Maria Ostashenko

Maria Ostashenko

Partner
Maria Ostashenko

Chambers Europe

She is pleasant and kind to work with, responds fast, and has a good understanding of the situation and what needs to be done.

Biography
Recent work
Publications and Insights
Rankings and awards

Maria Ostashenko is a Partner at ALRUD Law Firm, heading Commercial, Intellectual Property and Data Protection and Cybersecurity practice areas.

Leading team of Commercial practice Maria advises ALRUD clients on managing credit risks of parties, on forms of legal presence and models of conducting business in Russia, supports launching start-ups and implementation of complex projects related to international contracts.

In the Intellectual property area Maria renders legal support for formalizing IP rights, use, management and protection of brands and intangible assets, conducting marketing campaigns and advertising. She possesses extensive experience of resolving disputes regarding intellectual property, including alternative dispute resolution.

Maria represents international clients in the matters involving data protection regulation in Russia, advises on obligations of operators related to data processing, including cross-border data transfers, structuring data flow between the members of international groups.

Maria supports Russian and foreign clients providing her expertise in areas including pharmaceuticals and healthcare, FMCG, banks and financial institutions, retail trade, telecommunications, media and technology.

Maria is a frequent speaker at major Russian and foreign conferences and workshops, and an author of many analytical articles published in legal periodicals. Maria is a member of International Bar Association (IBA), International Trademark Association (INTA), International Technology Law Association (iTechLaw), International Distribution Institute (IDI), International Association of Privacy Professionals (IAPP). Maria also took part in working on the draft amendments to the Civil Code of the RF and presently conducts workshops on the Civil Code developments.

Maria is a certified specialist in the area of European data protection laws (CIPP/E).

Maria Ostashenko graduated from the Moscow State University in 2004 and was awarded a LL.M. degree in private law by the Russian Private Law School by the President of the RF in 2006. Maria joined ALRUD team the same year.

Include advising:

An innovative biopharmaceuticals manufacturer, global manufacturing leader in orphan disease treatment,

on relations with distributors in Russia and CIS countries, marketing strategy and activities.

A world-famous US manufacturer of smart phones and tablets

on issues related to the Client’s advertising campaigns in Russia.

A UK luxury fashion brand

on the issues related to business activities in Russia, including on entering into distribution agreements and importing products into Russia.

A retail group managing a worldwide coffeehouse chain

on entering into franchise agreement with a Russian partner and importing goods into Russia.

An international payment system

regarding Russian data protection legislation requirements applicable to the Client’s products and to cross-border data transfers within the company group.

Numerous clients from the retail industry

on protecting brands against infringements in the internet.

