| (1) |
A person who has applied for registration of a medicine in terms of section 15 of the Act, a holder of a certificate of registration in respect of a medicine or Scheduled substance, or a holder of a licence in terms of section 22C(1)(b) must inform the Authority, in the manner and within the time frame as determined by the Authority, of any— |
| (a) |
new or existing quality, safety or effectiveness concerns related to any medicine or scheduled substance, including but not limited to adverse drug reactions; and |
| (b) |
risk management activities associated with paragraph (a). |
| (2) |
A person who has applied for registration of a medicine in terms of section 15 of the Act, a holder of a certificate of registration in respect of a medicine or Scheduled substance, or a holder of a licence in terms of section 22C(1)(b) must maintain or have access to records of the reports and case reports referred to in subregulation (1) above. |
| (3) |
A health care provider, veterinarian or any other person should inform the Authority, in the manner as determined by the Authority, of any— |
| (a) |
suspected adverse drug reactions; or |
| (b) |
new or existing safety, quality or effectiveness concerns, |
occurring as a result of the use of any medicine or scheduled substance.
| (4) |
Any person referred to in subregulation (1) must— |
| (a) |
whenever requested by the Authority, conduct a concise critical analysis of the safety, quality or effectiveness of the medicine or Scheduled substance submit the results thereof to the Authority within a specified time frame; |
| (b) |
in the case where, after receipt of the results referred to in paragraph (a), the Authority determines that the medicine or Scheduled substance may not be safe to use, submit to the Authority, if required to do so— |
| (i) |
case reports of all adverse events or suspected or actual adverse drug reactions in respect of the medicine or Scheduled substance; |
| (ii) |
where applicable the usage figures of the medicines or Scheduled substance, as well as periodic safety update reports and performance studies; and |
| (iii) |
any other data as requested by the Authority; and |
| (c) |
keep and maintain or have access to records of the adverse event data in respect of their medicines or Scheduled substances. |
| (5) |
Subregulations (1), (2) and (3) also apply in the case of all categories of unregistered medicines sold or used which are not subject to registration or in terms of sections 14(3), 14(4), 15C, 21 and 36 of the Act. |
| (6) |
Nothing in this regulation shall be interpreted as prohibiting any person from reporting any adverse drug reaction, safety, quality or effectiveness concern related to any medicine or Scheduled substance to the Authority. |
Statistics Act, 1999
