All medicines containing Codeine and/or Diphenhydramine are with immediate effect categorised as Prescription only Medicines and will be sold as such, the Zambia Medicine Regulatory Authority (ZMRA) has ordered.
In a notice to all Pharmaceutical Importers, Distributors, Retailers and the public dated July 4, ZMRA Director General Bernice Mwale stated that the authority was concerned about the abuse of such medicines.
“The Zambia Medicines Regulatory Authority was established under the Medicines and Allied Substances Act (No. 3) of 2013 to ensure that all medicines and allied substances being made available to the Zambian people meet the required standard of quality, safety and efficacy throughout the chain of manufacture, importation, exportation, distribution, storage and sale, thereby protecting public health. The Authority has noted with deep concern the increase in the indiscriminate sell by pharmaceutical retail outlets in most cases with disregard to the assigned category of distribution and subsequent abuse by members of the general public of medicines containing Codeine, Diphenhydramine and Tramadol. Note that: All medicines (cough syrups) containing Codeine and/or Diphenhydramine are categorised as Pharmacy Medicines (P) and should only be sold in registered outlets and only by or under the supervision of a Pharmacist and, All medicines containing Tramadol are categorised as Prescription only Medicine (POM) and should only be sold in registered outlets by a Pharmacist upon presentation of a valid prescription written by an authorised prescriber,” Mwale stated.
“The Authority wishes to state that the sell or supply of any medicine categorised as Prescription only Medicine (POM) without presentation of a valid prescription is contrary to Section 42 subsection (1), which states that:
“A person shall not sell or supply medicine which is required to be sold by prescription only to any person without a prescription”. To this effect the Authority wishes to advise all pharmaceutical importers, distributors that in ensuring the effective regulation of the above mention medicines and in enhancing public safety, all medicines containing Codeine and/or Diphenhydramine are with immediate effect categorised as Prescription only Medicines and will be sold as such. Furthermore, the Authority advises all retail outlets to only dispense/sell all Tramadol containing products only upon receipt of a valid prescription.”
She warned that failure to comply with this would result in prosecution.