ur company provides a regulatory and compliance advisory service to all our foreign principals free of charge. The Regulatory Affairs Department is headed by an experienced, fully-qualified pharmacist accredited by the Professional Health Council of Zambia (HPCZ), assisted by a Pharmacy Consultant and two registered Pharmacy technicians. The Department ensures that Sterelin’s operational procedures meet both our local regulatory requirements and those of our principals. To achieve this, the Regulatory Affairs Department communicates regularly with The Zambia medicines Regulatory Authority(ZAMRA), formerly known as Pharmaceutical Regulatory Authority (PRA) and our principals in the following areas:
Ensuring that all activities that occur within the life span of a drug meet all legal standards, i.e. –from the time import orders are made to the time the drug is released on to the market.
Ensuring that all the pharmaceutical products that we import are registered with the PRA
Obtaining import permits from the PRA for all medicine imports after submission of Proforma Invoices and Screening Fees to the PRA.
Ensuring that all our principals renew marketing authorisation for the products they wish to retain at the beginning of each
year (retention fees payments) as prescribed in Statutory Instrument No 7 of 2008
Ensuring that our principals comply with the packaging and labelling requirements prescribed in Statutory Instrument No 47 of 1993
Submitting dossiers for registration or amending documents for variations on behalf of regulatory departments of our principals to the PRA , and following up on progress.
Regulatory Affairs Team
Reporting any adverse drug reaction-events to both the regulatory departments of our principals and the Zambia Pharmacovigilance Unit at the PRA.
Offering advisory services to all our principals and potential strategic partners on dosage, form and pack sizes and strengths
Advising principals and potential strategic partners on correct classification for registration of products in order to maximise market potential.
Providing continuous in-house training to all sales staff on new molecules and products introduced to Zambia.
Obtaining import and export permits for our principals for all dangerous drugs.
Closely monitoring the Warehouse Department and Logistics Department to ensure that the correct standards of practice are followed, such as:
Ensuring that all drugs are stored according to specified storage conditions in the warehouse and that GMP rules are followed
Maintaining a proper record-keeping system for invoices, in-coming imports, and expired and recalled drugs.
Making routine inspections of all drugs to check for expiry dates, damages and soiled containers, and correct labelling.
Ensuring that expired drugs are removed from the shelves and kept in a secure, lockable room, and that all such products are destroyed and disposed under approval and supervision by the PRA and the Environmental Council of Zambia.
Monitoring and controlling the import and sale of dangerous drugs(narcotics) according to the prescribed regulations.
Copyrights © 2015 Sterelin Medical & Diagnostics Limited . Design by Comnet International