Medicines and pharmaceutical products
- Document symbol
- G/LIC/N/3/RUS/6
- Original language
- English
- Published on
- 25/10/2021
Outline of Systems
Q1. Give a brief description of each licensing system as a whole and, with respect to each, reply to the following questions as relevant, placing all of the material with respect to a given system in sequence together, and using cross references as appropriate when elements which have already been described are also present in another system.
The List of Goods subject to import/export prohibitions or restrictions within the EAEU in trade with third countries is approved by the EEC under the Decision of the Board No.30, Annex 2.14 of the document sets out relevant for thsi chapter list of goods.
The approval process for medicines and pharmaceutical products consists of two steps:
- Permits are issued by the Federal Service on Surveillance in Healthcare;
- Based on permits licenses are issued by the Ministry of Industry and Trade.
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
The licensing system regulates the turnover of specified medicines and pharmaceutical products for protection of human, animal or plant life or health.
Q3. The system applies to goods originating in and coming from which countries?
The system is applied to goods originating in and coming from all countries.
Q4. Is the licensing intended to restrict the quantity or value of imports, and if not, what are its purposes? Have alternative methods of accomplishing the purposes been considered and if so which? Why have they not been adopted?
The use of import licenses enables the Government to monitor the quantities of controlled means imported. The system does not intended to restrict the quantity or volume of imports.
Q5. Cite the law, regulation and/or administrative order under which the licensing is maintained. Is the licensing statutorily required? Does the legislation leave designation of products to be subjected to licensing to administrative discretion? Is it possible for the government (or the executive branch) to abolish the system without legislative approval?
Is the licensing statutorily required?
The control on the importation of goods specified in this category is statutory requirement under the legislation detailed below:
- "Protocol on measures of non-tariff regulation in trade with third countries (Appendix No. 7, Treaty on the EAEU (ratified by Federal Law No.279-FZ)";
- "Instruction for registration of an application for license issuance for exports and/or imports of certain types of goods and for making up these licenses (approved by the EEC under the Decision of the Board No.30)";
- Decision of the Board of the EEC No.30;
- Federal Law No.164-FZ "On the Fundamentals of the State Regulation of Foreign Trade Activity";
- RF Government Resolution No.1567-p "On approving the list of federal executive bodies authorized for approval of applications for licenses to exports and/or imports of goods and execution of other permits in foreign trade in the cases provided for in applications on the application of restrictions on goods subject to bans or restrictions on its importation or exportation by Member States of the Customs Union within the EurAsEC in trade with third countries".
Is it possible for the government to abolish the system without legislative approval?
This system cannot be abolished without legislative approval.
Procedures
Q6. For products under restriction as to the quantity or value of imports (whether applicable globally or to a limited number of countries or whether established bilaterally or unilaterally):
Q6.I. Is information published, and where, concerning allocation of quotas and formalities of filing applications for licences? If not, how is it brought to the attention of possible importers? Of governments and export promotion bodies of exporting countries and their trade representatives? Is the overall amount published? The amount allocated to goods from each country? The maximum amount allocated to each importer? How to request any exceptions or derogations from the licensing requirement?
Q6.II. How is the size of the quotas determined: on a yearly, six-monthly or quarterly basis? Are there cases where the size of quota is determined on a yearly basis but licences are issued for imports on a six-monthly or quarterly basis? In the latter case, is it necessary for importers to apply for fresh licence on a six-monthly or quarterly basis?
Q6.III. Are licences allotted for certain goods partly or only to domestic producers of like goods? What steps are taken to ensure that licences allocated are actually used for imports? Are unused allocations added to quotas for a succeeding period? Are the names of importers to whom licences have been allocated made known to governments and export promotion bodies of exporting countries upon request? If not, for what reason? (Indicate products to which replies relate.)
Q6.IV. From the time of announcing the opening of quotas, as indicated in I above, what is the period of time allowed for the submission of applications for licences?
Q6.V. What are the minimum and maximum lengths of time for processing applications?
Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
Q6.VII. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
Q6.VIII. If the demand for licences cannot be fully satisfied, on what basis is the allocation to applicants made? First come, first served? Past performance? Is there a maximum amount to be allocated per applicant and, if so, on what basis is it determined? What provision is made for new importers? Are applications examined simultaneously or on receipt?
