Welcome to the most recent issue of our Russian Legislation Update, covering the period of 7 September – 8 November 2015.
On 3 November 2015 the Russian President signed Federal Law No. 299-FZ "On Ratification of a Treaty between the Governments of the Russian Federation and the Republic of Belarus on Mutual Recognition and Procedure for Implementation of Decisions to Deny Entry to the Territories of Member States of the Treaty" (the "Treaty").
The Law completes the ratification process of a Treaty signed on 3 March 2015 in Moscow. The Treaty establishes that a decision of one Member State to deny entry shall be recognised by another Member States as grounds for denying entry to a foreign citizen or a stateless person, refusing their visa application to travel to another Member State, or reducing the term of their temporary residence permit in the territory of such Member State.
Nevertheless, a Member State is entitled to grant entry or leave to stay in its territory to a foreign citizen or a stateless person who was barred from entry by another Member State. In such event, the admitting Member State shall inform the denying Member State about its decision, notify a foreign citizen or a stateless person about any entry restrictions in place.
The Law entered into force on 15 November 2015. The Treaty shall come into force on the day of receipt of the last written notification of its ratification by Russia and Belarus through diplomatic channels.
On 28 September 2015 the Russian Government adopted Resolution No. 1029 on criteria for classification of objects, which have a negative impact on the environment.
Pursuant to recent amendments in Federal Law No. 7-FZ "On Environmental Protection", objects that have a negative impact on the environment are divided into four categories depending on the level of their interference with the environment (e.g., objects in the 1st category have the highest level of hazard). The appropriate legal regime applicable to an object depends on the category it was assigned (e.g., objects of the 1st category are required to obtain a comprehensive environmental permit; objects of the 2nd category must submit a declaration on their environmental impact). The Resolution now sets the criteria on the basis of which objects will be classified into one of the 4 categories.
The Resolution entered into force on 9 October 2015.
On 28 October 2015 the Russian Government adopted Resolution No. 1155 to amend the Regulation on termination of rights to use subsoil deposits of federal significance for exploration and extraction of mineral resources under a combined licence to conduct geological survey, as approved by Government Resolution No. 697 of 16 September 2008.
Pursuant to the Law "On Mineral Resources", the Regulation establishes, in particular, a procedure for adopting decisions on termination of rights to use subsoil deposits of federal significance under a combined licence (for geological survey, exploration and production of mineral resources) by a licensee who is a foreign investor or a legal entity controlled by foreign investors. The Government may terminate the right to use a subsoil deposit of federal significance discovered during a geological study, if exploration and production in this deposit by a foreign subsoil user may pose a threat to national security.
After the subsoil deposit is discovered, the subsoil user must submit an application (together with the documents listed in the Regulation) to the Federal Agency on Subsoil Use for review of prospective exploration and production of natural resources in the discovered subsoil deposit of federal significance. The amendments expand the list of documents to be included in the application in order to obtain more comprehensive information on legal entities controlled by a foreign investor or being foreign investors. In particular, documents containing the following information must be submitted: (i) persons, directly or indirectly, in control of the subsoil user; (ii) participation of such persons in the management of the subsoil user and (iii) beneficiary owners.
The Resolution entered into force on 11 November 2015.
On 7 August 2015 the Ministry of Industry and Trade ("Minpromtorg") issued Order No. 2288 approving the form of an application for entering into an investment contract, and Order No. 2289 on monitoring and control over fulfilment by investors of their obligations under concluded investment contracts.
Orders were registered with the Ministry of Justice on 7 October 2015.
Federal Law No. 488-FZ "On Industrial Policy of the Russian Federation" provides for state support measures aimed at promoting development of commercially viable domestic industry. One of the measures is the opportunity to conclude special investment contracts pursuant to which investors undertake to create and develop industrial production in Russia, whereas the state shall ensure a stable business environment. The procedure for concluding special investment contracts and its model form were set earlier by the Resolution of the Government No. 708 dated 16 July 2015.
Order No. 2288 approves a form of an investor's application to conclude a special investment contract to be submitted to Minpromtorg. Depending on the type of investment project, the Order approves forms of applications for: (i) creation or modernisation of industrial production; (ii) integration of the best available technologies into industrial production; and (iii) development of production of industrial goods, which have no substitutes produced in Russia.
Order No. 2289 establishes a procedure for exercise of monitoring and control by Minpromtorg over fulfilment by investors of their obligations under concluded investment contracts. Specifically, monitoring is to be conducted every six months from the date of execution of the contract, and includes collection of the day-to-day information on the progress of project realisation under the contract. Following the results of monitoring, Minpromtorg shall send a letter to the investor. Control includes review of interim and final reports on fulfilment by the investor of his obligations under such contracts. Forms of these reports and deadlines for submission thereof are specified in the Order No. 2289. Following the results of such control, the Ministry shall prepare an appropriate determination to be sent to the investor, and to be published on the Ministry's official website.
Order No. 2288 entered into force on 20 October 2015 (save for certain provisions).
Order No. 2289 entered into force on 23 October 2015.
On 28 October 2015, the Russian Government adopted Resolution No. 1154 approving the Rules on Assessment of Drug Interchangeability (the "Rules").
The Rules establish a procedure for assessment of interchangeability of a drug at its state registration stage to take place during examination of its quality and/or assessment of the ratio between expected benefits and possible risks of its administration. The Scientific Centre for Assessment of Drugs of the Russian Ministry of Healthcare (the "Centre") carries outs examinations and makes determinations on interchangeability (non- interchangeability) of drugs. Such determination is based on comparison of the drug in question with a reference drug on parameters set out in the Law on the Circulation of Drugs, including: (i) the equivalence or comparability of the additives' composition; (ii) the equivalence of the methods of drug administration or use; (iii) the absence of clinically significant differences in the safety and effectiveness indices; (iv) the producer's compliance with the requirements of good manufacturing practice.
The decision on interchangeability (non-interchangeability) of a drug is executed in the form of an annex to the Centre's expert determination.
The Resolution entered into force on 10 November 2015.
 For details please refer to our update for 22 June – 19 July 2015.
 This form will apply from 1 January 2019.
 Article 27.1(1) of the Russian Law on the Circulation of Drugs.
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