ZWE - QB - REGISTRATION
ANIMAL HEALTH
Zimbabwe / Animal health
VETERINARY MEDICINAL PRODUCTS (VMPs)
REGISTRATION
questions
3 answers
document title
text/abstract
Medicines register: information to be recorded
Section 40. The Director-General shall enter in the register in respect of each medicine registered by the Authority –
(a) the date of the application for registration of the medicine; and
(b) the number allocated to the application for registration; and
(c) the proprietary name (trade mark) of the medicine, if any; and
(d) the housemark of the principal or manufacturer of the medicine, if any; and
(e) the particulars of the patent of the medicine, if any; and
(f) the approved name of the medicine;
Section 27 Medicines Register
(1) Subject to subsection (2), the Director-General shall keep a register, to be known as the Medicines Register, in a form approved by the Minister, in which he shall enter—
(a) the particulars of any medicine which the Authority has directed him to register, including the conditions, if any, subject to which that medicine has been registered;
(b) the cancellation of the registration or variation of the conditions of registration of any medicine in terms of this Act.
(2) The Register shall be in 2 parts as follows—
(a) Part I relating to medicines which are not veterinary medicines;
(b) Part II relating to veterinary medicines.
(3) The Register which, immediately before the 1st October, 1978, was being kept in terms of this section shall, on and after that date, continue to be kept in terms of this section as Part 1 of the Register.
Register of approved complementary medicines
Section 13. The Director-General shall enter in the register of
Complementary Medicines in respect of each complementary medicine
approved by the Authority-
1 answer
document title
text/abstract
Section 29 Sale of specified medicines
(1) Subject to this section, no person shall sell any specified medicine—
(a) unless it is registered; and
(b) if it is registered subject to any conditions, otherwise than in accordance with such conditions.
(1a) Subject to subsections (2) and (3), any person who contravenes subsection (1) shall be guilty of an offence and liable to a fine not exceeding level twelve or to imprisonment for a period not exceeding two years or to both such fine and such imprisonment.
inserted by Act 22 of 2001 with effect from 10 September, 2002
(2) Where a specified medicine which was available for sale in Zimbabwe before it became a specified medicine has not been registered but notification has been published in the Gazette in terms of paragraph (c) of subsection (2) of section thirty-one that application for the registration of that medicine has been made, a person may thereafter sell that specified medicine until notification is published in the Gazette—
(a) in terms of subsection (4) of section thirty-one, that the application for the registration of that medicine has been withdrawn; or
(b) in terms of section thirty-two, that the application for the registration of that medicine has lapsed; or
(c) in terms of subsection (6) of section thirty-three, that the Authority has approved or refused to approve, as the case may be, the registration of that medicine.
(3) Subsection (1) shall not apply in relation to the sale of a medicine compounded by a medical practitioner, pharmacist, dental practitioner or veterinary surgeon if that medicine—
(a) has not been advertised for sale in Zimbabwe; and
(b) does not contain any component the sale of which is prohibited by this Act; and
(c) is supplied for the treatment of a particular person or animal.
0 answer
1 answer
document title
text/abstract
Section 34 Cancellation and variation of conditions of registration
(1) If the Authority is of the opinion that—
(a) any person has failed to comply with the conditions subject to which a medicine has been registered; or
(b) the annual fee payable for the retention of the registration of a registered medicine referred to in paragraph (g) of subsection (2) of section seventy-four has not been paid; or
(c) a registered medicine does not comply with any prescribed requirements; or
(d) a registered medicine has been advertised in Zimbabwe in an advertisement which is false or misleading or does not comply with section forty; or
(e) it is not in the public interest that a registered medicine should be made or continue to be made available to the public; or
(f) it is in the public interest to vary the conditions of registration of a registered medicine; the Authority shall direct the Director-General to give notice thereof in writing to the person by whom or on whose behalf the application for the registration of that medicine was made: Provided that, where the annual fee payable for the retention of the registration of a registered medicine in terms of paragraph (b) has not been paid, the Authority need not direct the Director-General to give notice to the person concerned under this subsection but may direct the Director-General forthwith to cancel the registration concerned
2 answers
document title
text/abstract
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 67 (extract) -
(...) (3) Any person who tampers with any sample taken in terms of this Act, with intent to defraud or to frustrate the proper testing of the sample, shall be guilty of an offence and liable to a fine not exceeding level twelve or to imprisonment for a period not exceeding two years or to both such fine and such imprisonment.
(4) Any person who—
(a) in an application for the registration of any medicine; or
(b) in any statement to the Authority in connection with any medicine; or
(c) in the course of or for the purposes of selling any medicine; or
(d) for the purposes of this Act;
makes any statement which he knows to be misleading or false or which he does not have
reasonable grounds for believing to be true, shall be guilty of an offence and liable to a fine not
exceeding level twelve or to imprisonment for a period not exceeding two years or to both such fine and such imprisonment.
(...)
(8) Any person who sells or for gain uses any medicine manufactured, sold or represented as a
veterinary medicine for the treatment of any person shall be guilty of an offence and liable to a fine not exceeding level ten or to imprisonment for a period not exceeding one year or to both such fine and such imprisonment.