New penalties for the breach of the Russian personal data and information laws
On February 24th, 2021, the President has signed the law increasing administrative penalties for the breach of personal data laws and introducing new penalties for the breach of information laws. The law enters into force on March 27th, 2021. Liability terms for communication providers’ failure to en-sure sustainable operation enter into force on February 1st, 2023. Violations in the area of data processing Below you can find a material summarizing maximum penalties to be imposed on legal entities and compa-nies’ officials for the violation of Russian laws on per-sonal data (except the data localization requirement). 1. Data processing without an appropriate legal ground or excessive data processing Fine for legal entities up to RUB 100,000 (app. EUR 1,115, USD 1,355) for the first offence and RUB 300,000 (appr. EUR 3,345, USD 4,070) for a repeated offence Fine for company’s officials up to RUB 20,000 (app. EUR 220, USD 270) for the first offence and RUB 50,000 (app. EUR 560, USD 680) for a repeated offence 2. Data processing without written consent or in breach of the requirements for written consent (when such consent is statutory required) Fine for legal entities up to RUB 150,000 (app. EUR 1,670, USD 2,035) for the first offence and RUB 500,000 (app. EUR 5,575, USD 6,775) for a repeated offence Fine for company’s officials up to RUB 40,000 (app. EUR 440, USD 540) for the first offence and RUB 100,000 (app. EUR 1,115, USD 1,355) for a repeated offence 3. Failure to provide easy access to the privacy policy, which also includes absence of such policy Fine for legal entities up to RUB 60,000 (app. EUR 670, USD 815) Fine for company’s officials up to RUB 12,000 (app. EUR 135, USD 160) 4. Failure to handle data subject’s request to access their data Fine for legal entities up to RUB 80,000 (app. EUR 890, USD 1,085) Fine for company’s officials up to RUB 12,000 (app. EUR 135, USD 160) 5. Failure to comply with the requirements for data specification, blockage, deletion Fine for legal entities up to RUB 90,000 (app. EUR 1,000, USD 1,120) for the first offence and RUB 500,000 (app. EUR 5,575, USD 6,775) for a repeated offence Fine for company’s officials up to RUB 20,000 (app. EUR 220, USD 270) for the first offence and RUB 50,000 (app. EUR 560, USD 680) for a repeated offence 6. Violation of the requirements for non-automated (manual) data processing triggered unauthorized access or other unlawful data processing Fine for legal entities up to RUB 100,000 (app. EUR 1,115, USD 1,355) Fine for company’s officials up to RUB 20,000 (app. EUR 220, USD 270) Click here to learn more. We hope that the information provided herein will be useful for you. If you or any of your colleagues would like to receive our newsletters via e-mail, please fill in the 'Subscribe' form at the bottom of the page. Practice: Data protection and cybersecurity Note: Please be aware that all information provided in this letter was taken from open sources. Neither ALRUD Law Firm, nor the author of this letter bear any liability for consequences of any decisions made in reliance upon this information.
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ALRUD Intellectual property practice takes part in the IAA roundtable "Brand protection infrastructure in the world, Russia and the EEU"
From November 9th to 13th, an international retail industry forum: the Global Retail Week is taking place online. As part of the event, on November 12th, the expert session “Brand protection infrastructure in the world, Russia and the EEU” will be held. The International Advertising Association (IAA) is organizing this session. Among questions that are planned to be answered during this discussion: the role that brands play in the economy, brand protection in licensing and franchising, existing tools for IPR protection etc. Irina Anuykhina and Maria Ostashenko, ALRUD partners, with the support of the Global Advertising Lawyers Alliance (GALA), will prepare a topic related to brand protection in the online environment. Within this topic, the main problems associated with brand protection on the Internet, in connection with the spread of counterfeit products, will be highlighted and explored. In particular, the main tactics leading to dispute resolution will be presented, including the use of internal policies of social networks or marketplaces, as well as pre-trial procedures for resolving disputes with information intermediaries. Among other speakers and experts of the session there are Sergey Koptev, Program Director of the IAA World Congress 2021, David Haigh, CEO Brand Finance, Yana Sklyarova, Deputy Head of the Office for Control of Advertising and Unfair Competition of the FAS Russia (Federal Antimonopoly Service), Elena Dybova, Vice President, Chamber of Commerce and Industry of the Russian Federation and others. Please, follow the link to find more information about the session and registration details. Global Advertising Lawyers Alliance is an alliance of lawyers located throughout the world, with expertise and experience in advertising, marketing and promotion law. GALA provides a worldwide resource to individuals and corporations interested in answers to questions and solutions to problems involving the complex legal issues affecting advertisers and marketers. The International Advertising Association is the world’s only globally-focused, integrated advertising trade association. The IAA has over 4,000 individual and corporate members spanning marketing, advertising, media, IT communications and academic sectors – all involved in the wide range of brand marketing and marketing communications disciplines. Global Retail Week is the annual, key and large-scale industry event with the participation of retail, suppliers and manufacturers of products and solutions for retail, government authorities, provides an opportunity to exchange experiences and ideas, establish and expand business contacts with colleagues from different regions and countries.
