Class I: public notified within 24 hours, undistributed stock quarantined immediately, recall completed within 72 hours (s.6.2.4)
recall.class-i-24h-public-notification
For a Class I recall, the MAH, local responsible person, distributor and manufacturer must notify the public within 24 hours of the recall decision, quarantine undistributed stock immediately, and complete the recall within 72 hours. A problem that may lead to a Class I or II recall must be reported to ZAMRA by telephone within 24 hours (Appendix II note).
Conditions
- Class I recalls only for the 24-hour public notification; the 24-hour telephone report applies to potential Class I or II recalls.
Effective from 2023-03-01
Reporting uses the Pharmaceutical Product Reporting Form (Part I) and Recall Notification Form (Part II) in Appendix II, also posted on the ZAMRA Forms page.
Recalls are classified I, II or III by ZAMRA; Classes I and II are urgent safety-related recalls
recall.classification-authority-decides
Recalls are classified by severity into Class I, II and III. Class I and II are 'Urgent Safety-Related Recalls' that must be reported to ZAMRA for evaluation; Class III are minimum-risk recalls that must nevertheless be reported. ZAMRA determines the class of each recall, and for international recalls it considers decisions of other national regulatory agencies.
Effective from 2023-03-01
Table 1 gives examples per class (Class I: serious/life-threatening defects; Class III: non-compliance with the Act's quality, safety or efficacy requirements).
Non-adherence to the Recall Guideline is prosecuted under s.46(4) MASA (s.9.0)
recall.guideline-non-adherence-penalty
Where there is non-adherence to the Recall Guideline, ZAMRA institutes regulatory action and prosecution in accordance with s.46(4) of the Medicines and Allied Substances Act (fine up to one million penalty units and/or up to three years' imprisonment).
Effective from 2023-03-01
The 2023 Recall Guideline covers allied substances, expressly including medical devices, and both voluntary and statutory recalls
recall.guideline-scope-includes-devices
ZAMRA's Guideline on Recall of Medicines and Allied Substances (March 2023) applies to all quality-defect reports and safety/efficacy incidents for medicines and allied substances, and to local responsible persons, MAHs, distributors, manufacturers, wholesalers, retailers, health facilities and the public; its definitions state that allied substances include medical and surgical sundries, medical devices and condoms.
Effective from 2023-03-01
Guideline is dated 'MARCH, 2023' on its cover; exact day not stated. The guideline also defines 'Correction' (repair, modification, adjustment, re-labelling or inspection without physical removal), the FSCA-type action.
Recall initiation and physical-recall timelines by class (Table 3)
recall.initiation-completion-timelines
Recalls must be initiated within 24 hours (Class I), 48 hours (Class II) or 72 hours (Class III), and physically completed within 72 hours (Class I), 14 days (Class II) or 30 days (Class III).
Effective from 2023-03-01
Section 1.4 (Table 2) separately defines recall levels A (consumer), B (retail/user facility) and C (wholesale).
Inspectors may enter, search, seize products and take samples under warrant (s.55(4) MASA)
recall.inspector-seizure-sampling-powers
A ZAMRA inspector may, on the authority of a warrant, enter premises or conveyances believed to be used contrary to the Act and, among other powers, seize any medicine or allied substance (and related records or devices) that bears on an inspection or investigation or is used contrary to the Act, and take samples for testing, examination or analysis.
Conditions
- Entry requires a warrant and reasonable grounds (s.55(4)).
Effective from 2013-03-22
Market-surveillance enforcement power; s.55(5) requires a receipt for anything removed.
Interim report within 7 days, final report within 14 days, investigation/CAPA report within 30 days of the recall (s.6.2.6)
recall.interim-final-investigation-reports
The MAH, local responsible person, distributor or manufacturer must give ZAMRA an interim progress report within 7 calendar days of initiating the recall, a final report within 14 calendar days of commencing it (or obtain ZAMRA's approval for a later date), and a report on the investigation results and preventive action not more than 30 calendar days after the recall.
Effective from 2023-03-01
Final report content: circumstances, action taken, distribution extent in and outside Zambia, quantities returned/outstanding, confirmation of retailer returns, and method of destruction. Appendix IV provides the Post Recall Report Form.
Voluntary recall notices must be approved by ZAMRA before publication; statutory notices issue under s.46 (s.5.1)
recall.notice-approval-before-publication
A statutory recall notice is issued under s.46 of the Act. For a voluntary recall, the MAH, local responsible person, distributor or manufacturer must submit a draft notice with a factual statement of reasons and product identifiers to ZAMRA for approval before publication; the notice may not contain promotional material.
Effective from 2023-03-01
s.5.2 adds that for Class I/II recalls a media release (public warning) headed 'Urgent Medicine/Allied Substance Recall' is used.
Recall/withdrawal may be regulated by statutory instrument, and ZAMRA guidelines are binding once published (ss.68-69 MASA)
recall.regulation-and-guideline-powers
The Minister may by statutory instrument make regulations on the recall or withdrawal of medicines and allied substances that do not meet prescribed quality, efficacy and safety standards (s.69(2)(g)); separately, guidelines made by ZAMRA under s.68 become binding on all regulated persons upon publication in a daily newspaper of general circulation.
Effective from 2013-03-22
The 2023 Recall Guideline cites s.46 and s.68 as its legal basis (Guideline s.1.0).
Selling a product subject to a recall notice is an offence (s.46(3)-(4) MASA)
recall.sale-of-recalled-product-offence
No person may sell a medicine or allied substance that is the subject of a s.46(1) recall notice; contravention is an offence punishable on conviction by a fine of up to one million penalty units, imprisonment of up to three years, or both.
Effective from 2013-03-22
The Recall Guideline (s.9.0) states that non-adherence to the guideline is prosecuted under s.46(4).
ZAMRA may direct the return (recall) of a medicine or allied substance by written notice or Gazette (s.46(1)-(2) MASA)
recall.statutory-recall-power
Where ZAMRA determines it is not in the public interest that a medicine or allied substance be made available to the public, it may by written notice served on any person, or by Gazette notice, direct that person to return the product to the manufacturer, to the importer (for imported products) or to the Authority or its designee, and may direct the manufacturer or importer how to deal with or dispose of the returned stock.
Conditions
- Applies to any medicine or allied substance, which includes medical devices (s.2).
Effective from 2013-03-22
Marginal note reads 'Recall of medicine, etc. from circulation'.
Circumstances in which ZAMRA triggers a statutory (mandatory) recall (s.2.2)
recall.statutory-recall-triggers
ZAMRA triggers a statutory recall where a medicine or allied substance does not meet the set standard of quality, safety and efficacy; where continued supply violates the Act or another law; or where the Authority determines that continued availability is not in the public interest. Voluntary recalls (s.2.1) are triggered by the MAH/manufacturer on quality, complaint, stability or serious-safety-risk findings.
Effective from 2023-03-01
Definition on p.5: 'Mandatory (non-voluntary) recall: Is when the Authority requests/orders a product recall due to non-compliance to regulatory requirements.'
