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Guidelines for Advertising Prescription Medicines
Direct to the Consumer
January 2001

What all Medical Advertisements for Prescription Medicines must include to comply with the Advertising Requirements of the Medicines Act 1981 (sections 56 to 62) and the Medicines Regulations 1984 (regulations 7 to 11)

Consider these additional factors in your Medicine Advertisement
Labeling Regulations
Relevant Industry Codes of Practice

√
 
Name and Physical Form Section 57 (1)(c)  
The approved trade name and description as shown on the product label  
 
Ingredient(s) Properly Named Reg 8 (2)   
Refer to the definition of "Appropriate designation" in the Medicines Regulations   
 
Quantities of Active Ingredients Reg 8 (1)(a)   
Refer to the definition of "Appropriate quantitative particulars" in the Medicines Regulations   
 
Authorized Use(s) Reg 8 (1)(b)   
Approved indication(s) for the medicine  
 
Classification  Refer Note 2 Reg 8 (3)  
e.g. . "Prescription Medicine" conspicuously printed or clearly spoken  
 
Name and Address of Advertiser Section 59  
True name and address of the person for whom the advertisement is published  
 
Appropriate Precautions Refer Note 1 Reg 8 (1)(c)  
 
Contra-indications Refer Note 1 Reg 8 (1)(d)  
 
Adverse Effects Refer Note 1 Reg 8 (1)(e)  
 
The italic summaries are for guidance only. For full wording the relevant section of the legislation should be consulted.

Note 1

The Medicines Regulations 1984 require any advertisement for a medicine to include consumer information about any appropriate precautions, contra-indications and adverse effects of that medicine. This information must be readily available to consumers.
Therefore, prescription medicine advertisements directed to consumers must, where appropriate : *

The latter could include instructions for consumers to refer to

  1. advertisements with full information concurrently appearing in other (print) media;
  2. a toll free phone number;
  3. the product packaging;
  4. the advertiser's Internet Website;
  5. the advertiser's postal address;
  6. brochures;

or instruct consumers to contact their doctor, pharmacist or other health professional.

Other consumer information referrals include the Consumer Medicine Information (CMI)
Sheet, or the Data Sheet, both of which can be found on this website under 'Information for Consumers'  or 'Information for Health Professionals'.

NB. Advertisements for prescription medicines should have CMI available on the Medsafe Website if they are to be advertised direct to the consumer.

* The extent to, or manner in, which information in Note 1 is made available to consumers is dependent upon the advertising medium used.
For example in print, full disclosure of information about precautions, contra-indications and adverse effects that is both relevant to, and easily understood by, the consumer would be considered appropriate. Advertisers are encouraged also to direct consumers to other sources of additional information.
In a television advertisement, it is sometimes impractical to convey in a coherent way all the risk information . In these circumstances it would be considered appropriate to direct the consumer to an easily accessible source of additional information . This does not, however, exempt the advertiser from including in the advertisement information about major risks of which consumers should be made aware.
Such statements should be considered part of the advertiser's social responsibility in providing balance to any product benefit claims, and in informing any specific consumer group of the appropriateness of the advertised medicine.

It is important and responsible to inform the consumer that:

Note 2

To ensure that consumers have no doubt about the classification of a medicine the words "Prescription Medicine" must be "conspicuously" stated either visually or be clearly spoken.
Emphasis should also be given to an instruction to consumers to consult their Doctor for further advice.

 

Consider these additional factors in your Medicine Advertisement

√
 
Avoid absolute terms e.g. 'safe' or 'completely safe' Section 57(1)(g)  
Must not imply the medicine cannot harm or is not habit forming  
 
Length of time on screen (TV, cinema) Section 57 (2)  
Required information must be clearly legible and displayed on screen long enough to be read by the ordinary viewer  
Scientific information should be easily understood ASA Code Principle 4  
Scientific information should be accurate, appropriate, clear, and able to be readily understood by the audience to whom it is directed  
 
Does not imply endorsement by any Government agency Reg 7  
Cannot claim 'approval' by Medsafe/Ministry of Health  
 
Is not misleading Section 57 (1) (f)  
Does not mislead as to nature, qualities or effects of the medicine. Must not go beyond the approved indication/s  
 
No testimonials Section 58 (1)(c) (ii) & (iii)  
Professional recommendation and/or personal testimonials not permitted either by implication or suggestion  
 
Socially responsible ASA Code Principle 2  
Advertisements should observe a high standard of social responsibility particularly as consumers rely on medicines for their health and well-being  
 

 

Labelling regulations

The Medicines Act - Section 57 (1) (a), (b) & (c ) - refers to requirements to ensure consistency between package labeling and any advertisement for the medicine. It specifically refers to the use of statements that are contrary to, or prohibited by, or required by, (or the omission of), information required by the labeling requirements of the Medicines Regulations 1984.

 

Relevant Codes of Practice

It is recommended that advertisers consult the following self-regulatory Codes of Practice:

Advertisements for prescription medicines need to be pre-vetted for compliance with legislative and industry code requirements regarding advertising based on agreement by the Advertising Standards Authority (ASA) and the organisations which represent the media in which the advertisements are to be published. In association with the ASA, one of the contributing members, the Association of New Zealand Advertisers (ANZA) has set up the Therapeutic Advertising Pre-vetting System (TAPS) to provide this service. Organisations must first register with ANZA, P O Box 9348, Newmarket, Auckland, phone + 64 9 300 5932 in order to use the TAPS service.  Contact details for TAPS are Nigel Andrews, LAPS & TAPS Adjudicator, 43 Tirohunga Drive,Henderson,Waitakere 0612, phone (09) 836 2680, fax (09) 837 5057, email: nigel@rubicon.net.nz or Jill Desborough, 15 Ridings Road, Remuera, Auckland, phone + 64 9 522 8440, fax + 64 9 522 8448, mobile 025 2939 279, email desborough@clear.net.nz.

Acknowledgement

Medsafe acknowledges the valuable assistance of the Researched Medicines Industry (RMI) and the Non-Prescription Medicines Association of New Zealand Inc (NMA) in the preparation of these guidelines.

Disclaimer

While every care has been taken in the preparation of the information contained in these guidelines, the Ministry of Health is not responsible for the results of any act or omission, done or omitted in reliance, in whole or in part, on the basis of that information, nor for any error in or omission from the guidelines. The information in the guidelines is of a general nature and should be used as a guide only to the provisions in the Medicines Act 1981 and the Medicines Regulations 1984. The Ministry recommends that before arranging for the publication of any advertisement regulated by the Medicines Act or Regulations that you seek independent legal advice.