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

Regulations

General Regulations

Investigations, Offences and Penalties

52. Offences and Penalties

 

Any person who fails to comply with, contravenes the provisions of or furnishes incorrect information, as the case may be, in respect of—

(a) regulation 5(1)(c) or (d) with regard to the parallel importation of medicines;
(b) regulations 6 or 7 with regard to the importation or transmission of medicines;
(c) regulation 8 with regard to the possession of specified quantities of Schedule substances for personal medicinal use by persons entering the Republic;
(d) regulation 10 with regard to the labelling of medicines for human use;
(e) regulation 11 with regard to the professional information to be provided;
(f) regulation 12 with regard to the patient information leaflet;
(g) regulation 13 with regard to the labelling of veterinary medicines;
(h) regulation 14 with regard to the professional information for veterinary medicines;
(i) regulation 22 with regard to the licence to dispense, or compound and dispense medicines;
(j) regulation 23 with regard to the licence to manufacture, import or export act as a wholesaler or distribute medicines or Scheduled substances;
(k) regulation 26 with regard to the permits or authorisation issued in terms of section 22A of the Act;
(I) regulation 27 with regard to the importation or exportation of specified Schedule 5, Schedule 6, Schedule 7 or Schedule 8 substances;
(m) regulation 28 with regard to the information to be furnished annually to the Director-General by the holder of a permit to import or export specified Schedule 5, Schedules 6, 7 or 8 substances;
(n) regulation 29 with regard to authorisation of sale of unregistered medicine for certain purposes;
(o) regulation 30 with regard to the conduct of clinical trials;
(p) regulation 33 or 34 with regard to the particulars which must appear on a prescription or order for medicine;
(q) regulation 35 with regard to the prescription book or permanent record;
(r) regulation 36 with regard to the register for specified Schedule 5 and 6 medicines;
(s) regulation 37 with regard to the returns to be furnished in respect of specified Schedule 5, Schedules 6, 7 and 8 medicines and specified substances;
(t) regulation 39 with regard to the repackaging of medicines;
(u) regulation 42 with regard to the advertising of medicines or Scheduled substances;
(v) regulation 44 with regard to the destruction of medicines or Scheduled substances; or
(w) sells a medicine that has expired,

shall be guilty of an offence and upon conviction be liable to a fine or to imprisonment for a period not exceeding 10 years.

 

 


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