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- (a) Alcoholic beverages
  1. Some Members expressed concern over the restrictive consequences of the current activity licensing system for the sale of alcoholic beverages. They requested information on the intention of the Russian Federation to introduce new legislation in this area. Noting that the fees charged for the right to import alcoholic beverages greatly exceeded those charged for domestic distribution or export, these Members felt that more detail was also required on this and on any other activity licensing fees associated with importation. In particular, these Members sought information on any plans for establishment of a State monopoly on alcoholic beverages.
  2. The representative of the Russian Federation stated that Federal Law No. 171-FZ of 22 November 1995 "On State Regulation of Producing and Turnover of Ethyl Alcohol, Alcoholic and Alcohol Containing Products" (as last amended on 5 April 2010) established the legal basis for production and turnover of ethyl alcohol, alcoholic products (wine, alcoholic beverages, ethyl drinkable alcohol) and alcohol-containing products (alcohol-containing edible and non-edible products). He added that, previously, according to this Law, a specific requirement of licensing of export/import activity with those goods had existed. However, this requirement had been abolished upon the entry into force of Federal Law No. 102-FZ of 21 July 2005, amending Federal Law No. 171-FZ.
  3. A Member asked the Russian Federation to specify the requirements to obtain an activity licence related to alcohol. It expressed a concern that certain requirements updated in December 2010, such as, technical conditions for storage of alcohol, warehouse requirements (safety rules, anti-fire structures, humidity conditions and temperature, etc.), applied by the Federal Service for the Regulation of Alcohol (FSR) some of which differed from one type of alcohol product to another, were difficult to meet, and were applied in an inconsistent manner. This Member noted that these requirements were over-burdensome and could constitute a discriminatory and/or unjustifiable restriction on trade under the WTO Agreement.
  4. In response, the representative of the Russian Federation explained that these updated requirements were designed to create adequate conditions for storage and distribution of alcohol and alcoholic products, ensuring the quality and safety of the products and the safety of persons engaged in operation of warehouses. In his view, these requirements were not overly burdensome and were applied on a non-discriminatory basis.
  5. Some Members noted that the Russian Federation continued to require an activity licence to engage in producing or distributing alcoholic beverages and ethyl alcohol in order to obtain a licence to import these products. This requirement limited the companies that could import to those engaged in producing or distributing alcoholic beverages and ethyl alcohol in the Russian Federation. Furthermore, a requirement to obtain both the import licence, which could only be issued if an operator had obtained an activity licence, and the activity licence itself led to a cumbersome double licensing situation for foreign operators putting them at a disadvantage as compared to domestic producers. One Member urged the Russian Federation to eliminate this double licensing requirement, and noted that any such requirements, if maintained, would have to comply with the WTO Agreement.
  6. The representative of the Russian Federation answered that the elimination of the specific activity licence for imports and exports, mentioned in paragraph , already simplified the licensing procedures in the area of trade in alcoholic products. This change led to a system whereby activity licenses were required only for doing business, i.e., producing, distributing and storing alcoholic beverages and ethyl alcohol (the product coverage of the activity licensing system was listed in Table 12), such licenses were valid for no more than five years and whereby while no specific activity licence would be needed for import/export activities, an activity licence for producing, distributing and storing alcoholic beverages and ethyl alcohol was necessary to obtain a licence to import or to export these products. He confirmed that the licensing system did not have any turnover requirement. Conditions and requirements to be fulfilled by legal persons and individual entrepreneurs to get an activity licence to engage in producing, distributing and storing covered alcohol products were stipulated in Federal Law No. 171-FZ of 22 November 1995 (as last amended on 5 April 2010). Pursuant to Resolution No. 154 of 24 February 2009, activity licenses were issued by the FSR