KPMG Pharma Bulletin Issue #8, 2016 (August)
KPMG Pharma Bulletin Issue #8, 2016 (August)
In this issue:
- Ministry for Industry and Trade approved the procedure for issuing a document on pharmaceutical manufacturing stages in EEC
- State procurement suppliers may be requested to
disclose the shareholding structure
- Good Clinical Practice (GCP) rules approved by the Ministry of Healthcare
- Good Laboratory Practice (GLP) rules approved by the Ministry of Healthcare
- The Draft Resolution on the pharmaceuticals’ labeling and monitoring placed for public discussion
- List of pharmaceuticals dosage forms approved
- New pharmaceutical registration certificate form approved
- Criteria approved for pharmaceuticals having no analogues made in Russia
- Regulation approved for obtaining GMP compliance certificate
Ministry for Industry and Trade approved the procedure for issuing a document on pharmaceutical manufacturing stages in EEC
The approved Regulation sets out the procedure for issuance of the document required to submit a bid for state and municipal procurements and to confirm that the pharmaceuticals were produced in accordance with GMP rules. The document shall be submitted at the request of the regulator of the EEC member country of importation.
Manufacturers of pharmaceuticals within the EEС or their authorized representatives may act as the applicants for obtaining such a document.
To receive the document, an applicant should submit to the Ministry for Industry and Trade the signed application completed as per the required form, with the following attachments:
- a copy of industrial regulations and copies of documents setting out the production stages (in case no industrial regulations are available with the manufacturer), indicating the address of each production stage and technological process map;
- data of the state procurements timing;
- a copy of the license issued by the authorized body of the manufacturer's country.
The timeframes for approving/rejecting the application shall not exceed 30 business days from the date of receiving the application with the supporting documents by the Ministry.
State procurement suppliers may be requested to disclose the shareholding structure
The Draft law #1148251-6 "On Amendments to the Federal Law "On Procurement of Goods, Works and Services by Certain Legal Entities" and the Federal Law "On the Contracting System for Procurement of Goods, Works and Services for State and Municipal Needs" was submitted to the State Duma.
According to the draft law, companies submitting bids for state procurement may be obliged to disclose information on all of their beneficiaries, including founders, members of the collegial executive body or the sole executive body. The share of each particular beneficiary (an individual) in the share capital of the company applying for the bid may also have to be disclosed.
Good Clinical Practice (GCP) rules approved by the Ministry of Healthcare
The Good Clinical Practice (GCP) rules set out international ethical and scientific standards of planning and performing clinical studies involving a human as the subject of a study, as well as requirements to documenting and presenting the study results. The changes introduced by the Order are aimed at bringing the local clinical study standards in line with the international GCP rules.
The new rules entered into force from September 04, 2016 and apply to legal relationships in area of clinical trials of pharmaceuticals for medical use.
Good Laboratory Practice (GLP) rules approved by the Ministry of Healthcare
The GLP rules set out the requirements to ensure due quality of pre-clinical trials of pharmaceuticals, including requirements for organizing, planning, carrying out and quality control of such pre-clinical trials, as well as documenting, registering and archiving their results.
The document introduces certain changes to the existing rules approved by the Order of the Ministry of Healthcare # 780n dd. August 23, 2010. In particular, it is permitted to carry out phases/stages of pre-clinical trials at two or more testing laboratories, including those separated geographically and organization-wise. New requirements are introduced in respect of the clinical testing laboratories and their personnel. Each pre-clinical study shall be assigned with a unique identification number. There is also new requirements to storage of documents and materials of pre-clinical trials.
The Draft Resolution on the pharmaceuticals’ labeling and monitoring placed for public discussion
The Ministry of Healthcare has placed for public discussion the Draft Resolution of the Russian Government "On the Experiment of Labelling by Control (Identifying) Markers and Monitoring of Certain Pharmaceuticals for Medical Use."
The experiment is supposed to commence on January 1, 2017 on a voluntary basis.
In August 2016, the Head of Roszdravnadzor and the representatives of major pharmaceutical companies held a meeting dedicated to the pharmaceuticals labeling experiment. The participating companies were supposed to inform Roszdravnadzor by August 19 on their preliminary consent to join the experiment and to nominate candidates for the working group, to be engaged in developing the methodological guidelines.
The objectives of the pharmaceuticals labeling and monitoring experiment are:
- assessment of the efficiency and effectiveness of the system (now under development) of control over the pharmaceuticals circulation in Russia, overall from the manufacturer (importer) to the final consumer as well as at the level of each supply chain participant;
- identifying the necessary changes to the laws and regulation of Russia, governing the pharmaceuticals circulation, in case monitoring for certain pharmaceuticals if ultimately introduced;
- assessment of the technical capacity of the information system to be used in course of the experiment and of the needs for its further upgrade and development.
