Advertisements and promotions of CTGTP

Advertisers are responsible in ensuring compliance with legislation and guidelines before advertising and promoting cell, tissue and gene therapy products (CTGTP) in Singapore.

Overview

Advertisements of CTGTP do not require prior approval from us. However, you have to ensure that the advertisements comply with the principles and requirements as stated in the Health Products Act (HPA) and the Health Products (Advertisement of Specified Health Products) Regulations.

The CTGTP advertisement must be aligned with the intended uses (indications), as per its registration or notification.

Advertisements refer to any information that can promote the sale or use of the CTGTP. They can be in any forms or media, including but not limited to:

  • Publication in a newspaper, magazine, journal or other periodical.
  • Display of posters or notices.
  • Circulars, brochures, pamphlets, books.
  • Letters addressed to individuals or organisational bodies.
  •  Any other activity intended to introduce, publicise or raise the profile or public awareness or visibility of any CTGTP for the purpose of promoting the sale or use of it.

General requirements

You must adhere to the following general requirements for advertisements of CTGTP. You are not allowed to:

  • Advertise an unregistered or unnotified product.
  • Advertise an unregistered indication of a registered or notified product.
  • Make any false or misleading claims or representations.
  • Make unsubstantiated claims.
  • Make claims that mislead by emphasis, contrast or omission with regard to the safety, quality or efficacy of the product.
  • Make claims that give rise to any unrealistic expectations with regard to the effectiveness of the product.
  • Encourage inappropriate or excessive use.
  • Suggest guaranteed results without side effects.
  • Falsely claim any endorsement by public authority.
  • Include endorsements or recommendations by any healthcare professional or a person of celebrity, social or professional status.
  • Use the names or logos of HSA and any of our professional groups.
  • Offer refunds, in full or partial amounts, to users of the product.

Advertisements of CTGTP directed to the public is prohibited. Hence, these advertisements must not be made available in any public places.

Advertisements directed to healthcare professionals and for trade

Who are healthcare professionals

Healthcare professionals, as specified in the First Schedule to the Regulations, includes:

  • Qualified practitioners.
  • Registered pharmacists.
  • Enrolled nurses, registered nurses and registered midwives.
  • Persons undergoing training with a view to becoming practitioners, pharmacists, enrolled nurses, registered nurses or registered midwives.

Advertisements of prescription-only medicines and specified diseases and conditions

Advertisements of prescription-only medicines such as CTGTP or advertisements making reference to any specified diseases and conditions are only allowed in the following instances:

  • Advertisements distributed to relevant healthcare professionals.
  • Reference or trade advertisements.
  • For the purpose of information published on corporate websites, press releases and product launch events that are not opened to the public. Such information must be non-promotional and any representation concerning the product's intended purpose and efficacy must be consistent with its registration, product notification or supported by evidence and any risk-benefit profile.
  • Advertisements distributed at pharmaceutical trade fairs, exhibitions and scientific conferences, or forums which are restricted in attendance to medical or scientific professionals, and not opened to the general public.

Comparative claims

Comparative claims of the CTGTP are allowed in the following instances:

  • Advertisements distributed to relevant healthcare professionals.
  • Advertisements distributed at pharmaceutical trade fairs, exhibitions and scientific conferences, or forums which are restricted in attendance to medical or scientific professionals, and not opened to the general public.

Corporate websites 

Corporate websites refer to internet websites of product registrants or licensees that provide information about the company.

Local corporate websites belonging to product registrants and licensees may list factual information about their products. This information may include those related to the list of specified diseases and conditions.

Such information must be non-promotional, consistent with its registration or notification, or supported by evidence. It must not contain promotional elements for the purpose of inducing sales or usage of the product.

Discussion boards or forums relating to the product are not allowed on corporate websites.

Advertisements for unregistered or unnotified CTGTP or their unapproved uses

An advertisement of an unregistered or unnotified CTGTP may only be made under the following scenarios:

  • In the form of an article in a medical or scientific journal, review or publication.
  • In the course of providing or exchanging scientific or medical information at, and in accordance with the published programme or agenda of, a scientific conference or forum that is a private event.
  • At a pharmaceutical trade fair, pharmaceutical trade exhibition, scientific conference or scientific forum that is a private event. The CTGTP must be approved, licensed or registered in at least one country outside Singapore, and contain a statement that it is not registered or notified in Singapore.

In addition, any advertisement of an unregistered or unnotified CTGTP may contain a representation concerning its intended purpose or efficacy, which must be substantiated by objective scientific evidence.

Sales promotion activities

You must not, in the course of conducting the sales promotion, offer any prize to motivate the wholesale purchase of a CTGTP.

As part of sales promotion, a registered or notified CTGTP may be offered together with any medicinal or health product if they are intended to be supplied:

  • To a qualified practitioner or a registered pharmacist.
  • By wholesale by a person with a valid wholesaler's licence.

Corrective measures to contravening advertisements

You may be required to submit copies of advertisements to us when called upon. If your advertisement is found to breach the HPA and regulations, you may be required to do any or all of the following:

  • Stop the advertisement immediately.
  • Take reasonable measures to remove the offending advertisements that have been published or distributed.
  • Publish a corrective advertisement in a manner and with content specified by us.

A corrective advertisement typically contains:

  • An expression of regret or apology.
  • A corrective statement issued upon our order, about the product concerned.
  • Statement on the breach and a description of the correct facts.
  • Description of the case and including where and when the offending advertisement was placed.
  • Contact information for the public.

Note: Penalties may be imposed on errant advertisers who breach the HPA and regulations. Such penalties include a fine or imprisonment or both.

Feedback on advertisements

To report a breach or send a feedback, e-mail the Medical Advertisements & Compliance Monitoring Unit.

Your e-mail should provide:

  • Details of where and when the advertisement was published.
  • A copy or image of the advertisement.
  • Your concerns about the advertisement such as the non-compliance and its corresponding clause, provision or prescribed requirements (if known).