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Recommendations on submission dates for applicants of the DCP December 2008 Page 1 of 24 RECOMMENDATIONS ON SUBMISSION DATES FOR APPLICANTS OF THE DECENTRALISED PROCEDURE (DCP) Doc. Ref.: CMDh/005/2005/Rev3 December 2008 This document was produced by the CMD(h) in order to facilitate planning of submission dates of new applications going through the decentralised procedure. National holidays have not been taken into account when calculating the latest submission dates given in the Annexes; applicants therefore have to consider this issue to allow 14 calendar days for validation for all Concerned Member States (CMS). Reference is made to the CMD(h) Procedural Advice “Procedure for Automatic Validation of MR Procedures for New Applications” and “Decentralised Procedure Member States’ Standard Operating Procedure”. The CMD(h) would strongly advise applicants to discuss a timetable for the procedure with the Reference Member State (RMS) before the dossier is submitted to the CMS(s) and the RMS. This paper is meant as guidance and deviations might be accepted in certain cases provided that all involved parties agree. The CMD(h) has decided that the following principles would apply in order to ensure that crucial dates do not fall over the Christmas/New Year period (24 December to 1 January) i. Validation will not take place in the period 24 December to 1 January. Full 14 calendar days should be allowed outside this period It might be preferable to split up the validation phase in two schemes, e.g. 7 days before Christmas and 7 days after New Year. Example: Submission on 16 December will allow 7 days of validation before Christmas and 7 days after New Year. The procedure can then be started on 8 January. ii. Day 70 should not occur between 24 December and 1 January unless agreed with the RMS iii. Day 100 to 105 should not occur between 24 December and 1 January iv. Day 205 to 210 (day 85-day 90 in Assessment step II) should not fall between 24 December and 1 January Annex A provides information about submission dates, start date of the procedure and other important deadlines for Assessment step I within the Decentralised procedure. Annex B provides information that will enable RMS and the applicant to plan the timetable for Assessment step II within the Decentralised procedure. In Annex B the meeting days of the Coordination group are accentuated at day 195 (75) of the European assessment process followed by ****. CMD(h) would like to draw applicants attention to the CMD(h) document "Best Practice Guide on Break-out session (Revision 4, July 2006)" if a break-out session is considered during Assessment step II of the procedure. Used abbreviations and comments, Annex A and B: * PrAR = Preliminary Assessment Report

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Page 1: RECOMMENDATIONS ON SUBMISSION DATES FOR APPLICANTS … · In Annex B the meeting days of the Coordination group are accentuated at day 195 (75) of the European assessment process

Recommendations on submission dates for applicants of the DCP December 2008 Page 1 of 24

RECOMMENDATIONS ON SUBMISSION DATES FOR APPLICANTS OF THE DECENTRALISED PROCEDURE (DCP)

Doc. Ref.: CMDh/005/2005/Rev3

December 2008

This document was produced by the CMD(h) in order to facilitate planning of submission dates of new applications going through the decentralised procedure. National holidays have not been taken into account when calculating the latest submission dates given in the Annexes; applicants therefore have to consider this issue to allow 14 calendar days for validation for all Concerned Member States (CMS). Reference is made to the CMD(h) Procedural Advice “Procedure for Automatic Validation of MR Procedures for New Applications” and “Decentralised Procedure Member States’ Standard Operating Procedure”. The CMD(h) would strongly advise applicants to discuss a timetable for the procedure with the Reference Member State (RMS) before the dossier is submitted to the CMS(s) and the RMS. This paper is meant as guidance and deviations might be accepted in certain cases provided that all involved parties agree. The CMD(h) has decided that the following principles would apply in order to ensure that crucial dates do not fall over the Christmas/New Year period (24 December to 1 January) i. Validation will not take place in the period 24 December to 1 January. Full 14 calendar days should

be allowed outside this period It might be preferable to split up the validation phase in two schemes, e.g. 7 days before Christmas and 7 days after New Year. Example: Submission on 16 December will allow 7 days of validation before Christmas and 7 days after New Year. The procedure can then be started on 8 January.

ii. Day 70 should not occur between 24 December and 1 January unless agreed with the RMS

iii. Day 100 to 105 should not occur between 24 December and 1 January iv. Day 205 to 210 (day 85-day 90 in Assessment step II) should not fall between 24 December and 1

January Annex A provides information about submission dates, start date of the procedure and other important deadlines for Assessment step I within the Decentralised procedure. Annex B provides information that will enable RMS and the applicant to plan the timetable for Assessment step II within the Decentralised procedure. In Annex B the meeting days of the Coordination group are accentuated at day 195 (75) of the European assessment process followed by ****. CMD(h) would like to draw applicants attention to the CMD(h) document "Best Practice Guide on Break-out session (Revision 4, July 2006)" if a break-out session is considered during Assessment step II of the procedure. Used abbreviations and comments, Annex A and B: * PrAR = Preliminary Assessment Report

Page 2: RECOMMENDATIONS ON SUBMISSION DATES FOR APPLICANTS … · In Annex B the meeting days of the Coordination group are accentuated at day 195 (75) of the European assessment process

Recommendations on submission dates for applicants of the DCP December 2008 Page 2 of 24

** DAR = Draft Assessment Report *** n.a. = Not Applicable **** Refers to the meeting days of the Coordination Group and the possible dates for break-out sessions (August

meetings and third day of the CMD(h) only if needed) ¤ Indicate that these dates fall between 24 December and 1 January ¤¤ Indicate that the validation is split into two phases

Page 3: RECOMMENDATIONS ON SUBMISSION DATES FOR APPLICANTS … · In Annex B the meeting days of the Coordination group are accentuated at day 195 (75) of the European assessment process

Recommendations on submission dates for applicants of the DCP December 2008 Page 3 of 24

Annex A - Assessment step I

Latest submission date

Start of procedure Date of PrAR* CMS comments

on PrAR* Clock stop

Day - 14 Day 0 Day + 70 Day + 100 Day + 105 02-01-2009 16-01-2009 27-03-2009 26-04-2009 01-05-2009 03-01-2009 17-01-2009 28-03-2009 27-04-2009 02-05-2009 04-01-2009 18-01-2009 29-03-2009 28-04-2009 03-05-2009 05-01-2009 19-01-2009 30-03-2009 29-04-2009 04-05-2009 06-01-2009 20-01-2009 31-03-2009 30-04-2009 05-05-2009 07-01-2009 21-01-2009 01-04-2009 01-05-2009 06-05-2009 08-01-2009 22-01-2009 02-04-2009 02-05-2009 07-05-2009 09-01-2009 23-01-2009 03-04-2009 03-05-2009 08-05-2009 10-01-2009 24-01-2009 04-04-2009 04-05-2009 09-05-2009 11-01-2009 25-01-2009 05-04-2009 05-05-2009 10-05-2009 12-01-2009 26-01-2009 06-04-2009 06-05-2009 11-05-2009 13-01-2009 27-01-2009 07-04-2009 07-05-2009 12-05-2009 14-01-2009 28-01-2009 08-04-2009 08-05-2009 13-05-2009 15-01-2009 29-01-2009 09-04-2009 09-05-2009 14-05-2009 16-01-2009 30-01-2009 10-04-2009 10-05-2009 15-05-2009 17-01-2009 31-01-2009 11-04-2009 11-05-2009 16-05-2009 18-01-2009 01-02-2009 12-04-2009 12-05-2009 17-05-2009 19-01-2009 02-02-2009 13-04-2009 13-05-2009 18-05-2009 20-01-2009 03-02-2009 14-04-2009 14-05-2009 19-05-2009 21-01-2009 04-02-2009 15-04-2009 15-05-2009 20-05-2009 22-01-2009 05-02-2009 16-04-2009 16-05-2009 21-05-2009 23-01-2009 06-02-2009 17-04-2009 17-05-2009 22-05-2009 24-01-2009 07-02-2009 18-04-2009 18-05-2009 23-05-2009 25-01-2009 08-02-2009 19-04-2009 19-05-2009 24-05-2009 26-01-2009 09-02-2009 20-04-2009 20-05-2009 25-05-2009 27-01-2009 10-02-2009 21-04-2009 21-05-2009 26-05-2009 28-01-2009 11-02-2009 22-04-2009 22-05-2009 27-05-2009 29-01-2009 12-02-2009 23-04-2009 23-05-2009 28-05-2009 30-01-2009 13-02-2009 24-04-2009 24-05-2009 29-05-2009 31-01-2009 14-02-2009 25-04-2009 25-05-2009 30-05-2009 01-02-2009 15-02-2009 26-04-2009 26-05-2009 31-05-2009 02-02-2009 16-02-2009 27-04-2009 27-05-2009 01-06-2009 03-02-2009 17-02-2009 28-04-2009 28-05-2009 02-06-2009 04-02-2009 18-02-2009 29-04-2009 29-05-2009 03-06-2009 05-02-2009 19-02-2009 30-04-2009 30-05-2009 04-06-2009 06-02-2009 20-02-2009 01-05-2009 31-05-2009 05-06-2009 07-02-2009 21-02-2009 02-05-2009 01-06-2009 06-06-2009 08-02-2009 22-02-2009 03-05-2009 02-06-2009 07-06-2009 09-02-2009 23-02-2009 04-05-2009 03-06-2009 08-06-2009 10-02-2009 24-02-2009 05-05-2009 04-06-2009 09-06-2009

Page 4: RECOMMENDATIONS ON SUBMISSION DATES FOR APPLICANTS … · In Annex B the meeting days of the Coordination group are accentuated at day 195 (75) of the European assessment process

Recommendations on submission dates for applicants of the DCP December 2008 Page 4 of 24

