Importance of Regulations for Advertising Medicines and Medical Devices

Healthcare regulations safeguard public health by ensuring accurate information and ethical marketing. They prevent misleading claims, promote responsible advertising, and require scientific evidence for product claims. This empowers patients with reliable information and protects them from misuse of medications. Regulations also ensure fair competition within the industry.

1. Which laws apply when it comes to promoting medicines and medical devices?

1.1 Medicines

Medicines Act 1975
Medicines (Medical Advertisement) Regulations
Health Products Act 2007
Health Products (Advertisement of Specified Health Products) Regulations

1.2 Medical Devices

Health Products Act 2007
Health Products (Medical Devices) Regulations

2. Are there any additional legislative frameworks or self-regulatory codes of conduct?

Singapore Code of Advertising Practice: Regulates advertising across industries.
HSA Guidance Documents, including:
- Guide on Advertisements and Sales Promotion of Medicinal Products
- Explanatory Guidance to the Health Products (Advertisement of Specified Health Products) Regulations 2016
- Guidance for Licensees under the Private Hospitals and Medical Clinics Act and Healthcare Services Act

These codes and guidelines provide clarificatory and guiding principles.

3. What licenses, approvals, or fees are required for advertising?

3.1 Medicines

Therapeutic Products (TPs): No prior approval needed; must comply with relevant acts and regulations.

Medicinal Products (MPs): Prior approval from HSA is required. Advertising permits are valid for one year.

Application Type	Application Fee	Permit Fee (First Year)	Permit Fee (Subsequent Year)
Still Media Advertisement	$106	$106	$212
Sound Media Advertisement	$106	$106	$212
Light and Sound Media Advertisement	$212	$106	$318
Sales Promotion	$106	$106	$212
Amend a Permit	$54	N.A.	N.A.
Transfer of Advertisement or Sales Promotion Permit	$17	N.A.	N.A.

3.2 Medical Devices

No prior approval is required. Advertisements must comply with the Health Products Act and relevant regulations.

4. Difference between prescription-only and over-the-counter medicines

Prescription-only Medicines: Cannot be advertised to the general public. Advertising in public places is prohibited.
Over-the-counter Medicines: May be advertised to the general public if they comply with applicable laws and regulations.

5. Primary limits on promoting drugs and medical devices to the public

Therapeutic Products (TPs)

Advertisements must not be false or misleading
Must not prompt self-diagnosis or self-treatment of serious diseases
Must not encourage inappropriate or excessive use
Must not evoke fear, alarm, or distress or exploit lack of knowledge

Medical Devices

Advertisements must not convey false information
Must not create misconceptions regarding components, specifications, quality, safety, efficacy, or uses
Must not prompt self-diagnosis or self-treatment of serious diseases

6. Primary limits on promoting drugs and medical devices to healthcare professionals

Healthcare Professionals Defined

Qualified practitioners
Registered pharmacists
Enrolled nurses
Registered nurses and registered midwives
Persons undergoing training for the above professions

Advertising Limitations

Advertisements must not be freely accessible to the general public
Materials on unregistered products or unapproved uses may only be shared at:
- Pharmaceutical trade fairs or exhibitions
- Scientific conferences or forums
- Events closed to the general public

7. Required information for advertisements directed to healthcare professionals

All statements, assertions, certifications, awards, or distinctive features must be supported by factual evidence.

For medicines, any distinguishing claims must be substantiated with verifiable evidence.

For medical devices, claims of uniqueness, superiority, certifications, awards, or historical use must include identifying details such as certifying body, dates, and outcome evidence.

All evidentiary information must be clearly presented within the advertisement itself.

8. Information required in public-facing advertisements

The requirements set out in Section 7 above apply equally to public-facing advertisements.

9. Constraints on data supporting promotional claims

Medical Devices: Scientific data must not exploit public ignorance or misuse research results.
Medicines: Advertisements must not exploit consumers’ lack of knowledge.

10. Rules governing comparative advertising

Medicines

Advertisements must not compare a therapeutic product with any other named product or brand. Comparisons within the same brand by the same company are permitted.

Medical Devices

Comparative statements must not mislead or unfairly denigrate other products or sectors.

11. Advertising on the internet and social media

All digital and social media advertising must comply with the Health Products Act and relevant regulations.

12. Oversight bodies and legal consequences

Regulatory Authority

The Health Sciences Authority (HSA) oversees compliance with advertising regulations.

Enforcement Actions

Immediate cessation of advertisements
Removal of published advertisements
Issuance of corrective advertisements

Penalties

False or misleading advertising: Fine up to $20,000, imprisonment up to 12 months, or both
Advertising non-health products as health products: Fine up to $20,000, imprisonment up to 12 months, or both

13. Future developments in Singapore

No future developments are currently envisaged regarding the advertising of medicines and medical devices in Singapore.

How can OMC help?

Professional review of marketing and advertising materials with reports
Services to obtain authority approvals where required
Translation of marketing materials by an ISO 17100 certified professional translation agency