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Overview of comments received on procedural advice on the consultation of notified bodies in accordance with Article 9 of Regulation (EC) No. 1394/2007
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(English only)
|
|
03/03/2011
|
|
|
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Procedural advice on the evaluation of combined advanced therapy medicinal products and the consultation of notified bodies in accordance with Article 9 of Regulation (EC) No. 1394/2007
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(English only)
|
adopted
|
03/03/2011
|
|
|
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Procedural advice on the consultation of Notified Bodies in accordance with Article 9 of Regulation (EC) No. 1394/2007
|
(English only)
|
draft: consultation closed
|
29/07/2010
|
|
|
|
Guideline on the minimum quality and non-clinical data for certification of advanced therapy medicinal products
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(English only)
|
adopted
|
19/06/2009
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10/11/2010
|
|
|
Overview of comments received on draft scientific guideline on the minimum quality and non-clinical data for certification of advanced therapy medicinal products
|
(English only)
|
|
10/11/2010
|
|
|
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Procedural advice on the certification of quality and non-clinical data for small and medium-sized enterprises developing advanced therapy medicinal products
|
(English only)
|
adopted
|
17/04/2009
|
10/11/2010
|
|
|
Overview of comments received on procedural advice on the certification of quality and non-clinical data for small and medium-sized enterprises developing advanced therapy medicinal products
|
(English only)
|
|
10/11/2010
|
|
|
|
Procedural advice on the provision of scientific recommendation of classification of advanced therapy medicinal products in accordance with article 17 of regulation (EC) NO 1394/2007
|
(English only)
|
draft
|
05/02/2010
|
|
|
|
Procedural advice on the provision of scientific recommendation on classification of advanced therapy medicinal products in accordance with Article 17 of Regulation (EC) No 1394/2007
|
(English only)
|
adopted
|
22/02/2010
|
|
|
|
Overview of comments received on 'Procedural Advice on the Provision of Scientific Recommendation on Classification of Advanced Therapy Medicinal Products in Accordance with Article 17 of Regulation (EC) No. 1394/2007' (EMA/CAT/99623/2009)
|
(English only)
|
|
22/02/2010
|
|
|
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Scientific recommendation on classification of advanced therapy medicinal products: Request form and briefing information Article 17 - Regulation (EC) No 1394/2007
|
(English only)
|
|
26/05/2009
|
17/03/2011
|
|
|
EMEA announcement: To manufacturers, companies and hospitals having advanced therapy medicinal products legally on the Community market in accordance with national or Community legislation
|
(English only)
|
|
31/07/2008
|
|
|
|
Procedural advice on the evaluation of advanced therapy medicinal products in accordance with article 8 of Regulation (EC) No 1394/2007
|
(English only)
|
draft: consultation closed
|
31/03/2009
|
|
|
|
Procedural advice on the re-examination of CHMP opinions
|
(English only)
|
draft: consultation closed
|
12/02/2009
|
|
|
|
Guideline on safety and efficacy follow-up - risk management of advanced therapy medicinal products
|
(English only)
|
adopted
|
20/11/2008
|
|
31/12/2008
|