Latest submission date

Start of procedure Date of PrAR* CMS comments

on PrAR* Clock stop

Day - 14 Day 0 Day + 70 Day + 100 Day + 105 11-02-2009 25-02-2009 06-05-2009 05-06-2009 10-06-2009 12-02-2009 26-02-2009 07-05-2009 06-06-2009 11-06-2009 13-02-2009 27-02-2009 08-05-2009 07-06-2009 12-06-2009 14-02-2009 28-02-2009 09-05-2009 08-06-2009 13-06-2009 15-02-2009 01-03-2009 10-05-2009 09-06-2009 14-06-2009 16-02-2009 02-03-2009 11-05-2009 10-06-2009 15-06-2009 17-02-2009 03-03-2009 12-05-2009 11-06-2009 16-06-2009 18-02-2009 04-03-2009 13-05-2009 12-06-2009 17-06-2009 19-02-2009 05-03-2009 14-05-2009 13-06-2009 18-06-2009 20-02-2009 06-03-2009 15-05-2009 14-06-2009 19-06-2009 21-02-2009 07-03-2009 16-05-2009 15-06-2009 20-06-2009 22-02-2009 08-03-2009 17-05-2009 16-06-2009 21-06-2009 23-02-2009 09-03-2009 18-05-2009 17-06-2009 22-06-2009 24-02-2009 10-03-2009 19-05-2009 18-06-2009 23-06-2009 25-02-2009 11-03-2009 20-05-2009 19-06-2009 24-06-2009 26-02-2009 12-03-2009 21-05-2009 20-06-2009 25-06-2009 27-02-2009 13-03-2009 22-05-2009 21-06-2009 26-06-2009 28-02-2009 14-03-2009 23-05-2009 22-06-2009 27-06-2009 01-03-2009 15-03-2009 24-05-2009 23-06-2009 28-06-2009 02-03-2009 16-03-2009 25-05-2009 24-06-2009 29-06-2009 03-03-2009 17-03-2009 26-05-2009 25-06-2009 30-06-2009 04-03-2009 18-03-2009 27-05-2009 26-06-2009 01-07-2009 05-03-2009 19-03-2009 28-05-2009 27-06-2009 02-07-2009 06-03-2009 20-03-2009 29-05-2009 28-06-2009 03-07-2009 07-03-2009 21-03-2009 30-05-2009 29-06-2009 04-07-2009 08-03-2009 22-03-2009 31-05-2009 30-06-2009 05-07-2009 09-03-2009 23-03-2009 01-06-2009 01-07-2009 06-07-2009 10-03-2009 24-03-2009 02-06-2009 02-07-2009 07-07-2009 11-03-2009 25-03-2009 03-06-2009 03-07-2009 08-07-2009 12-03-2009 26-03-2009 04-06-2009 04-07-2009 09-07-2009 13-03-2009 27-03-2009 05-06-2009 05-07-2009 10-07-2009 14-03-2009 28-03-2009 06-06-2009 06-07-2009 11-07-2009 15-03-2009 29-03-2009 07-06-2009 07-07-2009 12-07-2009 16-03-2009 30-03-2009 08-06-2009 08-07-2009 13-07-2009 17-03-2009 31-03-2009 09-06-2009 09-07-2009 14-07-2009 18-03-2009 01-04-2009 10-06-2009 10-07-2009 15-07-2009 19-03-2009 02-04-2009 11-06-2009 11-07-2009 16-07-2009 20-03-2009 03-04-2009 12-06-2009 12-07-2009 17-07-2009 21-03-2009 04-04-2009 13-06-2009 13-07-2009 18-07-2009 22-03-2009 05-04-2009 14-06-2009 14-07-2009 19-07-2009 23-03-2009 06-04-2009 15-06-2009 15-07-2009 20-07-2009 24-03-2009 07-04-2009 16-06-2009 16-07-2009 21-07-2009

Page 5: RECOMMENDATIONS ON SUBMISSION DATES FOR APPLICANTS … · In Annex B the meeting days of the Coordination group are accentuated at day 195 (75) of the European assessment process

Recommendations on submission dates for applicants of the DCP December 2008 Page 5 of 24

Latest submission date

Start of procedure Date of PrAR* CMS comments

on PrAR* Clock stop

Day - 14 Day 0 Day + 70 Day + 100 Day + 105 25-03-2009 08-04-2009 17-06-2009 17-07-2009 22-07-2009 26-03-2009 09-04-2009 18-06-2009 18-07-2009 23-07-2009 27-03-2009 10-04-2009 19-06-2009 19-07-2009 24-07-2009 28-03-2009 11-04-2009 20-06-2009 20-07-2009 25-07-2009 29-03-2009 12-04-2009 21-06-2009 21-07-2009 26-07-2009 30-03-2009 13-04-2009 22-06-2009 22-07-2009 27-07-2009 31-03-2009 14-04-2009 23-06-2009 23-07-2009 28-07-2009 01-04-2009 15-04-2009 24-06-2009 24-07-2009 29-07-2009 02-04-2009 16-04-2009 25-06-2009 25-07-2009 30-07-2009 03-04-2009 17-04-2009 26-06-2009 26-07-2009 31-07-2009 04-04-2009 18-04-2009 27-06-2009 27-07-2009 01-08-2009 05-04-2009 19-04-2009 28-06-2009 28-07-2009 02-08-2009 06-04-2009 20-04-2009 29-06-2009 29-07-2009 03-08-2009 07-04-2009 21-04-2009 30-06-2009 30-07-2009 04-08-2009 08-04-2009 22-04-2009 01-07-2009 31-07-2009 05-08-2009 09-04-2009 23-04-2009 02-07-2009 01-08-2009 06-08-2009 10-04-2009 24-04-2009 03-07-2009 02-08-2009 07-08-2009 11-04-2009 25-04-2009 04-07-2009 03-08-2009 08-08-2009 12-04-2009 26-04-2009 05-07-2009 04-08-2009 09-08-2009 13-04-2009 27-04-2009 06-07-2009 05-08-2009 10-08-2009 14-04-2009 28-04-2009 07-07-2009 06-08-2009 11-08-2009 15-04-2009 29-04-2009 08-07-2009 07-08-2009 12-08-2009 16-04-2009 30-04-2009 09-07-2009 08-08-2009 13-08-2009 17-04-2009 01-05-2009 10-07-2009 09-08-2009 14-08-2009 18-04-2009 02-05-2009 11-07-2009 10-08-2009 15-08-2009 19-04-2009 03-05-2009 12-07-2009 11-08-2009 16-08-2009 20-04-2009 04-05-2009 13-07-2009 12-08-2009 17-08-2009 21-04-2009 05-05-2009 14-07-2009 13-08-2009 18-08-2009 22-04-2009 06-05-2009 15-07-2009 14-08-2009 19-08-2009 23-04-2009 07-05-2009 16-07-2009 15-08-2009 20-08-2009 24-04-2009 08-05-2009 17-07-2009 16-08-2009 21-08-2009 25-04-2009 09-05-2009 18-07-2009 17-08-2009 22-08-2009 26-04-2009 10-05-2009 19-07-2009 18-08-2009 23-08-2009 27-04-2009 11-05-2009 20-07-2009 19-08-2009 24-08-2009 28-04-2009 12-05-2009 21-07-2009 20-08-2009 25-08-2009 29-04-2009 13-05-2009 22-07-2009 21-08-2009 26-08-2009 30-04-2009 14-05-2009 23-07-2009 22-08-2009 27-08-2009 01-05-2009 15-05-2009 24-07-2009 23-08-2009 28-08-2009 02-05-2009 16-05-2009 25-07-2009 24-08-2009 29-08-2009 03-05-2009 17-05-2009 26-07-2009 25-08-2009 30-08-2009 04-05-2009 18-05-2009 27-07-2009 26-08-2009 31-08-2009 05-05-2009 19-05-2009 28-07-2009 27-08-2009 01-09-2009

Page 6: RECOMMENDATIONS ON SUBMISSION DATES FOR APPLICANTS … · In Annex B the meeting days of the Coordination group are accentuated at day 195 (75) of the European assessment process

Recommendations on submission dates for applicants of the DCP December 2008 Page 6 of 24

