The National Agency for Medicines and Health Products (ANMPS) in Tunisia has updated its roadmap for transitioning to electronic format, extending deadlines for laboratories to submit certain medicine dossiers electronically. This decision was made due to difficulties faced by some laboratories in switching from paper or old electronic formats to the new system. The ANMPS aims to facilitate this transition while maintaining necessary technical requirements for dossier processing.
The ANMPS has set new deadlines for laboratories to resubmit dossiers in electronic format. For new market authorization requests submitted in 2025 but not yet examined, laboratories have until December 31, 2026, to resubmit them digitally. For requests made in 2026, the deadline is March 31, 2027. Failure to resubmit before these dates will result in the loss of initial deposit priority, with the new date being the actual digital submission date.
A transition period is also planned for market authorization renewal requests. Until December 31, 2026, these requests can still be submitted in eSubmission format, which is an electronic dossier according to current modalities. From January 1, 2027, renewal requests must be submitted electronically. However, an exception is made for urgent modification requests or those likely to impact a near renewal, which can be submitted in eSubmission format until December 31, 2026.
For modification or renewal requests already submitted in eSubmission format, requested responses can continue to be transmitted in the same format. This possibility will remain valid until the end of the concerned dossiers' processing, even if it occurs after the set deadlines. Until the official opening of the ANMPS digital portal, practical submission modalities remain unchanged, with laboratories able to transmit dossiers through a secure electronic platform or by submitting an electronic support directly to the ANMPS.
The ANMPS will provide orientation documents and practical recommendations to laboratories after over four months of electronic submissions. These documents aim to help applicants prepare correct dossiers and avoid errors that may lead to rejection or slow down processing. The Agency calls on laboratories to strictly respect new deadlines and technical rules applicable to electronic and eSubmission formats.
The ANMPS emphasizes that respecting these requirements is necessary to guarantee electronic dossier conformity and avoid rejections and delays in processing. The Agency will communicate the official opening date of its digital portal at a later time. This move is part of Tunisia's efforts to modernize and streamline its regulatory processes for medicines.
The decision to extend deadlines and provide support reflects the ANMPS' commitment to facilitating a smooth transition to electronic submissions. By doing so, the Agency aims to improve the efficiency and transparency of the regulatory process, ultimately benefiting both laboratories and the healthcare sector in Tunisia.
Key points
- The ANMPS has extended deadlines for electronic submissions of medicine dossiers to facilitate a smooth transition to the new format.
- Laboratories have until December 31, 2026, or March 31, 2027, to resubmit dossiers in electronic format, depending on the submission date.
- The ANMPS will provide orientation documents and practical recommendations to laboratories to help them prepare correct dossiers and avoid errors.
