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TAPS Delegated Authority


Self-Learning Programme for
Advertisers of OTC Medicines
to Consumers & Healthcare
Professionals

BEING A DELEGATED
AUTHORITY
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Being a Delegated Authority


Introduction
The purpose of this self-learning programme is to enable you to become a Delegated
Authority for the TAPS service for advertisements for prescription medicines when
advertised to healthcare professionals. There are two key benefits in you becoming a TAPS
Delegated Authority;

 Your advertising review process for these advertisements will not require a TAPS
Adjudicator review step which saves you time and money.
 The more Delegated Authorities we have the greater the awareness and
understanding there is of the advertising self-regulation system in New Zealand.
These modules have been developed in order for you to understand the important aspects
of advertising compliance that are relevant to advertisements for prescription medicines to
healthcare professionals. The modules do not attempt to cover every possible aspect of
compliance with every possible means of advertising. This self-driven training assumes that
you have a comprehensive knowledge of the New Zealand Self Medication Industry Code of
Practice, regardless of whether or not your organisation is a member of the New Zealand
Self Medication Industry Association. It is the responsibility of each DA to keep themselves
up to date with compliance requirements and any changes that may arise after completing
this training programme.
At the end of the learning programme, there is a learning assessment questionnaire to be
completed and forwarded to ANZA, along with your Delegated Authority application form.
If you have questions during this self-learning programme, please do not hesitate to contact
a TAPS Adjudicator for help.
Nigel Andrews: Telephone (+649) 836 2680 or Email: nigel@rubicon.net.nz
Peter Pratt: Telephone (+644) 938 6409 or Email: peterpratt@paradise.net.nz
Maureen Roberts: Telephone (+649) 478 7776 or Email: maureenroberts@xtra.co.nz

Please Note: Completing this DA Self-Learning Programme does not


guarantee that your advertisements will always be 100% compliant with the
NZ Legislation and Advertising Codes. Responsibility for compliance is always
with the advertiser.
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This module contains the following sections;


1. The TAPS Mission Statement
2. Definition and limits of a TAPS Delegated Authority for
advertisements for OTC medicines to consumers &
healthcare professionals
3. TAPS Delegated Authority Procedures
At the end of this module you should complete the
Assessment.
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Module (1) Section 1. The TAPS Mission Statement


The TAPS service is part of the self-regulation of advertising system in New Zealand.
TAPS Mission
TAPS provides a professional advice service to advertisers to;
 Protect consumers and;
 Ensure that consumers are presented with information that has fair balance of disclosure for
therapeutics that are important for their health and well-being.
 Ensure compliance with the ASA Codes and NZ legislation, including observing a high
standard of social responsibility.
 Support the principle of self-regulation embodied by the ASA as a timely, cost effective and
reasonable method of protecting the consumer.
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Module (1) Section 2. Definition and limits of a TAPS Delegated Authority for
Advertisements for OTC Medicines directed to Consumers & Healthcare
Professionals
DEFINITION: A Delegated Authority (DA) is an appropriately qualified person who
holds a suitable position within the organisation and is nominated by the CEO who
can review and approve advertisements for OTC medicines to Healthcare
Professionals (as described below) on behalf of the Therapeutic Advertising Pre
Vetting Service (TAPS).
‘appropriately qualified’ means: A person who has experience and / or qualifications that are
relevant to a sound understanding of therapeutic issues in OTC medicine advertising and in the
legal and code compliance requirements for advertisements. They will follow a robust process of
reviewing advertisements and this process will include the TAPS requirements. They will also
need to be able to make unpopular decisions from time to time.

‘suitable position’ means: A position within the organisation that is sufficiently distanced from
the marketing and sales roles so that an objective review of advertisements can occur without
the influence from, or the involvement in, the design and development. i.e. generally a person in
regulatory affairs or the medical department.

A TAPS Delegated Authority has the responsibility of upholding the standards of advertising
review and approval that would be expected from a TAPS Adjudicator.

