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

Regulations

General Regulations

Investigations, Offences and Penalties

53. Compliance with requirements

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(1)Every medicine must continue to comply with the standards and specifications which were furnished to the Authority and which have been accepted by the Authority with regard to such medicine.

 

(2)Any proposed deviation from accepted standards and specifications referred to in subregulation (1) must be submitted to the Authority for prior approval as determined by the Authority and such deviation must not be introduced before the said approval has been granted.