Pursuant to section 105 of the Medicines Act 1981, Her Excellency the Governor-General, acting on the advice of the Minister of Health tendered after consultation with the organisations or bodies appearing to the Minister to be representative of persons likely to be substantially affected, and acting on the advice and with the consent of the Executive Council, makes the following regulations.

Preamble

1 Title

2 Commencement

3 Principal regulations amended

4 Application for licence to operate pharmacy

5 Fees

6 New Schedule 5A inserted

Schedule
New Schedule 5A inserted

1 Title

These regulations are the Medicines (Fees) Amendment Regulations 2006.

2 Commencement

These regulations come into force on 21 August 2006.

3 Principal regulations amended

These regulations amend the Medicines Regulations 1984.

4 Application for licence to operate pharmacy

Regulation 45A(1)(b) is amended by revoking subparagraph (i) and substituting the following subparagraph:
- “(i) the appropriate fee prescribed in Schedule 5A; and”.

5 Fees

(1) Regulation 61 is amended by revoking subclause (1) and substituting the following subclause:
- “(1) The licence fees set out in Schedule 5A are payable for the licences to which they relate.”
(2) Regulation 61(3) is amended by omitting “$15,300” and substituting “$122,625”.

(3) Regulation 61(4) is amended by omitting “$7, 800” and substituting “$43,875”.

(4) Regulation 61(6) is amended by omitting “$5,000” and substituting “$8,437”.

(5) Regulation 61(7) is amended by omitting “$1,600” and substituting “$3,200”.

(6) Regulation 61(8) is amended by omitting “$2,800” and substituting “$9,843”.

6 New Schedule 5A inserted

The Schedule 5A set out in the Schedule of these regulations is inserted after Schedule 5.

r 6

Schedule 5A
Licence fees

rr 45A(1)(b)(i), 61(1)

$

1 An application for a licence to manufacture medicines 13,750

2 An application for a licence to pack medicines 845

3 An application for a licence to sell medicines by retail 845

4 An application for a licence to sell medicines by wholesale 1,054

5 An application for a licence to hawk medicines 845

6 An application for a combined licence to pack, and to sell by retail, medicines 300

7 An application for a licence to operate a pharmacy 1,030

Diane Morcom,

Clerk of the Executive Council.

Explanatory note

This note is not part of the regulations, but is intended to indicate their general effect.

These regulations, which come into force on 21 August 2006, increase fees currently prescribed in regulations 45A and 61 of the Medicines Regulations 1984. These fees are payable under the Medicines Act 1981 for an application for a consent under section 20:

•an application for a consent under section 23:
•a notice deposited under section 24:
•an application for an approval under section 30:
•an application for a licence under section 50.

Issued under the authority of the Acts and Regulations Publication Act 1989.

Date of notification in Gazette: 20 July 2006.

Medicines (Fees) Amendment Regulations 2006