- Latest available (Revised)
- Original (As adopted by EU)
Regulation (EC) No 1394/2007 of the European Parliament and of the CouncilShow full title
Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance)
You are here:
What Version
More Resources
Revised version PDFs
- Revised 26/07/20190.30 MB
- Revised 02/07/20120.25 MB
- Revised 30/12/20070.10 MB
Legislation originating from the EU
When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.
This item of legislation originated from the EU
Legislation.gov.uk publishes the UK version. EUR-Lex publishes the EU version. The EU Exit Web Archive holds a snapshot of EUR-Lex’s version from IP completion day (31 December 2020 11.00 p.m.).
Status:
This is the original version as it was originally adopted in the EU.
This legislation may since have been updated - see the latest available (revised) version
Article 21Composition of the Committee for Advanced Therapies
1.The Committee for Advanced Therapies shall be composed of the following members:
(a)five members or co-opted members of the Committee for Medicinal Products for Human Use from five Member States, with alternates either proposed by their respective Member State or, in the case of co-opted members of the Committee for Medicinal Products for Human Use, identified by the latter on the advice of the corresponding co-opted member. These five members with their alternates shall be appointed by the Committee for Medicinal Products for Human Use;
(b)one member and one alternate appointed by each Member State whose national competent authority is not represented among the members and alternates appointed by the Committee for Medicinal Products for Human Use;
(c)two members and two alternates appointed by the Commission, on the basis of a public call for expressions of interest and after consulting the European Parliament, in order to represent clinicians;
(d)two members and two alternates appointed by the Commission, on the basis of a public call for expressions of interest and after consulting the European Parliament, in order to represent patients’ associations.
The alternates shall represent and vote for the members in their absence.
2.All members of the Committee for Advanced Therapies shall be chosen for their scientific qualification or experience in respect of advanced therapy medicinal products. For the purposes of paragraph 1(b), the Member States shall cooperate, under the coordination of the Executive Director of the Agency, in order to ensure that the final composition of the Committee for Advanced Therapies provides appropriate and balanced coverage of the scientific areas relevant to advanced therapies, including medical devices, tissue engineering, gene therapy, cell therapy, biotechnology, surgery, pharmacovigilance, risk management and ethics.
At least two members and two alternates of the Committee for Advanced Therapies shall have scientific expertise in medical devices.
3.The members of the Committee for Advanced Therapies shall be appointed for a renewable period of three years. At meetings of the Committee for Advanced Therapies, they may be accompanied by experts.
4.The Committee for Advanced Therapies shall elect its Chairman from among its members for a term of three years, renewable once.
5.The names and scientific qualifications of all members shall be made public by the Agency, in particular on the Agency’s website.
Options/Help
Print Options
PrintThe Whole Regulation
PrintThe Whole Chapter
PrintThis Article only
Legislation is available in different versions:
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As adopted by EU): The original version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.
Opening Options
Different options to open legislation in order to view more content on screen at once
More Resources
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as adopted version that was used for the EU Official Journal
- lists of changes made by and/or affecting this legislation item
- all formats of all associated documents
- correction slips
- links to related legislation and further information resources
More Resources
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as adopted version that was used for the print copy
- correction slips
Click 'View More' or select 'More Resources' tab for additional information including:
- lists of changes made by and/or affecting this legislation item
- confers power and blanket amendment details
- all formats of all associated documents
- links to related legislation and further information resources
All content is available under the Open Government Licence v3.0 except where otherwise stated. This site additionally contains content derived from EUR-Lex, reused under the terms of the Commission Decision 2011/833/EU on the reuse of documents from the EU institutions. For more information see the EUR-Lex public statement on re-use.