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Hoses are more often used than one thinks. On the one hand they are used in routine operations, on the other hand they can also be utilised as interim solution before a new pipe is drawn. They then fall into the first case situation. While one pays more consideration to pipes, their material quality and surfaces, hoses are often neglected. But what about requirements for hoses? Are there any?
The EMA has published a revised version of its list of relevant guidelines with regard to the contents of an SmPC. Read more about the document entitled "Scientific guidelines with SmPC recommendations".
The EMA recommends the suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs. Medicines where suitable alternative data are available can remain on market. Read more about the press release regarding medicines recommended for suspension.
The Implementing Regulation (EU) 2017/556 has been published in the Official Journal of the European Union on 25 March 2017. Read more about the details set regarding good clinical practice inspections of clinical trials.
On 2nd March 2017, the US FDA and the European Medicines Agency (EMA) informed that they concluded a so-called MRA (Mutual Recognition Agreement). Learn more about the FDA-EU MRA and the consequences for the Qualified Person (QP).