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Head Start to 2021 for the Pharmaceutical Industry in Russia
We would like to inform you about several important news items, in the pharmaceutical industry, at the beginning of 2021. The Rules of registration and assessment of medicines for medical use in the EAEU come into force According to the Decision of the Eurasian Economic Commission Council (“EEC”), dated November 3rd 2016 No. 78 (“Decision”), from January 1st 2021, medicines can be registered in the Russian Federation only in accordance with the Rules of registration and assessment of medicines for medical use, approved by the Decision (“EAEU Rules”). For the other member states of the Eurasian Economic Union ('EAEU'): the Republic of Armenia, the Republic of Belarus, the Republic of Kazakhstan and the Kyrgyz Republic, the EAEU Rules will become mandatory from July 1st 2021, in accordance with the Decision of the EEC Council, dated December 23rd 2020 No. 128. According to the lawmakers, the new rules of registration, and renewal of registration of medicines for medical use, are aimed at the circulating of medicines in the EAEU market, the quality, efficacy and safety of which has been assessed in accordance with the requirements, that take into account the best world practices. The EAEU Rules apply to the following procedures, related to the release of medicines, onto the EAEU market (“Procedures”): registration; confirmation of registration; making changes to the registration dossier; and assessment of medicines. In this letter, we would like to highlight the main changes that await participants in the pharmaceutical market, in 2021, in connection with the application of the mandatory EAEU Rules. 1. Procedure for the transition to a new regulation The transition period for the mandatory application of the EAEU Rules began on January 1st 2016. From this date, until January 1st 2021, applicants were able, among other things, to register new medicines, in accordance with national legislation, or the EAEU Rules, at their discretion. From January 1st 2021, applicants in the Russian Federation are able to register medicines for medical use only in accordance with the EAEU Rules. For the other member states, the EAEU Rules will become mandatory only from July 1st 2021. The transition period will end on December 31st 2025. Until this date, all registration certificates issued according to the national procedure remain valid, until December 31st 2025. Term registration certificates, with an expiration date earlier than this date, can be re-registered at the request of the applicant, under the national procedure and extended until December 31st 2025. Moreover, in the case of registration under the national procedure, the circulation of a medicinal product is carried out exclusively on the territory of such state. Thus, from January 1st, 2026, only those medicines that have been registered, or re-registered, under the EAEU Rules should remain on the territory of the EAEU. 2. Changes in the registration procedure for medicines Registration will be carried out, at the request of the applicant, in two ways: successively, in several EAEU member states, in accordance with the procedure for mutual recognition; simultaneously in several EAEU member states, in accordance with the decentralized registration procedure. Please note that, according to the EAEU Rules, applicants will have to take into account the requirements for the stability of medicines and pharmaceutical substances, the list of stages of medicines production and the classifier of units for measuring the dosage and concentration of active substances in the composition of medicines. In general, the EAEU Rules are aimed at the transparency of the Procedures, clarification of new requirements, contain a large number of examples, and also use international terminology. Also, with the beginning of the mandatory validity of the EAEU Rules, the rules of good manufacturing practice of the EAEU, approved by the Decision of the EEC Council of November 3rd 2016 No. 77 (“EAEU GMP Rules”), become mandatory. At the same time, due to the spread of the COVID-19 pandemic and the closure of borders, the only way to inspect foreign production facilities could be remote verifications. However, the EAEU inspectorates are deprived of such an opportunity due to the lack of appropriate legal procedures. We believe that the EEC will resolve this situation, in the near future. In addition, it is difficult to inspect foreign production facilities, for compliance with the EAEU GMP Rules, by Russian authorized persons, due to the lack of a sufficient volume of by-laws. We expect that the federal executive authorities will close all the gaps in local regulation, for the use of the EAEU Rules, in the near future. 