Part I: Preliminary

Question 1

Active Pharmaceutical Ingredients (APIs)

Answer 1

Any substance or combination of substances used in a finished pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological functions in human beings

Question 2

Authorised person

Answer 2

Any person given the responsibility for ensuring the medicines’ requirements are in compliance with the laws and regulations in force in Botswana.

Question 3

Bonded warehouse

Answer 3

A warehouse where goods are stored and held before being cleared to enter the country and these may also be used to store goods in transit.

Question 4

Complementary medicines

Answer 4

A labelled substance or mixture of substances manufactured, sold or represented for use as adjuvants to conventional therapy in

(a) the mitigation or prevention of an abnormal physical state; or

(b) restoring, correcting or modifying physical, mental or organic functions in humans,
and originate from plant, mineral, animal including microorganisms, homeopathic preparations, nutritional substances in accepted pharmaceutical dosage forms, a combination of the above or any other such preparations as may be approved by the Authority.

Question 5

Guidelines

Answer 5

Documents outlining regulatory requirements applied by the Authority in line with these Regulations as listed in Schedule 6.

Question 6

Notification

Answer 6

Changes that could have minimal or no adverse effects on the overall safety, efficacy and quality of the Finished Pharmaceutical Product (FPP).

Question 7

Parallel importation

Answer 7

Cross-border importation of a medicine or a product registered by the Authority, without the consent of the patentee, where the medicine has been put on the market by the patentee or by another acting with the patentee’s consent, or having an economic tie to the patentee.

Question 8

Qualified person

Answer 8

A person registered with the relevant professional body to undertake work or practise within a specific technical field or area meeting the minimum requirements in the guidelines.

Question 9

Variations

Answer 9

(a) major variations which are changes that could have major effects on the overall safety, efficacy and quality of the FPP;

(b) minor variations which are changes that may have minor effects on the overall safety, efficacy and quality of the FPP.