Rules for determining the interchangeability of drugs

On December 21, the FAS prepared amendments to Federal Law No. 61-FZ "On the Circulation of Medicinal Products," defining the rules and methods for creating a registry of interchangeable medicinal drugs that will compete with each other in tenders.

"The amendments were developed to empower the Russian Ministry of Health to request from marketing authorization holders the information necessary to determine the interchangeability of medicinal drugs... The draft law establishes the procedure and timelines for sending requests for data to determine drug interchangeability. The amendments authorize the competent body to suspend the use of a drug if the marketing authorization holder fails to provide the information after the first request and to cancel the state registration of the drug upon repeated failure to submit the requested documents," states the message published on the FAS website.

Furthermore, the draft law assigns the Russian Ministry of Health the authority to maintain the registry of interchangeable medicinal drugs, which will ensure the implementation of the decision of the EEC Council on the rights of EAEU member states to determine drug interchangeability in accordance with national legislation.

The developed amendments have been sent by the FAS to the Ministry of Health for review.

The parameters for determining drug interchangeability are established at the registration stage – experts conclude that drugs are interchangeable by comparing a drug with similar composition. However, to establish the interchangeability of drugs from different EAEU countries, additional post-registration comparative studies are required, which are not yet regulated by law. In March 2016, the Russian Ministry of Health proposed establishing a procedure for determining the interchangeability of registered drugs.