Ref. Ares(2018)5332580 - 17/10/2018
DIRECTORATE-GENERAL FOR RESEARCH & INNOVATION
Brussels, By registered letter with
acknowledgment of receipt:
Germany Advance copy by email:
Your application for access to documents – Ref GestDem No
Dear Mr Schneider,
I refer to your message of 28 August 2018 via which you submitted, within the
framework of Regulation (EC) No 1049/20011, a request for access to documents,
registered on 30 August under the abovementioned reference number.
With reference to the UCL-led clinical trial INTENS … Work Package 5 the
"transplantation of engineered intestine" in patients, to take place at UCL (London, UK)
and in UCLA (California, USA)
, you requested access to documents which contain the
- any issued ethical approvals for clinical trials on patients
- any approvals issued by EMA
- any recruiting clinical trials
- any transplantations already performed.
1 Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding
public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p.
Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË — Tel. +32 22991111
We regret to inform you that the Commission does not hold any documents that would
correspond to the description provided in your application.
The Horizon 2020 project INTENS (INtestinal Tissue ENgineering Solution) does not have
any deliverables related to clinical trials on patients under Regulation (EU) No 536/2014 of
the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal
products for human use, and repealing Directive 2001/20/EC.
As specified in Article 2(3) of Regulation 1049/2001, the right of access as defined in that
Regulation applies only to existing documents in the possession of the institution. Given
that no such documents corresponding to the description provided in your application are
held by the Commission, we are not in a position to handle your request.
In accordance with Art 7(2) of Regulation 1049/2001, you are entitled to make a
confirmatory application requesting the Commission to review this position. Such a
confirmatory application should be addressed within 15 working days upon receipt of this
letter to the Secretary-General of the Commission at the following address:
Unit SG.DSG2.B.4 - Transparency
by email to: email@example.com
Electronically signed on 16/10/2018 16:01 (UTC+02) in accordance with article 4.2 (Validity of electronic documents) of Commission Decision 2004/563