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

Regulations

General Regulations

Investigations, Offences and Penalties

50. Method of taking samples, certificate to be issued and reporting of analysis results

 

(1) An inspector may take a sample or any quantity of samples of a medicine or Scheduled substance for purposes of testing, examination or analysis in terms of the Act by a person designated as an analyst, pharmacologist or pathologist.

 

(2) The sample or samples contemplated in subregulation (1) shall—
(a) be taken in the presence of the person who is in charge of such medicine or substance, or in the absence of such person, in the presence of any witness present;
(b) be taken, transported and stored in such a manner as to ensure its integrity during the entire examination process of the sample; and
(c) be packed and sealed and suitably labelled or marked in such a manner as its nature may permit;
(d) be transmitted by any suitable means to an analyst, pharmacologist or pathologist; and
(e) be accompanied with the certificate signed by the inspector, a copy of which shall be issued to the person contemplated in paragraph (a) by the inspector at the earliest possible time.

 

(3) An analyst, pharmacologist or pathologist referred to in subregulation (1) shall, as soon as possible after receipt of the sample, test, examine or analyse the sample and report the results thereof to the Authority.

 

(4) An inspector referred to in subregulation (1), may take a sample during a routine inspection from a manufacturer, a wholesaler or retailer for testing, examination or analysis in terms of these regulations.

 

(5) Notwithstanding subregulation (1), the Authority may require any holder of a certification of registration to supply the Authority with a sample of a particular medicine or substance in order to test, examine or analyse such sample.

 

(6) Certificates or reports issued in terms of this regulation shall be submitted to the Chief Executive Officer within 7 days from the date of issue.