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These days there doesn’t seem to be a day that goes by where there isn’t some snippet of news on the great Brexit plan. Obviously, something of such magnitude has ramifications across all sectors of life. Naturally the regulatory aspects of drug registration and life cycle management are areas that will require very careful planning and implementation, as well as constant revision of such plans as more clarity is fed down from the EMA. What we know thus far is that on the 20th November the EMA has decided to relocate its offices from London to Amsterdam. The move has to be executed by 30 March 2019 at the latest, and there will be expected bumps along the way regarding transition. This recent development has been followed up by two new documents; firstly, the EMA has released updated procedural guidance on Brexit-related changes. This guidance includes how to classify variations, what supporting documents are required and whether variations can be grouped, as well as many more items. Subsequent to this, the EMA has just released an updated Q&A document giving organisations further guidance related to Brexit submissions – specifically covering situations where the UK is part of the MA registration in various aspects, such as API, batch release, QPPV, MAH and so on.
As the clock is ticking for Brexit, ELC Group has been working closely with its clients in helping to prepare and plan for all Brexit-related changes. There are only 16 months remaining and the regulatory landscape is expected to develop further, so it is imperative that a robust regulatory impact analysis is undertaken on your product portfolio. ELC Group can be your partner of choice whether that is acting as local QPPV, or as MAH or Batch release site, looking for a new API supplier or FP manufacturer, or an update to your PSMF. Our office location in Prague means we will still be part of the EU27 and, with our extensive network of EU partners, we offer an ideal solution for your pre- and post-Brexit needs.