Regulation 25 (extract):
(1) A person dealing with the manufacturing, import, export, storage, distribution, promotion, advertising and dispensing of medicines shall, according to his or her scope of operation, keep a record as outlined in the guidelines.

Section 29 (extract):
(1) An importer, exporter, manufacturer, distributer, dispenser, or user of veterinary medicinal products shall keep, in the prescribed form, records of all transactions or activities relating to the medicines they import, export, manufacture, distribute, dispense, or use.

Regulation 29 (extract):
(1) A presciber, pharmacist and health care proffesional shall report any safety, quality and efficay issues to the Authority and to the marketing authorisation holder in line with the guidelines.

Section 24 (extract):
(5) Where the holder of market authorisation is aware of a safety, efficacy or quality problem which could have detrimental effects on public health, the holder of the market authorisation shall, in consultation with the Authority, recall the medicine or cosmetic.

Section 32:
(1) A person whose medicine has been registered or exempted from registration under this Act shall report to the Authority, in the prescribed manner, any adverse reactions to the medicine.
(2) The following shall be reported to the Authority in the prescribed manner-
(a) any adverse reaction in a human to any registered medicine which report shall be made by the person with respect to whom the registration was granted;
(b) any adverse reaction in an animal to any medicine, which report shall be made by the person who administered the medicine;
(c) any adverse reaction in a human to any veterinary medicine ingested through eating an animal that was treated with a veterinary medicine, or was fed medicated feed; premix;
(d) any adverse reaction in a person to veterinary medicine through the handling of that medicine;
(e) lack of expected efficacy of a veterinary medicine or medicines used in humans, in relation to the indications claimed for the medicine; and
(f) any adverse reaction in an animal to a medicine used for humans where the use of that medicine in animals has been allowed.

Regulation 29 (extract):
(4) The marketing authorisation holders shall remove from the market and dispose at his or her cost, medicines, medical products or cosmetics that do not meet the required standards which disposal shall be in accordance with regulation 34.

Section 24 (extract):
(5) Where the holder of market authorisation is aware of a safety, efficacy or quality problem which could have detrimental effects on public health, the holder of the market authorisation shall, in consultation with the Authority, recall the medicine or cosmetic.

Regulation 29 (extract):
(4) The marketing authorisation holders shall remove from the market and dispose at his or her cost, medicines, medical products or cosmetics that do not meet the required standards which disposal shall be in accordance with regulation 34.