, active implantable medical devices and in vitro diagnostic medical devices, the forms of communications, the list of information stored in it and access regime, approved by the Ministry of Health of Ukraine Order of February 10, 2017 №122, information from the Register is provided by the State Service of Ukraine on Medicines and Drugs Control for written requests from government authorities, local authorities, persons responsible for introduction products into circulation, individuals and legal entities and civil society associations by providing written response in accordance with the requirements of the Laws “On Citizens’ Appeals”, “On Access to Public Information” and “On Personal Data”.

In accordance to part 6 of Article 5 of the Law of Ukraine “On Citizens’ Appeals”, a citizen submitted a written request by mail or delivered it personally. It is also may be submitted online (electronic communication). E-mail is a form of written request.

At the same time, we draw your attention to the fact that, in accordance with part 7 of Article 5 of the Law of Ukraine “On Citizens’ Appeal”, the request must specify citizen’s last name, first name, middle name, address, the essence of the issue, comments, proposals, statements or complaints, requests or demands. The applicant must sign the written application indicating the date.

The online request must also indicate the e-mail address to which the applicant may be answered or information on other means of communication. The use of an electronic digital signature is not required when sending an electronic request.

Accordingly, a citizen’s signature in an online request can be scanned, photographed etc.

In accordance with part 8 of Article 5 of the Law of Ukraine “On Citizens’ Appeals” a request made without stated requirements will be returned with explanations, not later than ten days from the day of its receipt.

The Law of Ukraine “On Access to Public Information” defines the request as “a person’s request to information holder to provide the information that in his possession”. The Law also specifies that the request may be submitted verbally, in writing or in any other form (by mail, fax, telephone, e-mail) on the choice of the applicant. The presentation of the request may be arbitrary (i.e. a reference to this Law or the use of the term “request” is optional).

The object of the request is a plea to information holder to provide the information. The Law “On Access to Public Information” grants the right of access to already existing information (documents) and does not require the creation of new information in response to a request (in particular, by carrying out analytical work).

The rules prohibit government employees and local government officials to disclose personal data of individuals, confidential and other information with restricted access, which they became aware of in connection with the performance of their duties and was established by the laws of Ukraine “On State Secret”, “On Information”, “On Protection of Personal Data” and “On Access to Personal Information”.