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:
The system is supposed to go live by January 1, 2019.
A pharmaceutical shall be classified as an Rx drug in the following 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.
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:
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.
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.
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.
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:
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.