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In accordance with the new provisions of the Federal Law № 61-FZ "On the Circulation of Pharamceuticals", Roszdravnadzor has established requirements to the scope and format of data subject for publication and disclosure regarding scientific and other events involving the participation of health professionals for companies engaged in the production, sale and promotion of medical products. In addition, the respective Notification template has been developed, which must be sent to the e-mail address email@example.com.
Russian drug manufacturers have been allowed to transition to GMP standards by 2016, because since the adoption in 2010 of the Federal Law "On the Circulation of Drugs", no regulative documents have been prepared governing the conditions and procedures for verifying production compliance to these standards.
The Government resolution legally paved the way for the option for a two-year transition to the new "rules for organising the production and quality control of drugs" (the Russian version of GMP) which will include eight basic requirements, four of which will need to be fulfilled by the beginning of 2015. Another requirement is to be fulfilled by 1 July 2015, and the other three (applicable to the most common types of production) by the beginning of 2016.
It is proposed to establish the transition periods based on the manufacturers’ need to carry out organisational and technical measures in respect of the groups of drugs subject to the specific requirements stated by the Regulations.
The schedule of appraisal (qualification) activities will be established by the Ministry for Industry and Trade, while the composition of the certifying committee is to be approved by the Ministry for Healthcare.
The Order of the Russian Ministry for Healthcare # 704n of 07.11.2013 came into force on 3 December 2013. Under the Order, the maximum waiting time for submitting documents required for providing public services, as well as for obtaining the results of the provision of public services, has been changed.
The time allotted for registering maximum selling prices of essential drugs, as well as for registering drugs for medical use, has been reduced from two hours to 15 minutes. The same timeframes will apply to: accepting applications for permission to import into / export out of Russia biological materials obtained during the clinical trials; applications to import batches of drugs intended for clinical trials; appraisals required for the state registration of drugs; and specific batches of unregistered pharmaceuticals intended to provide medical care to individual patients for life-saving reasons.
According to clarifications from the Ministry of Finance (Letter # 03-03-06/1/50586 of 25 November 2013), costs of pharmaceutical companies for organizing scientific conferences, professional workshops, and round tables for healthcare professionals shall be viewed as advertising and shall be deductible for income tax purposes in amount not exceeding 1 per cent of sales revenues.
Earlier, the Ministry already published similar clarification on the matter (please see the Letter # 03-03-06/1/32239 of 9 August 2013). However, the court practice on the issue is so far limited to one resolution, where the court rules for the company’s favor and anchored the opposite approach, distinguishing this type of expenses from advertising and confirming their full tax deductibility, without the mentioned restrictions.
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