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Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)

Regulations

General Regulations

Permits, Licensing and Authorisation

25. Exemption in terms of section 22H

 

(1) A wholesaler desiring to buy medicines from another wholesaler shall apply to the Director-General for an exemption referred to in section 22H(3) of the Act.

 

(2) An application referred to in subregulation (1) shall contain at least the following information:
(a) Name and address (both physical and postal) of applicant;
(b) name of the designated person;
(c) the name and quantity of the medicines, to be bought;
(d) source of supply; and
(e) the reason for sourcing the medicine from another wholesaler.

 

(3) The Director -General may grant an exemption referred to in subregulation (1): Provided that such exemption is limited for a specific period of time as may be determined by the Director-General and—
(a) it is intended to improve the availability of any medicine, Scheduled substance, medical device or IVD; and
(b) is in the public interest.