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clock Created with Sketch. 05/11/14
16:16
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Originally posted by Revreboot
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Now I've seen it all. Here are some extracts from the EMA guidelines on dealing with applications such as the one regarding Vitrogro:within 210 days after receipt of a valid application . Such opinion must then be included in the documentation on the device. The notified body, will give due consideration to the views expressed in the consultation when making its decision and it will convey its final decision to the competent body concerned."a maximum 210 day timetable with the opportunity for clock stops for the applicant to reply to questions or communicated deficiencies."
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Agree, and I still reckon that Big Pharma have something to do with these delays.
