Regulation8 Sept 2026Source: DRAP
DRAP Releases Revised Post-Registration Variation Guidelines (Revision 3)
DRAP has published revision 3 of its Post-Registration Variation (PRV) Guidelines for pharmaceutical and biological products.
The guidelines explain how changes to an already registered product, such as changes to its manufacturing, specifications or labelling, should be reported to and approved by the regulator. The approved document is available as a download from DRAP.
Key points
- Revision 3 of the PRV Guidelines was published on 8 September 2026.
- Applies to registered pharmaceutical and biological products.
- Sets out how post-registration changes are submitted to DRAP.
- The approved guideline can be downloaded from the DRAP website.
What it means for you
Registration holders and regulatory affairs pharmacists should check the new revision before submitting any variation for a registered product.
Post-Registration Variation Guidelines for Pharmaceutical and Biological Products
Summarised automatically from the official announcement. For educational purposes only — check the original source before making clinical decisions.