Distribution and marketing of drugs in the Russian Federation: overview
A Q&A guide to distribution and marketing of drugs law in the Russian Federation.
The Q&A gives a high level overview of distribution and marketing of drugs law, including pre-conditions for distribution; licensing; wholesale distribution; marketing to consumers; marketing to professionals and engagement with patient organisations.
To compare answers across multiple jurisdictions, visit the Distribution and Marketing of Drugs Country Q&A Tool.
This Q&A is part of the global guide to Distribution and Marketing of Drugs.
Pre-conditions for distribution
In order to be distributed in the Russian Federation, a drug must receive approval from the Ministry of Health. This authorisation requires a completed registration procedure involving:
Submission of a registration dossier and expert review of the drug.
Other regulatory steps.
Non-authorised medicines can only be distributed for a particular patient on the basis of a named permission issued by the Ministry of Health ("named patient basis"). Non-registered medicines can also be imported by individuals for their personal use and in a few other exceptional cases set out in the law (such as medicines intended to treat vehicle teams and passengers of passenger vehicles arriving in the Russian Federation, treatment of participants of international expeditions and so on).
The "named patient basis" is the only exception for commercial distribution of a non-authorised medicine (see Question 1). The importer must obtain permission from the Ministry of Health. Permission is issued based on an application supported by documents listed in the Regulations on Performance of the State Function of Issuance of Permissions for the Importation of a Particular Batch of Non-Authorised Medicines into the Territory of the Russian Federation adopted by the Order of the Ministry of Health of the Russian Federation dated 2 August 2012 No. 58n, including, among others:
A resolution from the Council of Physicians, signed by the head of the medical institution where a patient is being treated.
Justification for the quantity of units of medicine (vials, blisters, and so on).
A quality certificate.
The application for permission is to be reviewed by the Ministry of Health within five business days. Once issued, the permission is valid for six months.
From 1 July 2015, original drugs (except for orphan and paediatric ones) as well as the fourth and further generics of the same original drug must be authorised within 160 business days from the date of application. "Orphan" drugs in Russia are those intended exclusively for diagnostics and pathogenetic treatment of rare (orphan) diseases. The first three generics of an original drug, orphan drugs and paediatric drugs (that is, intended solely for minors) benefit from a streamlined registration procedure for authorisation within 80 business days. However, each of the above terms does not include clinical trials.
The drugs are authorised based on an application filed with the regulatory authority and supported by the registration dossier. The registration dossier must be presented in the form of a Common Technical Document (CTD) containing the following chapters:
Chapter of an administrative nature (licensing application, draft instruction of use, copies of licenses and permits required by law, good manufacturing practice (GMP) certificate and so on).
Chapter of chemical, pharmaceutical and biological documentation (detailed information about the drug and its active pharmaceutical ingredient (API)).
Chapter of pharmacological and toxicological documentation (reports on pharmacodynamic, pharmacokinetic and toxicological trials).
Chapter of clinical documentation (reports on clinical trials, bioequivalence trials and so on).
When an original drug is being registered, the full cycle of clinical trials is required. For registration of a generic drug, the applicant can provide the report on studies of bioequivalence with the original (reference) drug. For some kinds of generic drugs listed in the law (such as oral solutions and sprays) the bioequivalence studies are not required.
Once the regulatory authority receives the application and supporting documents, ethical and medical experts review the documents. If the review is positive, a permit for clinical trials is granted and the clinical trials can begin.
Under the law, clinical trials are to be made under the agreement between the sponsor or contract research organisation (CRO) and authorised medical institutions (the list is held by the authority and publicly available online, see www.grls.rosminzdrav.ru/Ree_orgCI2.aspx).
When the clinical trials are completed, a clinical trial report is submitted to the regulatory authority. The drugs in question are then subject to a drug quality analysis and a risk-benefit analysis. Specialised expert institutions, approved by the regulatory authority, must conduct these reviews. The regulatory authority's expert committee then evaluates the results of the reports when deciding on whether or not to authorise a drug licence for distribution.
The regulatory authority for the licensing of a drug for distribution is the Ministry of Health.
There is no simplified authorisation procedure for a drug already authorised in another jurisdiction or for parallel imports.
A simplified authorisation procedure is available for orphan drugs, the first three generics of the original drug and paediatric drugs, irrespective of whether or not these medicines have been registered in any other jurisdiction (see Question 2).
