Russian Federation: Life Sciences. Major Russian Legal Changes In The Second Half Of 2017

Last Updated: 13 March 2018
Article by Marat Mouradov and Alex Skoblo

Major Russian legal changes

1. The Russian government has introduced a risk-oriented approach for scheduled inspections in the healthcare industry

(RF Government Resolution No. 907 on Amendments to the Regulation on Federal State Supervision in the Circulation of Medicine, dated July 31, 2017)

(RF Government Resolution No. 801 on Amendments to the Regulation on State Control of the Quality and Safety of Medical Activity, dated July 5, 2017)

The risk-oriented approach affects, first of all, the frequency of inspections by the Federal Healthcare Supervisory Service ("Roszdravnadzor") and is intended to increase the efficiency and effectiveness of supervisory activity and reduce the administrative and financial burden such activity might place on businesses.

Four risk categories have been introduced for entities involved in the circulation of medicines: low, moderate, medium and significant risk. The assignment of business entities to these categories is to be based on the seriousness of potential negative consequences of a breach of applicable requirements by such entities. Resolution No. 907 describes the criteria and procedures to be followed in assigning a category to a given business. In particular, the director of Roszdravnadzor may issue a decision assigning an entity to a specific category; absent such decision, the entity is to be considered low-risk.

The frequency of inspections of entities involved in the circulation of medicines is to be as follows:

  • once every three years for significant-risk entities;
  • not more than once every five years for medium-risk entities; and
  • not more than once every six years for moderate-risk entities.

Low-risk entities will not be subject to scheduled inspections.

Resolution No. 801 establishes similar principles for entities engaging in medical activity, but adds two additional categories: extreme and high risk. Extreme-risk entities are to be inspected once a year, while high-risk entities shall be inspected once every two years. Resolution No. 801, unlike Resolution No. 907, does not provide for default assignment of an entity to a low-risk category in the absence of a specific decision by the director of Roszdravnadzor.

2. The Russian Ministry of Health has updated the registration dossier for pharmaceutical drugs for medical use

(RF Ministry of Health Order No. 409-n on the Approval of a Procedure for Forming the Registration Dossier for a Pharmaceutical and Documentary Requirements in the Dossier, Requirements Regarding the Scope of Information to Be Provided as Part of the Registration Dossier for Certain Types of Pharmaceutical Drugs and the Procedure for Submitting Documents from which the Registration Dossier for a Pharmaceutical Drug is Formed for the Purpose of its State Registration, dated July 12, 2017)

July 2017 saw changes to the list of documents and information that are required to be submitted for state registration of pharmaceutical drugs and that form part of the registration dossier, along with the procedure for their submission.

The regulator eliminated requirements that the filing entity submit information regarding compensation of clinical trial patients along with copies of their compulsory insurance contracts, the investigator's drug brochure, as well as other documents. At the same time, the regulator expanded other requirements related to clinical documentation and information, introduced the requirement to submit data on the pharmacovigilance system and measures and incorporated other additional requirements.

The Order incorporates current terminology and other recent legislative amendments.

3. "Telemedicine" – remote consultations

(Federal Law No. 242-FZ on Amendments to Certain Legislative Acts of the Russian Federation on the Application of Information Technologies in Healthcare, dated July 29, 2017)

In the course of modernizing applicable laws, amendments to Federal Law No. 323-FZ on the Fundamental Principles of Public Health Protection in the Russian Federation of November 21, 2011 were introduced. Specifically, the amendments introduce a so-called telemedicine service into the Russian healthcare system, i.e., they allow medical care to be provided by way of remote-access technology. The law sets forth an exhaustive list of purposes for which telemedicine technology can be used:

  • interaction between doctors and patients (or their legal representatives), as well as between doctors;
  • identification and authentication of telemedicine service users;
  • documentation of actions of medical staff and patients (or their legal representatives);
  • conducting of conferences and/or consultations; and
  • remote monitoring of patients' health.

A patient must still visit a doctor in person in order to get a diagnosis. Only after such first in-person visit will a doctor be able to remotely monitor the patient's condition, adjust treatments, issue online prescriptions (including for drugs containing narcotic substances), and remotely issue various medical documents (for example, medical disability certificates).

