VETERINARY MEDICINAL PRODUCTS (VMPs)
EXPORT
Does the law require all prospective exporters to be registered with or authorized by the competent authority?
1 answer
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.
Does the law require a prospective exporter of VMPs to acquire an export permit for each shipment?
1 answer
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.
Does the law require that shipments must be made available for inspection prior to export, if deemed appropriate by the competent authority?
1 answer
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.
Does the law prescribe a timeframe within which shipments must leave the country after inspection?
0 answer
Which kind of sanctions are imposed in case of offences (criminal, administrative) related to VMP export regulations?
1 answer
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-
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(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.
