Disposal of Unfit Medicines
Regulation No. 9. of the Tanzania Medicines and Medical Devices (Recall, Handling and Disposal of Unfit Medicines and Cosmetics) Regulations, 2015 prohibits any person to dispose off any unfit medicines unless approval to proceed with the disposal procedure is issued by the Authority.
Based on Regulation No.10 of the same Regulations, disposal of medicines that do not meet quality requirements may be initiated by TMDA, regional, district and hospital pharmacist, owner or in-charge of facility or premises, superintendent or an Inspector.
When disposal of medicines is initiated by TMDA following confiscation of medicines during inspection, the owner shall be required to incur the cost of disposal by payment of 25% of the total cost of medicines as per fees and charges regulations.
Based on Regulation No. 12 of the Tanzania Medicines and Medical Devices (Recall, Handling and Disposal of Unfit Medicines and Cosmetics) Regulations, 2015, it is important to elaborate that when disposal of medicines is initiated voluntarily, no disposal cost are paid to TMDA except payment to the disposal facility, payment of staff supervising the disposal and any other costs as shall be determined by the National Environment Management Council (NEMC).
Disposal of medicines shall be done by methods proposed by the National Environment Management Council (NEMC) and shall be supervised by TMDA inspector, Health Officer, Police officer , NEMC inspector and any other authorized officer.
The disposal of unfit medicines shall be performed only after the owner of the consignment has submitted applications for disposal to TMDA, verification of the consignment has been performed and NEMC has approved the disposal.
After disposal, TMDA issues disposal certificate. For more details on disposal, read the Guidelines for Recall, Handling and Disposal of Unfit Medicines. To access the Guidelines Click here
To apply for disposal of medicines, fill the Application form for disposal Click here to access the form and submit to TMDA. This application should be accompanied with the list of products to be disposed indicating the quantity and price of each product.