GOT MAIL FROM SWISSMEDIC?
Did you receive unpleasant correspondence from Swissmedic? Or correspondence with unclear potential consequences? Maybe a preliminary decision threatening you with the imposition of certain measures? Or even a final order imposing such measures? – In all of these cases, you should urgently get in touch.
GETTING IN TOUCH EARLY IS KEY
Measures imposed by Swissmedic rarely come «out of the blue». Usually, they are preceded by developments and interactions over several weeks or months. During this time, it is important that technical expertise is available to answer Swissmedic's queries adequately. However, early legal support is just as essential in order to correctly assess Swissmedic's actions and steer developments in such a way that adverse measures are avoided. Usually, there are the following
SWISSMEDIC PROCEDURAL STEPS:
INQUIRIES/REQUESTS FOR INFORMATION
Particularly in more complex cases, Swissmedic first requests information and documentation from economic operators. This may involve, for example, declarations of conformity, the technical documentation or explanations of certain activities. However, it is imperative to also involve legal support at this early stage already, as only a «legal eye» is able to identify certain keywords indicating what Swissmedic might be up to. Nevertheless, the goal remains a non-confrontational, «negotiated resolution» of the matter.
INTERIM ORDERS
If Swissmedic has already issued one or more interim orders, the procedure becomes more «formal». However, this does not necessarily mean that the matter is already decided. Here, support from a legal expert is all the more essential in order to prevent unfavourable developments.
PRELIMINARY DECISIONS
If a preliminary decision has been issued that holds out the prospect of concrete measures being taken with regard to the economic operator(s) concerned, rapid action involving legal expertise is key. In such cases, Swissmedic will set specific deadlines anyway (particularly for submitting a position on the preliminary decision).
FINAL ORDERS
Swissmedic procedures are ultimately concluded by issuing final orders against the economic operator(s) concerned. In the extreme, drastic measures such as bans on certain activities may be ordered. Once an order has been issued, nothing can (and should) be done without legal support. At this stage, the main question will be whether legal action should be taken against Swissmedic's ruling.
We provide you with fast, flexible and uncomplicated support in each of these phases. Just contact us.