STUDY UNIT 6.1

Question 1

REGISTRATION OF MEDICINE:

Answer 1

Medicine registration is valid for 5 years.

Question 2

WHAT IS A “MEDICINE”?

Answer 2

Medicine means any substance or mixture of substances used or purporting to be suitable for use or manufactured or sold for use in
a. the diagnosis, treatment, mitigation or modification or prevention of disease, abnormal physical or mental state, or the symptoms thereof in humans, or
-restoring, correcting or modifying any somatic or organic function in humans, and
b. includes any veterinary medicine.

Question 3

WHAT IS A “SCHEDULED SUBSTANCE”?

Answer 3

a scheduled substance is any medicine or other substance which is prescribed by the Minister of Health under s22A of the MRSA
-schedules 0-8
-medicines are subject to a scheduling process on the basis of the substances they contain.
-the primary consideration in scheduling a substance is its safety profile, in relation to the therapeutic indications of its use.

Question 4

WHAT IS AN “IVD”?

Answer 4

An IVD is a medical device, whether used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human body solely to provide information for diagnostic, monitoring, or compatibility purposes.

Question 5

FUNCTIONS OF SAHPRA IN s2B of MRSA:

Answer 5

1. ensure efficient, effective and ethical evaluation and registration of medicines, scheduled substances, medical devices or IVDs
2. periodic re-evaluation and monitoring of medicines, medical devices or IVDs
3. ensure that compliance with existing legislation is being promoted
4. liase with any other regulatory authority on matters of common interest.