Latest submission date

Start of procedure Date of PrAR* CMS comments

on PrAR* Clock stop

Day - 14 Day 0 Day + 70 Day + 100 Day + 105 06-05-2009 20-05-2009 29-07-2009 28-08-2009 02-09-2009 07-05-2009 21-05-2009 30-07-2009 29-08-2009 03-09-2009 08-05-2009 22-05-2009 31-07-2009 30-08-2009 04-09-2009 09-05-2009 23-05-2009 01-08-2009 31-08-2009 05-09-2009 10-05-2009 24-05-2009 02-08-2009 01-09-2009 06-09-2009 11-05-2009 25-05-2009 03-08-2009 02-09-2009 07-09-2009 12-05-2009 26-05-2009 04-08-2009 03-09-2009 08-09-2009 13-05-2009 27-05-2009 05-08-2009 04-09-2009 09-09-2009 14-05-2009 28-05-2009 06-08-2009 05-09-2009 10-09-2009 15-05-2009 29-05-2009 07-08-2009 06-09-2009 11-09-2009 16-05-2009 30-05-2009 08-08-2009 07-09-2009 12-09-2009 17-05-2009 31-05-2009 09-08-2009 08-09-2009 13-09-2009 18-05-2009 01-06-2009 10-08-2009 09-09-2009 14-09-2009 19-05-2009 02-06-2009 11-08-2009 10-09-2009 15-09-2009 20-05-2009 03-06-2009 12-08-2009 11-09-2009 16-09-2009 21-05-2009 04-06-2009 13-08-2009 12-09-2009 17-09-2009 22-05-2009 05-06-2009 14-08-2009 13-09-2009 18-09-2009 23-05-2009 06-06-2009 15-08-2009 14-09-2009 19-09-2009 24-05-2009 07-06-2009 16-08-2009 15-09-2009 20-09-2009 25-05-2009 08-06-2009 17-08-2009 16-09-2009 21-09-2009 26-05-2009 09-06-2009 18-08-2009 17-09-2009 22-09-2009 27-05-2009 10-06-2009 19-08-2009 18-09-2009 23-09-2009 28-05-2009 11-06-2009 20-08-2009 19-09-2009 24-09-2009 29-05-2009 12-06-2009 21-08-2009 20-09-2009 25-09-2009 30-05-2009 13-06-2009 22-08-2009 21-09-2009 26-09-2009 31-05-2009 14-06-2009 23-08-2009 22-09-2009 27-09-2009 01-06-2009 15-06-2009 24-08-2009 23-09-2009 28-09-2009 02-06-2009 16-06-2009 25-08-2009 24-09-2009 29-09-2009 03-06-2009 17-06-2009 26-08-2009 25-09-2009 30-09-2009 04-06-2009 18-06-2009 27-08-2009 26-09-2009 01-10-2009 05-06-2009 19-06-2009 28-08-2009 27-09-2009 02-10-2009 06-06-2009 20-06-2009 29-08-2009 28-09-2009 03-10-2009 07-06-2009 21-06-2009 30-08-2009 29-09-2009 04-10-2009 08-06-2009 22-06-2009 31-08-2009 30-09-2009 05-10-2009 09-06-2009 23-06-2009 01-09-2009 01-10-2009 06-10-2009 10-06-2009 24-06-2009 02-09-2009 02-10-2009 07-10-2009 11-06-2009 25-06-2009 03-09-2009 03-10-2009 08-10-2009 12-06-2009 26-06-2009 04-09-2009 04-10-2009 09-10-2009 13-06-2009 27-06-2009 05-09-2009 05-10-2009 10-10-2009 14-06-2009 28-06-2009 06-09-2009 06-10-2009 11-10-2009 15-06-2009 29-06-2009 07-09-2009 07-10-2009 12-10-2009 16-06-2009 30-06-2009 08-09-2009 08-10-2009 13-10-2009

Page 7: RECOMMENDATIONS ON SUBMISSION DATES FOR APPLICANTS … · In Annex B the meeting days of the Coordination group are accentuated at day 195 (75) of the European assessment process

Recommendations on submission dates for applicants of the DCP December 2008 Page 7 of 24

Latest submission date

Start of procedure Date of PrAR* CMS comments

on PrAR* Clock stop

Day - 14 Day 0 Day + 70 Day + 100 Day + 105 17-06-2009 01-07-2009 09-09-2009 09-10-2009 14-10-2009 18-06-2009 02-07-2009 10-09-2009 10-10-2009 15-10-2009 19-06-2009 03-07-2009 11-09-2009 11-10-2009 16-10-2009 20-06-2009 04-07-2009 12-09-2009 12-10-2009 17-10-2009 21-06-2009 05-07-2009 13-09-2009 13-10-2009 18-10-2009 22-06-2009 06-07-2009 14-09-2009 14-10-2009 19-10-2009 23-06-2009 07-07-2009 15-09-2009 15-10-2009 20-10-2009 24-06-2009 08-07-2009 16-09-2009 16-10-2009 21-10-2009 25-06-2009 09-07-2009 17-09-2009 17-10-2009 22-10-2009 26-06-2009 10-07-2009 18-09-2009 18-10-2009 23-10-2009 27-06-2009 11-07-2009 19-09-2009 19-10-2009 24-10-2009 28-06-2009 12-07-2009 20-09-2009 20-10-2009 25-10-2009 29-06-2009 13-07-2009 21-09-2009 21-10-2009 26-10-2009 30-06-2009 14-07-2009 22-09-2009 22-10-2009 27-10-2009 01-07-2009 15-07-2009 23-09-2009 23-10-2009 28-10-2009 02-07-2009 16-07-2009 24-09-2009 24-10-2009 29-10-2009 03-07-2009 17-07-2009 25-09-2009 25-10-2009 30-10-2009 04-07-2009 18-07-2009 26-09-2009 26-10-2009 31-10-2009 05-07-2009 19-07-2009 27-09-2009 27-10-2009 01-11-2009 06-07-2009 20-07-2009 28-09-2009 28-10-2009 02-11-2009 07-07-2009 21-07-2009 29-09-2009 29-10-2009 03-11-2009 08-07-2009 22-07-2009 30-09-2009 30-10-2009 04-11-2009 09-07-2009 23-07-2009 01-10-2009 31-10-2009 05-11-2009 10-07-2009 24-07-2009 02-10-2009 01-11-2009 06-11-2009 11-07-2009 25-07-2009 03-10-2009 02-11-2009 07-11-2009 12-07-2009 26-07-2009 04-10-2009 03-11-2009 08-11-2009 13-07-2009 27-07-2009 05-10-2009 04-11-2009 09-11-2009 14-07-2009 28-07-2009 06-10-2009 05-11-2009 10-11-2009 15-07-2009 29-07-2009 07-10-2009 06-11-2009 11-11-2009 16-07-2009 30-07-2009 08-10-2009 07-11-2009 12-11-2009 17-07-2009 31-07-2009 09-10-2009 08-11-2009 13-11-2009 18-07-2009 01-08-2009 10-10-2009 09-11-2009 14-11-2009 19-07-2009 02-08-2009 11-10-2009 10-11-2009 15-11-2009 20-07-2009 03-08-2009 12-10-2009 11-11-2009 16-11-2009 21-07-2009 04-08-2009 13-10-2009 12-11-2009 17-11-2009 22-07-2009 05-08-2009 14-10-2009 13-11-2009 18-11-2009 23-07-2009 06-08-2009 15-10-2009 14-11-2009 19-11-2009 24-07-2009 07-08-2009 16-10-2009 15-11-2009 20-11-2009 25-07-2009 08-08-2009 17-10-2009 16-11-2009 21-11-2009 26-07-2009 09-08-2009 18-10-2009 17-11-2009 22-11-2009 27-07-2009 10-08-2009 19-10-2009 18-11-2009 23-11-2009 28-07-2009 11-08-2009 20-10-2009 19-11-2009 24-11-2009

Page 8: RECOMMENDATIONS ON SUBMISSION DATES FOR APPLICANTS … · In Annex B the meeting days of the Coordination group are accentuated at day 195 (75) of the European assessment process

Recommendations on submission dates for applicants of the DCP December 2008 Page 8 of 24

Latest submission date

Start of procedure Date of PrAR* CMS comments

on PrAR* Clock stop

Day - 14 Day 0 Day + 70 Day + 100 Day + 105 29-07-2009 12-08-2009 21-10-2009 20-11-2009 25-11-2009 30-07-2009 13-08-2009 22-10-2009 21-11-2009 26-11-2009 31-07-2009 14-08-2009 23-10-2009 22-11-2009 27-11-2009 01-08-2009 15-08-2009 24-10-2009 23-11-2009 28-11-2009 02-08-2009 16-08-2009 25-10-2009 24-11-2009 29-11-2009 03-08-2009 17-08-2009 26-10-2009 25-11-2009 30-11-2009 04-08-2009 18-08-2009 27-10-2009 26-11-2009 01-12-2009 05-08-2009 19-08-2009 28-10-2009 27-11-2009 02-12-2009 06-08-2009 20-08-2009 29-10-2009 28-11-2009 03-12-2009 07-08-2009 21-08-2009 30-10-2009 29-11-2009 04-12-2009 08-08-2009 22-08-2009 31-10-2009 30-11-2009 05-12-2009 09-08-2009 23-08-2009 01-11-2009 01-12-2009 06-12-2009 10-08-2009 24-08-2009 02-11-2009 02-12-2009 07-12-2009 11-08-2009 25-08-2009 03-11-2009 03-12-2009 08-12-2009 12-08-2009 26-08-2009 04-11-2009 04-12-2009 09-12-2009 13-08-2009 27-08-2009 05-11-2009 05-12-2009 10-12-2009 14-08-2009 28-08-2009 06-11-2009 06-12-2009 11-12-2009 15-08-2009 29-08-2009 07-11-2009 07-12-2009 12-12-2009 16-08-2009 30-08-2009 08-11-2009 08-12-2009 13-12-2009 17-08-2009 31-08-2009 09-11-2009 09-12-2009 14-12-2009 18-08-2009 01-09-2009 10-11-2009 10-12-2009 15-12-2009 19-08-2009 02-09-2009 11-11-2009 11-12-2009 16-12-2009 20-08-2009 03-09-2009 12-11-2009 12-12-2009 17-12-2009 21-08-2009 04-09-2009 13-11-2009 13-12-2009 18-12-2009 22-08-2009 05-09-2009 14-11-2009 14-12-2009 19-12-2009 23-08-2009 06-09-2009 15-11-2009 15-12-2009 20-12-2009 24-08-2009 07-09-2009 16-11-2009 16-12-2009 21-12-2009 25-08-2009 08-09-2009 17-11-2009 17-12-2009 22-12-2009 26-08-2009 09-09-2009 18-11-2009 18-12-2009 23-12-2009

n.a.*** n.a. 19-11-2009 19-12-2009 24-12-2009¤ n.a. n.a. 20-11-2009 20-12-2009 25-12-2009 n.a. n.a. 21-11-2009 21-12-2009 26-12-2009 n.a. n.a. 22-11-2009 22-12-2009 27-12-2009 n.a. n.a. 23-11-2009 23-12-2009 28-12-2009 n.a. n.a. 24-11-2009 24-12-2009¤ 29-12-2009 n.a. n.a. 25-11-2009 25-12-2009 30-12-2009 n.a. n.a. 26-11-2009 26-12-2009 31-12-2009 n.a. n.a. 27-11-2009 27-12-2009 01-01-2010 n.a. n.a. 28-11-2009 28-12-2009 02-01-2010 n.a. n.a. 29-11-2009 29-12-2009 03-01-2010 n.a. n.a. 30-11-2009 30-12-2009 04-01-2010 n.a. n.a. 01-12-2009 31-12-2009 05-01-2010

