REGULATORY REQUIREMENTS FOR MARKETING AUTHORIZATION OF GENERIC DRUG PRODUCT IN BOTSWANA
Mo. Nasiruddin I Pawar, *Darshil B Shah, Dr. Dilip G Maheshwari
Immediately after independence in 1966, the pharmaceutical sector
became a priority for the Government, and for many years Botswana
pioneered numerous areas of pharmaceutical policy, receiving
international recognition for this work. The Botswana pharmaceutical
market is growing rapidly. It is heavily driven by imports. The
majority of pharmaceutical sales in the country are from prescription
drugs. There are two procedure by which a marketing authorization in
Botswana can be obtained, Registration of Medicine through General
format (MH 2048) and Registration of Medicines through CTD & SADC format. These both
procedure are applicable to innovator and generic medicines. Branded medicines play an
important role in medications, but generic medicines are their cost effective alternatives.
Generic Medicines are similar to branded drugs in terms of efficacy, purity and are perceived
to be safer as compared to new drug molecules, as they likely to be older and time tested.
This review article attempts an insight on the recent regulatory aspects and marketing
authorization procedures in Botswana by giving a detailed overview of the both General
format and CTD-SADC format for pharmaceutical applicants to make proper marketing
applications and market or place their pharmaceutical generic products in the Botswana.
Keywords: Generic drug product in Botswana, CTD & SADC format, Marketing authorization.
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