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Pharma IT Solutions
Quality & Compliance
Safety & Vigilance
09 february 2023
As in any field, branding and advertisement are effective ways to promote the sales of your product.
However, when it comes to pharmaceuticals, governments and the industry have a responsibility to safeguard patients against the unwanted influence of the industry.
The European Union established advertisement rules in the industry to ensure that collaboration between the industry and healthcare benefitted the general public’s safety. These advertisement rules were set out in the European Directive (2001/83/EC), national legislations and the EFPIA code of conduct, set up by the European biopharmaceutical industry. Based upon the EFPIA code and the national and EU legislations, European countries have established their national codes of conduct, which will overlap in many areas. However, these national codes differ from country to country, making it necessary to check promotional materials against the national code of conduct that applies to the intended distribution area.
With a global network and a strong presence in many EU countries, the ProductLife Group has several local representatives trained in their national code of conduct and legislation. We can support you with the assessment of different kinds of promotional and informational materials against several national codes of conduct. Evaluating material starts with determining if the material falls under the local code. This is generally the case when a direct or indirect reference to a prescription medication is made. When this is determined, a distinction must be made between who will receive the material and whether the material falls under ‘promotional’ or ‘informational’. Advertisement is allowed towards HCPs but is prohibited towards the public. However, information about a disease or medication to the public can be nationally allowed when specific rules are obliged. Balancing these local codes of conduct can sometimes be challenging for the creator and assessor. It can sometimes be a fine line between what is acceptable and what should be adapted.
Next to an assessment of your promotional and informational materials, we can support you further with preparing the abbreviated product information or preparation for an international medical event. For international medical events, industry and national codes apply, making it necessary to adapt your content, banners and appearance of your stand to the composition of the event’s audience. When the audience is mixed in HCPs and the public, it can be challenging to reach out to both audiences appropriately according to the codes. With advice and assessment of your materials by PLG for your stand, we can help you to make a memorable appearance.
For information on what the ProductLife Group can offer you, please get in touch with us here.
Our clients can benefit from our local and regional expertise. We will be happy to support you in your promotional activities, checking against the national codes of conduct of the industry and EU countries like the Netherlands, France, Italy, Germany, Spain and many more!
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