Accelerated Evaluation of First Multisource Drugs

In order to reduce the time, it takes to register a first multisource drug (generic drug), The INESSS has introduced an accelerated evaluation process. The INESSS is proposing 9 additional deadlines for the registration of a first multisource drug, in addition to the 9 deadlines for the regular process. 

In order to take advantage of this new accelerated process, manufacturers submitting a registration application must comply with all the requirements of Form 6 FIRST APPLICATION: New multisource drug (generic drug or natural health product), and undertake to answer the INESSS and RAMQ questions within a maximum of 24 hours. 

Requests for registration should be submitted, as usual, through the INESSS online filing portal. Manufacturers wishing to take advantage of the accelerated process for a first multisource drug (generic drug) must select the most recent update available in the system and check the box: Accelerated process - 1st generic drug. An acknowledgement of receipt will be issued within 10 working days of the submission deadline. It is important to note that an application for a first multisource drug submitted by the regular deadline takes precedence over one submitted later under the fast-track process. 

Furthermore, to ensure timely processing of registration applications, new manufacturers must ensure that they have duly completed and submitted their recognition documents to the RAMQ. If you have any questions about the recognition process, please contact fabricants@ramq.gouv.qc.ca.

The INESSS evaluation procedures remain unchanged, but the processing of this type of application will be accelerated. Recommendations concerning these products will be transmitted to Notices to the Minister and published.