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The certification procedure is one of the new procedures provided for Advanced Therapy Medicinal Products (ATMPs) in the Regulation (EC) No 1394/2007 on advanced therapy medicinal products. The regulation provides for implementing provisions for the certification procedure.
The certification procedure is the scientific evaluation by the Committee for Advanced Therapies (CAT) of quality and (where available) non-clinical data for ATMPs under development by Small and Medium-sized Enterprises (SMEs). Further to the scientific evaluation, the European Medicines Agency will issue a certificate. A 90-day procedure has been developed for the evaluation and certification.
For more information on the procedure for certification and on the content of an application for ATMP certification, please consult the following documents:
- Procedural advice on the Certification of quality and non-clinical data for small and medium-sized enterprises developing advanced therapy medicinal products
- Guideline on the minimum quality and non-clinical data for certification of advanced therapy medicinal products
To notify us of a future ATMP certification, please complete the below Pre-submission request form (Intent to submit ATMP certification) and return it to: pa-bus@ema.europa.eu
For the submission of an ATMP certification request, please complete the below Pre-submission request form (ATMP certification) and provide the ‘Annexes to the application form’ and the ‘Application (dossier) for certification’ (in line with the Scientific Guideline on minimum quality and non-clinical data for certification of advanced therapy medicinal product), and return to: pa-bus@ema.europa.eu
- Pre-submission request form (Intent to submit ATMP certification)
- Pre-submission request form (ATMP certification)
- Annexes to the application form
Submission deadlines for ATMP certification for 2011
| Submission of draft application | Submission of final application | Start of procedure | Coordinator’s evaluation report | Comments for CAT members and peer reviewer(s) | Consolidated evaluation report | Discussion at CAT (Day 60) | CAT adoption of opinion (provided that no need for written/oral explanation) |
|---|---|---|---|---|---|---|---|
| 28/11/2011 | 06/01/2012 | 16/0/2012 | 20/02/2012 | 27/02/2012 | 02/03/2012 | 09/03/2012 | 13/04/2012 |
| 03/01/2012 | 06/02/2012 | 16/02/2012 | 26/03/2012 | 02/04/2012 | 10/04/2012 | 13/04/2012 | 16/05/2012 |
| 02/02/2012 | 12/03/2012 | 22/03/2012 | 30/04/2012 | 07/05/2012 | 10/05/2012 | 16/05/2012 | 15/06/2012 |
| 06/03/2012 | 13/04/2012 | 24/04/2012 | 29/05/2012 | 04/06/2012 | 08/06/2012 | 15/06/2012 | 13/07/2012 |
| 02/04/2012 | 11/05/2012 | 21/05/2012 | 25/06/2012 | 02/07/2012 | 06/07/2012 | 13/07/2012 | 17/08/2012 |
| NA | NA | NA | NA | NA | NA | NA | NA |
| 25/05/2012 | 06/07/2012 | 16/07/2012 | 28/08/2012 | 03/09/2012 | 07/09/2012 | 14/09/2012 | 12/10/2012 |
| 02/07/2012 | 10/08/2012 | 20/08/2012 | 24/09/2012 | 01/10/202 | 05/10/2012 | 12/10/2012 | 09/11/2012 |
| 30/07/2012 | 07/09/2012 | 17/09/2012 | 22/10/2012 | 29/10/2012 | 05/11/2012 | 09/11/2012 | 07/12/2012 |
| 24/08/2012 | 05/10/2012 | 15/10/2012 | 19/11/2012 | 26/11/2012 | 30/11/2012 | 07/12/2012 | 11/01/2013 |
| 01/10/2012 | 09/11/2012 | 19/11/2012 | 03/01/2013 | 07/01/2013 | 09/01/2013 | 11/01/2013 | 15/02/2013 |
| 15/11/2012 | 21/12/2012 | 03/01/2013 | 28/01/2013 | 04/02/2013 | 08/02/2013 | 15/02/2013 | 15/03/2013 |
| 03/12/2012 | 11/01/2013 | 21/01/2013 | 25/02/2013 | 04/03/2013 | 08/03/2013 | 15/03/2013 | 19/04/2013 |
| 07/01/2013 | 15/02/2013 | 25/02/2013 | 02/04/2013 | 08/04/2013 | 12/04/2013 | 19/04/2013 | 24/05/2013 |
| 04/02/2013 | 15/03/2013 | 25/03/2013 | 06/05/2013 | 13/05/2013 | 17/05/2013 | 24/05/2013 | 21/06/2013 |
| 04/03/2013 | 12/04/2013 | 22/04/2013 | 03/06/2013 | 10/06/2013 | 14/06/2013 | 21/06/2013 | 19/07/2013 |
| 09/04/2013 | 17/05/2013 | 28/05/2013 | 01/07/2013 | 08/07/2013 | 12/07/2013 | 19/07/2013 | 16/08/2013 |
Related information
Contact point
- Questions relating specifically to the authorisation of advanced therapy medicinal products may be submitted to: AdvancedTherapies @ema.europa.eu
- SMEs planning to submit an application for certification in the next months should contact AdvancedTherapies @ema.europa.eu for further assistance.
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