The Ministry of Industry and Trade of the Russian Federation has published a number of documents within the project for labeling drugs for foreign manufacturers.
- The standard form of the contract for the provision of labeling codes for drug circulation entities (foreign legal entities)
The draft order was developed in order to establish a procedure for charging fees for the provision of marking codes to foreign legal entities. Labeling codes are provided by the operator of the state information system for monitoring the movement of drugs for medical use, provided that the participant pays for them before entering information on the application of the labeling code into the relevant information system.
The fee for the provision of Labeling Codes is 50 kopecks per 1 Labeling Code, excluding value-added tax. The VAT in the amount stipulated by the tax legislation of the Russian Federation is paid in excess of the cost of one marking code.
- The standard form of an agreement on the provision of emission recorder to drug circulation entities (foreign legal entities)
Under this form Operator of the monitoring system will transfer emission recorders to foreign manufacturers on a gratuitous basis. The Operator has the right to demand to return recorder if it is not used by the Participant for 9 consecutive months.
- The standard form of the agreement on the provision of emission recorders by providing remote access to it free of charge
The Operator undertakes to provide the Participant with the right to use movable property, the emission recorder, free of charge by providing remote access. The equipment is the property of the Operator, it is held by the Operator and is not transferred to the Participant.