A draft order of the Ministry of Health has been developed “On Amending the List of Diseases and Conditions and Corresponding Medicines Containing Narcotic Drugs or Psychotropic Substances in order to import them into the territory of the Russian Federation for the provision of health care according to the vital indications of a specific patient or group of patients, approved by the order of the Ministry Healthcare of the Russian Federation No. 80n dated February 13, 2020”.
The draft proposes to invalidate the Decree of the Government of the Russian Federation of March 16, 1996 No. 278 “On the procedure for the import into the Russian Federation and export from the Russian Federation of potent and poisonous substances that are not precursors of narcotic drugs and psychotropic substances”.
The draft establishes that the import of these substances is carried out on the basis of a license issued by the Ministry of Industry and Trade in the form of an electronic document signed with an enhanced electronic signature.
To obtain a license through the Federal State Information System “Unified Portal of State and Municipal Services (Functions)” or the information system “One Window”, the following documents and information are submitted in the form of an electronic document:
- application for a license;
- a copy of a foreign trade agreement (contract), annex and (or) addendum to it (for a one-time license), and in the absence of a foreign trade agreement (contract) – a copy of another document confirming the intentions of the parties;
- a copy of the document (information) on registration with the tax authority or on state registration.
The grounds for refusal to issue a license are:
- presence of incomplete or inaccurate information in the documents submitted by the applicant for obtaining a license;
- termination or suspension of one or more documents serving as the basis for issuing a license;
- violation of international obligations of the member states of the Eurasian Economic Union, which may occur as a result of the execution of the agreement (contract) for the implementation of which the license is requested;
- exhaustion of the quota, as well as the tariff quota, or their absence (in the case of a license for the goods being quoted).
If changes are made to the constituent documents of a legal entity (change of the organizational and legal form, name or location of its location), or the passport data of the applicant-individual is changed, the applicant must apply with a request to terminate the issued license and issue a new license with an application attached and documents confirming these changes.
It is important to note that the regulator has the right to decide on the termination or suspension of the license in the following cases:
- application of the applicant submitted in the form of an electronic document;
- amendments to the constituent documents of an applicant who is a legal entity, or change the passport data of an applicant who is an individual;
- identification of inaccurate information in the documents submitted by the applicant for obtaining a license;
- termination or suspension of one or more documents on the basis of which the license was issued;
- violation of the international obligations of a member state of the Eurasian Economic Union during the execution of the agreement (contract) on the basis of which the license was issued;
- revocation of a license to carry out a licensed type of activity, if this type of activity is associated with the turnover of goods for which licensing has been introduced;
- identification of violations committed during the issuance of a license that entailed the issuance of a license, which, subject to the established procedure, could not be issued;
- failure of the license holder to comply with the conditions for issuing a license established by international regulatory legal acts or regulatory legal acts of a member state of the Eurasian Economic Union;
- availability of a court decision.
In this case, the validity of the suspended license can be renewed after the elimination of the reasons that caused the suspension of its validity. Suspension of a license is not a basis for its renewal.
June 10, 2021