The National Drug and Health Products Agency of Tunisia has announced an exceptional extension of deadlines for pharmaceutical laboratories to submit files for new marketing authorizations in electronic format. This decision aims to facilitate the transition to the new international standardized electronic technical file format. According to the agency, this move is part of its efforts to monitor the implementation of the electronic format and support applicants for marketing authorizations.
The extension was made necessary due to difficulties encountered by some laboratories in transitioning to electronic formats. The agency stated that it had recorded some laboratories experiencing difficulties in adapting to the new electronic format. As a result, the agency has extended the deadline for re-submitting files in the new electronic format. For files submitted in 2025 that were not processed and did not benefit from priority status, the deadline for re-submission has been extended to December 31, 2026.
For new files submitted in 2026, the deadline for re-submission in the new electronic format has been extended to March 31, 2027. The agency emphasized that any file not re-submitted within the specified deadlines will lose its priority status linked to the initial submission date. Instead, the date of actual submission in the new electronic format will be considered the new file date.
The National Drug and Health Products Agency also announced that, exceptionally, applications for renewing marketing authorizations can continue to be submitted in the current electronic format until December 31, 2026. However, starting January 1, 2027, renewal applications will be subject exclusively to the new electronic technical file format, with prior submission of the basic file being mandatory.
The agency will announce the official opening date of the electronic portal for the new format for applicants of marketing authorizations at a later time. Until then, current submission methods will remain unchanged. Additionally, the agency will provide guidance documents and practical recommendations for preparing and submitting files in the new format to minimize errors that could lead to file rejection or impact processing times.
This decision aims to ensure compliance with technical requirements and facilitate the evaluation process for marketing authorization applications. The National Drug and Health Products Agency plays a crucial role in ensuring the quality, safety, and efficacy of medicinal products in Tunisia. By implementing this new electronic format, the agency seeks to enhance transparency and efficiency in the evaluation and authorization process.
The introduction of the new electronic technical file format is part of Tunisia's efforts to align with international standards and best practices in the pharmaceutical sector. The agency's efforts to support pharmaceutical laboratories in this transition are expected to contribute to the development of a more robust and efficient regulatory framework in the country.
Key points
- The National Drug and Health Products Agency of Tunisia has extended deadlines for pharmaceutical laboratories to submit new marketing authorization files in electronic format.
- The new electronic technical file format is an international standardized format for preparing, organizing, and submitting technical files for medicinal products electronically.
- The agency has set new deadlines for re-submitting files in the new electronic format, including December 31, 2026, for files submitted in 2025 and March 31, 2027, for files submitted in 2026.
