Everybody knows that the marketing authorisation is a state-recognised documents certifying and guaranteeing full compliance of a particular medical product with all specifications and requirements to this type of products. Availability of the marketing authorisation confirms quality and safety of the medical product for its use by a patient.

Medical products can't be utilized without the following relevant permits: Marketing authorisation and Declaration of conformity

The Marketing authorisation has no limitations of validity and is used for years. But sometimes it may be damaged or lost. But don't worry as your product is registered in the RZN state register and all the data is collected there. So it's quite easy to submit the necessary documents and to issue a duplicate of the marketing authorisation.

This procedure can be conducted only if the matrketing authorisation was lost or damaged.

If you want to obtain a duplicate of the marketing authorisation (MA) for some other reason, it's not possible and legal as all the other reasons are not specified by the Russian legislation.

To issue a duplicate of the marketing authorisation for a medical product, it's necessary:

• Write and send an application to the registering authority concerning necessity of this procedure in full compliance with attachment No.3 to the Administrative Regulation
• Specify one of the two reasons (damage or loss) for these actions
• Attach a confirmation of payment of the state duty
• Send a letter from the manufacturer confirming necessity of issuance of a duplicate of the marketing authorisation
• Original of the marketing authorisation (in case of damage)

After submission of all required documents, RZN makes decision on issuance (if the application was executed correctly) or denial of issuance of the duplicate of the marketing authorisation (if the application was executed incorrectly or there are no reasonable grounds for issuance of the duplicate).

The state duty for issuance of the duplicate of MA is ₽1,500. The price of obtainment of the duplicate of MA is ₽45,000.

With our help, you'll get the duplicate of MA within 7 business days after the first submission!