Part ii: Medicines

Question 1

Application for medicine registration

Answer 1

An application for registration of medicine shall be in Form 1 set out in Schedule 4 and shall be accompanied by —

(a) an application fee set out in Schedule 5;

(b) the Common Technical Document in Form 2 set out in Schedule 4; and

(c) a sample as described in the guidelines.

Question 2

Authority’s registration conditions

Answer 2

The Authority shall specify conditions for registration […] and may —
(a) amend any conditions for registration;
(b) specify product labelling requirements; or
(c) determine what is to be described in the label or packages of medicines.

Question 3

Registration validity period

Answer 3

A registration certificate […] shall be valid for five years subject to annual submission of information accompanied by a fee set out in Schedule 5.

Question 4

Renewal application requirements

Answer 4

An application […] shall be —
(a) in Form 1 set out in Schedule 4;
(b) accompanied by a renewal fee set out in Schedule 5; and
(c) submitted […] not later than six months before the expiry date.

Question 5

Personal-use import exemption

Answer 5

A medical practitioner may apply in Form 4 […] to exempt the registration of medicines from outside Botswana, for his or her patient’s personal use.

Question 6

Personal import limits

Answer 6

(1) A person […] for personal use shall not import more than one month’s supply […]
(2) […] where a person brings more than one month’s supply, but less than three months’ supply, he or she shall produce […] a certified copy of the prescription.

Question 7

Wholesale exemption conditions

Answer 7

The application shall —
(a) comply with the guidelines; and
(b) be accompanied by the application fee in Form 5 set out in Schedule 5.

Question 8

Variation without approval

Answer 8

A marketing authorisation holder shall not make a variation […] without prior approval […] except where the change is a notification.

Question 9

Recall information requirements

Answer 9

Marketing authorisation holder shall provide:
(a) information on the batches;
(b) recall plan and procedure;
(c) distribution list; and
(d) report of investigation before and after recall

Question 10

Authority recall procedure

Answer 10

Authority shall inform the —
(a) public […] through all possible communication media; and
(b) marketing authorisation holder in writing […] stating reasons

Question 11

Market withdrawal requirements

Answer 11

Marketing authorisation holder shall provide:
(a) information on withdrawal decision;
(b) effective date;
(c) reasons; and
(d) communication plan to prescribers/dispensers.

Question 12

Suspension/revocation conditions

Answer 12

Reasons including —
(a) failure to report adverse reactions;
(b) failure to meet safety/quality/efficacy; or
(c) implementing variations without approval.