Rapid Alert System
Where substandard or falsified medicines are encountered in the market, effective and rapid communication will facilitate prevention of use of the medicines and hence prevent harm to consumers.
TMDA works in collaboration with the World Health Organization (WHO) by receiving alerts on falsified medicines encountered in other countries by rapid alert e-mails through the TMDA/WHO Substandard and Falsified Medicines (SF) Focal Person.
On the other hand, information on falsified medicines encountered on the market by TMDA is sent to WHO by the SF Focal Person through the Global Surveillance Monitoring System (GSMS) and in turn this information is shared to other countries.
Within the TMDA, reports for problems in quality of products can be received from inspectors, through complaints or information from manufacturers. Once information of availability of poor quality medicines is received, the first step is confirmation in TMDA Integrated Management Information System (IMIS) if the respective medicines have been registered by TMDA.
If the medicines are not registered, TMDA informs all the zonal offices to conduct inspection and remove the unregistered medicines from the market.
For a medicines that are of poor quality but found to be registered by the Authority, TMDA communicates with the manufacturers through the local agents to confirm if the medicines were manufactured by the facilities as indicated in the product labels. If the manufacturers agree to have manufactured the medicines, this call for a recall of the medicines and other actions appropriate for recalls. To read more on recalls Click here.
However, if the manufacturers confirm that the medicines were not manufactured by the facilities despite the resemblance, the medicines are confirmed to be falsified. Sample of such medicines are sent to the TMDA laboratory for identification test and assay (if not sent before) in order to get information on the actual health risk of the medicines and guidance on proper decision making.
Generally, falsified medicines call for issuance of press release to the public so that they are able to identify them and stop further use and distribution.