ZAMRA ZAMRAZAMRA guideline, March 2023
ZAMRA guideline, March 2023 is the official ZAMRA identifier for “Guideline on Recall of Medicines and Allied Substances”. ZAMRA guideline, March 2023 is the official identifier ZAMRA uses for this instrument.
- Instrument
- ZAMRA
- Full name
- ZAMRA guideline, March 2023
- Category
- Vigilance
- Authority source
- English
- Readable HTML
- 19 articles · 1 language version
- Published
- —
- Effective
- 2023-03-01
Open a language version
Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
Guideline on Recall of Medicines and Allied Substances
ZAMRA's recall guideline, dated March 2023 on its cover and stated to be a cross-product instrument: its scope covers medicines and allied substances, and devices fall in through the Act's definition of "allied substances". It sets the recall classes and levels, the steps of the recall procedure, notification of a quality problem or defect, initiation and risk evaluation, assessment and recall strategy, the roles and responsibilities of each stakeholder (ZAMRA, the marketing authorisation holder, wholesalers, health facilities, retail outlets, health professionals and the public), effectiveness checks, reinstatement of supply and penalties. Five appendices are ingested with it, including the reporting form, the customer reply form and the post-recall report form. Note that the copy's own table of contents carries several "Error! Bookmark not defined." placeholders where page numbers failed to generate — a defect of the source, ingested as published.
ZAMRA guideline, March 2023 is the official identifier ZAMRA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.