Under Russian procedural law, a decision of a state authority (including Ministry of Health) can be appealed in a state commercial arbitration court. The appeal must be based on applicable laws and regulations that, in the appellant's view, were breached by the authority when making a licensing decision. The court must consider the appeal within three months from the date of its submission.
The major part of the costs required for drug authorisation is the sponsorship of clinical trial. This cost can vary depending on, among others:
The number of hospitals and patients involved.
The type of disease.
The area of medicine.
The authorisation of a drug distribution licence also involves the payment of several kinds of state fees. The main state fees are:
Ethical and medical review of the documents to receive permission for a clinical trial: RUB110,000.
Fee for permission for a clinical trial: RUB5,000.
Fee for a drug quality analysis and a risk-benefit analysis: RUB325,000.
Fee for issuance of the drug registration certificate (paper original): RUB10,000.
Fee for analysis of a possibility to consider a drug as orphan one (if applicable and requested): RUB25,000.
In addition, other related expenses (for example, notarisation and translation) must be considered when applying for a drug distribution licence. In particular, when registering a foreign drug, the applicant must present all the required documents to the regulatory authority in Russian. This usually involves the translation of the registration dossier into Russian and the payment of relevant translation fees.
Distribution to consumers
Russia uses the following categorisation of drugs for distribution:
Over-the-counter (OTC) (consumer) drugs.
Additionally, the medicines are separated into:
Those listed on the Essential Drug List (EDL), which are subject to pricing limitation by means of state registration of a maximum sale price and limitation of allowable mark-ups.
Drugs not included into the EDL that are not subject to pricing limitation and suppliers can set prices for these drugs as they do on a free market.
Only pharmacies are authorised to distribute prescription drugs to consumers. The pharmacy must hold a licence for pharmaceutical retail activity.
Only pharmacies are authorised to distribute over-the-counter (OTC) drugs to consumers. The pharmacy must hold a license for pharmaceutical retail activity. Currently, retail shops are not allowed to sell OTC medicines in Russia. However, this right may be granted in the future (see Question 35).
Currently, distance selling of drugs (including by means of postal delivery) is prohibited. However, it is expected that from 2017 the Russian authorities will allow the distance sale of drugs for the pharmacies that:
Duly hold a retail pharmaceutical licence.
Have an operating website used for the distance sale of drugs.
Possess duly registered premises (outlets) for retailing drugs directly to customers.
These outlets can be used by consumers to submit complaints and return drugs of improper quality. Therefore, only pharmacies with duly licensed sale outlets will be able to expand their business to offer distance selling of drugs to be delivered by couriers from these outlets. Meanwhile, purely Internet pharmacies (that is, existing only in the Internet without a registered sales outlet) will remain prohibited.
Not permitted, see above, Conditions.
The Federal Service for Surveillance on Consumers Rights Protection and Human Wellbeing (Rospotrebnadzor) supervises all consumer-related distribution activities (including distribution of drugs). The Rospotrebnadzor:
Considers and reacts to consumer claims on violations of the consumers' rights.
Conducts scheduled and unscheduled audits of retail and other companies interacting with consumers.
Imposes penalties to individuals and companies breaching consumer rights.
Issues orders to rectify breaches.
Furthermore, the Rospotrebnadzor supervises the compliance with sanitary and epidemiological requirements.
The Russian Federal Service on Surveillance in Healthcare (Roszdravnadzor) also supervises distribution of drugs to consumers by monitoring compliance with rules on retail of drugs and relevant licensing requirements, auditing pharmacies, detection of drugs whose quality or labelling fail to comply with the law.
The procedure is the same as for appealing a licensing decision (see Question 6). The appeal is submitted to a state commercial arbitration court.
As a general rule, a breach of consumer rights protection laws can lead to a penalty of up to RUB20,000 for each violation unless a particular breach is subject to more serious sanctions directly specified in the law. Potential breaches of consumer rights protection laws that lead to a penalty include, for example:
Failing to provide the consumer with full and accurate information on the goods being sold.
Use of unreasonably disadvantageous contractual conditions in the sale and purchase agreement with the consumer.
Selling a counterfeit, falsified or unregistered drugs or drugs of improper quality to a consumer is deemed a crime and could lead to a maximum prison term of eight or ten years, depending on the statutory requirements breached. Those convicted may also have to pay a fine of up to RUB3 million or equal to their personal income for a period of up to three years.
