BWA- QC – LICENSING
ANIMAL HEALTH
Botswana / Animal health
VETERINARY MEDICINAL PRODUCTS (VMPs)
LICENSING
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1 answer
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Section 26:
(1) No person shall practise as a pharmacist or operate a pharmacy or a dispensary on any premises
unless-
(a) the person has applied for and been issued with a licence in respect of the said premises for operating the pharmacy or dispensary;
(b) the premises, in the case of a pharmacy, are under the continuous supervision of a pharmacist; and
(c) in the case of a dispensary, the person is authorised in writing by the Director of Health Services or the Director of Veterinary Services as the case may be, to dispense.
(2) An application for a licence under subsection (1) shall be made by a pharmacist who is resident in Botswana, and shall be made in the prescribed form and accompanied by the prescribed fee.
(3) The retailing of Schedule 3 medicine, shall be through a pharmacy duly licensed as such under this Act.
(4) A person who contravenes the provisions of this section commits an offence and is liable to a fine not exceeding P15 000, or to imprisonment for a term not exceeding three years, or to both.
(5) Where the Authority is of the view that a pharmacy or dispensary is not being operated in accordance with good professional standards, the Authority may, in writing, suspend the licence issued in terms of subsection (2) pending compliance with any directions the Authority considers necessary, or cancel the licence where the non-compliance continues.
(6) Where a licence is cancelled under subsection (5), the licence holder shall dispose of the stock within six months and in a manner approved by the Authority.
(7) Where there is a change in the ownership of a pharmacy, the owner shall notify the Authority as
soon as is practicable after the change of ownership.
Section 27 (extract):
(1) The manufacture of medicine may only be undertaken in an establishment licensed by the Authority.
(2) A person who wishes to manufacture medicines shall apply in the prescribed form and pay the prescribed fee to the Authority, and shall supply any further information which the Authority may require to satisfy itself that the premises to be used are suitable for the purpose and will be operated in accordance with standards of good practice in the manufacture and quality control of medicines.
(3) The manufacture of medicines shall be under the continuous supervisory control of a registered pharmacist who possesses such practical experience as the Authority may prescribe.
(4) Where the Authority is satisfied that the conditions of any licence are not being observed, or that the manufacture of any medicine is not being carried out in accordance with the provisions of this Act or standards of good practice in the manufacture and quality control of medicines, the Authority may, after
notice in writing to the licence holder, cancel the licence issued under this section.
(5) Where the Authority cancels a licence in terms of subsection (4), the licence holder shall cease all manufacturing
1 answer
document title
text/abstract
Section 26:
(4) A person who contravenes the provisions of this section commits an offence and is liable to a fine not exceeding P15 000, or to imprisonment for a term not exceeding three years, or to both.
(5) Where the Authority is of the view that a pharmacy or dispensary is not being operated in accordance with good professional standards, the Authority may, in writing, suspend the licence issued in terms of subsection (2) pending compliance with any directions the Authority considers necessary, or cancel the licence where the non-compliance continues.
(6) Where a licence is cancelled under subsection (5), the licence holder shall dispose of the stock within six months and in a manner approved by the Authority.
Section 27 (extract):
(4) Where the Authority is satisfied that the conditions of any licence are not being observed, or that the manufacture of any medicine is not being carried out in accordance with the provisions of this Act or standards of good practice in the manufacture and quality control of medicines, the Authority may, after notice in writing to the licence holder, cancel the licence issued under this section.
(5) Where the Authority cancels a licence in terms of subsection (4), the licence holder shall cease all manufacturing.