KPMG Pharma Bulletin Issue #7, 2016 (July) | KPMG | RU

KPMG Pharma Bulletin Issue #7, 2016 (July)

KPMG Pharma Bulletin Issue #7, 2016 (July)

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Pharmaceuticals

New rules for pharmaceuticals preparing in pharmacies entered into force

The Order # 751n issued on October 26, 2015 by the Russian Ministry of Healthcare "On approval of the rules for pharmaceuticals preparing and dispensing by pharmacies, individual entrepreneurs that have the license for pharmaceutical activity" entered into force on July 1, 2016.
Under the new rules, in the course of pharmaceuticals preparing the pharmacies are obliged to use pharmaceutical substances included in the State Register of drugs for medical use. The quality of the prepared pharmaceutical is determined by its compliance with the requirements of the certified pharmacopoeial item, the general pharmacopoeial item, and in case of their absence - by compliance with a quality control document, containing the requirements and methods for determining the quality of drugs.
The Order prescribed specifications for preparing of solid and liquid pharmaceutical substances, including homeopathic granules, powders, concentrated solutions, drops, aqueous extracts of medicinal plants, suspensions, emulsions, ointments. The order also prescribes the quality control rules for pharmaceuticals.

http://www.pharmvestnik.ru/publs/lenta/v-rossii/v-rossii-dejstvujut-novye-pravila-izgotovlenija-lekarstv-v-aptekax.html#.V7VrXK0aAbx

https://www.rosminzdrav.ru/documents/9500-prikaz-ministerstva-zdravoohraneniya-rf-ot-26-oktyabrya-2015-g-751n-ob-utverzhdenii-pravil-izgotovleniya-i-otpuska-lekarstvennyh-preparatov-dlya-meditsinskogo-primeneniya-aptechnymi-organizatsiyami-individualnymi-predprinimatelyami-imeyuschimi-litsenziyu-na-farmatsevticheskuyu-deyatelnost

Pharmaceuticals

New rules for pharmaceuticals preparing in pharmacies entered into force

The Order # 751n issued on October 26, 2015 by the Russian Ministry of Healthcare "On approval of the rules for pharmaceuticals preparing and dispensing by pharmacies, individual entrepreneurs that have the license for pharmaceutical activity" entered into force on July 1, 2016.

Under the new rules, in the course of pharmaceuticals preparing the pharmacies are obliged to use pharmaceutical substances included in the State Register of drugs for medical use. The quality of the prepared pharmaceutical is determined by its compliance with the requirements of the certified pharmacopoeial item, the general pharmacopoeial item, and in case of their absence - by compliance with a quality control document, containing the requirements and methods for determining the quality of drugs.

The Order prescribed specifications for preparing of solid and liquid pharmaceutical substances, including homeopathic granules, powders, concentrated solutions, drops, aqueous extracts of medicinal plants, suspensions, emulsions, ointments. The order also prescribes the quality control rules for pharmaceuticals.

http://www.pharmvestnik.ru/publs/lenta/v-rossii/v-rossii-dejstvujut-novye-pravila-izgotovlenija-lekarstv-v-aptekax.html#.V7VrXK0aAbx

https://www.rosminzdrav.ru/documents/9500-prikaz-ministerstva-zdravoohraneniya-rf-ot-26-oktyabrya-2015-g-751n-ob-utverzhdenii-pravil-izgotovleniya-i-otpuska-lekarstvennyh-preparatov-dlya-meditsinskogo-primeneniya-aptechnymi-organizatsiyami-individualnymi-predprinimatelyami-imeyuschimi-litsenziyu-na-farmatsevticheskuyu-deyatelnost

An order for formation the list of pharmaceuticals that have mandatory requirements for the container volume is established

The Government of the Russian Federation has established an order for formation of the list of pharmaceuticals for medical and veterinary use that have mandatory requirements for container volume, packaging and completeness, and the order for such requirements setting. Prime Minister signed respective Resolution #716 of July 23, 2016.
The lists are formed in accordance with international nonproprietary names, and in case of their absence - by grouping or chemical names of pharmaceuticals.
The requirements for the container volume are determined based on the following criteria:

  • dosage schedule, methods for pharmaceutical injection and administration, as well as the duration of treatment;
  • possibility of pharmaceutical administration for purposes other than prescribed;
  • volume fraction of alcohol contained in pharmaceutical (in percentages).

http://www.pharmvestnik.ru/publs/lenta/v-rossii/opredelen-porjadok-formirovanija-perechnej-lekarstv-v-otnoshenii-kotoryx-ustanavlivajutsja.html#.V6GZLq0aATg

http://rulaws.ru/goverment/Postanovlenie-Pravitelstva-RF-ot-23.07.2016-N-716/

The amendments to the regulation on Ministry for Industry and Trade license control of pharmaceutical production were developed

Administrative Regulations of execution by the Ministry for Industry and Trade the government function on implementation of pharmaceutical production licensing control, approved by the Order of Ministry for Industry and Trade on October 4, 2013 # 1607".
The document was developed in order to bring the specified administrative regulations in compliance with the laws and regulations of the Russian Federation.
In particular, an inspector should inform a head of the licensee or the other authorized person on documents and information that have been obtained in the course of inter-agency information exchange.
In addition, there are certain amendments to the subsection "Rights and duties of officials upon exercising of state control (surveillance)".

http://www.pharmvestnik.ru/publs/lenta/v-rossii/razrabotany-popravki-v-reglament-ispolnenija-minpromtorgom-litsenzionnogo-kontrolja.html#.V6GY0K0aATg

http://regulation.gov.ru/projects/List/AdvancedSearch#npa=50458

The Ministry of Healthcare prepared Draft Order amending the registration dossier

