1. Code Awareness
SESSION 3

2. Introduction
My second code awareness session focussed on the importance of preparing yourself to
successfully defend any promotional complaint that could affect your marketing performance.
This third session will focus Clause 14 CERTIFICATION and Clause 15 REPRESENTATIVES of the
Marketing code Part A*
Presentations are provided for interest or for use in-house for training purposes
* Promotion of medicines (S0-S7) to healthcare professionals

3. Clause 14: Certification
Definition: Official in-house approval process whereby marketing material and activities are
reviewed & signed to be compliant with the Marketing and Company regulations before
distribution/use
The code prescribes the following conditions;
Appointment of person(s) responsible as Company Code Compliance Officer for approval of
promotional material, meetings or activities.
Usually this is your Medical Advisor and the certification team consists of a sub-team from
marketing, regulatory and medical. A job-bag will circulate the reviewers with changes being
made until material is in its final form and ‘signed off’. It is vital that this process is documented
and in case of complaint, able to be proven that correct procedure took place.

4. Certification cont.
Further conditions as follows;
Promotional material and activities must not be issued unless certified
Each company should have a Standard Operating Procedure (SOP) for the approval process
 Certificate of certification is required and must be retained together with final form of
material or meeting details for 5 years
Recertification of promotional material still in use must be re-certified every 2 years to ensure
that it continues to conform to the relevant regulations and the Code

5. Certification cont.
ACTIVITIES such as the following require certification too:
1. Continued Professional Development (CPD)
2. Professionally educational events
3. The presentation of scientific or promotional material
4. Journal club meetings organised and/or sponsored by the company
5. The use of observational/non-interventional studies for promotional purposes, etc.
Meetings that fall within the ordinary scope of the day-to-day activities of company Sales
Representatives, and/or where the events, parts of the event, a speaker or an attendee is not
sponsored by the company, are not subject to certification.

6. Clause 15: Representatives
The code prescribes the following requirements for reps promoting products;
Gaining interviews - Representatives must not employ any inducement or subterfuge to gain
an interview. No fee should be paid/donation to charity offered for the granting of an interview
Calls - Representatives must ensure that the frequency, timing and duration of calls on
Healthcare Professionals and alike, do not cause inconvenience
Representatives must transmit to the Scientific service of their companies (Clause 13) any
information that they receive in relation to the use of the health products that they promote,
particularly reports of adverse events
Meetings must be in accordance with Clause 18 – Meetings

7. Representatives cont.
When Representatives introduce a medicine to a healthcare professional for the first time, they
should provide a copy of the package insert. On subsequent occasions, such information should
be available on request
Companies may prepare detailed briefing material for Representatives on the technical
aspects of each healthcare product that they will promote. Briefing material must comply with
the Code and must be approved/certified
Companies are responsible for ensuring that the activities of their representatives comply
with the Code and all applicable laws and regulations
Companies must ensure representatives receive adequate training in advertising laws, code
compliance and scientific knowledge for the products they promote

8. Learning Points
Did you know that meeting agendas and all related information for Sponsored Meetings
require to be 1. Certified and 2. Kept on record for 5 years?
Did you know that your marketing materials needed review and re-certification every 2 years?
Did you know that reps required 1. Briefing materials detailing how to promote a product with
every new piece of advertising material you supply them with and 2. This briefing material
required certification?
How is this relevant you may ask? An example: A complaint comes in about rep activity,
complainant describes how rep incorrectly promoted a product based on a graph in a new detail
aid. How will you defend this? This is where the MCA would ask you to respond as to how the rep
was 1. Trained (evidence) 2. Briefed on detail aid (evidence) 3. Detail aid certified
(evidence)…..See the pattern emerging?

9. In Conclusion
It is important for you to have a smooth approval process to get your marketing materials and
activities certified and out there working for you. Too often a job-bag sits in the review process
too long, time is lost and marketing campaign timelines lag behind. A slick approval and
knowledgeable cross functional team translates to more effective promotion and confident
marketing practices.
Remember a company should have their own Certification and Representative internal policies
– the Marketing Code is there to guide these. How do your policies compare?

10. Thank you
I hope you enjoyed Session 3 of Code
Awareness. Follow me next week for more on
the Code and Pharmaceutical Marketing.
Yours in Pharma
Jessica
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11. Medical Services for
Pharmaceutical Marketing
and Medical Affairs
JESSICA
CALDERWOOD
BPHARM RHODES UNIVERSITY
jessica@iwrite-consulting.co.za
4 Sandberry Avenue
Tokai,Cape Town, 7945
www.iwrite-consulting.co.za
Tel 0837458240
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