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Questions about the Code

Do you have a question about the Code? We are committed to making compliance clear. Put your question to us and we commit to coming back with an answer from one of our team of experts.

Here is an example of a recent question we were posed, and our response to it.

There is no Czech affiliate so, if the UK affiliate employs a Czech representative who calls only on Czech HCPs, does that representative have to sit the reps exam?

Regarding your query about training, the representative’s exam has to be taken by representatives who fall under the scope of the UK Code (ie, those that promote medicines to health professionals etc). The UK Code is clear in Clause 1.1 that promotion of medicines is to UK health professionals. Therefore, a UK employee promoting to non-UK health professionals may not necessarily be defined as a ‘representative’.

If the Czech employee does not call on UK health professionals, then, in our opinion, they do not need to sit the UK representative’s exam.

The UK Code will still apply to their activities and materials so it would be best to ensure the employee has sat a local exam/course so they have a good understanding of ‘body systems, diseases and treatments, the development of new medicines and the structure and function of local Czech healthcare organisations and the pharmaceutical industry,’ as well as the requirements of the UK company’s SOP. A record of validation of their knowledge would be advisable.

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Having consulted Rina and the experienced team on numerous ‘one-off’ situations, I have never been left without a clear answer or direction in which to proceed... the advice is always delivered. Not having this option would be akin to sailing without a rudder.

Compliance Manager