Page 9: RECOMMENDATIONS ON SUBMISSION DATES FOR APPLICANTS … · In Annex B the meeting days of the Coordination group are accentuated at day 195 (75) of the European assessment process

Recommendations on submission dates for applicants of the DCP December 2008 Page 9 of 24

Latest submission date

Start of procedure Date of PrAR* CMS comments

on PrAR* Clock stop

Day - 14 Day 0 Day + 70 Day + 100 Day + 105 n.a. n.a. 02-12-2009 01-01-2010 06-01-2010

10-09-2009 24-09-2009 03-12-2009 02-01-2010 07-01-2010 11-09-2009 25-09-2009 04-12-2009 03-01-2010 08-01-2010 12-09-2009 26-09-2009 05-12-2009 04-01-2010 09-01-2010 13-09-2009 27-09-2009 06-12-2009 05-01-2010 10-01-2010 14-09-2009 28-09-2009 07-12-2009 06-01-2010 11-01-2010 15-09-2009 29-09-2009 08-12-2009 07-01-2010 12-01-2010 16-09-2009 30-09-2009 09-12-2009 08-01-2010 13-01-2010 17-09-2009 01-10-2009 10-12-2009 09-01-2010 14-01-2010 18-09-2009 02-10-2009 11-12-2009 10-01-2010 15-01-2010 19-09-2009 03-10-2009 12-12-2009 11-01-2010 16-01-2010 20-09-2009 04-10-2009 13-12-2009 12-01-2010 17-01-2010 21-09-2009 05-10-2009 14-12-2009 13-01-2010 18-01-2010 22-09-2009 06-10-2009 15-12-2009 14-01-2010 19-01-2010 23-09-2009 07-10-2009 16-12-2009 15-01-2010 20-01-2010 24-09-2009 08-10-2009 17-12-2009 16-01-2010 21-01-2010 25-09-2009 09-10-2009 18-12-2009 17-01-2010 22-01-2010 26-09-2009 10-10-2009 19-12-2009 18-01-2010 23-01-2010 27-09-2009 11-10-2009 20-12-2009 19-01-2010 24-01-2010 28-09-2009 12-10-2009 21-12-2009 20-01-2010 25-01-2010 29-09-2009 13-10-2009 22-12-2009 21-01-2010 26-01-2010 30-09-2009 14-10-2009 23-12-2009 22-01-2010 27-01-2010

n.a.*** n.a. 24-12-2009¤ 23-01-2010 28-01-2010 n.a. n.a. 25-12-2009 24-01-2010 29-01-2010 n.a. n.a. 26-12-2009 25-01-2010 30-01-2010 n.a. n.a. 27-12-2009 26-01-2010 31-01-2010 n.a. n.a. 28-12-2009 27-01-2010 01-02-2010 n.a. n.a. 29-12-2009 28-01-2010 02-02-2010 n.a. n.a. 30-12-2009 29-01-2010 03-02-2010 n.a. n.a. 31-12-2009 30-01-2010 04-02-2010 n.a. n.a. 01-01-2010 31-01-2010 05-02-2010

10-10-2009 24-10-2009 02-01-2010 01-02-2010 06-02-2010 11-10-2009 25-10-2009 03-01-2010 02-02-2010 07-02-2010 12-10-2009 26-10-2009 04-01-2010 03-02-2010 08-02-2010 13-10-2009 27-10-2009 05-01-2010 04-02-2010 09-02-2010 14-10-2009 28-10-2009 06-01-2010 05-02-2010 10-02-2010 15-10-2009 29-10-2009 07-01-2010 06-02-2010 11-02-2010 16-10-2009 30-10-2009 08-01-2010 07-02-2010 12-02-2010 17-10-2009 31-10-2009 09-01-2010 08-02-2010 13-02-2010 18-10-2009 01-11-2009 10-01-2010 09-02-2010 14-02-2010 19-10-2009 02-11-2009 11-01-2010 10-02-2010 15-02-2010 20-10-2009 03-11-2009 12-01-2010 11-02-2010 16-02-2010

Page 10: RECOMMENDATIONS ON SUBMISSION DATES FOR APPLICANTS … · In Annex B the meeting days of the Coordination group are accentuated at day 195 (75) of the European assessment process

Recommendations on submission dates for applicants of the DCP December 2008 Page 10 of 24

Latest submission date

Start of procedure Date of PrAR* CMS comments

on PrAR* Clock stop

Day - 14 Day 0 Day + 70 Day + 100 Day + 105 21-10-2009 04-11-2009 13-01-2010 12-02-2010 17-02-2010 22-10-2009 05-11-2009 14-01-2010 13-02-2010 18-02-2010 23-10-2009 06-11-2009 15-01-2010 14-02-2010 19-02-2010 24-10-2009 07-11-2009 16-01-2010 15-02-2010 20-02-2010 25-10-2009 08-11-2009 17-01-2010 16-02-2010 21-02-2010 26-10-2009 09-11-2009 18-01-2010 17-02-2010 22-02-2010 27-10-2009 10-11-2009 19-01-2010 18-02-2010 23-02-2010 28-10-2009 11-11-2009 20-01-2010 19-02-2010 24-02-2010 29-10-2009 12-11-2009 21-01-2010 20-02-2010 25-02-2010 30-10-2009 13-11-2009 22-01-2010 21-02-2010 26-02-2010 31-10-2009 14-11-2009 23-01-2010 22-02-2010 27-02-2010 01-11-2009 15-11-2009 24-01-2010 23-02-2010 28-02-2010 02-11-2009 16-11-2009 25-01-2010 24-02-2010 01-03-2010 03-11-2009 17-11-2009 26-01-2010 25-02-2010 02-03-2010 04-11-2009 18-11-2009 27-01-2010 26-02-2010 03-03-2010 05-11-2009 19-11-2009 28-01-2010 27-02-2010 04-03-2010 06-11-2009 20-11-2009 29-01-2010 28-02-2010 05-03-2010 07-11-2009 21-11-2009 30-01-2010 01-03-2010 06-03-2010 08-11-2009 22-11-2009 31-01-2010 02-03-2010 07-03-2010 09-11-2009 23-11-2009 01-02-2010 03-03-2010 08-03-2010 10-11-2009 24-11-2009 02-02-2010 04-03-2010 09-03-2010 11-11-2009 25-11-2009 03-02-2010 05-03-2010 10-03-2010 12-11-2009 26-11-2009 04-02-2010 06-03-2010 11-03-2010 13-11-2009 27-11-2009 05-02-2010 07-03-2010 12-03-2010 14-11-2009 28-11-2009 06-02-2010 08-03-2010 13-03-2010 15-11-2009 29-11-2009 07-02-2010 09-03-2010 14-03-2010 16-11-2009 30-11-2009 08-02-2010 10-03-2010 15-03-2010 17-11-2009 01-12-2009 09-02-2010 11-03-2010 16-03-2010 18-11-2009 02-12-2009 10-02-2010 12-03-2010 17-03-2010 19-11-2009 03-12-2009 11-02-2010 13-03-2010 18-03-2010 20-11-2009 04-12-2009 12-02-2010 14-03-2010 19-03-2010 21-11-2009 05-12-2009 13-02-2010 15-03-2010 20-03-2010 22-11-2009 06-12-2009 14-02-2010 16-03-2010 21-03-2010 23-11-2009 07-12-2009 15-02-2010 17-03-2010 22-03-2010 24-11-2009 08-12-2009 16-02-2010 18-03-2010 23-03-2010 25-11-2009 09-12-2009 17-02-2010 19-03-2010 24-03-2010 26-11-2009 10-12-2009 18-02-2010 20-03-2010 25-03-2010 27-11-2009 11-12-2009 19-02-2010 21-03-2010 26-03-2010 28-11-2009 12-12-2009 20-02-2010 22-03-2010 27-03-2010 29-11-2009 13-12-2009 21-02-2010 23-03-2010 28-03-2010 30-11-2009 14-12-2009 22-02-2010 24-03-2010 29-03-2010 01-12-2009 15-12-2009 23-02-2010 25-03-2010 30-03-2010

Page 11: RECOMMENDATIONS ON SUBMISSION DATES FOR APPLICANTS … · In Annex B the meeting days of the Coordination group are accentuated at day 195 (75) of the European assessment process

Recommendations on submission dates for applicants of the DCP December 2008 Page 11 of 24

Latest submission date

Start of procedure Date of PrAR*

CMS comments on PrAR* Clock stop

Day - 14 Day 0 Day + 70 Day + 100 Day + 105 02-12-2009 16-12-2009 24-02-2010 26-03-2010 31-03-2010 03-12-2009 17-12-2009 25-02-2010 27-03-2010 01-04-2010 04-12-2009 18-12-2009 26-02-2010 28-03-2010 02-04-2010 05-12-2009 19-12-2009 27-02-2010 29-03-2010 03-04-2010 06-12-2009 20-12-2009 28-02-2010 30-03-2010 04-04-2010 07-12-2009 21-12-2009 01-03-2010 31-03-2010 05-04-2010 08-12-2009 22-12-2009 02-03-2010 01-04-2010 06-04-2010 09-12-2009 23-12-2009 03-03-2010 02-04-2010 07-04-2010 10-12-2009 02-01-2010¤¤ 13-03-2010 12-04-2010 17-04-2010 11-12-2009 03-01-2010 14-03-2010 13-04-2010 18-04-2010 12-12-2009 04-01-2010 15-03-2010 14-04-2010 19-04-2010 13-12-2009 05-01-2010 16-03-2010 15-04-2010 20-04-2010 14-12-2009 06-01-2010 17-03-2010 16-04-2010 21-04-2010 15-12-2009 07-01-2010 18-03-2010 17-04-2010 22-04-2010 16-12-2009 08-01-2010 19-03-2010 18-04-2010 23-04-2010 17-12-2009 09-01-2010 20-03-2010 19-04-2010 24-04-2010 18-12-2009 10-01-2010 21-03-2010 20-04-2010 25-04-2010 19-12-2009 11-01-2010 22-03-2010 21-04-2010 26-04-2010 20-12-2009 12-01-2010 23-03-2010 22-04-2010 27-04-2010 21-12-2009 13-01-2010 24-03-2010 23-04-2010 28-04-2010 22-12-2009 14-01-2010 25-03-2010 24-04-2010 29-04-2010 23-12-2009 15-01-2010 26-03-2010 25-04-2010 30-04-2010

n.a.*** n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a.

