We are glad to bring to your attention the latest Digest of regulation of the Russian pharmaceutical industry in January 2019, prepared by the BRACE Law Firm.
Traditionally, in connection with the beginning of the year, in January 2019, legislative activity was at a rather low level. At the same time, a number of important legal acts were adopted.
Significant innovations were approved by the Board of the Eurasian Economic Commission: Guidelines for the selection of trade names of drugs, as well as guidelines for the production of finished dosage forms of drugs. The development of these documents is based on the Rules for Registration and Expertise of Medicines for Medical Use, approved by the Decision of the Council of the Eurasian Economic Commission N 78 of November 03, 2016 and the Rules of Good Manufacturing Practice of the Eurasian Economic Union, approved by the Decision of the Council of the Eurasian Economic Commission N 77 of November 3, 2016 November 3, 2016.
In accordance with the Guidelines for the Selection of Trade Names of Medicinal Products, the trade name of a medicinal product must not have any misleading connotations based on therapeutic and/or pharmaceutical information. It is not allowed to use the trade name of the medicinal product, which is of an advertising nature, and it is also not recommended to use the trade name of the medicinal product, which is perceived as offensive or contains negative connotations in one of the official languages of the EEU member states.
According to the Guidelines for the production of finished dosage forms for the manufacture of finished dosage forms of drugs, the description of the manufacturing process should reflect data on critical stages and intermediate products and trace the relationship between pharmaceutical development, the proposed control strategy, and process validation. For each stage of the production process, it is necessary to provide information on all participating production sites and testing laboratories, including control and analytical laboratories (quality control laboratories). The description of the manufacturing process must be properly justified.
An important change was the possibility, from January 1, 2019, the formation of prescriptions for medicines containing narcotic drugs and psychotropic substances in the form of electronic documents. At the same time, there is a high probability that in practice there may be serious problems related to the unreadiness of doctors, medical organizations or pharmacies to issue prescriptions in electronic form.
The Ministry of Health of Russia proposed to cancel the annual approval of the list of essential and essential medicines.
1. Laws, by-laws, legal news
1.1. The Board of the Eurasian Economic Commission approved the Guidelines for the selection of trade names of drugs.
Recommendation N 2 of the Board of the Eurasian Economic Commission dated January 29, 2019 “On guidelines for the selection of trade names of drugs”
The said Guidelines define the rules for the selection and assessment of trade names of medicinal products for medical use, registered on the basis of the Rules for registration and examination of medicinal products for medical use, approved by the Decision of the Council of the Eurasian Economic Commission dated November 3, 2016 N 78.
It is noteworthy that in assessing the trade name, the authorized bodies do not take into account issues of intellectual property rights. The trade name of the medicinal product must not have any misleading connotations based on therapeutic and / or pharmaceutical information. It is not allowed to use the trade name of the medicinal product, which is of an advertising nature, and it is also not recommended to use the trade name of the medicinal product, which is perceived as offensive or contains negative connotations in one of the official languages of the EEU member states.
The Recommendation established that the approach to the assessment of trade names of orphan drugs coincides with the approach to the assessment of trade names for unordered drugs. To assess the trade names of orphan drugs, it is especially important to provide detailed information on the specific conditions in which the drug will be released and used, as well as its target population.
If the trade name of a drug is a newly invented word, it should not be confusingly similar to or replicate another international non-proprietary common name.
It should also be noted that very short trade names, consisting, for example, of a set of letters, may be unacceptable for the designation of a medicinal product in the certain EEU Member States.
1.2. The Board of the Eurasian Economic Commission approved the Guidelines for the production of finished dosage forms of drugs.
Recommendation N 3 of the Board of the Eurasian Economic Commission dated January 29, 2019 “On Guidelines for the Production of Prepared Dosage Forms for the Production of Prepared Dosage Forms of Drugs”
The Guidelines was elaborated taking into account the requirements of the Good Manufacturing Practice Rules of the Eurasian Economic Union, approved by the Decision of the Council of the Eurasian Economic Commission dated November 03, 2016 N 77.
The document establishes that the description of the production process should reflect data on critical stages and intermediate products and trace the relationship between pharmaceutical manufacturer, the proposed control strategy and the process validation.
For each stage of the production process, it is necessary to provide information on all participating production sites and testing laboratories, including control and analytical laboratories (quality control laboratories). The description of the manufacturing process must be properly justified.
The description of the production process of a medicinal product should be as complete as possible and should contain an annex to the scheme, which will show each stage of the process with appropriate internal control (if necessary), and also indicate each stage at which materials are introduced into production.
Important criteria for describing production processes are completeness, an indication of the necessary details and a consistent description of the stages of the production process, including the size of the series and the type (size) of equipment (if necessary). Particular attention should be paid to the frequency of internal control, as well as the timing of the issuing tests of finished products.
An annex to the manual provides an example of such a description of the production process.
1.3. The Federal State Statistics Service explained the procedure for filling out small and medium-sized businesses with a form of federal statistical observation.
Order of Federal State Statistics Service of January 23, 2019 N 22 “On Approval of Instructions for Completing the Federal Statistical Observation Form N PM “Information on the main indicators of small business activity”
As a general rule, a form of federal statistical observation N PM “Information on the main indicators of a small enterprise’s activity” is provided by legal entities that are small enterprises (except for micro enterprises).
