KPMG Pharma Bulletin Issue #2, 2017 (February)
KPMG Pharma Bulletin Issue #2, 2017 (February)
Draft amendments to the Resolution No. 865 dd. October 29, 2010 "On the State Regulation of Prices for Pharmaceuticals Included into the Essential Drug List" are published on the website regulation.gov.ru.
The Draft proposes changes to the rules of registration and re-registration of maximum ex-factory prices for Essential Drugs (ED); in particular, the document:
- revises the requirements to completing the application for registration (re-registration), documents submission, calculation of maximum ex-factory prices, etc., for foreign manufacturers performing primary and (or) secondary packaging of pharmaceuticals in Russia;
- envisages the procedure for submitting an application for reducing the registered maximum ex-factory price;
- specifies the procedure for keeping the state register of maximum ED ex-factory prices;
- amends the methodology for maximum ED ex-factory prices calculation;
- prohibits an increase the maximum ex-factory price for a foreign ED in case of change of the manufacturer in the registration certificate.
The amendments are mainly aimed at foreign manufacturers performing primary and (or) secondary packaging of pharmaceuticals in Russia.
The Russian Ministry of Healthcare has published a draft Resolution "On Approval of the Procedure for Remote Retail Trade of Pharmaceuticals for Medical Use and for Veterinary Use (except for Narcotic and Psychotropic Pharmaceuticals) and of the Amendments to Certain Legislative Acts of the Government of the Russian Federation", aimed at regulation of remote trade of pharmaceuticals.
Remote retail trade of pharmaceuticals includes receipt, orders assembly, storage, orders delivery for pharmaceuticals for medical use and their shipment.
Remote retail trade of pharmaceuticals shall be carried out by pharmacies meeting the following requirements:
− the pharmacy owns no more than one internet website, attested by the certificate of compliance of the informational (automated) system with the data security requirements;
− the pharmacy holds the license for remote retail trade of pharmaceuticals.
Roszdravnadzor shall be responsible for maintaining the register of the websites of pharmacies engaged in remote retail trade of pharmaceuticals.
The Resolution of the Government of the Russian Federation dd. 24.01.2017 N 62 "On Carrying out the Experiment on Labeling by Control (Identification) Marks and Monitoring the Circulation of Certain Types of Pharmaceuticals for Medical Use", announces the start of the experiment on labeling certain pharmaceuticals by identification (control) marks, for the period from February 01, 2017 through December 31, 2017.
Roszdravnadzor placed on its website the Draft Guidelines for the participants of the experiment on labeling certain types of pharmaceuticals for medical use by control (identification) signs (CIS) and their further monitoring.
The Guidelines, in particular, establish the rules for selecting companies to be included into the experiment. The participants are to be selected on a voluntary basis via submission of applications.
The Guidelines set out the following:
− the content of the data to be included into the CIS that are placed on the secondary (consumer) and the tertiary (ex-factory, consignment) packaging of the pharmaceutical;
− requirements to the equipment used for labeling and reading the codes;
− requirements to the information system on CIS labeling (the “Labeling” system) developed by the Russian Federal Tax Service;
− the rules for data transmission and exchange, including requirements to protection of the data transmitted;
− the procedures of interaction of the “Labeling” system with other relevant information systems of the federal executive bodies via the interdepartmental electronic system;
− the procedure for submission of applications for participation in the experiment and registration of the participants in the “Labeling” system;
− the procedure for the experiment participants' interaction, including the list and the order of data submission to the ”Labeling” system.
In accordance with the Governmental Resolution No. 149 dd. February 8, 2017, the procedure for setting the initial (maximum) price of a state procurement contract to be concluded with a single supplier (contractor, executor) for pharmaceuticals for medical use is established by the Ministry of Healthcare subject to the agreement with the Ministry for Economic Development and the Federal Antitrust Service.
By the the Resolution of the Government No. 124 dd. 02.02.2017, the Russian Government has amended the Decree on the Ministry of Healthcare, granting to the Ministry the authority on state registration of biomedical cellular products (BCP).
In particular, the Ministry of Healthcare is now empowered to:
− exercise the state registration of BCP;
− issue permits for importing BCP into the Russian Federation;
− to certify the authorized representatives of BCP manufacturers;
− to certify the experts of a federal budget institution authorized to perform expert examination of BCP.
In addition, the Ministry is authorized to define:
− the procedure for expert examination of BCP quality by using the manufacturer’s equipment;
− the procedure for issuing a permit for BCP clinical trials;
− the procedure for keeping the state register of BCPs;
− the proforma of the specification for a BCP;
− the procedure for suspending circulation of a BCP intended for medical use.
In addition, the Government amended the Decree on the Federal Service on Surveillance in Healthcare and Social Development (Roszdravnadzor), by the corresponding Resolution No. 114 dd. 31 January 2017.
The document expands Roszdravnadzor’s powers in areas of monitoring BCP safety, state control over BCP circulation, selective quality control of BCPs.
The registration certificates for medical devices with the unlimited validity period, issued prior to January 01, 2013, should be replaced with the new ones as per the template established by Roszdravnadzor. The period during which the replacement can be done, is extended for 4 additional years – till January 01, 2021. The corresponding Governmental Resolution No. 160 dd. 10.02.2017 was signed by the Prime Minister.
Roszdravnadzor published templates of payment orders for state duties for granting a license / issuing a copy of a license for the following activities:
− medical (healthcare) activities;
− pharmaceutical activities;
− activities in areas of circulation of narcotic drugs, psychotropic substances and their precursors, cultivation of narcotic plants.
The members of the State Duma Health Protection Committee supported the concept of the Draft law No. 54490-7 "On Amendments to Article 1 of the Federal Law "On Procurement of Goods, Works, Services by Certain Types of Legal Entities" and the Federal Law "On the Contract System for Procurement of Goods, Works, Services for State and Municipal Needs".
The document regulates the procurement of pharmaceuticals by state and municipal unitary enterprises engaged in pharmaceutical activities.
According to the Committee, exempting the said enterprises from the procurement rules established by the Federal Law No. 44-FZ dd. 05.04.2013 should allow optimize the legal basis of their activities, considering the industry specifics, and ensure equal opportunities for all the pharmaceutical market participants.
The previous Pharma Bulletin issues are accessible our site.
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