Some offences can also result in the offender's disqualification from the holding of certain positions for a maximum of three or five years, depending on the breach. If the commission of the offence has led to the death of two or more persons, then the maximum prison term, fine and/or disqualification period prescribed by law will be even higher than those stated above.
Additionally, failing to comply with pharmaceutical retail licence requirements (for example, holding duly equipped premises for pharmacy retail, employment of required number of pharmacists) can lead to a licence revocation.
Only the companies holding a licence for conducting a pharmaceutical wholesale are allowed to wholesale drugs. The wholesale of drugs is permitted to:
Other companies undertaking the wholesale of drugs.
Manufacturers of drugs for manufacturing purposes.
Research institutions for scientific and research activities.
Individual entrepreneurs holding a licence for pharmaceutical activity or medical activity.
The wholesale of drugs must be made using a sale and purchase agreement, provided that the medicines being sold are duly authorised in Russia, of proper quality and do not violate the intellectual property rights of third parties.
The regulatory authority responsible for supervising wholesale distribution is the Russian Federal Service on Surveillance in Healthcare (Roszdravnadzor).
The Roszdravnadzor issues licences for wholesale and retail pharmaceutical activities and supervises compliance with the licence requirements by license holders.
Additionally, the Roszdravnadzor investigates claims of improper, counterfeit or unregistered drugs distributed via wholesale activities. It can issue an order to withdraw these drugs from circulation and have them destroyed.
Since 2015, the Roszdravnadzor can perform on-site audits (both scheduled and unscheduled) of wholesale and retail pharmaceutical companies to monitor the compliance of companies with the applicable pharmaceutical legislation.
Rights of appeal
An authority's decision can be appealed in the state commercial arbitration court.
If a company disagrees with the Rosdravnadzor's order to destroy improper drugs and/or refuses to perform such an order, the Roszdravnadzor can bring a court action.
Wholesale of counterfeit, falsified or unregistered drugs or drugs of an improper quality is subject to the same criminal sanctions as the sale of the same drugs to consumers (see Question 15).
Failure to comply with pharmaceutical wholesale licence requirements (for example, holding duly equipped pharmaceutical warehouse) can lead to a licence revocation.
Over-the-counter (OTC) drugs can be advertised and promoted in public, subject to restrictions provided for in the laws of advertising (for example, such advertising must not be addressed to minors, refer to individual case of recovery with the use of the promoted drug, create an impression of needlessness to visit a doctor and so on). OTC drugs can also be subject to special offers, discounts and other similar marketing activities. Prescription drugs can only be promoted among healthcare professionals (HCPs) in compliance with laws governing advertising and interactions with HCPs. Advertising in Russia is governed by the Federal Law of the Russian Federation, dated 13 March 2006, No. 38-FZ "On Advertising" (Law on Advertising).
Limits to marketing activities
Provided the marketing activities are compliant with the applicable legal requirements, there are no limits to the frequency or budgets of marketing campaigns provided for in the law.
However, under Russian tax legislation the company's expenses on drugs advertising may be deductible for the purposes of corporate profit tax only if such expenses do not exceed 1% of the company's turnover. The advertising costs exceeding this limit are not tax-deductible.
Marketing of drugs in Russia may also be subject to the Code of Practice of the Association of International Pharmaceutical Manufacturers (AIPM). The AIPM Code sets out certain rules for, among others:
Advertising and marketing drugs.
Interaction with healthcare professionals (HCPs).
Compliance with the Code is mandatory for companies who are members of the AIPM. However, it is not a statutory law and, therefore, not mandatory under Russian legislation. The companies failing to comply with the AIPM Code can lose their membership in the AIPM without return of the paid membership fee. However, they cannot be penalised by the Russian authorities for actions breaching the AIPM Code unless these actions also breach Russian legislation.
Marketing to consumers
Over-the-counter (OTC) drugs can be promoted to consumers through:
Advertising in media, internet, billboards and in other lawful forms (provided the applicable restrictions are complied with).
Disease awareness campaigns and similar educational materials.
Special offers, discounts and other similar selling marketing activities (see Question 23).
The Federal Anti-monopoly Service (FAS) is responsible for supervising advertising and fair competition in Russia.
The FAS conducts the following activities:
Reviewing and assessing advertising materials and advertising campaigns from the point of compliance with law.