The Ministry of Healthcare has placed on the website of legal information disclosure the Draft Order "On approval the application form for amending the documents contained in the registration dossier for pharmaceutical'.
The Draft Order has approved the form of the application for amending the documents contained in the registration dossier for the registered pharmaceutical. In addition, the document will abolish the Order of the Ministry of Health and Social Development on August 26, 2010 #760n "On Approval of the application for the amendment of the documents contained in the registration dossier to the registered pharmaceutical."

http://www.pharmvestnik.ru/publs/lenta/v-rossii/minzdrav-podgotovil-proekt-prikaza-o-vnesenii-izmenenij-v-registratsionnoe-dosje.html#.V7Vr_q0aAby

http://regulation.gov.ru/projects#npa=50567

Medical devices

Maximum mark-ups to sales prices for medical devices may be determined in percentages or in rubles

The Ministry of Healthcare provided recommendations on the procedure for calculating the maximum wholesale mark-ups to the actual selling prices of medical devices implanted into the human body. The recommendations extend to cases where free medical care is provided through a program of state guarantees of the Russian Federation on the territory of the region.
The maximum wholesale mark-ups are allowed to be set based on planned indicators, which may be differentiated by the maximum selling price of the manufacturer. This price does not include VAT, but it includes the costs associated with the distribution of medical devices. In the table, which the Ministry of Healthcare cited as an example, the mark-ups are set in a percentage and monetary terms for different intervals of actual selling prices for medical devices. There is also a notice that the region should apply the lesser of the two indicators.

http://rulaws.ru/acts/Pismo-Minzdrava-Rossii-ot-05.07.2016-N-1482_25-3/

The procedure for registration and examination of the medical device within the EEC was introduced

Council of the Eurasian Economic Commission issued Decision #46 of February 12, 2016 "On the Rules of registration and examination of safety, quality and effectiveness of medical devices". The Rules prescribe the procedure for registration and examination of safety, quality and effectiveness of medical devices, amendments to the registration dossier of a medical device, issuance of registration certificates' duplicates, as well as the refuse to register the medical devices, suspension and cancellation (annulment) of the registration certificate for a medical device. Annexes to the Rules contain the application forms and the list of documents required for medical devices’ registration.
In accordance with the established Rules, during the transitional period until 31 December 2021:

  • Registration of medical device at the discretion of the producer may be carried out either in accordance with the Rules or in accordance with the legislation of the Member State of the EEC
  • Medical devices registered in accordance with the legislation of the Member State of the EEC, should circulate in this State;
  • documents confirming the fact of medical devices registration issued by the authorized body of the EEC Member State in accordance with the laws of that State, should be valid until their expiry, but not later than December 31, 2021.
  • Decision enters into force after 10 calendar days from the date, on which, the Protocol on accession of the Republic of Armenia to the Agreement on common principles and rules for the circulation of medical devices (devices for medical use and medical equipment) in the framework of the Eurasian Economic Union on December 23, 2014 is entered into force, but not earlier than 10 calendar days from the date of the official publication of this Decision.

http://docs.cntd.ru/document/456008980

Ministry of Healthcare updates resolution on medical devices market regulation

Ministry of Healthcare posted on the website of legal information disclosure a notice on drafting a document "On amendments to some acts of the Government of the Russian Federation on the circulation of medical devices."
The reason for changes is a non-compliance of certain Government Resolutions with the current legislation, including the following:

  • Resolution # 1416 "On approval of Rules of state registration of medical devices";
  • Resolution # 615 "On approval of Rules of maintenance of the state register of medical devices and organizations (individual entrepreneurs), engaged in the production and manufacture of medical devices";
  • Resolution # 970 "On the approval of the Regulation of the state control over the circulation of medical devices."

http://www.pharmvestnik.ru/publs/lenta/v-rossii/minzdrav-obnovljaet-postanovlenija-praviteljstva-po-regulirovaniju-rynka-medizdelij.html#.V6GX-q0aATg

The Ministry of Healthcare is about to establish new state duties for registration of medical devices and biomedical cell products

The Ministry of Healthcare developed and placed for public debates the draft of the Federal Law "On Amendments to Chapter 25.3 of the Tax Code of the Russian Federation." The document determines differentiated rates of state duties for registration of medical devices and biomedical cell products.
The draft Law is developed in connection with the planned entering into force of the Federal Law "On circulation of biomedical cell products" and envisages the amendments to the Art. 333.32.2 of the Chapter 25.3 of the Tax Code.
This article determines the state duty rates applied upon execution of various regulatory procedures. The list of the procedures includes: registration, examination of safety, quality and efficiency; amendments to the registration certificate; amendments to the registration dossier; issuance of registration certificates duplicate; clearance of expert opinion, depending on types of tests conducted, examination and classification by class of potential risk.

http://www.pharmvestnik.ru/publs/lenta/v-rossii/minzdrav-gotovit-novye-poshliny-dlja-registratsii-medizdelij.html#.V6GXpK0aATg

http://www.pharmvestnik.ru/publs/lenta/v-rossii/opredeleny-razmery-gosposhliny-pri-provedenii-gosregistratsii-biomeditsinskix-kletochnyx-produktov.html#.V6GY5q0aATg

http://regulation.gov.ru/projects/List/AdvancedSearch#npa=50791

http://regulation.gov.ru/projects#npa=50271

The previous Pharma Bulletin issues are accessible our site. 

Prepared for you by KPMG in Russia and the CIS, Healthcare & Pharmaceuticals Sector.

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