Page 12: RECOMMENDATIONS ON SUBMISSION DATES FOR APPLICANTS … · In Annex B the meeting days of the Coordination group are accentuated at day 195 (75) of the European assessment process

Recommendations on submission dates for applicants of the DCP December 2008 Page 12 of 24

Annex B - Assessment step II

Applicant´s submission of

Response

Start of procedure RMS sends

DAR**

CMS comments on

DAR

Possible break-out session

CMS final position

Closure of procedure or

referral to CMD

Day + 106 Day + 120 (0) Day + 145 (25) Day + 195 (75) Day + 205 (85) Day + 210 (90) 02-01-2009 16-01-2009 10-02-2009 01-04-2009 11-04-2009 16-04-2009 03-01-2009 17-01-2009 11-02-2009 02-04-2009 12-04-2009 17-04-2009 04-01-2009 18-01-2009 12-02-2009 03-04-2009 13-04-2009 18-04-2009 05-01-2009 19-01-2009 13-02-2009 04-04-2009 14-04-2009 19-04-2009 06-01-2009 20-01-2009 14-02-2009 05-04-2009 15-04-2009 20-04-2009 07-01-2009 21-01-2009 15-02-2009 06-04-2009 16-04-2009 21-04-2009 08-01-2009 22-01-2009 16-02-2009 07-04-2009 17-04-2009 22-04-2009 09-01-2009 23-01-2009 17-02-2009 08-04-2009 18-04-2009 23-04-2009 10-01-2009 24-01-2009 18-02-2009 09-04-2009 19-04-2009 24-04-2009 11-01-2009 25-01-2009 19-02-2009 10-04-2009 20-04-2009 25-04-2009 12-01-2009 26-01-2009 20-02-2009 11-04-2009 21-04-2009 26-04-2009 13-01-2009 27-01-2009 21-02-2009 12-04-2009 22-04-2009 27-04-2009 14-01-2009 28-01-2009 22-02-2009 13-04-2009 23-04-2009 28-04-2009 15-01-2009 29-01-2009 23-02-2009 14-04-2009 24-04-2009 29-04-2009 16-01-2009 30-01-2009 24-02-2009 15-04-2009 25-04-2009 30-04-2009 17-01-2009 31-01-2009 25-02-2009 16-04-2009 26-04-2009 01-05-2009 18-01-2009 01-02-2009 26-02-2009 17-04-2009 27-04-2009 02-05-2009 19-01-2009 02-02-2009 27-02-2009 18-04-2009 28-04-2009 03-05-2009 20-01-2009 03-02-2009 28-02-2009 19-04-2009 29-04-2009 04-05-2009 21-01-2009 04-02-2009 01-03-2009 20-04-2009**** 30-04-2009 05-05-2009 22-01-2009 05-02-2009 02-03-2009 21-04-2009**** 01-05-2009 06-05-2009 23-01-2009 06-02-2009 03-03-2009 22-04-2009**** 02-05-2009 07-05-2009 24-01-2009 07-02-2009 04-03-2009 23-04-2009 03-05-2009 08-05-2009 25-01-2009 08-02-2009 05-03-2009 24-04-2009 04-05-2009 09-05-2009 26-01-2009 09-02-2009 06-03-2009 25-04-2009 05-05-2009 10-05-2009 27-01-2009 10-02-2009 07-03-2009 26-04-2009 06-05-2009 11-05-2009 28-01-2009 11-02-2009 08-03-2009 27-04-2009 07-05-2009 12-05-2009 29-01-2009 12-02-2009 09-03-2009 28-04-2009 08-05-2009 13-05-2009 30-01-2009 13-02-2009 10-03-2009 29-04-2009 09-05-2009 14-05-2009 31-01-2009 14-02-2009 11-03-2009 30-04-2009 10-05-2009 15-05-2009 01-02-2009 15-02-2009 12-03-2009 01-05-2009 11-05-2009 16-05-2009 02-02-2009 16-02-2009 13-03-2009 02-05-2009 12-05-2009 17-05-2009 03-02-2009 17-02-2009 14-03-2009 03-05-2009 13-05-2009 18-05-2009 04-02-2009 18-02-2009 15-03-2009 04-05-2009 14-05-2009 19-05-2009 05-02-2009 19-02-2009 16-03-2009 05-05-2009 15-05-2009 20-05-2009 06-02-2009 20-02-2009 17-03-2009 06-05-2009 16-05-2009 21-05-2009 07-02-2009 21-02-2009 18-03-2009 07-05-2009 17-05-2009 22-05-2009 08-02-2009 22-02-2009 19-03-2009 08-05-2009 18-05-2009 23-05-2009 09-02-2009 23-02-2009 20-03-2009 09-05-2009 19-05-2009 24-05-2009

Page 13: RECOMMENDATIONS ON SUBMISSION DATES FOR APPLICANTS … · In Annex B the meeting days of the Coordination group are accentuated at day 195 (75) of the European assessment process

Recommendations on submission dates for applicants of the DCP December 2008 Page 13 of 24

Applicant´s submission of

Response

Start of procedure RMS sends

DAR**

CMS comments on

DAR

Possible break-out session

CMS final position

Closure of procedure or

referral to CMD

Day + 106 Day + 120 (0) Day + 145 (25) Day + 195 (75) Day + 205 (85) Day + 210 (90) 10-02-2009 24-02-2009 21-03-2009 10-05-2009 20-05-2009 25-05-2009 11-02-2009 25-02-2009 22-03-2009 11-05-2009 21-05-2009 26-05-2009 12-02-2009 26-02-2009 23-03-2009 12-05-2009 22-05-2009 27-05-2009 13-02-2009 27-02-2009 24-03-2009 13-05-2009 23-05-2009 28-05-2009 14-02-2009 28-02-2009 25-03-2009 14-05-2009 24-05-2009 29-05-2009 15-02-2009 01-03-2009 26-03-2009 15-05-2009 25-05-2009 30-05-2009 16-02-2009 02-03-2009 27-03-2009 16-05-2009 26-05-2009 31-05-2009 17-02-2009 03-03-2009 28-03-2009 17-05-2009 27-05-2009 01-06-2009 18-02-2009 04-03-2009 29-03-2009 18-05-2009 28-05-2009 02-06-2009 19-02-2009 05-03-2009 30-03-2009 19-05-2009 29-05-2009 03-06-2009 20-02-2009 06-03-2009 31-03-2009 20-05-2009 30-05-2009 04-06-2009 21-02-2009 07-03-2009 01-04-2009 21-05-2009 31-05-2009 05-06-2009 22-02-2009 08-03-2009 02-04-2009 22-05-2009 01-06-2009 06-06-2009 23-02-2009 09-03-2009 03-04-2009 23-05-2009 02-06-2009 07-06-2009 24-02-2009 10-03-2009 04-04-2009 24-05-2009 03-06-2009 08-06-2009 25-02-2009 11-03-2009 05-04-2009 25-05-2009**** 04-06-2009 09-06-2009 26-02-2009 12-03-2009 06-04-2009 26-05-2009**** 05-06-2009 10-06-2009 27-02-2009 13-03-2009 07-04-2009 27-05-2009**** 06-06-2009 11-06-2009 28-02-2009 14-03-2009 08-04-2009 28-05-2009 07-06-2009 12-06-2009 01-03-2009 15-03-2009 09-04-2009 29-05-2009 08-06-2009 13-06-2009 02-03-2009 16-03-2009 10-04-2009 30-05-2009 09-06-2009 14-06-2009 03-03-2009 17-03-2009 11-04-2009 31-05-2009 10-06-2009 15-06-2009 04-03-2009 18-03-2009 12-04-2009 01-06-2009 11-06-2009 16-06-2009 05-03-2009 19-03-2009 13-04-2009 02-06-2009 12-06-2009 17-06-2009 06-03-2009 20-03-2009 14-04-2009 03-06-2009 13-06-2009 18-06-2009 07-03-2009 21-03-2009 15-04-2009 04-06-2009 14-06-2009 19-06-2009 08-03-2009 22-03-2009 16-04-2009 05-06-2009 15-06-2009 20-06-2009 09-03-2009 23-03-2009 17-04-2009 06-06-2009 16-06-2009 21-06-2009 10-03-2009 24-03-2009 18-04-2009 07-06-2009 17-06-2009 22-06-2009 11-03-2009 25-03-2009 19-04-2009 08-06-2009 18-06-2009 23-06-2009 12-03-2009 26-03-2009 20-04-2009 09-06-2009 19-06-2009 24-06-2009 13-03-2009 27-03-2009 21-04-2009 10-06-2009 20-06-2009 25-06-2009 14-03-2009 28-03-2009 22-04-2009 11-06-2009 21-06-2009 26-06-2009 15-03-2009 29-03-2009 23-04-2009 12-06-2009 22-06-2009 27-06-2009 16-03-2009 30-03-2009 24-04-2009 13-06-2009 23-06-2009 28-06-2009 17-03-2009 31-03-2009 25-04-2009 14-06-2009 24-06-2009 29-06-2009 18-03-2009 01-04-2009 26-04-2009 15-06-2009 25-06-2009 30-06-2009 19-03-2009 02-04-2009 27-04-2009 16-06-2009 26-06-2009 01-07-2009 20-03-2009 03-04-2009 28-04-2009 17-06-2009 27-06-2009 02-07-2009 21-03-2009 04-04-2009 29-04-2009 18-06-2009 28-06-2009 03-07-2009 22-03-2009 05-04-2009 30-04-2009 19-06-2009 29-06-2009 04-07-2009 23-03-2009 06-04-2009 01-05-2009 20-06-2009 30-06-2009 05-07-2009