Imposing penalties for breaches of the laws on advertising.
Issuing orders to remedy a breach (including the deletion or destruction of improper advertising materials or suspending the distribution of incompliant advertising).
Rights of appeal
The FAS consists of the federal Head Office in Moscow and regional subdivisions. Both are entitled to supervise advertising activities. However, a decision of regional subdivision of the FAS may be appealed to the Head Office. Furthermore, both decisions of regional and federal FAS may be appealed to a state commercial arbitration court irrespective of whether or not a decision of regional FAS has been appealed to the federal FAS.
A breach of the laws on advertising can lead to the imposition of a fine from RUB200,000 to RUB500,000. The fine is supported by an order to remedy the breach (for example, destruction of the advertising materials and/or stop distributing the materials breaching the advertising laws).
If the regulatory authority decides that a violation is minor, it can issue an order only to remedy the breach, not to pay the fine.
Marketing to professionals
The permitted forms of marketing activities relating to healthcare professionals (HCPs) include:
Promotional activities at pharmaceutical conferences, congresses and symposia.
Advertising of drugs (including prescription drugs) in professional print media intended to HCPs solely and in the frames of professional events for HCPs (for example, conferences, congresses and symposia).
Provision of reprints, scientific and educational materials (including articles and brochures).
Educational seminars in hospitals organised in accordance with the internal policies and procedures and agreed with the hospital's management.
Educational video conferences, webinars or other similar activities.
Distribution of small items/souvenirs with company's brand (for example, pens and pencils), provided that the distribution is made at a public event on a de-personalised basis and no items are given to an HCP personally.
The following marketing activities are prohibited in relation to healthcare professionals (HCPs) in Russia:
Provision of gifts (including gifts of an insignificant value and educational nature).
Provision of samples for further distribution among patients.
Engagement in market research or any kinds of marketing activities.
Inducement to use prescription forms containing information of a promotion nature.
There are no restrictions on targeting HCPs via emails or phone. However, personal face-to-face visits are prohibited.
Provision of hospitality
There are no particular restrictions with respect to the amount of hospitality, but the hospitality must always be reasonable, modest and secondary to the main purpose of the meeting or event.
There are no requirements to include any particular information when advertising to healthcare professionals (HCPs).
However, any information included in the drug advertising must be correct, accurate, limited to the indications included in the instruction on application and compliant with the applicable general restrictions for drug advertising.
There are no specific rules on comparisons with other products in Russian legislation that are particularly applicable to drugs.
The Code of Practice of the Association of International Pharmaceutical Manufacturers (AIPM Code) states that "the comparative advertising should be correct, compare identical characteristics, and should not mislead consumers through the absence of any significant information in the advertisement" (clause 2.3.6, AIPM Code).
Under the general advertising rules, any comparison must be correct. An incorrect comparison of advertised goods may be interpreted as activities of unfair competition and penalised. From a practical standpoint, a correct comparison supposes:
The same parameters of comparison.
The comparison of all the parameters which are to be of importance for the compared goods.
Using the same and correct methodology of comparison.
Healthcare professionals (HCPs) must not procure drugs from pharmaceutical companies themselves (unless they are acting as consumers outside of their job responsibilities). Therefore, any discounts are not applicable. Discounts to medical institutions are permitted subject to negotiations between seller and buyer and granted on the basis of respective contractual conditions.
It is permitted to provide professionals with free samples, provided that the samples are intended for the HCP's information only. Provision of samples for further transfer to patients is prohibited.
Sponsorship of professionals
As a general rule, direct sponsorship of HCP is prohibited as it could be considered as a gift to HCP, which is prohibited.
Direct sponsorship of HCPs is only possible if such sponsorship is a part of mutually binding agreement between a pharmaceutical company and HCP setting out mutual consideration from both parties. For example, delivering a lecture by an HCP in return of sponsorship of his/her attendance of a scientific event for upgrade of his/her professional level and improvement of the quality of scientific services to be rendered by the HCP.
Other items, funding or services
Pharmaceutical companies may engage HCPs in provision of scientific or pedagogical services or participation in clinical trials on a remuneration basis.
Provision of scientific services is lawful if it leads to obtaining new fundamental or practical knowledge. Scientific services can be rendered in the form of lecture delivering, article writing and other similar forms by well-qualified HCPs whose experience and professional knowledge enable them to achieve new scientific knowledge.
