Recall of Medicines
Regulation No.4 of the Tanzania Medicines and Medical Devices (Recall, Handling and Disposal of Unfit Medicines and Cosmetics) Regulations, 2015 prohibits to sell, offer or expose for sale or supply medicinal products subjected to recall.
Regulation No.5 of the same regulations, provides room for recall of Medicines to be initiated by TMDA, Manufacturer, Registrant or MAH after receiving complaints from customers or following identification of potentially life threatening products during Post Marketing Surveillance activities. According to the Regulation, the costs of recall shall be borne by manufactures, marketing authorization holders or Registrants.
Regulation No. 7 Tanzania Medicines and Medical Devices (Recall, Handling and Disposal of Unfit Medicines and Cosmetics) Regulations, 2015 calls for an evaluation of the health risk presented by a product being recalled or considered for recall.
After the assessment of relative health risks of the medicines, the recall may be classified as Class I, II and III. Class I recall is for medicines with the highest risks, the recall of which should be completed within 14 days from the day of approval of the recall by the Authority. Class II recall is for moderate risk and recall should be completed within 21 days. Class III recall time limit is 30 days. More details on recall are found in the Guidelines for Recall, Handling and Disposal of Unfit Medicines. To access the Guidelines Click here.