[No.
of 2013 35
Medicines and Allied Substances
PART IX
GENERAL PROVISIONS
56. (1) A person aggrieved with a decision of the Authority
may appeal to the Minister within thirty days from the date of Appeals
service of the decision.
(2) The Minister shall make a decision on the appeal lodged
under subsection (1) within ninety days of receiving the appeal.
(3) A person aggrieved with the decision of the Minister under
subsection (2) may appeal to the High Court within thirty days
from the date of service of the decision.
57. (1) Notwithstanding the provisions of the Patents Act or
any other written law, where—
(a) the Minister declares a national health emergency or state
of extreme urgency;
(b) the public interest so requires; or
(c) any medicine or allied sustance is required for public noncommercial use;
the Authority may authorise the manufacture locally, or importation,
of a generic formulation of a medicine or allied substance, not
withstanding that a patent in respect of that medicine has been
issued in Zambia.
Authority to
manufacture
patented
medicine
Cap. 400
(2) The Authority shall not grant authorisation to a person to the
exclusion of the patent holder.
(3) The grant of an authorisation under subsection (1), shall be
subject to review by a court.
58. (1) A person who fraudulently obtains a licence, permit,
authorisation or registration under this Act or makes any false or
misleading statement in connection with any medicine or allied
substance commits an offence and is liable, upon conviction, to a
fine not exceeding one million penalty units or to imprisonment for
a period not exceeding three years, or to both.
(2)
A person who—
(a) deals in unregistered medicines or allied substances;
(b) tampers with any sample taken for purposes of this Act;
(c) obtains medicines or allied substances from unauthorised
suppliers; or
(d) fails to maintain records for medicines or allied substances
registered under this Act;
General
offences