List of pharmaceuticals dosage forms approved
The name of a finished dosage form should contain the core element identifying the unique homogeneous group of dosage forms, which may be supplemented by one or more additional elements specifying: the properties of the dosage form, its degree of readiness for use, mode of administration, route of administration, technological specifics, apportioning, patients age group, the purpose or therapeutic area of use.
The Order applies to pharmaceuticals submitted for registration with the Ministry of the Healthcare after the Order enactment.
New pharmaceutical registration certificate form approved
The holders or owners of the old-pattern certificates are not required to re-register the corresponding pharmaceuticals. However, for pharmaceuticals under registration as of now, the registration certificates (RC) shall be issued as per the new form.
The new RC form consists of three sections:
- the first one contains the information about the RC holder (owner), the date of the pharmaceutical’s registration, the RC validity period, and the date the RC amendment or re-issuance;
- the second section contains information about the registered drug: trade name; international non-proprietary, or grouping, or chemical name; dosage form; dosage; qualitative and quantitative composition of active substances and excipients; product release form; regulatory documents details;
- the third section provides detailed information on the production sites engaged in the pharmaceutical’s manufacturing process, including the corresponding production stages, names and addresses of the production sites.
Criteria approved for pharmaceuticals having no analogues made in Russia
The Russian Government issued the Resolution #744 dd. August 8, 2016, approving the criteria for classifying pharmaceuticals and medical devices as industrial products which have no analogues manufactured in Russia.
According to the above, the following products are considered as manufactured in Russia starting from January 1, 2017:
- pharmaceuticals, serums and vaccines: if duly registered in Russia and if the extent of manufacturing conducted in the EEU corresponds to the entirety of: finished dosage form production, packaging, release quality control.
- pharmaceutical substances: if recorded in the State Register of Pharmaceuticals and the following technological operations are conducted in the EEU: chemical synthesis, and/or bio-technological synthesis, and/or extraction from natural mineral raw materials and/or extraction from biological and/or animal based sources, and/or extraction from vegetable sources.
- medical devices: criteria may vary depending on medical device types. For instance, the core criterion for magnetic resonance imaging scanners shall be the share of foreign products/materials used for manufacturing (not more than 70% of a scanner’s final price). Whereas for diagnostic and surgical needles, for example, the set of mandatory criteria includes: the manufacturer’s tax residence in an EEU member state; the legal rights for technical and construction documentation to the extent sufficient to ensure the production during at least 5 years; the share of foreign products/materials used for manufacturing (not more than 50% of a needle’s final price).
Regulation approved for obtaining GMP compliance certificate
The Ministry of Justice has registered the Order of the Ministry for Industry and Trade #1714 dd. May 26, 2016 "On Approval of the Administrative Regulations of the Ministry for Industry and Trade on Rendering the Public Services of Issuing GMP Compliance Confirmation to Pharmaceuticals Manufacturers".
The Order contains an exhaustive list of documents required to receive the public service, held by local authorities and other regulatory bodies involved and which the applicant shall submit, as well as the procedure of obtaining/submitting such documents by applicants.
The public services shall be rendered within 30 business days, with the applicable stamp duty of 7,500 Russian rubles.
The Government postponed introduction of pricing regulations for implantable medical devices
The Russian Government postponed the timeframe for enactment of the Resolution #1517 dd. December 30, 2015 "On State Pricing Regulations for Medical Devices Implanted into a Human’s Body under Program of State Guarantees on Free Medical Care Rendering to Citizens."
The document moves the deadline for submitting to Roszdravnadzor data for state registration of maximum ex-factory prices for medical devices from July 15, 2016 to July 15, 2017.
The executive authorities of the Russian regions have been instructed to set the maximum wholesale mark-ups to ex-factory prices according to the rules stipulated by the Government's Resolution #1517, by September 1, 2017 (the initial deadline was September 1, 2016).
In addition, the deadline for the Russian Ministry of Healthcare and other state bodies involved is also prolonged. The regulators shall submit to the Government proposals on the procedures for medical devices maximum ex-factory prices re-registration by October 1, 2017 (instead of October 1, 2016 as initially anticipated).
Advertisement of BAAs with online trade option could be banned
The Federal Anti-Trust Service of Russia highlighted to its territorial bodies that para. 1 of Article 7 of the Federal Law "On Advertising" prohibits not only advertising of certain products banned from circulation in the Russian Federation, but also advertising which mentions sales channels prohibited for the corresponding products.
Pursuant to the above, should advertising of BAAs refer to the possibility of their distance (online) sale, it could be considered inappropriate and violating the law, including the mentioned clause of the Federal Law "On Advertising".
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