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Production Inspection: How Much Does It Cost?

By the order of the Ministry of Industry and Trade of the Russian Federation of January 11, 2016 No 9  a method of determining the amount and the maximum amountof payments for services of inspection of drug manufacturers producing their products outside the RF for compliance with good manufacturing practice, was approved.

It was suggested, that from mid February public discussion of the draft of law would be held. But it was  already reported in the Ministry of Justice on February 2. One may say that it was not unexpected for pharmaceutical community. But we will still have to act according to the circumstances. And they are what they are.

Now federal budget institution “State Institute o f Drugs and Good Practices (FBI SID&GP  is authorized to perform inspection).

The sum of payment was determined for each applicant separately, considering the required works, according to the list, and economically justified material and labor costs”. Calculation is made according to the following formula: С = t x Сe x (1 + (Ccp + Cie) / 100) + Сte + Сm, where С — cost in rubles ex-value added tax  (VAT); t — labor intensity, person/hour.; Сe — cost estimation of one hour of work of one specialist from an authorized institution, ruble/person/hour (including all compensating and stimulating costs, paid according to the legislation of the Russian Federation); Ccp — coefficient of charge on payroll according to the legislation of the Russian Federation as per cent; Cie — coefficient of indirect expenses of the organization, which are impossible to attribute directly to costs, directly related costs, as per cent; Сte —trip expenses directly related to services, rubles; Сm —material costs, directly related to the process of service provision, rubles; t — work labor input is determined by the total duration of works by specialists of the authorized federal budgetary institution in each specific case.

The maximum amount of payment for the inspection services without account of trip costs with 18% VAT is 1,708,345.12 rubles, the amount of travel expenses directly related to the service, with 18% VAT — 1,173,510 rubles, the maximum cost of service including travel expenses with 18% VAT is 2,881,855.12 rubles.

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