From now on, notifications of temporary and permanent discontinuation of manufacturing and reactivation of medicines manufacturing can be found in the Solicita System. Due to this migration, current requests should only be made electronically.
Despite the change, the codes for electronic petitioning have not changed. In this way, the same existing codes can be used by companies. In addition, additional subjects for electronic petitioning of notified drugs and radiopharmaceuticals were created, since these previously did not have specific codes.
Migrated subjects:
- 10517 – DYNAMIZED – Notification of definitive discontinuance of manufacture or import.
- 10518 – SPECIFIC – Notification of definitive discontinuance of manufacture or import.
- 10519 – PHYTOTHERAPY – Notification of definitive discontinuance of manufacture or import.
- 10520 – GENERIC – Notification of definitive discontinuance of manufacture or import.
- 10521 – NEW DRUG – notification of definitive discontinuance of manufacture or import.
- 10522 – BIOLOGIC PRODUCT – notification of definitive discontinuance of manufacture or import.
- 10523 – SIMILAR – Notification of definitive discontinuance of manufacture or import.
- 10524 – DYNAMIZED – Notification of temporary discontinuance of manufacture or import.
- 10525 – SPECIFIC – Notification of temporary discontinuance of manufacture or import.
- 10526 – PHYTOTHERAPY – Notification of temporary discontinuance of manufacture or import.
- 10527 – GENERIC – Notification of temporary discontinuance of manufacture or import.
- 10528 – NEW DRUG – Notification of temporary discontinuance of manufacture or import.
- 10529 – BIOLOGIC PRODUCT – Notification of temporary discontinuance of manufacture or import.
- 10530 – SIMILAR – Notification of temporary discontinuance of manufacture or import.
- 10538 – DYNAMIZED – Notification of reactivation of manufacture or import.
- 10539 – SPECIFIC – Notification of reactivation of manufacture or import.
- 10540 – PHYTOTHERAPY – Notification of reactivation of manufacture or import.
- 10541- GENERIC – Notification of reactivation of manufacture or import.
- 10542 – NEW DRUG – Notification of reactivation of manufacture or import.
- 10543 – BIOLOGIC PRODUCT – Notification of reactivation of manufacture or import.
- 10544 – SIMILAR – Notification of reactivation of manufacture or import.
New subjects created:
- 12145 – SIMPLIFIED NOTIFICATION – Notification of temporary discontinuance of manufacture or import.
- 12146 – SIMPLIFIED NOTIFICATION – Notification of definitive discontinuance of manufacture or import.
- 12147- SIMPLIFIED NOTIFICATION – Notification of reactivation of manufacture or import.
- 12148 – RADIOPHARMACEUTICALS – Notification of temporary discontinuance of manufacture or import.
- 12149 – RADIOPHARMACEUTICALS – Notification of definitive discontinuance of manufacture or import.
- 12150 – RADIOPHARMACEUTICALS – Notification of manufacture or import reactivation.
What is the Solicita System?
To submit documents for process petitions at Anvisa, there are currently two systems: the Electronic Petition and the Solicita System.
The Solicita System was developed by Anvisa to digitize the demands of users to the agency’s services. It was implemented in 2019 to improve efficiency in the analysis of processes and enabling access to the Solicita System through modern browsers. Initially, it was developed for the sectors that still received paper processes, such as: food; sanitary inspection and investigation; technovigilance; airports, ports, borders and customs areas (in express shipments); and toxicology.
The Solicita System is essential for ANVISA’s digital transformation, reducing the need for citizens to travel to physical counters and eliminating the need for paper to be sent to ANVISA. In these almost 3 years in which the Solicitas System has been operating, several functionalities have been incorporated into it, among them: access to the company’s mailbox; tool for compliance with requirements; request for company operating authorization (AFE) and special authorization (AE); transfer of ownership of medicines and health products; consultation of reasons for rejection and non-consent of medical devices.
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