1. WORKSHOP ON OPTIMAL PROCUREMENT OF AFFORDABLE AND QUALITY ASSURED LIFE-SAVING COMMODITIES FOR MATERNAL HEALTH KAMPALA, UGANDA - REGULATORY STATUS AND QUALITY ASSURANCE OF UN COMMISSION LIFE SAVING MEDICINES IN ZAMBIA, AUGUST 2015.
BY: BILLY CHABALENGE

2. Background information
The history of medicines regulation in Zambia dates back to 1941 when the Pharmacy and Poisons Act was first enacted. This Act was to provide for the control of the profession of pharmacy and trade in drugs and poisons. The Pharmacy and Poisons Board (PPB) was established under this law to oversee its enforcement.

3. Background information cont…
In 2004, the Pharmaceutical Act was enacted by parliament. The Act established the Pharmaceutical Regulatory Authority (PRA).
In 2013, the Pharmaceutical Act was repealed and renamed as the Medicines and Allied substances Act. The act established the Zambia Medicines Regulatory Authority (ZAMRA).

4. Registration status of the UN Commission life saving medicines

5. Brands & manufacturers registered

6. Brands & manufacturers registered cont…

7. Assurance of quality of procured medicines from manufacturers/ before importation
Conduct inspections to verify manufacturing site compliance to GMP, GCP and GLP.
Assessment of Quality, Safety and Efficacy of all the products before they are registered.

8. Assurance of quality of procured medicines from manufacturers/ within the country
Regulation of facilities that handle medicines
Monitoring performance of products on the Market through conduct post-marketing surveillance.
Conduct pharmacovigilance activities

9. Experiences with Quality Assurance of the UN Commission lifesaving medicines
From the products that have been tested by ZAMRA lab in the past 12 months, none of the listed products have recorded any failure/ quality issues.
Male condoms ??

10. Conclusion and recommendation
The number of brands and manufacturers of RH products registered in the country is still limited.
There is therefore a need to review the registration of the number of brands and manufacturers of RH and child health products registered in the country

11. END OF PRESENTATION
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