and were required to be issued within 30 days after submission of the complete set of documents. Under the draft FSR Administrative Regulation, operators were allowed to apply for a renewal of their existing activity licence not earlier than 60 days before the date of its expiration. In accordance with Federal Law No. 171-FZ, the FSR was required to conclude its consideration of the application for renewal of an activity licence within 15 calendar days from the date of receipt of the application and to issue and notify the applicant in writing of its decision within three calendar days after the FSR concluded its considerations. In response to a question from some Members, the representative of the Russian Federation explained that if, for whatever reason, the activity licence expired while the renewal application was pending, the FSR would require a new application, but would not charge a new fee. However, the goods stored under the terms of the expired activity licence would become illegal from the date of expiration of the licence and subject to seizure.
  7. Some Members expressed serious concerns that applicants for activity licence renewal that had complied with all the legal requirements, but nevertheless had not been granted a renewal, were subject to penalties including seizure of their goods, and did not have effective legal recourse and that these measures as applied were open to abuse and unreasonably restricted access to the market.
  8. In response, the representative of the Russian Federation stated that, in his view, the current procedure for the renewal of an activity licence did not constitute a restriction on trade, nor was the renewal process overly burdensome. The FSR could refuse to issue a licence only on the basis of the criteria set-out in paragraph 9 of Article 19 of Federal Law No. 171-FZ and could not refuse to issue or renew a licence on the basis of minor documentation errors. An applicant>
  9. In response to a question from a Member the representative of the Russian Federation explained that in cases where an existing activity licence expired, but an application for renewal was pending, an import licence issued to the same operator would remain valid until the end of its term albeit not operational until the issuance of the renewed activity licence. In such cases, the operator would not be required to seek a new import licence if the previously issued import licence had not expired. That is, the import licence would not be automatically considered null and void upon the expiration of the related activity licence.
  10. One Member asked for confirmation that the period for which an activity licence was issued or renewed would not be restricted on the grounds that the applicant did not hold a lease on its storage facilities for the full duration of the requested period.
  11. In response, the representative of the Russian Federation explained that Federal Law No. 171 FZ stipulated the exhaustive list of documents which were required for the application for an activity licence. In accordance with Article 19.17 of the Federal Law the activity licence can be renewed for the period requested by the applicant, but not more than five years. Neither Federal Law No. 171-FZ, nor other legal acts contained the requirement for the applicant to provide a lease contract on storage facilities valid within the term of validity of an activity licence. He further confirmed that the FSR would only undertake actions in conformity with the Federal Law.
  12. One Member emphasized that the Russian Federation should ensure full national treatment in respect of all laws, regulations and requirements concerning internal sale, offering for sale, purchase, transportation, distribution or use of imported alcoholic beverages and ethyl alcohol.
  13. In response to a question from a Member, the representative of the Russian Federation confirmed that the non-automatic import licensing requirements were explained in the Section "Quantitative Import Restrictions, including Prohibitions and Quotas and Import Licensing Systems" of this Report and repeated that, from the date of the accession of the Russian Federation to the WTO, non-automatic import licensing for alcoholic beverages would be eliminated and replaced by an automatic licensing procedure whereby licenses would be issued upon submission of the appropriate and complete documentation.
  14. The representative of the Russian Federation explained that, taking into account the specificity of the alcohol market, i.e., potential danger of low-quality alcohol products for the health of people, the Government of the Russian Federation imposed the following requirements to alcohol products, which were applied in a non-discriminatory manner towards domestic and foreign made products:

