Part iii: Licensing

Question 1

Pharmaceutical operations licensing application

Answer 1

An application for licensing of pharmaceutical operations shall be submitted to the Authority, in Form 8 set out in Schedule 4 accompanied by an application fee set out in Schedule 5.

Question 2

License issuance conditions

Answer 2

The Authority may […] grant the applicant a licence in Form 9 set out in Schedule 4 and the Authority may attach conditions thereto as it may consider necessary.

Question 3

Premises supervision requirement

Answer 3

Where premises are licensed, the premises shall be under the supervision of a qualified person in line with the guidelines.

Question 4

Manufacturing facility license application

Answer 4

An applicant may apply to the Authority for a licence to manufacture medicine in Form 8 set out in Schedule 4 accompanied by an application fee set out in Schedule 5.

Question 5

Pharmacy license application

Answer 5

An application for a licence to operate a pharmacy shall be made to the Authority in Form 8 set out in Schedule 4 and accompanied by a fee set out in Schedule 5.

Question 6

Pharmaceutical wholesaler license application

Answer 6

An application for a licence to operate a pharmaceutical wholesaler shall be made to the Authority in Form 8 set out in Schedule 4 and accompanied by a fee set out in Schedule 5.

Question 7

Group practice pharmacy license conditions

Answer 7

(2) […] the licence may be under that of a hospital or a pharmacy where the pharmacy services are outsourced.

(3) The Authority shall issue a licence in Form 9 […] subject to submission of a licence or provisional licence of a hospital or a group practice.

Question 8

Institutional dispensary license requirements

Answer 8

Where the institutions are required to be licensed by other authorities, the Authority shall issue a licence in Form 9 […] subject to submission of a licence or provisional licence of a surgery or an institution.

Question 9

License variation application

Answer 9

(1) A licence holder shall apply to the Authority for variation of his or her licence.

(2) The application for variation shall be in Form 8 […] accompanied by a fee set out in Schedule 5.

Question 10

License suspension/withdrawal procedures

Answer 10

(1) Where the licence holder does not meet the required standards […] the Authority may suspend or withdraw the licence.
(2) The Authority shall notify the licence holder […] and give […] seven days to respond.
(3) The facility shall be closed for the duration of the suspension.
(4) Where a licence is withdrawn the facility shall cease to operate

Question 11

License renewal requirements

Answer 11

(1) An application […] shall be made at least three months before expiry […]

(2) The application shall be in Form 8 […] and […] in accordance with the guidelines.

(3) The application shall be accompanied by a fee set out in Schedule 5