Industry Guidelines for Post-Registration Vaccine Dossier Quality Variations and Exception Codes

“This communication outlines the procedures and guidelines for managing post-registration quality variations and exception codes for updating registered vaccine dossiers to eCTD format. Key points include:

1. Extended Evaluation Timelines: The evaluation period for Type IB variations has been extended to 67 working days (previously 37). Timelines are calculated in working days by SAHPRA.
2. Submission of Variations: Quality and clinical variations should be submitted separately but at the same time, each with relevant fees. Proprietary name changes or Transfer of HCR applications should not be combined with Type I or Type II variations to streamline evaluations.
3. Requests for Additional Information: SAHPRA may request further details or reverse an implemented variation to maintain medicine quality and safety.
4. Quality Amendments: Any quality-related amendments to the medicine’s PI/PIL must be approved by the Quality unit before implementation.
5. Grouped Submissions: Variation applications grouped into a single submission will proceed at the pace of the most restrictive variation type.
6. Separate Applications for Variation Types: Type I and Type II variations should be submitted as separate applications.
7. Exception Codes: Specific exception codes from EMA/SAHPRA are provided for different alterations to pharmaceutical products.
8. Accepted Monographs: SAHPRA accepts monographs from Recognised Regulatory Authorities as outlined in the General Information and Quality and Bioequivalence guidelines.
9. Variations for Reliance-Registered Products: Products registered through reliance may have variations classified differently, provided certain conditions and documentation requirements are fulfilled.
10. Handling Queries: Queries regarding status updates, z-code requests, and extension requests should be sent to a dedicated email address, not to individual staff members.

These guidelines ensure a streamlined process for post-registration quality variations, maintaining compliance and ensuring timely updates to vaccine dossiers.”

Source:https://www.sahpra.org.za/communication-to-industry/##~https://www.sahpra.org.za/document/quality-variations/

Region: South Africa