3. Our recommendations The Russian authorities and the EEC have repeatedly stressed that, in connection with the implementation of the Procedures under the new mandatory EAEU Rules, the load of the entire system of state regulation of the Procedures will increase many times over. Despite the fact that, in the near future, the EEC may decide on the possibility of using the results of inspections, for compliance with the national rules of good manufacturing practice for the implementation of the Procedures under the EAEU Rules, most likely this opportunity will remain short-lived. In view of the above, we recommend planning, in advance, the process of organizing the Procedures, choosing a reference state and other stages of the transition to supranational regulation, in order to avoid significant delays in the implementation of the Procedures, the risk of suspension of medicines’ circulation, or disruption, to the market entry of the EAEU member states. The first out-of-court compulsory license for a medicine On December 31st 2020, the Government of the Russian Federation adopted the Order No. 3718-р (“Order”), which allowed the Russian joint-stock company Pharmasintez to produce a medicine with an international non-proprietary name: Remdesivir, a medicine for the therapy of COVID- 19, during 2021, without the consent of Gilead Sciences, Inc., the patents holder for this medicine. The Russian laws provide for obtaining a compulsory license for inventions, utility models, and industrial designs (“objects of patent rights”) in two ways: by a judicial procedure; with the permission of the Government of the Russian Federation, in the interests of national security. The first compulsory license for a medicine, in Russia, was obtained by a judicial procedure. In June 2018, the Moscow Arbitration Court issued Nativa LLC a compulsory non-exclusive license for Lenalidomide. This medicine was protected by the patent of the American corporation Celgene. The parties have acknowledged that the new medicine is dependent on another. It cannot be used by the owner without violating the rights of the first patent holder. The second procedure, for issuing a compulsory license, provides for the right of the Government of the Russian Federation to authorize the use of objects of patent rights, in the interests of national security, without the consent of the patent holder, notifying him/her promptly of this and with the payment of a proportional compensation. Precisely this right was exercised, for the first time, in relation to the patents for Remdesivir. According to the Order, the Ministry of Industry and Trade of the Russian Federation must submit to the Government of the Russian Federation information, on the payment of a proportional compensation to the patents holders from Pharmasintez, within 3 months. At the same time, the procedure for payment and the amount of compensation was not determined by the Government of the Russian Federation and will probably be determined and approved in the future. The importance of the Order The Government of the Russian Federation used its right to issue a compulsory license for only the first time. This demonstrates that this decision is exceptional and associated with the COVID-19 pandemic. Until now, the question of whether it is possible to issue compulsory licenses for medicines, based on the criterion “in the interests of national security”, has remained open. In this case, the Government of the Russian Federation chose the path of broad interpretation, for prompt authorizing of the use of patents, without the consent of the copyright holder, in the out-of-court procedure. For the same purposes, the State Duma is considering a draft law that allows the Government of the Russian Federation to make a decision on the use of an invention without the consent of the patent holder, in case of emergency related to ensuring the national defense and state security, protecting the life and health of citizens, without the consent of the patent holder, only notifying him/her promptly of this and with the payment of a proportional compensation. In this case, the methodology for determining the amount of compensation, and the procedure for its payment, are approved by the Government of the Russian Federation. Such procedure for compulsory licensing appears not to have become a common practice of authorizing the use of patents. Although it cannot be ruled out that such licenses will be issued, in case of emergency due to a pandemic, or a shortage of patented medicines, on the Russian market. We will continue to monitor the developments in this area and will be ready to provide the necessary legal support on issues related to the protection of patents and ensuring the interests of patent holders in Russia. <> Download this newsletter. We hope that the information provided herein will be useful for you. If you or any of your colleagues would like to receive our newsletters via e-mail, please fill in the 'Subscribe' form at the bottom of the page. Industry: Healthcare and Pharmaceutical Industry Note: Please be aware that all information provided in this letter was taken from open sources. Neither ALRUD Law Firm, nor the author of this letter bear any liability for consequences of any decisions made in reliance upon this information.
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New rules in Russia for the remuneration payment for the employees’ inventions
We would like to inform you that the Government of the Russian Federation approved new rules covering the remuneration payment for employees’ inventions, utility models and industrial designs (“Rules”) by the Decree dated November 16th 2020, No. 1848 (“Decree”). The Decree comes into force on January 1st 2021 and will be valid for 6 years, until January 1st 2027. The text of the Decree is available in Russian here. Legal regime of employees’ inventions If the employees of your company create patentable objects (inventions, utility models, industrial designs) under their employment duties, or as a specific task, as a rule, exclusive rights to such objects belong to the employer. At the same time, it should be noted that a certain formalization is required to establish the legal regime of employees’ inventions - (i) ensuring the inclusion of the corresponding duties of the employee in the employment contract, or job description, or (ii) issuing a specific task on the creation of the patentable object. Moreover, the employer must file an application for a patent, transfer the right to obtain a patent, for an employee’s invention, to a third party, or inform the employee about the secrecy of the created object, within 4 months from the date when the employee notified the employer of the creation