- Todos > Medicine Programme Coordination > Programme Coordination
- Todos > Quality and Safety: Medicines > Regulatory Support
(2008; 76 pages)
The Vision of the National Drug Policy as inculcated in the Ministry of Health mission on drug legislation and regulation is to provide equity of access for all Zambians to good quality, safe and efficacious medicines which are affordable and rationally used as close to the family as possible.
In order to ensure that medicines conform to the required standards of quality, safety and efficacy throughout the chain of manufacture, importation, exportation, storage, distribution, supply, sale and use, the Pharmaceutical Regulatory Authority is established by an Act of Parliament, i.e. the Pharmaceutical Act (No. 14) of 2004 to not only ascertain that the medicines are safe, effective and of good quality but also that they are manufactured in facilities which are in compliance with current Good Manufacturing Practices (cGMP) standards as recommended by the WHO.
This register has been compiled by the PRA pursuant to Section 28 of the Pharmaceutical Act and contains licensed or registered medicinal products which have been assessed and evaluated based on the information currently available, to conform to the required standards of quality, safety and efficacy. The register has been compiled in such a way as to provide information and guidance to the Ministry of Health, hospitals, clinics, healthcare providers, pharmaceutical industry, consumers (users), general public and interested parties and provides details on the name of the medicinal product, name of product license holder, product license number, presentation or dosage form and method of sale to the public. It should be noted that this is a living document which will be subject to amendments from time to time as medicinal products may be withdrawn for various reasons including their safety, quality and efficacy as data become available from post marketing surveillance activities or additions may be made as we approve them for placement on the Zambian market...