EMA Fails to Follow Legislation and Its Own Policy, page-2

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kosenar

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05/11/14

16:16

Post #: 14240241
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Originally posted by Revreboot ↑

Now I've seen it all. Here are some extracts from the EMA guidelines on dealing with applications such as the one regarding Vitrogro:

"In accordance with Annex II (EC declaration of conformity), section 4.3, second paragraph and Section 5 of Annex III (EC type-examination) of both Directive 93/42/EEC, as amended, and Directive 90/385/EEC, as amended the competent authorities of medicinal products shall issue an opinion 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."

Within 210 days after receipt of valid application. If the application was invalid I'm sure we would have heard about it before now. Of course the 210 days only refers to the time spent by EMA on the application and any "clock stops" during which the company are answering questions and gathering evidence are not included. This is indicated in the following section:

"The CHMP will follow the same assessment timetable as used for a new application to the European Medicines Agency according to the Centralised Procedure as described in EudraLex notice to applicants Volume 2A, Chapter 4 i.e. a maximum 210 day timetable with the opportunity for clock stops for the applicant to reply to questions or communicated deficiencies."

To tell TIS that they may not submit for 3 months because they can't handle the workload breaches Directive 93/42/EEC. If we took this to court they would be forced to accept our submission whenever we chose to make it. The obvious problem here is that by the time the court made the decision the 3 months (and more) would have expired anyway.

To put that into colloquial terms: This is bs mate!

Rev

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Agree, and I still reckon that Big Pharma have something to do with these delays.

All in my opinion of course as I have nothing at all to back it up - other than the impediments that have been thrown at TIS during this process and that have been presented here from time to time by various posters.

Regards..........................

TIS Price at posting: 31.0¢ Sentiment: Buy Disclosure: Held
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EMA Fails to Follow Legislation and Its Own Policy, page-2

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