Each patient should get a digital signature for identification purposes. The digital signature allows a patient to access an identification system to which doctors and medical institutions also have access.

The amendments entered into force on January 1, 2018, save that the amendments on remote prescription of drugs containing narcotic and psychotropic substances will take effect on January 1, 2019.

4. The Essential Medicines list to be in effect in 2018 has been updated

(RF Government Oder No. 2323-r on Approval of the List of Essential Medicines for 2018 and the List of Pharmaceutical Drugs and the Minimum Range of Drugs Needed to Provide Medical Care, dated October 23, 2017)

Due to their social significance, medicines included in the Essential Medicines list have special legal status; in particular, such medicines are subject to special pricing regulations and restrictions on public procurement of drugs manufactured abroad (the so-called "third one is out" rule). The list has been updated regularly by the Russian government since it was introduced. On January 1, 2018 the list was expanded by adding 60 drugs and eight dosage forms of drugs already included in the list.

We note that in early 2017, the Russian President suggested optimizing pricing methods with respect to medicines on the Essential Medicines list in order to prevent spikes in their prices. The Russian Ministry of Health thereby prepared a draft Methodology for calculating the maximum sale price for medicines included in the Essential Medicines list. In June 2017, the Russian Federal Antimonopoly Service ("FAS") didn't endorse the proposed Methodology, which is now under discussion at a special commission of the Russian Ministry of Health.

5. New requirements for the description of pharmaceutical drugs procured for state needs

(RF Government Decree No. 1380 on the Specifics of Describing Pharmaceutical Drugs for Procurement for State and Municipal Needs, dated November 15, 2017)

The Decree, which entered into effect on January 1, 2018, states that as a general rule, the following information must be indicated in the description of pharmaceuticals for public procurement:

  • the international nonproprietary name or chemical / grouping names;
  • the dosage form of the drug;
  • the dosage of the drug; and
  • the remaining shelf life.

Importantly, it is prohibited, among other things, to indicate the fill volume of the primary packaging or the form of the drug, auxiliary substances, fixed storage temperature requirements if there is an alternative, the quantity of drug units in the secondary packaging, and also to indicate "other characteristics of the pharmaceutical drug contained in the product instructions pointing to a specific manufacturer." These measures are intended to limit the state customer's ability to encourage unfair competition by indicating restrictive criteria with a view to causing a specific supplier to be chosen.

However, the Decree allows indicating such characteristics in the description on an exceptional basis if "it is not otherwise possible to describe the pharmaceuticals" (with justifications why it is necessary). Such an exception poses a risk that state customers could further misuse restrictive descriptions.

6. System for monitoring the movement of pharmaceutical drugs to start operating in Russia

(Federal Law No. 425-FZ on Amendments to the Federal Law on the Circulation of Medicines, dated December 28, 2017)

It is anticipated that a system to monitor the movement of pharmaceutical drugs will become mandatory as from January 1, 2020. Some manufacturers are already known to be labeling medicines voluntarily as part of an experiment started by the Russian government.

The monitoring system will track the movements of medicines from manufacturers to end consumers by using special identifiers placed by manufacturers on packaging. Companies and individual entrepreneurs involved in the circulation of medicines must then enter related data into the monitoring system. The Russian government has not yet established requirements for such identifiers or maintenance of the monitoring system (including the scope of data required).

The federal law that introduced the monitoring system includes other amendments. For example, in order to register medicines and pharmaceutical substances, information about the applicant's and manufacturer's taxpayer registration in their respective countries of incorporation together with the taxpayer's identification number is required. Holders or owners of registration certificates for medicines, as well as manufacturers of medicines and pharmaceutical substances registered before January 1, 2018, must provide information about their taxpayer registration by January 1, 2019.

Practice news and development trends

7. Precedent-setting decision on introducing generics into civil circulation

In recent years, the problem of generic drugs being registered prior to expiry of the patent for the original drugs has become more common. Among other cases, many large pharmaceutical companies have filed suits against Nativa LLC, which has managed to register multiple generic drugs in breach of patent holders' rights.

