Biomedical Cellular Products (BMCP)
The Ministry of Healthcare of the Russian Federation published the draft Order "On Approval of the List of Referential Pharmaceuticals included into the List of Essential Drugs Approved Annually by the Government of the Russian Federation".
The project envisages separation of the process for re-registering the previously registered maximum selling prices for the EDL pharmaceuticals:
− under the first stage, envisages maximum selling prices for referential EDL pharmaceuticals should be re-registered;
− under the second stage, maximum selling prices for generic and biosimilar pharmaceuticals should be re-registered.
The draft decree is supposed to help reduce the terms of state (re)registration of maximum EDL selling prices.
The Moscow Healthcare Department by its Order of 08.08.2017 N 559 "On Approval of the List of Mandatory Requirements and Legal Acts Containing Mandatory Requirements to the Prices for Essential Drugs" approved the following:
− the list of mandatory requirements which compliance is assessed during the state control over pricing for Essential Drugs at the regional level; this covers compliance with the rules for setting maximum wholesale and retail prices, issuance pricing protocols and other rules;
− the list of provisions of legal acts regulations stipulating the above mandatory requirements.
The State Duma received the draft law # 236034-7 "On Amendments to the Federal Law "On Contract System for Procurement of Goods, Works and Services for State and Municipal Needs".
The draft reduces the timeframe for publishing the information about the state bid to 1 day in case of the bid invalidation and to 3 days in other cases of making changes.
The Russian Ministry of Healthcare by the Order # 409н dd. 12.07.2017 approved the order of the registration dossier formation and requirements to the documents included therein.
A dossier is a set of technical documents and materials and generally includes several sections, in particular, administrative, chemical, pharmaceutical/biological, pharmacological, toxicological and clinical documentation. The above Order stipulates rules for these sections formation.
In case of registering different dosage forms of each pharmaceutical the applicant shall submit separate applications and dossier documents for each form.
The new rules apply to dossiers which are submitted to the Ministry of Health (along with the corresponding applications for pharmaceuticals registration) after the enactment of the Order.
Currently, the pricing rules for Essential Drugs do not account for the impact of special tax regimes applied by some pharmaceutical companies. According to the FAS clarifications, the wholesalers and retailers operating under the general taxation regime should calculate their maximum selling prices as the sum of:
− purchase price of the ED product, net of VAT;
− markup (not exceeding the maximum wholesale or retail markup allowed in the corresponding region), calculated based on the actual ex-factory net of VAT;
− VAT calculated based on the sum of the above purchase price and markup.
The Government has approved Accreditation Rules for medical institutions conducting clinical trials of BMCP. The corresponding Decree #1015 dd. 25.08.2017 was signed by the Prime Minister.
The accreditation is carried out by the Ministry of Healthcare to acknowledge the healthcare provider’s ability to conduct BMCP clinical trials.
The Rules define the purpose of the accreditation, the requirements to a medical institution, the list of documents to be submitted to the accreditation body, the procedure of decision-making on issuance/denial of the accreditation certificate and the template of such a certificate.
The Russian Ministry of Healthcare has approved the procedure for the quality assessment of BMCP in the location of its production. The corresponding Order of the Ministry of Healthcare # 195н dd. 28.04.2017 was registered by the Ministry of Justice on the 3rd of August.
The Order defines the rules for conducting the quality assessment of BMCP with a shelf-life less than 15 days in the location of its manufacturing and using the manufacturer’s equipment. The assessment shall be conducted under the order of the Ministry of Healthcare by a commission of experts of an expert institution reporting to the Ministry.
Should the information in the documents submitted by the applicant be considered as insufficient or invalid, the expert reports to the Ministry of Healthcare, requesting to clarify the information. Should the applicant fail to submit the requested documents, the quality assessment is performed using the documents and data available to the expert.
Resolutions of the Russian Government ##967 and 968 dd. 14.08.2017 set out the specific rules for state procurement of disposable medical devices made of polyvinyl-chloride (PVC) plastics.
In particular, under the Resolution # 967, access to public (municipal) procurement will be available to those companies who carry out projects on expansion and localization the manufacturing of such medical devices in Russia during 2017-2024.
The Resolution # 968 approved the List of disposable medical devices of foreign origin made of PVC-plastics restricted from access to public procurement during the period of complex projects realization. A Complex project presumes inter-related activities and processes, limited by time and resources, aimed at offsetting-up high-tech production of all the types of medical devices from the said List.
While realizing a complex project, the company must fulfil the following conditions:
− Availability of rights for technical and design documentation for own production of all the types of medical devices from the above-said List, for a period not less than 10 years after the project completion and ensuring manufacturing not less than 100% of the output projected in the business-plan;
− By 01 November 2023, the share of the cost of “made-in-Russia” materials and the added value in the final selling price should be at least 75% for at least 3/4 of all the medical devices included into the List;
− By 01 January 2025, the export sales of all the medical devices from the List should be not less than 30% of the annual domestic sales of the same products.
The list of medical devices implanted into a human body in scope of the program of free medical aid under state guarantees was supplemented by 23 types of medical devices by the Resolution of the Government of the Russian Federation dd. 25.07.2017 # 1587-R.
21 type of devices are those used for preparing to the implantation and preventing complications during surgery, for delivery, fixation, and extraction of medical devices implanted into a human body.
Roszdravnadzor developed the Methodical recommendations on introducing amendments to registration documents for medical devices. The Methodical recommendations establish the procedures for amending the registration certificate and registration documents, the replacement/issuance of the registration certificate and the list of necessary documents for each procedure.
Each procedure is autonomous: for example, it is not possible to simultaneously apply for obtaining a duplicate copy and for making changes in a registration certificate.
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