ZWE - QD - SAFETY AND QUALITY CONTROL
ANIMAL HEALTH
Zimbabwe / Animal health
VETERINARY MEDICINAL PRODUCTS (VMPs)
SAFETY AND QUALITY CONTROL
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2 answers
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Section 30 Registrability of medicines
(1) The Authority shall approve the registration of a medicine if it considers that—
(a) the availability of that medicine is in the public interest; and
(b) the safety, quality and therapeutic efficacy of that medicine—
(i) in the case of a medicine which is not a veterinary medicine, in relation to its effect on the health of man;
(ii) in the case of a veterinary medicine, in relation to its effect on the health of animals; warrant its registration; and
(c) in the case of a medicine manufactured in Zimbabwe, the premises at which it is manufactured and all processes of manufacture are satisfactory.
(2) Notwithstanding subsection (1), the Authority shall not approve the registration of any medicine manufactured outside Zimbabwe, unless a valid certificate of registration in respect of such medicine issued by the appropriate authority established for the registration of medicines in the country of origin of that medicine has been produced to the satisfaction of the Authority.
Section 14. After approving a complementary medicine, the DirectorGeneral shall issue a certificate of approval in Form C.M.2 to the
applicant or principal, as the case may be.
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Section 35(2)(h)- Every application for the registration of a medicine shall be submitted in Form
M.C. 8 and shall be accompanied by – (h) the appropriate fee, together with such additional fee as may be fixed by the
Authority for the purpose of analysing such medicine. Return of medicines three months before expiry
Section 56. (1) Any person who practises or carries on the business of a pharmacist or dispenses any medicines may, where a medicine is due to expire, return such medicine not less than three months before the expiry date of such medicine to the manufacturer, agent or distributor, as the case may be:
Provided that a person shall return such medicine in its original unbroken package, as sealed by the manufacturer.
(2) On receipt of such medicine the manufacturer; agent or distributor, as the case may be—
(a) shall store such medicine in a quarantine area of the premises; and
(b) may reimburse the person who returned such medicine by –
(i) awarding a credit; or
(ii) replacing such surrendered medicine; or
(iii) where the Authority extends the expiry date of such medicine in terms of subsection (2) of section 58, returning such medicine duly relabelled; to the person concerned.
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Section 2(2)-Where a medicine is required by this Act to be labelled with any information, such information shall be written, printed or otherwise marked on a label which is—
(a) attached or affixed to the package of that medicine ; or
(b) packed with and refers to that medicine.
Section 36 Medicines to be labelled
(1) Subject to this section, no person shall sell any registered medicine unless it is labelled with its registered name and registered number, in addition to any other prescribed requirements.
Section 10 (extract) -
(I) Every complementary medicine shall, unless otherwise directed by the Authority, bear or incorporate a label on the package in which such complementary medicine is sold, on which is printed in clear and indelible letters in the English language and any other
language as may be directed or approved by the Authority, in addition to the approval number, the following particulars which relate to that complementary medicine only- (...)
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Section 52A(2)- Every person who is engaged in the wholesale dealing of medicines shall keep a
record of –
(a) every quantity of a medicine –
(i) acquired by him;
(ii) supplied by him;
(b) in respect of each acquisition and disposal of a medicine—
(i) details of the quantity;
(ii) the date of the transaction;
(iii) the supplier;
(iv) the person to whom the medicine is supplied;
(v) the batch number of such medicine;
(vi) the expiry date of the medicine; Return of medicines three months before expiry Section 56. (1) Any person who practises or carries on the business of a pharmacist or dispenses
any medicines may, where a medicine is due to expire, return such medicine not less than
three months before the expiry date of such medicine to the manufacturer, agent or
distributor, as the case may be:
Provided that a person shall return such medicine in its original unbroken package, as sealed
by the manufacturer. Section 57 Return of expired medicines
57. (1) Any person who practises or carries on the business of a pharmacist or dispenses
any medicine shall, where a medicine has expired –
(a) return such expired medicine to the manufacturer, agent or distributor, as the case
may be; or
(b) keep a record or cause a record to be kept of such returned expired medicine; and
(c) send a copy of such record to the Director-General. Disposal of existing stocks
Section 104. If at any time any medicine becomes a prohibited or specially restricted medicine, any person other than a person to whom a medicine is lawfully dispensed who is in possession of such medicine at the time shall inform the Authority of his possession and shall dispose of such medicine in such manner as the Authority may direct.
Section 19 (2) (b)Every person who is engaged in the wholesale dealing
of complementary medicines shall keep a record of-[…]
(b) in respect of each acquisition and disposal of a complementary medicine-
(i) details of the quantity;
(ii) the date of the transaction;
(iii) the name and address of the supplier;
(iv) the name and address of the person to whom the complementary medicine is supplied;
( v) the batch number of such complementary medicine;
(vi) the expiry date of the complementary medicine.
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Section 106. Any person who contravenes the provisions of these regulations, other than a provision for the contravention of which a penalty is provided by subsection (3) of section 38 or subsection (2a) of section 39 of the Act, shall be guilty of an offence and liable to a fine not exceeding level seven or to imprisonment for a period not exceeding six months or to both such fine and such imprisonment.
Section 27 (3) Any person who contravenes subsection (I) shall be guilty of an offence and liable to a fine not exceeding level seven or to imprisonment for a period not exceeding six months or to both such fine and such imprisonment.