- marking of alcoholic products containing more than 9 per cent specific volume of ethyl alcohol by excise stamps, which were available for foreign exporters;

- registering of ethyl alcohol, alcoholic products and alcohol-containing products in the Unified Federal Automatic Information System; and

- mandatory labelling of every unit of alcoholic beverages with a warning inscription about the negative effect of alcohol for the health.
  1. Some Members noted the electronic system for the control of alcoholic products, the Unified Federal Automatic Information System (UFAIS), which was linked to the mandatory use of excise duty stamps, had caused problems when the system was introduced and disrupted trade. While noting that these initial problems had been rectified, Members expressed continuing concerns about the excessive reporting requirements which obliged importers to produce detailed reports about the use of every single excise duty stamp. Members noted that this mandatory requirement was very burdensome and questioned the need for it. Members also expressed concern that domestic producers were not subject to the same requirements. In response, the representative of the Russian Federation stated that as of 8 January 2009, according to Government Resolution No. 522 of 25 August 2006 (as last amended on 9 March 2010), importers and domestic producers had the same reporting requirements related to stamps for alcoholic beverages. Furthermore, Members requested a confirmation that the excise stamps issued under an activity licence would continue to remain valid also, if that licence was renewed. Members also asked about the intention of the authorities of the Russian Federation to introduce a new excise duty stamp which would need to be applied in addition to the stamp introduced already ("second stamp").
  2. Some Members also asked about mandatory guarantees required for imported products in accordance with Order No. 663 of the Federal Customs Service, dated 13 April 2009. They expressed concern about the fixed guarantee levels set-out in this document which were in many cases excessive compared to the actual customs payments due. They also raised concerns about the reimbursement periods of these excessive payments, which were often very lengthy and caused significant economic losses to the operators. Further, some Members asked about the requirement for a second guarantee concerning the delivery of goods.
  3. In response to the question of some Members about the basic guarantee required for imported products, the representative of the Russian Federation confirmed that the requirements regarding basic guarantees were established by Order No. 663 of the Federal Customs Service. Pursuant to the Order, the fixed amount of basic guarantees was set in accordance with Article 88.4 of the CU Customs Code. Pursuant to Article 88.1, the amount of guarantee of customs payment was calculated on the basis of the sums of the customs duties and taxes payable in the CU Party where the goods were to be released for domestic consumption or export. If the goods entered the Russian Federation under customs transit to another CU Party, the amount of the guarantee of payment was determined on the basis of the amount of the customs duties and taxes payable in the CU Party in which the goods would be released or from which they would be exported, but the guarantee amount would be no less than the customs duties and taxes that would be paid if the goods were released in or exported from any other CU Party. Where the sum of payable customs duties and taxes could not be exactly calculated due to the non-provision to the customs body of exact information on the nature of the goods, their name, quantity, country of origin and customs value at the time the guarantee payment was assessed, the amount of the guarantee of payment was to be set on the basis of the highest rates of customs duties and taxes, the value of goods and/or their natural physical characteristics (quantity, weight, volume and other characteristics) which could be assessed on the basis of available data.
  4. Further, he confirmed that Governmental Resolution No. 699 of 24 October 2007 "On Amending Governmental Resolution No. 866 of 31 December 2005" had abolished the double bank guarantee on imported alcohol products. He confirmed that, concerning guarantees and deposits for imports of alcoholic products, no additional documents, such as "transit guarantee certificates" or other requirements, were necessary for the importation of alcoholic products. As regards some concern from Members on the limitation of the number of banks that could provide guarantees to importers and on the cap on the value of guarantees that could have been provided by banks, the representative of the Russian Federation explained that these provisions were imposed to secure customs payments and interest payable at the clearance of goods for free circulation and they were not aimed at indirect protection of domestic products. He added that both foreign and domestic producers could provide guarantees issued by only those banks which had been included in the list of banks participants of the system of insured accounts and that there was no discrimination on the basis of origin of an operator in issuing the guarantees by these listed banks. He added that, pursuant to Article 62 of Federal Law No. 86-FZ of 10 July 2002 "On the Central Bank of the Russian Federation" (as last amended on 26 April 2007), the Bank of Russia could set special standards for banks in order to ensure stability of credit organizations. The maximum level of risks for each borrower was limited by one of these standards.
