Access to CHMP files

The request was successful.

Dear European Medicines Agency,

Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I am requesting documents which contain the following information:

'Applications for new human medicines under evaluation by the CHMP'.

I am aware that these documents are published on the EMA website dating back to March 2012. I have been informed by personnel at the EMA that before this time these documents were not posted online.

However, I am emailing to request files regarding the applications for new human medicines under evaluation by the CHMP, which contain a list of applications for centralized marketing authorization for human medicines that the EMA has received for evaluation. I am looking for the documents with the international non-propriety names and therapeutic areas for all new medicines under evaluation by the CHMP.

I am looking for this information regarding non-orphan medicinal products, non-orphan generic and biosimilar medicinal products and orphan medicinal products.

I am requesting the documents holding this information starting from February 2012 (following the last available file online) and as far back as possible that the EMA holds. As I understand from the documents currently available online these are usually files dated monthly. If this is not possible I would like to request the information, more specifically, for the period of February 2012-February 2007.

Yours faithfully,

Lucie Ellis

EMA Info, European Medicines Agency

Dear Ms Ellis,
 
Thank you for your query.
 
Please kindly note that the information you are referring to can be found
in the annexes of the EMA Annual reports:
 
[1]http://www.ema.europa.eu/ema/index.jsp?c...
 
[2]http://www.ema.europa.eu/ema/index.jsp?c...
 
Kind regards,
Document & Information Services
European Medicines Agency
7 Westferry Circus
Canary Wharf
London
E14 4HB
United Kingdom

[3]http://www.ema.europa.eu
New web form for submitting requests for information and documents is now
available. Please use this form to send a question to EMA.
[4]http://www.ema.europa.eu/ema/index.jsp?c...
 
The most Frequently Asked Questions (FAQs) received by the EMA are
published here:
[5]http://www.ema.europa.eu/ema/index.jsp?c...
 
This message and any attachment contain information which may be
confidential or otherwise protected from disclosure. It is intended for
the addressee(s) only and should not be relied upon as legal advice unless
it is otherwise stated. If you are not the intended recipient(s) (or
authorised by an addressee who received this message), access to this
e-mail, or any disclosure or copying of its contents, or any action taken
(or not taken) in reliance on it is unauthorised and may be unlawful. If
you have received this e-mail in error, please inform the sender
immediately.
 
 

show quoted sections