The National Agency for Medicines and Health Products in Tunisia has announced an exceptional extension of certain deadlines granted to laboratories to obtain drug marketing licenses. This decision comes as part of the transition to a new electronic technical file format, an international standard for preparing, organizing, and submitting technical files for drugs electronically. The move aims to facilitate the process for laboratories and ensure compliance with technical requirements.
According to the National Agency for Medicines and Health Products, the extension was necessary due to difficulties faced by some laboratories in transitioning to electronic formats. The agency has extended the deadline for new license applications submitted in 2025 that were not processed and did not receive priority, allowing them to resubmit in the new electronic format by December 31, 2026. Similarly, new applications submitted in 2026 have been granted an extension until March 31, 2027.
The agency emphasized that any files not resubmitted within the specified deadlines will lose their priority status based on the original submission date. Instead, the new submission date in the electronic format will be considered the new file date. This measure aims to ensure a smooth transition to the new electronic system while minimizing disruptions to the licensing process.
In addition to the extensions for new license applications, the National Agency for Medicines and Health Products has allowed renewal applications for drug marketing licenses to continue using the current electronic submission format until December 31, 2026. However, starting January 1, 2027, renewal applications will be required to use the new electronic technical file format exclusively, with prior submission of the basic file being mandatory.
The agency plans to announce the official opening date of the new electronic portal for drug marketing license applicants at a later time. Until then, current submission methods will remain in effect. To support applicants, the agency will provide guidance documents and practical recommendations on preparing and submitting files in the new format, aiming to reduce errors that could lead to file rejection or delays in processing.
The transition to the new electronic technical file format is part of Tunisia's efforts to modernize its regulatory framework for medicines and align with international standards. The National Agency for Medicines and Health Products is responsible for ensuring the quality, safety, and efficacy of medicines in Tunisia. By streamlining the licensing process and improving transparency, the agency aims to enhance the overall regulatory environment for the pharmaceutical industry.
The extensions granted by the National Agency for Medicines and Health Products are expected to provide relief to laboratories facing challenges in adapting to the new electronic system. By allowing for a phased transition, the agency can ensure a more efficient and effective licensing process, ultimately benefiting public health in Tunisia.
Key points
- The National Agency for Medicines and Health Products in Tunisia has extended deadlines for laboratories to obtain drug marketing licenses.
- The extensions apply to new and renewal applications, with specific deadlines for resubmission in the new electronic format.
- The transition to the new electronic technical file format aims to modernize Tunisia's regulatory framework for medicines and align with international standards.
