Medicines (Licensing, Standard Provisions and Fees) Regulations

Medicines Act

(CHAPTER 176, Section 74)

Rg 6

G.N. No. S 174/1987

REVISED EDITION 1990

(25th March 1992)

[30th June 1987]

Citation

1. These Regulations may be cited as the Medicines (Licensing, Standard Provisions and Fees) Regulations.

Standard provisions for licences

2. The standard provisions for licences (including provisional licences) to be granted under Part II of the Act shall be the following:

(a)	for product licences, those provisions set out in the First Schedule;
(b)	for import licences, those provisions set out in the Second Schedule;
(c)	for wholesale dealer’s licences, those provisions set out in the Third Schedule; and
(d)	for manufacturer’s licences, those provisions set out in the Fourth Schedule.

Ordinary and provisional product licences; import licences

3.—(1) An ordinary product licence shall be granted for a period of 5 years.

(2) A provisional product licence, a wholesale dealer’s licence and a manufacturer’s licence shall be granted for a period of 3 years or such shorter period as the licensing authority may determine.

(3) An import licence shall be granted to any person authorised by the holder of a product licence for a period of 3 years and to any other person on a per consignment basis.

Fees

4.—(1) The fees for licences and certificates granted by the licensing authority and for any variations or amendments thereof shall be as set out in the Fifth Schedule.

(2) No refund shall be made in respect of any fees paid under these Regulations.

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