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.
Statistics Act, 1999
