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

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(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.