The document states that line 18 of the form reflects the cost of medicines issued by the pharmacies to the population, legal entities and individual entrepreneurs, the cost of services in the amount of the commission for the sale of finished medicines for free and preferential prescriptions (if the pharmacy does not buy these medicines).
1.4. On the territory of advanced social and economic development “Galich” provides for the production of medicines.
Decree of the Government of the Russian Federation of January 25, 2019 N 37 “On the creation of the territory of advanced socio-economic development “Galich”
The said Decree of the Government of Russia on the territory of advanced social and economic development “Galich” provides, among other things, for such a type of economic activity as the production of medicines and materials used for medical purposes.
During the first year after the legal entity was included in the register of residents of the territory of advanced socio-economic development, the minimum amount of capital investments of the resident of the territory of priority development carried out within the framework of an investment project implemented by the specified resident in respect of relevant economic activities is 2.5 million rubles, and the minimum number of new permanent jobs created as a result of the investment project is 10 units.
1.5. The government of the Russian Federation has approved an action plan for the Transformation of the Business Climate, which provides for a number of measures in relation to veterinary medicines.
Order of the Government of the Russian Federation of January 17, 2019 N 20-r “On approval of the plan “Transformation of the business climate” and recognition of acts of the Government of the Russian Federation as invalid”
The specified document for February 2019 provides for such an event as the preparation and submission of proposals to the List of veterinary medicines prohibited for use by productive animals in the customs territory of the Eurasian Economic Union regarding the prohibition of the use of medicines containing nitrofurans (including furazolidone). Responsible performers for this event are the Ministry of Agriculture of Russia, the Ministry of Industry and Trade of Russia, the Ministry of Economic Development of Russia.
1.6. Information from the register of issued permits for import into the territory of Russia and export outside the territory of Russia of biological materials obtained during a clinical study of medicine for medical use can be provided as an inter-agency interaction.
Order of the Government of Russia of January 19, 2019 N 35-r “On Amendments to the List approved by the Order of the Government of the Russian Federation of April 19, 2016 N 724-r”
The list of documents and (or) information requested and received within the framework of interdepartmental information interaction by state control (supervision) bodies, municipal control bodies when organizing and conducting inspections from other state bodies, local self-government bodies or organizations subordinated to state bodies or local self-government bodies, the disposal of which are these documents and (or) information supplemented. Now, the Ministry of Health of Russia in the order of interdepartmental cooperation provides information from the register of issued permits (decisions on refusing to issue permits) for import in Russia and export outside the territory of Russia of biological materials (samples of biological fluids, tissues, secrets and products of human activity, physiological and pathological secretions, smears, scrapings, swabs, microorganisms, biopsy material) obtained during the clinical study of a medicine for medical use.
1.7. From January 1, 2019, it became possible to formulate prescriptions for medicines containing narcotic drugs and psychotropic substances in the form of electronic documents.
Federal Law of July 29, 2017 N 242-FZ “On Amendments to Certain Legislative Acts of the Russian Federation on the Use of Information Technologies in the Field of Health Protection”
This law establishes that medical assistance using telemedicine technologies is organized and provided in the manner established by the authorized federal executive body, as well as in accordance with the procedures for providing medical care and on the basis of standards of medical care. prescriptions containing the purpose of narcotic drugs or psychotropic substances are drawn upon special forms on paper or are formed with the consent of the patient or his legal representative in the form of electronic documents signed with the use of enhanced qualified electronic signature of the attending physician or paramedic, midwife charged with treating a doctor, and the appropriate medical organization.
2. Drafts of legal acts
2.1. In connection with the ratification of the Agreement on Common Principles and Rules for the Circulation of Medicinal Products within the Eurasian Economic Union, the Ministry of Health of Russia proposes amendments to the Law “On Circulation of medicines” in order to improve the regulatory legal regulation in the field of circulation of medicines.
Draft federal law “On Amendments to Certain Legislative Acts of the Russian Federation on Drug Provision of Citizens”
It is proposed to amend Article 6.2 of the Federal Law of July 17, 1999 N 178-FZ “On State Social Assistance”, to the Federal Law of 12.04.2010 N 61- FZ “On Circulation of Medicinal Products”, Federal Law of November 21, 2011 N 323-FZ "On the Principles of Health Protection of Citizens in the Russian Federation". The draft bill eliminates the need for annual approval of the list of vital and essential medicines, and also provides that within the framework of the territorial program of state guarantees of free medical care for citizens, the state authorities of the constituent entities of the Russian Federation establish a list of medicines when providing medical care to citizens in outpatient conditions in the amount of not less than the list of vital and essential medicines except the drugs used according to the instructions for medical use only in a hospital.
2.2. The Public discussions on the draft of changes were completed, providing for taking into account the state of the drug markets when determining the sole supplier based on acts of the President and the Government.
Draft federal law “On introducing amendments to Article 93 of the Federal Law “On the contract system in the field of procurement of goods, works, services for state and municipal needs”
The said draft proposes an amendment to Article 93 of the Law on the Contractual System, providing that the drafting of legal acts of the President of the Russian Federation and the Government of the Russian Federation determining the sole supplier should be based on the criteria for the state of the drug markets, which can be purchased from a single supplier, and criteria that must be met by the only suppliers of drugs.