Snapshot

The Abbreviated Assessment pathway has been developed by the of Tunisia.

This pathway can be used where medicinal products for human use (reference, generic, biosimilar, vaccine, etc.) that have been granted marketing authorization by at least one recognized reference authority.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is 1. Abbreviated Assessment based on reliance on WHO: The authority will finalize the registration process for applications submitted via this route and will issue the marketing authorization (MA) within 90 working days, from receipt of the WHO/SRA reports, provided that all required documents are duly completed. Target assessment time for variations is 30 working days. 2. Abbreviated Assessment through ANMPS internal procedure: (i) Interested applicants must submit an application to the ANMPS, mentioning the intention to use the regulatory trust route. The model in annex 7 of the ‘WHO trs1010-annex11’ guide may be considered. (ii) The request is sent to the ANMPS by e-mail in order to check the eligibility of the request and to ensure that the submission meets the requirements. The applicant must attach to his/her application proofs of eligibility. (iii) Issuance of the ANMPS decision on eligibility to use this pathway: The applicant will receive the agency's decision within 15 working days. In the event of non-eligibility, the applicant will be directed to the standard registration procedure. (iv) The target assessment time for this marketing authorization procedure is 90 working days. The target assessment time for variations is 30 working days. .