BWA- QG – IMPORT
ANIMAL HEALTH
Botswana / Animal health
VETERINARY MEDICINAL PRODUCTS (VMPs)
IMPORT
questions
2 answers
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Regulation 26 (extract):
(1) A person shall apply to the Authority for a permit to import medicines, medical products […] in Form 10 set out in Schedule 4 and accompanied by a fee set out in Schedule 5.
Section 28 (extract):
(1) No person shall import, export, distribute or sell medicines except in accordance with a licence issued for the import, export, distribution or sale of medicines in terms of this Act.
(2) A person who wishes to import, export, distribute or sell medicines shall apply to the Authority, in the prescribed form accompanied by such fee as may be prescribed and such information as the Authority may require.
1 answer
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Section 28 (extract):
(4) The import, export, distribution or sale of medicines in terms of this section shall be under the continuous supervisory control of a pharmacist, or veterinary surgeon.
2 answers
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Section 154:
The Director may provide for the inspection, sampling and examination of vaccines, vaccine lymph, sera, toxins, anti-toxins, antigens, insulin, and other therapeutic substance as may be defined by regulations, imported into, or manufactured in Botswana, and intended or used for the prevention or treatment of human or animal diseases, and (a) shall regulate their sale or supply;
(b) prohibit their sale or supply; and
(c) prohibit the importation, manufacture, sale or use of the substance which is considered to be unsafe or to be liable to be harmful or dangerous to health.
Regulation 5:
Any officer whose normal duty it is to conduct inspection under the Act shall, on arrival at the premises of any importer, manufacturer or any other person on routine inspection duties, declare his official capacity and purpose and produce the authority issued to him by the Director to conduct such inspection, but the provisions of this regulation shall not apply in circumstances which the Director considers exceptional.
Regulation 72:
Every importer, exporter, manufacturer or owner of any goods shall, whenever required to
do so by the proper officer, convey without delay any package selected for examination to
any place approved or indicated by the proper officer for such examination and shall ensure
that such package is opened and unpacked and at any time indicated by the proper officer.
2 answers
document title
text/abstract
Section 154:
The Director may provide for the inspection, sampling and examination of vaccines, vaccine lymph, sera, toxins, anti-toxins, antigens, insulin, and other therapeutic substance as may be defined by regulations, imported into, or manufactured in Botswana, and intended or used for the prevention or treatment of human or animal diseases, and (a) shall regulate their sale or supply;
(b) prohibit their sale or supply; and
(c) prohibit the importation, manufacture, sale or use of the substance which is considered to be unsafe or to be liable to be harmful or dangerous to health.
Section 106 (extract):
(1) The Commissioner General may at any time for the safe
guarding of public health or for the safety of the public, and at the expense and risk of the importer, exporter, owner or pilot concerned, as the Commissioner General may determine —
(a) cause any goods under excise control forthwith to be destroyed or otherwise disposed of;
1 answer
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Section 28 (extract):
(6) A person who contravenes the provisions of this section commits an offence and is liable-
(a) in the case of importing, exporting or selling medicine to a fine not exceeding P100 000, or to imprisonment for a term not exceeding 10 years, or to both; or
(b) in the case of import, export, distribution, or selling medicine, dispensing or keeping in storage contrary to such conditions as may be prescribed, any medicine after the date of expiry indicated on the package of the medicine, to a fine not exceeding P100 000, or to imprisonment for
term not exceeding 10 years, or to both.
Section 66:
(1) A person who contravenes the provisions of this Act or who-
[...]
(b) obstructs or fails to comply with any reasonable request by the Authority, in the exercise of its functions under this Act;
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(2) Any person who imports, exports, manufactures, distributes, sells, dispenses, prescribes or advertises any medicine or other substance falsely purporting to be, or intended to or likely to induce anyone to a mistaken belief that it is a registered medicine, commits an offence and is liable to a fine of P100 000, or to imprisonment for 10 years, or to both.
(3) Where any person is convicted of an offence under this Act or any regulation made under it, the court may, at the request of the Authority, order any medicine or other substance in respect of which the offence was committed to be seized and disposed of as the Authority may require, and the Authority may at the same time withdraw any approval or authorisation previously given by the Authority to that person.