Substitution of Marketing Authorisation

The Russian legislation strictly controls utilization of medical products in Russia. That's why absolutely all types of medical products should have permits, otherwise they can't be applied in our country.

The Marketing Authorisation (MA) is a state-recognised form, format of which may be changed in accordance with changes of the legislation in the area of registration of medical products. That's why it's very important to track changes of the legislation and timely substitute MA.

Almost all manufacturers of medical products have different questions linked with substitution of MA for medical products. For instance, what year's MA are subject to substitution, what list of documents will be required and is the state duty collected. You have a unique possibility to get answers for the most relevant questions in this area which will help you find the required solutions. If necessary, you always can order offsite consultations of our specialists. We carry out such events quite often and they are very popular among the manufacturers of medical products. Informational support will set you on the right track and will help you find a solution for any issue related to the registration procedure.

You probably already know that the marketing authorisations obtained from January 1, 2007 throughout December 31, 2012 are subject to the MA Substitution procedure.

No subject to substitution
MA granted after
January 1, 2013
MA amended after
January 1, 2013
MA granted for medical products manufactured
by individual orders of patients and designed
only for personal use by specific patient
by medical prescription and to which
special requirements are applied
Please note!

MA substitution period is extended for another four years — until 2021!

For Substitution of MA the following documents should be submitted to RZN
  • Application taking into account the information specified in Decree No. 1416
  • List of documents executed pursuant to the regulated order
  • Power of attorney for the applicant by means of which he/she is being authorised to carry out this procedure on behalf of a foreign manufacturer (required only in case the manufacturer of the medical product is the foreign one)
  • If desired, the applicant may also submit a copy or original of the marketing authorisation to be substituted
Please note!

Substitution of MA is performed only on the basis of an application with specification of all information regulated by the Rules of the State Registration and no additional documents

After submittal of all documents, the applicant gets a copy of the list with remark of the date of acceptance of the application and the package of documents. It is the confirmation of acceptance of the documents and the beginning of the period within which the service should be provided.

After obtainment of the new MA, the remark on invalidity is put in the old one.

The process of MA Substitution is performed within 30 calendar days, the state duty is not collected. The cost of the MA Substitution procedure is ₽15,000, the period of implementation is 30 calendar days.

If the MA was spoilt, you can obtain the counterpart of the marketing authorisation

The grounds for granting
of the counterpart of the marketing
authorisation for a medical product
in case of loss of MA for a medical product
in case of spoiling of MA for a medical product

As noted above, in 2013, the new rules of the state registration of medical products were introduced. These changes caused necessity to substitute all the MA's obtained previously. During formation of the required documentation, some issues which can prolong the process of issuance and obtainment of MA for a medical product may arise. In return, it may influence the company's business activity on the whole.

The processes related to the Substitution of MA are not very time-consuming as it's not necessary to pass long registration procedures. Our experts will help you pass this procedure as soon as possible.

Did you obtain MA before December 31, 2012?! — So you have to substitute it!

Contact us