of the employee’s invention. As soon as the employer performs one of these actions, the employee has the right to receive remuneration. The remuneration cannot be included in the employee's salary and must be paid separately. The main developments of the Rules In 2014, the Government of the Russian Federation established the procedure, rates and terms for the payment of the remuneration payment for employees’ inventions and other patentable objects. The main change, introduced by the new Rules, is an increase in the amount of the remuneration, for the use of employees’ patentable objects: With regard to the employees’ inventions - the remuneration is increased by 3 times (from one to three average salaries). With regard to the employees’ utility models and industrial designs – by 2 times (from one to two average salaries). Such remuneration is paid within a month, after the expiration of each year, in which the employer used the employee’s invention. If the employer and the employee have not established the amount, conditions and procedure for the remuneration payment, at their own discretion by an agreement, the new Rules will be applied to the relationship between such employee and the employer. Recommendations for employers Taking into consideration the above special aspects, of the legal regime of employees’ inventions, we would like to suggest the following recommendations: Duly formalize the employee's responsibilities for creation of employees’ inventions – double-check employment contracts and job descriptions, or elaborate specific tasks for creation of the employees’ inventions; Build the company's internal system of the formalization of the company’s rights to employees’ inventions – develop a notification procedure regarding creation of an invention by employees, sign acts on acceptance with employees, etc. Ensure that remuneration for employees’ inventions and other patentable objects is paid separately from employee’s salary: in particular, make sure that such remuneration is made as a separate payment and is indicated on a separate line in the pay slips; In case the amount of remuneration is not determined by an agreement with the employee, it is possible to determine this amount by entering into an agreement (it can be either less, or more, than the amount specified in the Rules), or be guided by the amount specified in the Rules; If the amount of remuneration was previously determined by an agreement with the employee, no additional actions are required in this regard. <> Download We hope that the information provided herein will be useful for you. If you or any of your colleagues would like to receive our newsletters via e-mail, please fill in the 'Subscribe' form at the bottom of the page. Intellectual Property Practice, Labour and Employment Practice Note: Please be aware that all information provided in this letter was taken from open sources. Neither ALRUD Law Firm, nor the author of this letter bear any liability for consequences of any decisions made in reliance upon this information.
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Blocking websites for non-compliance of healthcare regulations
On September 18th, 2020, the Federal Service for Surveillance in Healthcare (Roszdravnadzor) adopted a new Order approving the criteria for blocking the websites with the content infringing the healthcare regulations. The document establishes criteria for identifying and blocking websites that illegally sale or distribute content that forms a positive image of persons engaged in prohibited retail trade of medicines. Grounds for blocking The key criteria for blocking a website are the following: offering counterfeit, poor-quality and substandard prescription medicines; offering distance retail sale of prescription medicines; offering distance retail sale of narcotic and psychotropic medicines; offering alcohol-containing medicinal products with a volume fraction of ethyl alcohol of more than 25%; offering medicinal products remotely using domain names or site page pointers that are not indicated in the distance selling permit; offering sales of medicine by persons who do not have a license. Enforcement Right holders and the General Prosecutor are entitled to file a claim in court. Moreover, Roszdravnadzor is also entitled to make decisions on website blockage independently. Upon the court’s or Roszdravnadzor’s decision on the website blocking, telecom operators and a hosting provider obtain a notification on the obligation to restrict access to the website with the infringing content. The telecom operator is obliged to immediately restrict access to the website. If the owner of the website deletes the infringing content within 24 hours, the access to the website is restored. Otherwise, the website remains blocked, unless there is a further specific court decision on its unblocking. As for September 28th, 2020, 42 websites illegally selling medicines have been blocked based on the Order. Takeaways and Recommendations Summarizing the above, we would like to emphasize the following: The new mechanism can be useful for ensuring protection of the right holders in the life science industry who face counterfeit sales. Pharmaceutical companies, online retailers and online platforms should be more careful with their content related to life sciences industry. Marketplaces and e-commerce retailers should specify requirements for the content to pharmaceutical sector in order to avoid their websites’ blockage due to the placement of the infringing content. <> Download We hope that the information provided herein will be useful for you. If you or any of your colleagues would like to receive our newsletters via e-mail, please fill in the 'Subscribe' form at the bottom of the page. Practice: Healthcare and Pharmaceutical Note: Please be aware that all information provided in this letter was taken from open sources. Neither ALRUD Law Firm, nor the author of this letter bear any liability for consequences of any decisions made in reliance upon this information.