Page 14: RECOMMENDATIONS ON SUBMISSION DATES FOR APPLICANTS … · In Annex B the meeting days of the Coordination group are accentuated at day 195 (75) of the European assessment process

Recommendations on submission dates for applicants of the DCP December 2008 Page 14 of 24

Applicant´s submission of

Response

Start of procedure RMS sends

DAR**

CMS comments on

DAR

Possible break-out session

CMS final position

Closure of procedure or

referral to CMD

Day + 106 Day + 120 (0) Day + 145 (25) Day + 195 (75) Day + 205 (85) Day + 210 (90) 24-03-2009 07-04-2009 02-05-2009 21-06-2009 01-07-2009 06-07-2009 25-03-2009 08-04-2009 03-05-2009 22-06-2009**** 02-07-2009 07-07-2009 26-03-2009 09-04-2009 04-05-2009 23-06-2009**** 03-07-2009 08-07-2009 27-03-2009 10-04-2009 05-05-2009 24-06-2009**** 04-07-2009 09-07-2009 28-03-2009 11-04-2009 06-05-2009 25-06-2009 05-07-2009 10-07-2009 29-03-2009 12-04-2009 07-05-2009 26-06-2009 06-07-2009 11-07-2009 30-03-2009 13-04-2009 08-05-2009 27-06-2009 07-07-2009 12-07-2009 31-03-2009 14-04-2009 09-05-2009 28-06-2009 08-07-2009 13-07-2009 01-04-2009 15-04-2009 10-05-2009 29-06-2009 09-07-2009 14-07-2009 02-04-2009 16-04-2009 11-05-2009 30-06-2009 10-07-2009 15-07-2009 03-04-2009 17-04-2009 12-05-2009 01-07-2009 11-07-2009 16-07-2009 04-04-2009 18-04-2009 13-05-2009 02-07-2009 12-07-2009 17-07-2009 05-04-2009 19-04-2009 14-05-2009 03-07-2009 13-07-2009 18-07-2009 06-04-2009 20-04-2009 15-05-2009 04-07-2009 14-07-2009 19-07-2009 07-04-2009 21-04-2009 16-05-2009 05-07-2009 15-07-2009 20-07-2009 08-04-2009 22-04-2009 17-05-2009 06-07-2009 16-07-2009 21-07-2009 09-04-2009 23-04-2009 18-05-2009 07-07-2009 17-07-2009 22-07-2009 10-04-2009 24-04-2009 19-05-2009 08-07-2009 18-07-2009 23-07-2009 11-04-2009 25-04-2009 20-05-2009 09-07-2009 19-07-2009 24-07-2009 12-04-2009 26-04-2009 21-05-2009 10-07-2009 20-07-2009 25-07-2009 13-04-2009 27-04-2009 22-05-2009 11-07-2009 21-07-2009 26-07-2009 14-04-2009 28-04-2009 23-05-2009 12-07-2009 22-07-2009 27-07-2009 15-04-2009 29-04-2009 24-05-2009 13-07-2009 23-07-2009 28-07-2009 16-04-2009 30-04-2009 25-05-2009 14-07-2009 24-07-2009 29-07-2009 17-04-2009 01-05-2009 26-05-2009 15-07-2009 25-07-2009 30-07-2009 18-04-2009 02-05-2009 27-05-2009 16-07-2009 26-07-2009 31-07-2009 19-04-2009 03-05-2009 28-05-2009 17-07-2009 27-07-2009 01-08-2009 20-04-2009 04-05-2009 29-05-2009 18-07-2009 28-07-2009 02-08-2009 21-04-2009 05-05-2009 30-05-2009 19-07-2009 29-07-2009 03-08-2009 22-04-2009 06-05-2009 31-05-2009 20-07-2009**** 30-07-2009 04-08-2009 23-04-2009 07-05-2009 01-06-2009 21-07-2009**** 31-07-2009 05-08-2009 24-04-2009 08-05-2009 02-06-2009 22-07-2009**** 01-08-2009 06-08-2009 25-04-2009 09-05-2009 03-06-2009 23-07-2009 02-08-2009 07-08-2009 26-04-2009 10-05-2009 04-06-2009 24-07-2009 03-08-2009 08-08-2009 27-04-2009 11-05-2009 05-06-2009 25-07-2009 04-08-2009 09-08-2009 28-04-2009 12-05-2009 06-06-2009 26-07-2009 05-08-2009 10-08-2009 29-04-2009 13-05-2009 07-06-2009 27-07-2009 06-08-2009 11-08-2009 30-04-2009 14-05-2009 08-06-2009 28-07-2009 07-08-2009 12-08-2009 01-05-2009 15-05-2009 09-06-2009 29-07-2009 08-08-2009 13-08-2009 02-05-2009 16-05-2009 10-06-2009 30-07-2009 09-08-2009 14-08-2009 03-05-2009 17-05-2009 11-06-2009 31-07-2009 10-08-2009 15-08-2009 04-05-2009 18-05-2009 12-06-2009 01-08-2009 11-08-2009 16-08-2009

Page 15: RECOMMENDATIONS ON SUBMISSION DATES FOR APPLICANTS … · In Annex B the meeting days of the Coordination group are accentuated at day 195 (75) of the European assessment process

Recommendations on submission dates for applicants of the DCP December 2008 Page 15 of 24

Applicant´s submission of

Response

Start of procedure RMS sends

DAR**

CMS comments on

DAR

Possible break-out session

CMS final position

Closure of procedure or

referral to CMD

Day + 106 Day + 120 (0) Day + 145 (25) Day + 195 (75) Day + 205 (85) Day + 210 (90) 05-05-2009 19-05-2009 13-06-2009 02-08-2009 12-08-2009 17-08-2009 06-05-2009 20-05-2009 14-06-2009 03-08-2009 13-08-2009 18-08-2009 07-05-2009 21-05-2009 15-06-2009 04-08-2009 14-08-2009 19-08-2009 08-05-2009 22-05-2009 16-06-2009 05-08-2009 15-08-2009 20-08-2009 09-05-2009 23-05-2009 17-06-2009 06-08-2009 16-08-2009 21-08-2009 10-05-2009 24-05-2009 18-06-2009 07-08-2009 17-08-2009 22-08-2009 11-05-2009 25-05-2009 19-06-2009 08-08-2009 18-08-2009 23-08-2009 12-05-2009 26-05-2009 20-06-2009 09-08-2009 19-08-2009 24-08-2009 13-05-2009 27-05-2009 21-06-2009 10-08-2009 20-08-2009 25-08-2009 14-05-2009 28-05-2009 22-06-2009 11-08-2009 21-08-2009 26-08-2009 15-05-2009 29-05-2009 23-06-2009 12-08-2009 22-08-2009 27-08-2009 16-05-2009 30-05-2009 24-06-2009 13-08-2009 23-08-2009 28-08-2009 17-05-2009 31-05-2009 25-06-2009 14-08-2009 24-08-2009 29-08-2009 18-05-2009 01-06-2009 26-06-2009 15-08-2009 25-08-2009 30-08-2009 19-05-2009 02-06-2009 27-06-2009 16-08-2009 26-08-2009 31-08-2009 20-05-2009 03-06-2009 28-06-2009 17-08-2009 27-08-2009 01-09-2009 21-05-2009 04-06-2009 29-06-2009 18-08-2009 28-08-2009 02-09-2009 22-05-2009 05-06-2009 30-06-2009 19-08-2009 29-08-2009 03-09-2009 23-05-2009 06-06-2009 01-07-2009 20-08-2009 30-08-2009 04-09-2009 24-05-2009 07-06-2009 02-07-2009 21-08-2009 31-08-2009 05-09-2009 25-05-2009 08-06-2009 03-07-2009 22-08-2009 01-09-2009 06-09-2009 26-05-2009 09-06-2009 04-07-2009 23-08-2009 02-09-2009 07-09-2009 27-05-2009 10-06-2009 05-07-2009 24-08-2009 03-09-2009 08-09-2009 28-05-2009 11-06-2009 06-07-2009 25-08-2009 04-09-2009 09-09-2009 29-05-2009 12-06-2009 07-07-2009 26-08-2009 05-09-2009 10-09-2009 30-05-2009 13-06-2009 08-07-2009 27-08-2009 06-09-2009 11-09-2009 31-05-2009 14-06-2009 09-07-2009 28-08-2009 07-09-2009 12-09-2009 01-06-2009 15-06-2009 10-07-2009 29-08-2009 08-09-2009 13-09-2009 02-06-2009 16-06-2009 11-07-2009 30-08-2009 09-09-2009 14-09-2009 03-06-2009 17-06-2009 12-07-2009 31-08-2009 10-09-2009 15-09-2009 04-06-2009 18-06-2009 13-07-2009 01-09-2009 11-09-2009 16-09-2009 05-06-2009 19-06-2009 14-07-2009 02-09-2009 12-09-2009 17-09-2009 06-06-2009 20-06-2009 15-07-2009 03-09-2009 13-09-2009 18-09-2009 07-06-2009 21-06-2009 16-07-2009 04-09-2009 14-09-2009 19-09-2009 08-06-2009 22-06-2009 17-07-2009 05-09-2009 15-09-2009 20-09-2009 09-06-2009 23-06-2009 18-07-2009 06-09-2009 16-09-2009 21-09-2009 10-06-2009 24-06-2009 19-07-2009 07-09-2009 17-09-2009 22-09-2009 11-06-2009 25-06-2009 20-07-2009 08-09-2009 18-09-2009 23-09-2009 12-06-2009 26-06-2009 21-07-2009 09-09-2009 19-09-2009 24-09-2009 13-06-2009 27-06-2009 22-07-2009 10-09-2009 20-09-2009 25-09-2009 14-06-2009 28-06-2009 23-07-2009 11-09-2009 21-09-2009 26-09-2009 15-06-2009 29-06-2009 24-07-2009 12-09-2009 22-09-2009 27-09-2009

