The Zambia Medicines Regulatory Authority (ZAMRA) is what used to be known as the Pharmaceutical Regulatory Authority (PRA). It ceased to be PRA in March 2013 when the Pharmaceutical Act (No. 14) of 2004 which established PRA was repealed by the Medicines and Allied Substances Act (No. 3) of 2013 which provided for the continuation of PRA but renamed as ZAMRA.
The Pharmaceutical Act (No. 14) of 2004 was repealed by the Medicines and Allied Substances Act (No.3) of 2013 as part of the Business Licensing Reforms. Through these reforms the Pharmaceutical Act was identified as one of the pieces of legislation under the health sector that required reviewing in order to bring it in line with government policy on Private Sector Development Reform Programme (PSDRP).
The aim of the PSDRP was to improve the investment climate in Zambia by reducing the cost of doing business.
The other reason for the repeal of the Act and subsequent repealing of the Pharmaceutical Act was to increase access to safe, quality and efficacious medicines to all Zambians through the regulation and registration of health shops and agro- vet shops.
Yes! The Medicines and Allied Substances Act mandates ZAMRA to provide for the regulation and control of all medicines including herbal Medicines.
Prior to importation or exportation of medicines for personal use, an application should be made in writing addressed to the Director General. The quantity to be imported must not exceed the required quantity and for chronic medical conditions the quantity must not exceed one year.
The application should specify:
a) Name and address of the applicant b) Name , strength, dosage form and quantity (ies) of the medicines c) Port of entry or exit
For Prescriptions only Medicines (POM) the application should be accompanied by a prescription from a physician or authorized prescriber. In case of a person traveling with controlled medicines (narcotic drug and psychotropic substances) to Zambia, such a person is required to possess a certificate or permit issued by an organization responsible for authorizing such a person in the country of departure.
A fee of K50.00 is payable to the authority for issuance of a permit to import or export medicines for personal use.
Section 14 (1) of the Medicines and Allied Substances Act (No. 3) of 2013 stipulates that a person shall not (a) operate, either on that person’s own behalf or on behalf of another person, a pharmacy that is not registered under this Act or a health shop or agro- veterinary shop without a permit issued by the Authority.
Subsection (2) Stipulates that a person who contravenes subsection (1) commits an offense and is liable , upon conviction, to a fine not exceeding three million penalty units ( K540,000 ) or to imprisonment for a period not exceeding five years, or to both.
ZAMRA is therefore, enforcing this law by conducting regular inspections of facilities conducting pharmaceutical businesses throughout the supply chain. This is done through the Directorate of Inspectorate and Licensing which ensures compliance to set standards. The Department works closely with the Zambia Police, the Drug Enforcement Commission and the Local Council to ensure that those selling medicines without authorization from ZAMRA are prosecuted in accordance with the Medicines and Allied Substances Act. In Addition ZAMRA conducts public awareness activities to raise awareness and sensitize members of the public on the dangers of selling or buying medicines from un authorized outlets.