The pedagogical services may be rendered in collaboration with educational institutions in the frames of adopted educational programmes.
In order to be involved in clinical trials, an HCP must meet certain professional requirements (for example, the principal investigator must have a medical speciality relevant to the clinical trial to be performed and have no less than three years of professional experience in clinical trials).
However, under the Code of Practice of the Association of International Pharmaceutical Manufacturers (AIPM Code), all payments made by AIPM members to HCPs must be made publicly available. However, the requirements of legislation on personal data must be complied with.
The Roszdravnadzor is responsible for supervising marketing activities regarding healthcare professionals (see Question 13).
The authority supervises the compliance with the rules on interactions between pharmaceutical companies and healthcare professionals by both sides (companies and physicians).
Rights of appeal
As in other cases, an authority's decision can be appealed to a state commercial arbitration court.
Currently, the liability for breaching the rules on interactions between pharmaceutical companies and healthcare professionals has not yet been established. However, physicians breaching these rules may be subject to job disciplinary responsibility in accordance with the employer's policies and regulations. The consequences for the company are generally limited to reputational damage and orders to stop the improper marketing activity.
Meanwhile, the distribution of advertising intended to healthcare professionals (HCPs) which breaches applicable requirements is subject to the same sanctions as other breaches of pharmaceutical advertising rules (see Question 26).
Engagement with patient organisations
There are no specific restrictions on engagement with patient organisations in Russia, apart from a general limitation that a patient organisation being a non-commercial entity must not be involved in commercial activities (for example, sales and marketing, among others) and can only carry out those activities that are relevant to charter purposes of the patient organisation.
Pharmaceutical companies may collaborate with patient organisations for the following purposes:
Studying patient opinions about the impact of diseases on the quality of life of patients or persons taking care of them.
Providing informational support to patient organisations.
Creating patient registers (subject to strict compliance with the legislation on personal data protection and medical secrecy);
Launching campaigns to keep the general public informed about a specific disease.
Co-operating with medical organisations and providing them with non-registered pharmaceutical products that are necessary to provide medical care to specific patients in accordance with their vital needs.
Provision charitable aid.
Other purposes that are compliant with the applicable legislation.
However, when interacting with the patient organisations (POs), pharmaceutical companies must observe the following rules and restrictions:
A pharmaceutical company must not be the only pharmaceutical company acting as the founder of a PO.
A pharmaceutical company must explicitly disclose the fact and nature of its co-operation with a PO on its website.
Any kind of financing or donations to a PO should be made on the basis of a written request from the PO.
Financing or donation must not be aimed directly or indirectly at encouraging the PO to make decisions in favor of the financing pharmaceutical company or its products.
Any relations between pharmaceutical companies and POs must be properly documented.
Pharmaceutical companies can provide financial support for events arranged by POs if:
the primary purpose of such events is educational, scientific or otherwise of a public benefit; and
these events help the PO achieve its objective.
In 2016, the "Transfer of value" concept was introduced in Russia. Since then, pharmaceutical companies that are members of the Association of International Pharmaceutical Manufacturers (AIPM) must make publicly available any payments made to healthcare professionals (HCPs) and healthcare organisations (HCOs) in the previous calendar year. This includes, for example, payments under clinical trial agreements, speaker fees to HCPs and charitable donations to HCOs. Therefore, the Russian Federation is part of the trend of transparency in relationships between the pharmaceutical industry and the medical community, which is supported in most developed countries in the world.
The Good Clinician Practice was adopted by the Russian Ministry of Health in April 2016. There is also a draft of Good Distribution Practice prepared by the Ministry of Health, which is expected to be enforced in the near future.
The legalisation of sales of OTC medicines in supermarkets is still under consideration. It is possible to happen in 2017.
Finally, it is expected that by 2017 the common market of the Eurasian Economic Union (currently comprising of the Russian Federation, Belarus, Kazakhstan, Armenia and Kyrgyzstan) will start to operate. This essentially means that a drug that is duly licensed under the common rules of the Eurasian Union in one of the member countries, can then be freely sold in all countries of the Eurasian Union without having to go through a full registration process in other member countries.
Professional qualifications. Lawyer, Russian Federation
Areas of practice. Life sciences; contractual law; competition; dispute resolution; public procurement; personal data; transportation law.
Languages. English, Russian