Page 16: RECOMMENDATIONS ON SUBMISSION DATES FOR APPLICANTS … · In Annex B the meeting days of the Coordination group are accentuated at day 195 (75) of the European assessment process

Recommendations on submission dates for applicants of the DCP December 2008 Page 16 of 24

Applicant´s submission of

Response

Start of procedure RMS sends

DAR**

CMS comments on

DAR

Possible break-out session

CMS final position

Closure of procedure or

referral to CMD

Day + 106 Day + 120 (0) Day + 145 (25) Day + 195 (75) Day + 205 (85) Day + 210 (90) 16-06-2009 30-06-2009 25-07-2009 13-09-2009 23-09-2009 28-09-2009 17-06-2009 01-07-2009 26-07-2009 14-09-2009 24-09-2009 29-09-2009 18-06-2009 02-07-2009 27-07-2009 15-09-2009 25-09-2009 30-09-2009 19-06-2009 03-07-2009 28-07-2009 16-09-2009 26-09-2009 01-10-2009 20-06-2009 04-07-2009 29-07-2009 17-09-2009 27-09-2009 02-10-2009 21-06-2009 05-07-2009 30-07-2009 18-09-2009 28-09-2009 03-10-2009 22-06-2009 06-07-2009 31-07-2009 19-09-2009 29-09-2009 04-10-2009 23-06-2009 07-07-2009 01-08-2009 20-09-2009 30-09-2009 05-10-2009 24-06-2009 08-07-2009 02-08-2009 21-09-2009**** 01-10-2009 06-10-2009 25-06-2009 09-07-2009 03-08-2009 22-09-2009**** 02-10-2009 07-10-2009 26-06-2009 10-07-2009 04-08-2009 23-09-2009**** 03-10-2009 08-10-2009 27-06-2009 11-07-2009 05-08-2009 24-09-2009 04-10-2009 09-10-2009 28-06-2009 12-07-2009 06-08-2009 25-09-2009 05-10-2009 10-10-2009 29-06-2009 13-07-2009 07-08-2009 26-09-2009 06-10-2009 11-10-2009 30-06-2009 14-07-2009 08-08-2009 27-09-2009 07-10-2009 12-10-2009 01-07-2009 15-07-2009 09-08-2009 28-09-2009 08-10-2009 13-10-2009 02-07-2009 16-07-2009 10-08-2009 29-09-2009 09-10-2009 14-10-2009 03-07-2009 17-07-2009 11-08-2009 30-09-2009 10-10-2009 15-10-2009 04-07-2009 18-07-2009 12-08-2009 01-10-2009 11-10-2009 16-10-2009 05-07-2009 19-07-2009 13-08-2009 02-10-2009 12-10-2009 17-10-2009 06-07-2009 20-07-2009 14-08-2009 03-10-2009 13-10-2009 18-10-2009 07-07-2009 21-07-2009 15-08-2009 04-10-2009 14-10-2009 19-10-2009 08-07-2009 22-07-2009 16-08-2009 05-10-2009 15-10-2009 20-10-2009 09-07-2009 23-07-2009 17-08-2009 06-10-2009 16-10-2009 21-10-2009 10-07-2009 24-07-2009 18-08-2009 07-10-2009 17-10-2009 22-10-2009 11-07-2009 25-07-2009 19-08-2009 08-10-2009 18-10-2009 23-10-2009 12-07-2009 26-07-2009 20-08-2009 09-10-2009 19-10-2009 24-10-2009 13-07-2009 27-07-2009 21-08-2009 10-10-2009 20-10-2009 25-10-2009 14-07-2009 28-07-2009 22-08-2009 11-10-2009 21-10-2009 26-10-2009 15-07-2009 29-07-2009 23-08-2009 12-10-2009 22-10-2009 27-10-2009 16-07-2009 30-07-2009 24-08-2009 13-10-2009 23-10-2009 28-10-2009 17-07-2009 31-07-2009 25-08-2009 14-10-2009 24-10-2009 29-10-2009 18-07-2009 01-08-2009 26-08-2009 15-10-2009 25-10-2009 30-10-2009 19-07-2009 02-08-2009 27-08-2009 16-10-2009 26-10-2009 31-10-2009 20-07-2009 03-08-2009 28-08-2009 17-10-2009 27-10-2009 01-11-2009 21-07-2009 04-08-2009 29-08-2009 18-10-2009 28-10-2009 02-11-2009 22-07-2009 05-08-2009 30-08-2009 19-10-2009**** 29-10-2009 03-11-2009 23-07-2009 06-08-2009 31-08-2009 20-10-2009**** 30-10-2009 04-11-2009 24-07-2009 07-08-2009 01-09-2009 21-10-2009**** 31-10-2009 05-11-2009 25-07-2009 08-08-2009 02-09-2009 22-10-2009 01-11-2009 06-11-2009 26-07-2009 09-08-2009 03-09-2009 23-10-2009 02-11-2009 07-11-2009 27-07-2009 10-08-2009 04-09-2009 24-10-2009 03-11-2009 08-11-2009

Page 17: RECOMMENDATIONS ON SUBMISSION DATES FOR APPLICANTS … · In Annex B the meeting days of the Coordination group are accentuated at day 195 (75) of the European assessment process

Recommendations on submission dates for applicants of the DCP December 2008 Page 17 of 24

Applicant´s submission of

Response

Start of procedure RMS sends

DAR**

CMS comments on

DAR

Possible break-out session

CMS final position

Closure of procedure or

referral to CMD

Day + 106 Day + 120 (0) Day + 145 (25) Day + 195 (75) Day + 205 (85) Day + 210 (90) 28-07-2009 11-08-2009 05-09-2009 25-10-2009 04-11-2009 09-11-2009 29-07-2009 12-08-2009 06-09-2009 26-10-2009 05-11-2009 10-11-2009 30-07-2009 13-08-2009 07-09-2009 27-10-2009 06-11-2009 11-11-2009 31-07-2009 14-08-2009 08-09-2009 28-10-2009 07-11-2009 12-11-2009 01-08-2009 15-08-2009 09-09-2009 29-10-2009 08-11-2009 13-11-2009 02-08-2009 16-08-2009 10-09-2009 30-10-2009 09-11-2009 14-11-2009 03-08-2009 17-08-2009 11-09-2009 31-10-2009 10-11-2009 15-11-2009 04-08-2009 18-08-2009 12-09-2009 01-11-2009 11-11-2009 16-11-2009 05-08-2009 19-08-2009 13-09-2009 02-11-2009 12-11-2009 17-11-2009 06-08-2009 20-08-2009 14-09-2009 03-11-2009 13-11-2009 18-11-2009 07-08-2009 21-08-2009 15-09-2009 04-11-2009 14-11-2009 19-11-2009 08-08-2009 22-08-2009 16-09-2009 05-11-2009 15-11-2009 20-11-2009 09-08-2009 23-08-2009 17-09-2009 06-11-2009 16-11-2009 21-11-2009 10-08-2009 24-08-2009 18-09-2009 07-11-2009 17-11-2009 22-11-2009 11-08-2009 25-08-2009 19-09-2009 08-11-2009 18-11-2009 23-11-2009 12-08-2009 26-08-2009 20-09-2009 09-11-2009 19-11-2009 24-11-2009 13-08-2009 27-08-2009 21-09-2009 10-11-2009 20-11-2009 25-11-2009 14-08-2009 28-08-2009 22-09-2009 11-11-2009 21-11-2009 26-11-2009 15-08-2009 29-08-2009 23-09-2009 12-11-2009 22-11-2009 27-11-2009 16-08-2009 30-08-2009 24-09-2009 13-11-2009 23-11-2009 28-11-2009 17-08-2009 31-08-2009 25-09-2009 14-11-2009 24-11-2009 29-11-2009 18-08-2009 01-09-2009 26-09-2009 15-11-2009 25-11-2009 30-11-2009 19-08-2009 02-09-2009 27-09-2009 16-11-2009**** 26-11-2009 01-12-2009 20-08-2009 03-09-2009 28-09-2009 17-11-2009**** 27-11-2009 02-12-2009 21-08-2009 04-09-2009 29-09-2009 18-11-2009**** 28-11-2009 03-12-2009 22-08-2009 05-09-2009 30-09-2009 19-11-2009 29-11-2009 04-12-2009 23-08-2009 06-09-2009 01-10-2009 20-11-2009 30-11-2009 05-12-2009 24-08-2009 07-09-2009 02-10-2009 21-11-2009 01-12-2009 06-12-2009 25-08-2009 08-09-2009 03-10-2009 22-11-2009 02-12-2009 07-12-2009 26-08-2009 09-09-2009 04-10-2009 23-11-2009 03-12-2009 08-12-2009 27-08-2009 10-09-2009 05-10-2009 24-11-2009 04-12-2009 09-12-2009 28-08-2009 11-09-2009 06-10-2009 25-11-2009 05-12-2009 10-12-2009 29-08-2009 12-09-2009 07-10-2009 26-11-2009 06-12-2009 11-12-2009 30-08-2009 13-09-2009 08-10-2009 27-11-2009 07-12-2009 12-12-2009 31-08-2009 14-09-2009 09-10-2009 28-11-2009 08-12-2009 13-12-2009 01-09-2009 15-09-2009 10-10-2009 29-11-2009 09-12-2009 14-12-2009 02-09-2009 16-09-2009 11-10-2009 30-11-2009 10-12-2009 15-12-2009 03-09-2009 17-09-2009 12-10-2009 01-12-2009 11-12-2009 16-12-2009 04-09-2009 18-09-2009 13-10-2009 02-12-2009 12-12-2009 17-12-2009 05-09-2009 19-09-2009 14-10-2009 03-12-2009 13-12-2009 18-12-2009 06-09-2009 20-09-2009 15-10-2009 04-12-2009 14-12-2009 19-12-2009 07-09-2009 21-09-2009 16-10-2009 05-12-2009 15-12-2009 20-12-2009

