Professional Documents
Culture Documents
Module 1 - OTC Medicine Self Learning DA Training
Module 1 - OTC Medicine Self Learning DA Training
BEING A DELEGATED
AUTHORITY
Page |2
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
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.
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.
Page |7
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
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.