  5. In reply to the question about the UFAIS system, the representative of the Russian Federation stated that the UFAIS system had been introduced by amendments to Federal Law No. 171-FZ with the aim of establishing better control upon the alcoholic products which were distributed in the territory of the Russian Federation and preventing the introduction of counterfeit products into the market. This informational system contained information provided by the enterprises performing production and distribution of ethyl alcohol, alcoholic products and alcohol-containing products. According to the rules of the functioning of the system, established by Resolution of the Government of the Russian Federation No. 522 of 25 August 2006 (as last amended on 9 March 2010), the information about the products subject to import and about the company which would distribute the products in the territory of the Russian Federation (taxpayer identification number, information about the activity licence and, if appropriate, on the import licence), was provided to the customs authorities in electronic form. In response to a question from a Member concerning the impact of the creation of the Customs Union on the UFAIS system, the representative explained that the excise duty stamps and the UFAIS system were specific to the Russian Federation, and that alcoholic products from Kazakhstan and Belarus were treated as imports for the purpose of the UFAIS system.
  6. In response to a question from a Member, the representative of the Russian Federation explained that excise stamps already issued under an activity licence would remain valid and could continue to be used if that activity licence was renewed.
  7. The representative of the Russian Federation underlined that there were currently no plans to introduce additional requirements concerning a second excise duty stamp and if such a requirement were introduced, it would be non-discriminatory and otherwise consistent with WTO requirements. He further confirmed that any excise stamp requirement would be applied consistent with the WTO Agreement. He also added that the Russian Federation would apply the requirements regarding the guarantees in a manner consistent with the WTO Agreement, including by ensuring that the guarantees would not significantly exceed the actual payments due. The Working Party took note of these commitments.
  8. In response to the question of some Members about the regulation of import to the Russian Federation of denaturized substances and denaturized alcohol-containing products, the representative of the Russian Federation said that, since 1 July 2007, the production and sale of such products (including import) was limited to those which were specified in the list established by Government Resolution No. 401 of 25 June 2007 (as last amended on 31 October 2009) implementing Federal Law No. 171-FZ of 22 November 1995 that had entered into force on 9 December 1995 (as amended on 29 December 2006).
  9. In response to the question of some Members concerning State monopoly on alcohol, he informed that Federal Law No. 171-FZ of 22 November 1995 "On State Regulation of Producing and Turnover of Ethyl Alcohol, Alcoholic and Alcohol-Containing Products" (as amended on 1 December 2007) envisaged the possibility of establishing a State monopoly for manufacture and (or) turnover of ethyl alcohol, alcoholic products and alcohol-containing products in the territory of the Russian Federation. Similarly, the CU Agreement on Non-Tariff Regulation envisioned the possibility of an exclusive licence to import certain products to be granted by the CU Commission. However, neither the establishment of a State monopoly nor the grant of an exclusive import licence was anticipated at this time.
  10. The representative of the Russian Federation noted that licensing fees were provided for in the Tax Code of the Russian Federation (see Table 12). The Code was designed to provide a unified licensing fee rate for the right of production, storage and sale of alcoholic products. The representative of the Russian Federation further stated that discriminatory fees on imported products in relation to licensing procedures had been eliminated.

