Intellectual Property Rights from Publicly Financed Research and
R 385
Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsGeneral RegulationsPermits, Licensing and Authorisation25. 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. |
