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

Regulations

General Regulations

Supply of Medicines

6. Importation of medicines into Republic

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(1)No person shall import any medicine or scheduled substance, including medicines imported in terms of section 15C of the Act, into the Republic except through one of the following ports of entry:
(a)Cape Town International Airport or harbour;
(b)Port Elizabeth International Airport or harbour;
(c)King Shaka International Airport or Durban harbour; and
(d)O.R. Tambo International Airport.

 

(2)A person shall only import a medicine or scheduled substance if such person—
(a)is licensed in terms of the Act to import medicines; and
(b)in the case of unregistered medicines, is authorised by the Authority to import such unregistered medicines.

 

(3)An application for authorisation referred to in subregulation (2)(b) shall contain at least the following information:
(a)Name and address (both physical and postal) of the applicant;
(b)designation of the person representing the applicant;
(c)contact details of the applicant including the—
(i)telephone number; and
(ii)facsimile number or email address;
(d)the name of the medicine being imported;
(e)the quantity of medicine being imported;
(f)the batch number of the medicine being imported; and
(g)the expiry date of the medicine.