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New rules for the Chamber of Patent Disputes: what should applicants expect
On September 6th, 2020, “Rules for the Consider-ation and Resolution of Administrative Disputes by the Federal Service for Intellectual Property”, approved by the order of the Russian Ministry of Education and Science and the Ministry of Economic Development (“Rules”) came into force. The Rules were developed jointly with the Federal Service for Intellectual Property (Rospatent). The Rules provide significant advantages for applicants, including digitalization and optimization of the procedural aspects of the dispute resolution, expansion of the procedural rights of the parties as well as reducing the terms of the dispute resolution procedures. The main changes are as follows: Digitalization The possibilities of electronic interaction are expanding. This includes filing objections, statements and other documents via the official website. Moreover, there is an opportunity to acquire information and case materials on the official website. In addition, the parties may ask, to be sent to them, information about the dispute resolution, by e-mail. Procedural terms The Rules set out specific procedural terms: formal check - 5 business days; the first hearing on objections to the decision - after 1 month, the first hearing on other objections and statements - after 2 months. In addition, the grounds and terms to postpone the hearing, as well as to suspend the consideration of the dispute, are directly detailed in the Rules. More transparent procedures There is a requirement for parties to provide their positions in advance. The decision-making process is rather formalized: the conclusion is announced by the board at the hearing, a written opinion is delivered, and then the head of Rospatent or a person authorized by it makes a decision on the basis of the conclusion, or rejects the conclusion, within 2 months after the announcement of the conclusion. Submission of additional evidence The Rules eliminate restrictions on providing new arguments in support of the claims in the course of a dispute and providing new documents, as well as those relating to joint consideration of objections, or statements, in which the same parties are involved. Independent experts Independent experts can be involved in the consideration, at the initiative of the parties or the board. Audio and video recording Audio and video recordings of the hearing are stored for at least 4 months and provided at the request of the parties. The parties also have the right to make audio and video recordings on their own, provided they have notified the board. Takeaways The Rules introduce more flexible and transparent procedures with precise terms. One can expect that this modernization of the dispute resolution procedure will allow the right holders to protect their exclusive rights to intellectual property more effectively. <> Download We hope that the information provided herein will be useful for you. If you or any of your colleagues would like to receive our newsletters via e-mail, please fill in the 'Subscribe' form at the bottom of the page. Practice: Intellectual Property Note: Please be aware that all information provided in this letter was taken from open sources. Neither ALRUD Law Firm, nor the author of this letter bear any liability for consequences of any decisions made in reliance upon this information.
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Joint webinar ALRUD and Thomson Reuters
On July 23, a joint webinar of ALRUD and Thomson Reuters “Dialogue with business: search for effective solutions in a crisis” was held. The webinar was held in the format of an open panel discussion, during which experts from ALRUD and Thomson Reuters spoke with business representatives about what situations companies face in times of instability and what tools can be used to solve emerging difficulties. During the discussion, in particular, the following issues were raised: Debt collection in crisis, Performance of obligations in case of bankruptcy of the counterparty, Change and termination of obligations due to unforeseen circumstances, Practical aspects of crisis contract work. The speakers were Maria Ostashenko, ALRUD Partner and Head of Commercial, Intellectual property, Data Protection and Cybersecurity practices, Ksenia Erokhina, ALRUD Senior Associate and Ilona Golovkina, Territorial sales Manager in Thomson Reuters. Invited speakers from business were: Egor Nuzhdin, Legal Director of Kraft Heinz in Russia, Poland, Ukraine and the CIS, and Vyacheslav Bochkarev, Senior lawyer, legal support of SIBUR.
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Digital labelling of medications
As of July 1, the Russian requirements on digital labelling of medications and transmitting the data on medications’ turnover to the Chestny ZNAK system have become mandatory. Start of mandatory digital labelling From 1 July, all market participants of the pharmaceutical industry (manufacturers, distributors, pharmacies, etc.) must reflect information on all operations made with medications in the monitoring system. Failure to transmit the data to the track & trace system or transmission of inaccurate information regarding the medications, production, sale of unlabeled medications will result in administrative liability in the form of an administrative fine for legal entities (from RUB 50,000 up to RUB 300,000) along with possible seizure of unlabeled medications. Besides, if the authorities consider it a grave violation of license requirements, they may administratively suspend legal entity’s operations for the period up to 90 days. Grave violation