Q6.IX. In the case of bilateral quotas or export restraint arrangements where export permits are issued by exporting countries, are import licences also required? If so, are licences issued automatically?
Q6.X. In cases where imports are allowed on the basis of export permits only, how is the importing country informed of the effect given by the exporting countries to the understanding between the two countries?
Q6.XI. Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
Q7. Where there is no quantitative limit on importation of a product or on imports from a particular country:
Q7.a. How far in advance of importation must application for a licence be made? Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence (for example, owing to inadvertency)?
How far in advance of importation must application for a licence be made?
There is no minimum advance notice required for a license.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
Goods arriving at the port without a license cannot be imported and retrospective permits cannot be issued. The maximum processing time for permit and license is 20 days.
Q7.b. Can a licence be granted immediately on request?
No.
Q7.c. Are there any limitations as to the period of the year during which application for licence and/or importation may be made? If so, explain.
No.
Q7.d. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
Which administrative body is responsible for approving application of licences?
Import licenses are issued by the Ministry of Industry and Trade of the Russian Federation.
Must the applications be passed on to other organs for visa, note or approval?
The application must be approved the Federal Service for Surveillance in Healthcare.
Q8. Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria? Are the reasons for any refusal given to the applicant? Have applicants a right of appeal in the event of refusal to issue a licence and, if so, to what bodies and under what procedures?
Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?
A license may not be granted if the applicant does not meet ordinary criteria.
Are the reasons for any refusal given to applicants?
If applications are not granted, applicants will be informed about the reasons for that in writing.
Have applicants a right of appeal in the event of refusal to issue a licence? If so, to what bodies and under what procedures?
An applicant may apply to the Ministry of Industry and Trade of the Russian Federation for a review of the decision not to issue a license.
Eligibility of Importers to Apply for Licence
Q9. Are all persons, firms and institutions eligible to apply for licences: (If not, is there a system of registration of persons or firms permitted to engage in importation? What persons or firms are eligible? Is there a registration fee? Is there a published list of authorized importers?) a) under restrictive licensing systems? b) under non-restrictive systems?
All persons, entities and institutions are eligible to apply for licenses.
Documentational and Other Requirements for Application for Licence
Q10. What information is required in applications? Submit a sample form. What documents is the importer required to supply with the application?
What information is required in applications?
Application forms are available on the special website "Support for foreign trade participants" (http://www.non-tariff.gov.ru).
What documents is the importer required to supply with the application?
An importer is required to submit the following documents with the application:
- Digital copy of an application form;
- Copy of a contract;
- Copy of the document on registration with tax authority or the copy of the document on state registration;
- Permit from the Federal Service for Surveillance in Healthcare of the Russian Federation or data on existence of the license for implementation of the licensed type of activity (https://www.rosminzdrav.ru);
- The applicant has the right to submit the documents specified in last two subparagraphs on his own initiative.
Q11. What documents are required upon actual importation?
Upon importation, an importer is required to submit standard customs documentation along with a valid license.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
Is there any licensing fee or administrative charge?
License application fees are charged.
What is the amount of the fee or charge?
Fees are 7,500 roubles.
Q13. Is there any deposit or advance payment requirement associated with the issue of licences? If so, state the amount or rate, whether it is refundable, the period of retention and the purpose of the requirement.
There is no deposit or advance payment requirement associated with the issue of licenses.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?
Licenses are valid for the certain period.
Q15. Is there any penalty for the non-utilization of a licence or a portion of a licence?
There is no penalty for the non-utilisation of a license or a portion of a license.
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Licenses are not transferable between importers.
Q17. Are any other conditions attached to the issue of a licence? a) for products subject to quantitative restriction? b) for products not subject to quantitative restriction?
There are no conditions attached to the issuance of a license.
Other Procedural Requirements
Q18. Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
There are no other administrative procedures, apart from import licensing required prior to importation.
Q19. Is foreign exchange automatically provided by the banking authorities for goods to be imported? Is a licence required as a condition to obtaining foreign exchange? Is foreign exchange always available to cover licences issued? What formalities must be fulfilled for obtaining the foreign exchange?
Foreign exchange is automatically provided by the banking authorities for goods to be imported.