- (b) Pharmaceuticals
  1. Some Members requested additional information concerning the future elimination of activity licensing requirements as a condition for importation in the area of pharmaceuticals and sought clarifications regarding the steps taken by the authorities of the Russian Federation to bring existing practices into consistency with WTO requirements.
  2. The representative of the Russian Federation said that in order to protect human and animal life and health, the right to import pharmaceuticals, including veterinary drugs, was granted to the following Russian entities, including foreign-invested enterprises, registered as a Russian legal person, in accordance with Federal Law No. 61-FZ of 12 April 2010 "On the Circulation of Medicines":

- enterprises manufacturing pharmaceuticals, which imported pharmaceutical products for their own manufacturing of pharmaceuticals;

- wholesale enterprises of pharmaceuticals;

- research and development institutes and laboratories, which carried out development research and quality control, effectiveness, and safety of pharmaceuticals;

- foreign developers and foreign producers of pharmaceuticals for clinical trials, State Registration of pharmaceuticals, inclusion of pharmaceutical substances in the State registry of pharmaceuticals and quality control of them under the permission of the authorised body; and

- medical organizations for the provision of medical assistance to certain patients.
  1. Pursuant to Federal Law No. 128-FZ of 8 August 2001 "On Licensing of Specific Types of Activities" (as last amended on 28 September 2010), the activity licensing in respect of pharmaceuticals, including veterinary drugs, was maintained because of potential damage of such activity to human or animal life and health. Licenses for the production or distribution of these goods were issued for a period of five years. In accordance with Article 15 of Federal Law No. 128-FZ, a fee of RUB 2,600 was charged for the issuing of each activity licence for pharmaceutical activity, e.g., production of pharmaceuticals, including veterinary drugs, and for activities in distribution of pharmaceutical products for medical purposes.
  2. Some Members of the Working Party requested the Russian Federation to confirm that the ability to request an activity licence for trade in pharmaceuticals was reserved for Russian Federation firms and to explain what that meant in practice for foreign-owned firms in the Russian Federation, foreign exporting firms not established in the Russian Federation, and domestic or foreign individual entrepreneurs seeking to export pharmaceuticals to the Russian Federation. They asked the Russian Federation to confirm that activity licenses would be made available to all registered companies (domestic or foreign). They noted that this would not prevent the Russian Federation from operating State-trading enterprises or applying controls on imports and exports for example for purposes of human health, as long as these were applied in a manner consistent with relevant WTO obligations.
  3. In response, the representative of the Russian Federation recalled that foreign legal persons intending to import pharmaceuticals, including veterinary drugs, into the territory of the Russian Federation were required to register as a legal person of the Russian Federation to hold a licence to engage in the relevant type of pharmaceutical activity (production, distribution) in the territory of the Russian Federation, pursuant to the provisions of Federal Law No. 128-FZ and to acquire import licenses from the Ministry of Industry and Trade.
  4. Members continued to express concerns regarding these requirements. An importer had to obtain an activity licence to engage in production or distribution of pharmaceuticals in the Russian Federation as a condition for receiving an import licence. The criteria applied to obtain these activity licenses did not relate to importation and requiring an importer of pharmaceuticals to meet the requirements to produce or wholesale pharmaceuticals in the Russian Federation could limit imports of these goods.
  5. The representative of the Russian Federation stated that, under Article 48 of Federal Law No. 61-FZ of 12 April 2010 "On the Circulation of Medicines", domestic and foreign natural persons were not permitted to import pharmaceuticals, including veterinary drugs, to the Russian Federation. Some Members of the Working Party requested information on whether natural persons were permitted to manufacture pharmaceuticals in the Russian Federation. Those Members noted that the fee for each importation was burdensome, delayed imports and unnecessarily added to the expenses of importation, and appeared to be a revenue measure. In response, the representative of the Russian Federation explained that under Federal Law No. 128-FZ of 8 August 2001 "On Licensing of Specific Types of Activities" (as last amended on 30 September 2010) and according to Government Resolution No. 684 of 3 September 2010 "On Regulations on Licensing of the Manufacturing of Pharmaceuticals" the manufacturing of pharmaceuticals in the Russian Federation could not be carried out by natural persons. Regarding importation of pharmaceuticals, he noted that legal persons with foreign participation (including fully foreign-owned legal persons) enjoyed the same rights as other Russian legal persons in the Russian Federation and could obtain the required activity licence under the same conditions.
  6. The representative of the Russian Federation confirmed that activity licenses were made available to all companies registered in the Russian Federation as legal entities (including those with foreign participation and those entirely owned by foreigners), which satisfied government regulatory criteria. He further noted that the Rules of Import and Export of Medicines Registered in the Russian Federation (approved by Government Resolution No. 438 of 16 July 2005 "On the Procedure for Importation and Exportation of Medicines for Medical Purposes"), Federal Law No. 61-FZ of 12 April 2010 "On the Circulation of Medicines", as well as the CU Agreements listed in paragraph , CU Commission Decision No. 132, and, more specifically, by the Regulations on the Order of Entry into the Customs Territory of the Customs Union of Medicines and Pharmaceutical Ingredients, defined the procedure for importation/exportation of medicines and pharmaceutical substances registered in the Russian Federation. The representative of the Russian Federation also recalled the information contained in the Section on "Quantitative Import Restrictions, including Prohibitions and Quotas and Import Licensing Systems" regarding acquisition of licenses for the importation of pharmaceuticals.