A DA for the advertising of OTC medicines to healthcare professionals may also approve OTC
medicine advertisements to consumers that meet the following criteria:

Advertising in all media must be pre-vetted and approved by a TAPS adjudicator(s) or TAPS Delegated
Authority.
A TAPS DA can approve minor changes to TAPS approved advertisements that:
 follow a TAPS Adjudicator pre-approved campaign and use claims and imagery consistent with that
campaign;
 change details relating to Approval Label/Data Sheet updates;
 re-format a pre-approved piece.

All other advertisements to consumers for OTC medicines must be


reviewed and approved by a TAPS Adjudicator.
Notes:

1. A DA in this role is restricted to approvals for OTC medicine advertising to


consumers & healthcare professionals only. The DA role does not extend to advertising
for other classes of products such as Prescription medicines.
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2. DAs are able and encouraged to obtain advice from the TAPS Adjudicators at any time, free of charge
for limited short phone calls of 5 – 10 minutes duration otherwise a charge applies.

3. DAs may use the TAPS review and approval service at any time for any advertisements to HCPs where
they consider a second opinion would be helpful or an independent review is sought where there is
any doubt. If in doubt it is better to get a second opinion from a TAPS Adjudicator.
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Module (1) Section 3. TAPS Delegated Authority Procedures


Procedure to become a DA
A. Advertiser to obtain DA self-learning training programme, assessment paper and DA application form
from ANZA.
B. DA to complete self-learning training and assessment paper.
C. Email assessment paper and completed application form to a TAPS Adjudicator (check with ANZA as
to which Adjudicator to send it to). Please note;
1. DA to be nominated by the CEO and form signed by CEO
2. DA is responsible to the CEO
3. Oversight of DA approved advertising lies directly with the CEO
D. Once a pass-mark of 85% or greater is achieved for the assessment;
1. ANZA CEO and TAPS Adjudicators review and approve application for suitability as a DA.
2. ANZA issues invoice for annual DA registration Fee.
3. ANZA issues unique code for the DA to use on all their approved advertisements.
a. This unique code is recognised by the media as belonging to the individual DA.

Notes:
1. A DA should have the;
a. Authority to give directions to the Sales and Marketing department to ensure they
understand the process.
b. Ability to make unpopular decisions and the discernment to refer to the TAPS Adjudicators
when appropriate.
c. The capacity to keep themselves up to date with relevant advertising compliance knowledge.
d. Willingness to refer to a TAPS Adjudicator or request a second opinion when unsure if any
aspect of advertising compliance that they are dealing with.
2. The Systems and Processes (e.g. Standard Operating Procedures) used by advertisers to review and
approved advertisements should incorporate the TAPS DA review and approval requirements.
3. DA registration fees must be renewed annually. ANZA issues annual invoices. Contact ANZA for
details of costs for ANZA members and non-members
a. The annual fee funds administration, and evaluation expenses and covers ongoing advice
given to the DA by the TAPS Adjudicators

Changing Delegated Authorities


A delegated Authority number is assigned to a person not a company. If the CEO wishes to change the DA
the CEO can apply to change at any time by:
 Advising ANZA that the current DA is to be deregistered.
 Completing and returning a new Delegated Authority Registration application form for the new DA
(obtainable from ANZA) for consideration by the ANZA CEO and TAPS Adjudicators.
 The nominee must have completed DA training and assessment prior to sending the DA Application
to ANZA.
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TAPS Approval Process – Suggested Items to include is Standard Operating Procedure (or equivalent)
 A TAPS job number / reference number
 DA Approval Code
 DA Signature
 Date
 Other signatures for sign-off (e.g. CEO) and date
 Product name
 Advertisement title
 Media Used
 Track advertisements changes
 Compliance Check-list
o ASA Codes
 Advertising Code of Ethics
 Therapeutic and Health Advertising Code
 Code for Comparative Advertising
 Code for People in Advertising
o NZ Legislation
 Medicines Act 1981
 Medicines Regulations 1984
o New Zealand Self Medication industry Code of Practice
o Other Internal Company requirements
 Filing system to retain / archive approvals (with final copy) for up to 3 years in case of a later dispute
 Re-validation process for previously approved unchanged advertisements in line with internal
processes e.g. every 1 – 3 years.

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