EMEA/V/A/059 - Opinion following an Article 34 referral for Doxycycline 50% WSP

La demande est réussie.

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:

The assessment data of the residue depletion studies in chickens - supporting a meat withdrawal period of 5 days when chicken are administered at 25 mg doxycycline hyclate/kg body weight/day for 5 days - , data submitted during procedure EMEA/V/A/059.
I would appreciate to receive the study numbers of the studies conducted, report dates, and a copy of the scientific assessment conducted by the CVMP rapporteur and co-rapporteur with their conclusions.

Yours faithfully,

Peter Verhoeve

EMA Info, Agence européenne des médicaments

Dear Mr Verhoeve,
 
Thank you for your e-mail dated 07 Feb 2013 in which you request access to
documents held by the European Medicines Agency.
 
Provision of information in an open and transparent manner is part of the
mission of the Agency.
 
We will deal with your request as soon as possible and in accordance with
the principles and limits established in Regulation (EC) 1049/2001
regarding public access to European Parliament, Council and Commission
documents as applicable to the EMA pursuant to article 73 of Regulation
(EC) 726/2004.
 
This regulation sets out provisions which guarantee openness and
transparency of the activities of European Institutions, whilst also
ensuring the protection of certain public and private interests.
 
Under the above stated Regulation, you will receive a reply within 15
working days.
 
 
 
Kind Regards,
 
Document & Information Services
European Medicines Agency
7 Westferry Circus
Canary Wharf
London
E14 4HB
United Kingdom

[1][EMA request email]
[2]http://www.ema.europa.eu
 
Frequently Asked Questions (FAQs) have now been published on the Agency's
website. It comprises answers to the most commonly asked questions
submitted to the EMA. You are invited to consult it here:
[3]http://www.ema.europa.eu/ema/index.jsp?c...

This message and any attachment contain information which may be
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the addressee(s) only and should not be relied upon as legal advice unless
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e-mail, or any disclosure or copying of its contents, or any action taken
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EMA Info, Agence européenne des médicaments

1 Attachment

Dear Mr Verhoeve,
 
Please find herewith enclosed our response letter.
 
 
The relevant document will be sent shortly via secure EudraLink.
 
Kind Regards,
Document & Information Services
European Medicines Agency
7 Westferry Circus
Canary Wharf
London
E14 4HB
United Kingdom

[1]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:
[2]http://www.ema.europa.eu/ema/index.jsp?c...
 
The most Frequently Asked Questions (FAQs) received by the EMA are
published here:
[3]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.
 
 

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EMA Info, Agence européenne des médicaments

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Dear Mr Verhoeve,
 
Please find herewith the requested document.
 
Unfortunately, our EudraLink system could not send it to your e-mail
address:
 
 
Kind Regards,
Document & Information Services
European Medicines Agency
7 Westferry Circus
Canary Wharf
London
E14 4HB
United Kingdom

[1]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:
[2]http://www.ema.europa.eu/ema/index.jsp?c...
 
The most Frequently Asked Questions (FAQs) received by the EMA are
published here:
[3]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.
 
 

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From: EMA Info
Sent: 08 February 2013 10:36
To: Peter Verhoeve
Subject: RE: access to information request - EMEA/V/A/059 - Opinion
following an Article 34 referral for Doxycycline 50% WSP RFI-2013 No
02-091
 
 
Dear Mr Verhoeve,
 
Thank you for your e-mail dated 07 Feb 2013 in which you request access to
documents held by the European Medicines Agency.
 
Provision of information in an open and transparent manner is part of the
mission of the Agency.
 
We will deal with your request as soon as possible and in accordance with
the principles and limits established in Regulation (EC) 1049/2001
regarding public access to European Parliament, Council and Commission
documents as applicable to the EMA pursuant to article 73 of Regulation
(EC) 726/2004.
 
This regulation sets out provisions which guarantee openness and
transparency of the activities of European Institutions, whilst also
ensuring the protection of certain public and private interests.
 
Under the above stated Regulation, you will receive a reply within 15
working days.
 
 
 
Kind Regards,
 
Document & Information Services
European Medicines Agency
7 Westferry Circus
Canary Wharf
London
E14 4HB
United Kingdom

[7][EMA request email]
[8]http://www.ema.europa.eu
 
Frequently Asked Questions (FAQs) have now been published on the Agency's
website. It comprises answers to the most commonly asked questions
submitted to the EMA. You are invited to consult it here:
[9]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.
 

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