In the spring of 2017, Bristol-Myers Squibb lost a case against Nativa LLC in the court of first instance. The court found that the mere registration of a generic drug does not violate the patent protection regime, and the law does not contemplate the possibility to impose restrictions on future intentions with respect to a registered drug. The claimant dropped its case at the appellate level, then initiated new litigation.

However, in September 2017, the Moscow Region Commercial Court delivered a decision that may be precedent-setting. In this case, Novartis convinced the court to enjoin Nativa LLC against putting a generic drug into circulation prior to expiry of the patent.

However, even if court practice develops further in this direction, this approach does not entirely eliminate the risks for pharmaceutical manufacturers, who will be obligated to constantly monitor the actions of unscrupulous competitors putting generics into circulation and protect their rights in court, including by claiming damages for such violations. Precisely for this reason it is important to note that Novartis petitioned the court (first the court of the first instance, then the appellate court) to order Nativa LLC to apply to the Russian Ministry of Health to suspend registration of the generic drug in question, but that claim was dismissed.

Meanwhile, the Association of International Pharmaceutical Manufacturers sent FAS a letter requesting urgent steps to fight this problem. The letter listed specific cases where generic drugs that were under patent protection won public procurement tenders.

8. Further steps to unify the rules on circulation of medicines in the Eurasian Economic Union (the "EAEU")

Legislative activity to support the circulation of medicines in the EAEU common market continues. For example, a unified information system is being developed on the basis of the EAEU's unified register of registered medicines. The legislative foundation for such a system was laid in 2016.

The unified information system is intended to help lift administrative barriers to introducing medicines into circulation in the EAEU, and will additionally create standards on medicine quality.

Among the relevant measures are Russian Government Resolution No. 1159, dated September 25, 2017, which tasked the Russian Ministry of Health with the functions of registering medicines intended for circulation in the EAEU; and the Federal Tax Service order of September 27, 2017, which approved the form and format of the tax return for indirect taxes for EAEU goods imports.

9. Remote sale of medicines

On December 13, 2017, the Russian State Duma adopted in the first reading a draft law introducing a new type of work (service) for the remote retail sale of medicines.

However, it is worth noting that the draft law (in its current version) allows only pharmacies to engage in such activity, and requires reapplication for a license in order to include a special provision on remote sales.

At the same time, it prohibits the remote retail sale of prescription drugs. In order to prevent such sales, the draft law empowers federal authorities to block a website without a trial.

10. Recommendations on pharmaceutical advertising

Pharmaceutical associations (in particular the Association of European Businesses, the Association of International Pharmaceutical Manufacturers, the Association of Russian Pharmaceutical Manufacturers and the Union of Professional Pharmaceutical Organizations) have prepared draft Recommendations on Advertising of Medicines. Together with general requirements regarding the format and content of advertising in accordance with Federal Law No. 38-FZ on Advertising of March 13, 2006, the draft Recommendations set forth the following express prohibitions:

  • against use of images of fairytale and fictional doctors or medical workers (such as Doctor Aybolit);
  • against addressing the consumer directly with questions and/or suggestions and against assuming that someone has a particular illness based on specified symptoms (for example, "Coughing? You have the flu!"); and
  • against presenting competitors in a negative light.

It should be noted that even with FAS support, these Recommendations will not be binding on pharmaceutical manufacturers and will be merely guidelines. However, drug manufacturers hope that complying with the Recommendations will help reduce the number of FAS complaints regarding pharmaceutical advertising.

Dentons is the world's first polycentric global law firm. A top 20 firm on the Acritas 2015 Global Elite Brand Index, the Firm is committed to challenging the status quo in delivering consistent and uncompromising quality and value in new and inventive ways. Driven to provide clients a competitive edge, and connected to the communities where its clients want to do business, Dentons knows that understanding local cultures is crucial to successfully completing a deal, resolving a dispute or solving a business challenge. Now the world's largest law firm, Dentons' global team builds agile, tailored solutions to meet the local, national and global needs of private and public clients of any size in more than 125 locations serving 50-plus countries.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of

To Use you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions