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Section 13
Registered vaccine to be supplied
: (1) The organization supplying the vaccine shall only supply the vaccine registered in the Department of Drug Administration.
(2) The vaccine to be supplied as per sub-section (1) must be manufactured by adopting good manufacturing process and certified by the World Health Organization as being of good quality.
(3) Notwithstanding anything contained in sub-section (2), a vaccine which has not been certified as being of good quality by the World Health Organization may be supplied in the following cases:
(a) Produced following good manufacturing processes,
(b) has been used in the country of manufacture or in another country,
(c) registered with the regulatory body of the country of manufacture, and
(d) Certified by the Drug Administration Department as per clauses (a), (b) and (c).
(2) The vaccine to be supplied as per sub-section (1) must be manufactured by adopting good manufacturing process and certified by the World Health Organization as being of good quality.
(3) Notwithstanding anything contained in sub-section (2), a vaccine which has not been certified as being of good quality by the World Health Organization may be supplied in the following cases:
(a) Produced following good manufacturing processes,
(b) has been used in the country of manufacture or in another country,
(c) registered with the regulatory body of the country of manufacture, and
(d) Certified by the Drug Administration Department as per clauses (a), (b) and (c).