Graduated plan procedure and Community referrals

Safety first

The prevention of risks due to medicinal products is the top priority of the national and European supervisory authorities. In the event of a referral the pharmaceutical companies are faced with an extensive catalogue of questions. Furthermore, they must respond at short notice to measures planned by the authorities such as a restriction of indications.

Precise problem analysis

In the event of a referral – at both national and European level – we analyse the problem quickly and precisely and ascertain in what way and to what extent your product is affected. In so doing, we not only scrutinise the potential risks by applying medical expertise, but also take legal and epidemiological aspects into consideration.

Answer and solution

We help you to implement immediate measures and support you in the acquisition and evaluation of data and the preparation of your answer. If you are asked to advance proposals for risk minimisation we will work with you to create a practicable concept geared to the facts. Finally, we communicate with the authorities on your behalf.