of license requirements takes place in case of failure to comply with requirements on registration in the track & trace system, transmitting information on the medications’ turnover, applying of mandatory labelling. New procedure for releasing unlabeled products into turnover At the same time, the procedure for putting unlabeled medications into the market established by the Resolution of the Government of the Russian Federation No. 955 dated June 30 (in force until January 1, 2021) (“Resolution”) which was published on July 1. Besides, on July 13, 2020, the President of Russia signed the bill No. 902457-7 (“Amendments”) amending Article 67(7.1) of Federal Law No. 61-FZ dated April 12, 2010 “On Turnover of Medications” and thus authorizing the Russian Government to provide for details of marketing of medications produced during the period from July 1, 2020, till October 1, 2020. Though the Resolution was adopted before the Amendments entered into force, the Russian legislature coordinated the law with executive regulation. Therefore, currently, the Resolution and the Amendments supplement each other and have full legal force. The Resolution states that medications produced in Russia from July 1 until October 1, 2020, as well as the ones produced outside of Russia before October 1, are marketed according to a decision of a specially created interdepartmental commission established by the Russian health supervisory authority (“RZN”). Certain medications do not fall under this special procedure: pursuant to the Resolution, medications that are meant for people after organ and/or tissue transplantation or for people with the following diseases are excluded from its scope: hemophilia, cystic fibrosis, pituitary nanism, Gaucher's disease, malignant neoplasms of lymphoid, hematopoietic and related tissues, multiple sclerosis. Obtaining a permit for turnover of unlabeled medications A permit for the marketing of the unlabeled medications is issued for 45 calendar days and free of charge. In order to obtain the permit, it is necessary to file an application in electronic form and attach the annexes stated in the Resolution using a personal account in RZN’s automated information system. The application is considered within 10 business days. Information on the permits issued will be made available in a special register, which will be located on the RZN’s official website. An application for a permit must be accompanied by a number of documents completed in or translated into the Russian language, among others: copies of the documents in Russian of a marketing authorization holder, which confirm the applicant’s authority to submit documents for obtaining the permit, reasons for the inability to label medication packages, copies of documents for the delivery and installation of labelling equipment at each of the production sites specified in the application, as well as for the development or refinement of software interacting with the monitoring system, action plan to implement the monitoring system (please note that it is necessary to specify the final date when the producer is ready to apply QR codes to the packages and to transfer this data to the monitoring system). We hope that the information provided herein will be useful for you. If you or any of your colleagues would like to receive our newsletters via e-mail, please fill in the 'Subscribe' form at the bottom of the page. Practice: Healthcare and Pharmaceutical Note: Please be aware that all information provided in this letter was taken from open sources. Neither ALRUD Law Firm, nor the author of this letter bear any liability for consequences of any decisions made in reliance upon this information.
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ALRUD experts prepared an article for the “Business Quarterly” magazine of the Association of European Businesses
The Association of European Businesses has published the next issue of the “Business Quarterly” magazine, devoted to the topic of labeling. Maria Ostashenko, partner and head of Commercial practice in ALRUD, Dina Kravchenko, associate in ALRUD and Vladislav Dorozhkin, ALRUD attorney prepared an article on the topic: “Digital labelling of medicines: preliminary results and perspectives“. In the article the authors described the concept of a system for monitoring the movement of medicines, the goals, stages and perspectives of the project, talked about the practical difficulties arising during the implementation of the project, its current status and impact of COVID-19. The magazine is available here. The Association of European Businesses (AEB) is the main representative body of foreign investors in Russia. Founded in 1995, the AEB is an independent non-profit organisation of over 500 European and Russian companies. The AEB members are multinational corporations and small and medium-sized enterprises. They all share a commitment to boosting cooperation between the EU and Russia, as well as the desire to improve the investment climate of the Russian Federation. “Business Quarterly” Magazine is a quarterly edition of AEB with analytical information, cases and expert opinions.
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Best Lawyers 2021 recommends Maria Ostashenko for Intellectual Property, Technology, Media and Telecommunications.
Chambers Global, 2020 recommends Maria Ostashenko for Intellectual Property, Technology, Media and Telecommunications.
Chambers Europe, 2020 recommends Maria Ostashenko for Intellectual Property.
The Legal 500 Europe, Middle East & Africa 2020 recommends Maria Ostashenko for Intellectual Property, Technology, Media and Telecommunications, Commercial, Corporate and M&A.
Who’s Who Legal 2019 recommends Maria Ostashenko for Data Privacy and Protection, Labour & Employment and Information Technology.
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