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Home / Activities / Advertising / Regulation of Advertising of Medicines

Regulation of Advertising of Medicines

 

Introduction

The advertising of medicines is regulated by the Medicines Act, 2003 and its subsidiary legislation the Medicinal Products (Advertising) Regulations, 2005 Subsidiary Legislation 458.32. The regulations stipulate/establish the different requirements for advertising to the general public and healthcare professionals.  

Advertising can be presented in several forms, including:

  • medical journals – scientific/professional/medical
  • magazines
  • newspapers
  • television and radio advertisements
  • advertising on the internet including websites and social media
  • posters.

The scope behind the regulation of advertising is to:

  • encourage the rational use of the medicines, by presenting it objectively and without exaggerating its properties;
  • ensuring that they are honestly promoted with regards to their benefits by complying with the particulars listed in the summary of product characteristics of the medicine; and
  • not be misleading.

The control of medicines advertising in Malta, from 1 May 2004, is based on the system of self-regulation. The Medicines Authority does not evaluate advertisements prior to their publication. The Medicines Authority sets guidance which is published, monitors advertisements, assesses complaints received and evaluates any cases of possible breaches as well as providing advice to industry, health professionals, consumers and other regulatory bodies.

It is an offence for any person to breach the regulations. Should there be a breach in the advertising regulations warnings, sanctions and penalties will be enforced.

Medicines Authority Guidance Notes

The Medicines Authority has compiled the following guidance notes.

Complaints procedure

Complaints on advertised medicinal products can be made to the Medicines Authority. The complaint form must be filled in and posted to the Post-Licensing Directorate, Medicines Authority, Sir Temi Żammit Buildings, Malta Life Sciences Park, San Ġwann SĠN 3000

Or

Fill in the online form, print it, sign it, and send it via email to: advertising.medicinesauthority@gov.mt. All relevant fields must be completed so that the complaint can be processed and investigated. 

Advertising of medicinal treatment services

Although advertising of medicinal treatment services falls outside of the scope of the Medicinal Products (Advertising) Regulations, 2005 (Subsidiary Legislation 458.32), advertisers promoting medical or medical aesthetic services to the general public should do so without promoting specific prescription-only medicines (POMs).

It should be noted that Botox is one of various trade names for medicinal products containing Botulinum toxin. Botox and other injectable medicinal products containing Botulinum toxin are registered as a prescription-only medicine (POM) in Malta, and therefore in line with Regulation 5.(2)(a) of the Medicinal Products (Advertising) Regulations, 2005 may not be advertised to the general public.

 Such prohibited advertising includes:

  • Printed media (such as magazines, flyers, posters etc...) and digital media (such as websites, social media, online audio-visuals etc...) distributed to and/or made available to general public, which directly or indirectly reference “Botox”, “botulinum toxin” or other trade names for medicinal products containing Botulinum toxin.
  • Advertising materials referring to recommendations, endorsements, and testimonials by scientists, health professionals or persons who because of their profession or celebrity status could encourage or promote the use of Botox or other Botulinum toxin containing medicines [Regulation 7.(f)].
  • Pictorial representations, including before and after photos illustrating the claimed benefits of Botox or other Botulinum toxin containing medicines [Regulation 7.(k)].

 

Advertising of treatment of hyperhidrosis of the axillae and facial lines should be done in a non-specific way without a reference to Botox or other Botulinum toxin containing prescription medicines.

 

Further information

Further advice can be obtained by contacting the Medicines Authority via email on: advertising.medicinesauthority@gov.mt

 

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