In this issue:
- Concept is adopted for developing the state information system for monitoring pharmaceuticals circulation
- Rules adopted for Rx and OTC classification of pharmaceuticals
- The regulators will collect data on series and batches of pharmaceuticals entered into circulation
- The Ministry of Health adopted requirements to storage of narcotic drugs
- Russian Government may cancel clinical trials for US- and EU-registered drugs
- Draft law on suspension of pharmacies’ licenses submitted to the Government
Concept is adopted for developing the state information system for monitoring pharmaceuticals circulation
The Ministry of Healthcare has adopted the concept for developing the state information system for monitoring pharmaceuticals circulation by The Order # 866 dd. November 30, 2015 "On Approval of the Concept for Developing the State Information System for Monitoring Pharmaceuticals Circulation from the Manufacturer to the Ultimate Customer by means of Labeling".
The system is intended for continuing monitoring of pharmaceuticals circulation from a manufacturer to the end-consumer, to ensure effective quality control of pharmaceuticals and protecting from counterfeitdrugs.
The system is supposed to:
- enable all the users to register the movements of pharmaceuticals at all stages of their circulation;
- monitor the shelf-life periods;
- monitor the withdrawal from circulation of counterfeit, poor-quality and unregistered pharmaceuticals;
- monitor the destruction of pharmaceuticals’;
- provide all the users with various types of reports and analytics within the scope of their user rights.
The system is supposed to go live by January 1, 2019.
Rules adopted for Rx and OTC classification of pharmaceuticals
- the authorities of the member states of the Eurasian Economic Community responsible for pharmaceuticals circulation regulation.
- registration certificate holders while registering (re-registering) pharmaceuticals and while amending the registration dossier to the extent requiring the risk-benefit ratio expert evaluation.
A pharmaceutical shall be classified as an Rx drug in the following cases:
- it may cause direct or indirect harm to health when applied correctly but without due medical supervision;
- there are numerous cases of incorrect use of this pharmaceutical;
- it contains substances or compounds, which effects or reactions to are understudied;
- it should be used parenterally (in most cases).
The document also provides for criteria to sub-categorize Rx pharmaceuticals.
The lists of OTC and Rx pharmaceuticals shall be updated at least once a year.
The regulators will collect data on series and batches of pharmaceuticals entered into circulation
On January 15, 2016, the Clause 2 of the Order of Federal Service for Surveillance in Healthcare (Roszdravnadzor) dd. August 7, 2015 # 5539 "On adopting the procedure of sample quality control of pharmaceuticals for medical use" came into force.
According to the Order, Roszdravnadzor shall collect the data on series and batches of pharmaceuticals entering into civil circulation in Russia, reported by pharmaceuticals’ manufacturers and importers on a mandatory basis, in particular:
- trade name;
- international non-proprietary name;
- pharmaceutical form;
- manufacturer’s name;
- size of the batch;
- name of the company entering the pharmaceutical into circulation;
- address of the warehouse storing the batch after the compliance procedures are passed (release into circulation is permitted);
- number and date of the declaration on conformity submission, name of the certification authority, name of the entity which accepted the declaration.
The Ministry of Health adopted requirements to storage of narcotic drugs
The Ministry of Healthcare of the Russian Federation by the Order #484n dd. July 24, 2015 approved special requirements to storage conditions for narcotic drugs and psychotropic substances registered as pharmaceuticals intended for medical use by pharmacies, medical, research and development, educational companies and wholesalers.
The Order specifies the procedure for storage of narcotic pharmaceuticals and pharmaceutical substances which have to be protected from heat, as well as the rules for storage of poor-quality narcotic drugs.
Russian Government may cancel clinical trials for US- and EU-registered drugs
The Ministry of Healthcare in cooperation with other federal executive bodies is considering cancellation of clinical trials procedure for pharmaceutical registered in the US and the EU. Oleg Salagay, Director of the Public Health and Communications Department of the Ministry of Healthcare, has announced this initiative when commenting submission of the respective proposal by the Federal Antitrust Service to the Government.
The current provisions of the Federal Law #61-FZ dd. December 22, 2014 “On Circulation of Pharmaceuticals” provide for the possibility of acknowledging the clinical trials results conducted in a foreign country under the reciprocity principles. Similar exception is made for orphan drugs.
Draft law on suspension of pharmacies’ licenses submitted to the Government
The Government of Russia is reviewing the draft law initiated by the Federal Service on Surveillance for Healthcare and Social Development (Roszdravnadzor) which suggests stricter sanctions for pharmacies inflating prices for Essential Drugs.
According to Clause 1 of Article 14.6 of the Russian Code of Administrative Offence , a breach of pricing regulations entails a fine up to RUB 100 000 (for legal entities). The proposed amendments set additional liability in the form of suspending the pharmaceutical licenses held by a pharmacy for the period up to 90 days.
Ministry of Healthcare developed the documents governing medical devices circulation in EEC
The Russian Ministry of Healthcare placed for public discussions 11 draft resolutions of the Eurasian Economic Commission governing the circulation of medical devices. The results of the public discussions are available on the following links:
- "On Special Mark for Medical Devices Circulating in the Eurasian Economic Union market";
- "On Adopting the Classification Rules for Medical Devices Based on the Risk Grade";
- "On Adopting General Requirements to Safety and Effectiveness of Medical Devices, Requirements to their Labeling and Maintenance Documentation";
- "On Rules for Medical Devices Nomenclature Bookkeeping";
- "On Adopting Rules for Technical Testing of Medical Devices, Requirements to Entities Authorized for Technical Testing of Medical Devices and Procedures for Compliance Assessment for the Authorized Entities";
- "On Adopting the List of Medical Devices Qualifying for Measuring Equipment upon Registration";
- "On Rules for Clinical and Clinical-Laboratory Trials of Medical Devices, Requirements to Entities Authorized for Clinical and Clinical-Laboratory Trials of Medical Devices, the Procedure for Compliance Assessment of Authorized Entities";
- "On Adopting the Rules for Designing and Maintenance of Information System for Medical Devices Circulation”;
- "The Procedure for Designing and Maintenance of Information System for Medical Devices Circulation";
- "The Rules for Monitoring of Safety, Quality and Effectiveness of Medical Devices";
- "The Rules for Conducting Researches (Trials) to Assess Biological Effect of Medical Devices, Requirements to Entities Authorized for Researches (Trials) for Assessment of Biological Effect of Medical Devices, the Procedure for Compliance Assessment of Authorized Entities".
Rules adopted for subsidizing industrial clusters residents
The procedure for granting subsidies to participants of industrial clusters engaged in joint projects on industrial production has been established by the Government’s Resolution # 41 dd. January 28, 2016.
Subsidies will be granted upon the applicant’s request, provided that the industrial cluster complies with the requirements established and the applicant commits to achieve the agreed-upon KPIs.
The subsidies can provide reimbursement of maximum 50% of costs incurred by the industrial clusters’ residents when realizing a joint project.
The Resolution also sets out criteria for admission of cluster residents to project selection process.
The previous Pharma Bulletin issues are accessible our site.
Prepared for you by KPMG in Russia and the CIS, Healthcare & Pharmaceuticals Sector.