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No. S 548

Medicines Act

(CHAPTER 176)

Medicines (Medical Advertisements)
(Amendment) Regulations 2016

In exercise of the powers conferred by section 52 of the Medicines Act, the Minister for Health makes the following Regulations:

Citation and commencement

1. These Regulations are the Medicines (Medical Advertisements) (Amendment) Regulations 2016 and come into operation on 1 November 2016.

Deletion and substitution of regulation 2

2. Regulation 2 of the Medicines (Medical Advertisements) Regulations (Rg 2) (called in these Regulations the principal Regulations) is deleted and the following regulation substituted therefor:

“Definitions

2. In these Regulations —

“grant”, in relation to a permit from the licensing authority, includes a renewal of the permit;

“medical advertisement” means any advertisement of a medicinal product, but does not include any advertisement mentioned in section 51(1)(a) or (b) or (2) of the Act;

“sales promotion” means any medical advertisement in the form of —

(a)	a sales campaign (including door-to-door sales and price discounts);
(b)	an exhibition;
(c)	a competition; or
(d)	any other activity meant to introduce, publicise or raise the profile, public awareness or visibility of, the medicinal product.”.

Amendment of regulation 4

3. Regulation 4 of the principal Regulations is amended by inserting, immediately after the words “application for”, the words “, or to renew,”.

Amendment of regulation 8

4. Regulation 8 of the principal Regulations is amended by inserting, immediately after the words “medical advertisement”, the words “that is not a sales promotion”.

Deletion of regulation 9

5. Regulation 9 of the principal Regulations is deleted.

Deletion and substitution of regulation 10

6. Regulation 10 of the principal Regulations is deleted and the following regulation substituted therefor:

“Exception for trade, business or profession

10. Regulation 3 does not apply to any medical advertisement that —

(a)	is directed exclusively at a person who may lawfully sell or supply any medicinal product in the course of that person’s trade, business or profession; and
(b)	is not accessible to the general public.”.

Amendment of regulation 11

7. Regulation 11 of the principal Regulations is amended by deleting paragraph (2) and substituting the following paragraph:

“(2) In this regulation —

“reference advertisement” means an advertisement —

(a)	containing a brief description of a medicinal product, its use, or any contra-indications or warnings relating to the medicinal product; and
(b)	appearing without charge in a publication consisting mainly of such advertisements where the publication is sent or delivered to practitioners or pharmacists by a person who is not involved in the sale of or dealings in that medicinal product as a manufacturer, supplier, retailer, importer or exporter;

“trade advertisement” means an advertisement, relating to a medicinal product, that —

(a)	is in a catalogue, price list or other document for the purpose of supplying the medicinal product by wholesale; and
(b)	does not contain any recommendation relating to the use of the medicinal product other than as part of the name of the medicinal product or part of any heading or sub‑heading indicating a therapeutic classification.”.

Deletion and substitution of regulation 12

8. Regulation 12 of the principal Regulations is deleted and the following regulation substituted therefor:

“Permit number

12. A person who issues or publishes any medical advertisement (including conducting a sales promotion) must ensure that the number of the permit granted in respect of the medical advertisement is displayed on, or on material accompanying, the medical advertisement in accordance with such terms and conditions as the licensing authority may specify in the permit.”.

Amendment of regulation 13

9. Regulation 13 of the principal Regulations is amended by deleting the words “No person shall alter or amend” and substituting the words “A person must not alter or amend the contents of”.

Amendment of regulation 14

10. Regulation 14(1) of the principal Regulations is amended by inserting, immediately after the words “a permit” in sub‑paragraph (b), the words “or the renewal of a permit”.

Amendment of regulation 15

11. Regulation 15 of the principal Regulations is amended by deleting “9,”.

Deletion and substitution of Schedule

12. The Schedule to the principal Regulations is deleted and the following Schedule substituted therefor:

“THE SCHEDULE

Regulation 14(1)

fees

Application fee for a permit for —

(a)	a medical advertisement using light and sound projection

$200

(b)	any other medical advertisement that is not a sales promotion

$100

Application fee for a permit for a sales promotion, in addition to the fee in item 1, if any

$100

Fee for a permit, for the first year, for —

(a)	a medical advertisement using light and sound projection

$100

(b)	any other medical advertisement that is not a sales promotion

$100

Fee for a permit, for the first year, of a sales promotion, in addition to the fee in item 3, if any

$100

Fee for the renewal of a permit, for each subsequent year, for —

(a)	a medical advertisement using light and sound projection

$300

(b)	any other medical advertisement that is not a sales promotion

$200

Fee for the renewal of a permit, for each subsequent year, for a sales promotion, in addition to the fee in item 5, if any

$200

Fee for an application to amend a permit

$50

”.

[G.N. Nos. S 679/2005; S 27/2007]

Made on 31 October 2016.

AUBECK KAM

Permanent Secretary,
Ministry of Health,
Singapore.

[HSA/LPPD/711:12/12-001; AG/LEGIS/SL/176/2015/10 Vol. 1]