Ann: Positive feedback received on Paediatric Investigation Plan, page-163

@mephistophles sorry just woke up sure, below the whole email with my question:

Dear Mr XXXXXX

Thank you for contacting the European Medicines Agency.

In response to your question, we can confirm that pharmaceutical companies and medicine developers are informed in real time about decisions taken by EMA’s Committees. Applicants are first informed verbally as soon a decision has been taken, and they also receive the formal opinion in writing once this has been adopted, which normally happens during the last day of each Committees’ meeting.

We hope you find the above information useful.

Kind regards,

M.Spanu - Stakeholders & Communication Division

European Medicines Agency

Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
Send us a question. Go to www.ema.europa.eu/contact Telephone: +31 (0)88 781 6000

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We received your question(s) on: 20/10/2021

Subject of your enquiry: Feedback to companies following the Paediatric Committee (PDCO)

Your question(s):
Good Morning,

It is not clear from all the information you have on your website, when the companies are informed about the positive or negative adoption of an opinion following the meetings. For example, there was a meeting held on the 12-15 October 2021 by the PDCO committee; when can a company (included in the agenda) expect to receive initial feedback? The final minutes are issued weeks and months after the meeting. But I cannot imagine that companies need to wait that long, since in a lot of cases there are lives at stake and a delay of 1-2 months just to provide a positive feedback risks lives...

In summary, how many days after the meeting do the companies get informed about the outcome?

Thank you in advance.

Regards,
XXXXXXXXXXXX

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