Page 18: RECOMMENDATIONS ON SUBMISSION DATES FOR APPLICANTS … · In Annex B the meeting days of the Coordination group are accentuated at day 195 (75) of the European assessment process

Recommendations on submission dates for applicants of the DCP December 2008 Page 18 of 24

Applicant´s submission of

Response

Start of procedure RMS sends

DAR**

CMS comments on

DAR

Possible break-out session

CMS final position

Closure of procedure or

referral to CMD

Day + 106 Day + 120 (0) Day + 145 (25) Day + 195 (75) Day + 205 (85) Day + 210 (90) 08-09-2009 22-09-2009 17-10-2009 06-12-2009 16-12-2009 21-12-2009 09-09-2009 23-09-2009 18-10-2009 07-12-2009 17-12-2009 22-12-2009 10-09-2009 24-09-2009 19-10-2009 08-12-2009 18-12-2009 23-12-2009

n.a.*** n.a. n.a. 09-12-2009 19-12-2009 24-12-2009¤ n.a. n.a. n.a. 10-12-2009 20-12-2009 25-12-2009 n.a. n.a. n.a. 11-12-2009 21-12-2009 26-12-2009 n.a. n.a. n.a. 12-12-2009 22-12-2009 27-12-2009 n.a. n.a. n.a. 13-12-2009 23-12-2009 28-12-2009 n.a. n.a. n.a. 14-12-2009**** 24-12-2009¤ 29-12-2009 n.a. n.a. n.a. 15-12-2009**** 25-12-2009 30-12-2009 n.a. n.a. n.a. 16-12-2009**** 26-12-2009 31-12-2009 n.a. n.a. n.a. 17-12-2009 27-12-2009 01-01-2010 n.a. n.a. n.a. 18-12-2009 28-12-2009 02-01-2010 n.a. n.a. n.a. 19-12-2009 29-12-2009 03-01-2010 n.a. n.a. n.a. 20-12-2009 30-12-2009 04-01-2010 n.a. n.a. n.a. 21-12-2009 31-12-2009 05-01-2010 n.a. n.a. n.a. 22-12-2009 01-01-2010 06-01-2010

25-09-2009 09-10-2009 03-11-2009 23-12-2009 02-01-2010 07-01-2010 26-09-2009 10-10-2009 04-11-2009 24-12-2009¤ 03-01-2010 08-01-2010 27-09-2009 11-10-2009 05-11-2009 25-12-2009 04-01-2010 09-01-2010 28-09-2009 12-10-2009 06-11-2009 26-12-2009 05-01-2010 10-01-2010 29-09-2009 13-10-2009 07-11-2009 27-12-2009 06-01-2010 11-01-2010 30-09-2009 14-10-2009 08-11-2009 28-12-2009 07-01-2010 12-01-2010 01-10-2009 15-10-2009 09-11-2009 29-12-2009 08-01-2010 13-01-2010 02-10-2009 16-10-2009 10-11-2009 30-12-2009 09-01-2010 14-01-2010 03-10-2009 17-10-2009 11-11-2009 31-12-2009 10-01-2010 15-01-2010 04-10-2009 18-10-2009 12-11-2009 01-01-2010 11-01-2010 16-01-2010 05-10-2009 19-10-2009 13-11-2009 02-01-2010 12-01-2010 17-01-2010 06-10-2009 20-10-2009 14-11-2009 03-01-2010 13-01-2010 18-01-2010 07-10-2009 21-10-2009 15-11-2009 04-01-2010 14-01-2010 19-01-2010 08-10-2009 22-10-2009 16-11-2009 05-01-2010 15-01-2010 20-01-2010 09-10-2009 23-10-2009 17-11-2009 06-01-2010 16-01-2010 21-01-2010 10-10-2009 24-10-2009 18-11-2009 07-01-2010 17-01-2010 22-01-2010 11-10-2009 25-10-2009 19-11-2009 08-01-2010 18-01-2010 23-01-2010 12-10-2009 26-10-2009 20-11-2009 09-01-2010 19-01-2010 24-01-2010 13-10-2009 27-10-2009 21-11-2009 10-01-2010 20-01-2010 25-01-2010 14-10-2009 28-10-2009 22-11-2009 11-01-2010 21-01-2010 26-01-2010 15-10-2009 29-10-2009 23-11-2009 12-01-2010 22-01-2010 27-01-2010 16-10-2009 30-10-2009 24-11-2009 13-01-2010 23-01-2010 28-01-2010 17-10-2009 31-10-2009 25-11-2009 14-01-2010 24-01-2010 29-01-2010 18-10-2009 01-11-2009 26-11-2009 15-01-2010 25-01-2010 30-01-2010 19-10-2009 02-11-2009 27-11-2009 16-01-2010 26-01-2010 31-01-2010

Page 19: RECOMMENDATIONS ON SUBMISSION DATES FOR APPLICANTS … · In Annex B the meeting days of the Coordination group are accentuated at day 195 (75) of the European assessment process

Recommendations on submission dates for applicants of the DCP December 2008 Page 19 of 24

Applicant´s submission of

Response

Start of procedure RMS sends

DAR**

CMS comments on

DAR

Possible break-out session

CMS final position

Closure of procedure or

referral to CMD

Day + 106 Day + 120 (0) Day + 145 (25) Day + 195 (75) Day + 205 (85) Day + 210 (90) 20-10-2009 03-11-2009 28-11-2009 17-01-2010 27-01-2010 01-02-2010 21-10-2009 04-11-2009 29-11-2009 18-01-2010**** 28-01-2010 02-02-2010 22-10-2009 05-11-2009 30-11-2009 19-01-2010 29-01-2010 03-02-2010 23-10-2009 06-11-2009 01-12-2009 20-01-2010 30-01-2010 04-02-2010 24-10-2009 07-11-2009 02-12-2009 21-01-2010 31-01-2010 05-02-2010 25-10-2009 08-11-2009 03-12-2009 22-01-2010 01-02-2010 06-02-2010 26-10-2009 09-11-2009 04-12-2009 23-01-2010 02-02-2010 07-02-2010 27-10-2009 10-11-2009 05-12-2009 24-01-2010 03-02-2010 08-02-2010 28-10-2009 11-11-2009 06-12-2009 25-01-2010 04-02-2010 09-02-2010 29-10-2009 12-11-2009 07-12-2009 26-01-2010 05-02-2010 10-02-2010 30-10-2009 13-11-2009 08-12-2009 27-01-2010 06-02-2010 11-02-2010 31-10-2009 14-11-2009 09-12-2009 28-01-2010 07-02-2010 12-02-2010 01-11-2009 15-11-2009 10-12-2009 29-01-2010 08-02-2010 13-02-2010 02-11-2009 16-11-2009 11-12-2009 30-01-2010 09-02-2010 14-02-2010 03-11-2009 17-11-2009 12-12-2009 31-01-2010 10-02-2010 15-02-2010 04-11-2009 18-11-2009 13-12-2009 01-02-2010 11-02-2010 16-02-2010 05-11-2009 19-11-2009 14-12-2009 02-02-2010 12-02-2010 17-02-2010 06-11-2009 20-11-2009 15-12-2009 03-02-2010 13-02-2010 18-02-2010 07-11-2009 21-11-2009 16-12-2009 04-02-2010 14-02-2010 19-02-2010 08-11-2009 22-11-2009 17-12-2009 05-02-2010 15-02-2010 20-02-2010 09-11-2009 23-11-2009 18-12-2009 06-02-2010 16-02-2010 21-02-2010 10-11-2009 24-11-2009 19-12-2009 07-02-2010 17-02-2010 22-02-2010 11-11-2009 25-11-2009 20-12-2009 08-02-2010 18-02-2010 23-02-2010 12-11-2009 26-11-2009 21-12-2009 09-02-2010 19-02-2010 24-02-2010 13-11-2009 27-11-2009 22-12-2009 10-02-2010 20-02-2010 25-02-2010 14-11-2009 28-11-2009 23-12-2009 11-02-2010 21-02-2010 26-02-2010 15-11-2009 29-11-2009 24-12-2009¤ 12-02-2010 22-02-2010 27-02-2010 16-11-2009 30-11-2009 25-12-2009 13-02-2010 23-02-2010 28-02-2010 17-11-2009 01-12-2009 26-12-2009 14-02-2010 24-02-2010 01-03-2010 18-11-2009 02-12-2009 27-12-2009 15-02-2010**** 25-02-2010 02-03-2010 19-11-2009 03-12-2009 28-12-2009 16-02-2010 26-02-2010 03-03-2010 20-11-2009 04-12-2009 29-12-2009 17-02-2010 27-02-2010 04-03-2010 21-11-2009 05-12-2009 30-12-2009 18-02-2010 28-02-2010 05-03-2010 22-11-2009 06-12-2009 31-12-2009 19-02-2010 01-03-2010 06-03-2010 23-11-2009 07-12-2009 01-01-2010 20-02-2010 02-03-2010 07-03-2010 24-11-2009 08-12-2009 02-01-2010 21-02-2010 03-03-2010 08-03-2010 25-11-2009 09-12-2009 03-01-2010 22-02-2010 04-03-2010 09-03-2010 26-11-2009 10-12-2009 04-01-2010 23-02-2010 05-03-2010 10-03-2010 27-11-2009 11-12-2009 05-01-2010 24-02-2010 06-03-2010 11-03-2010 28-11-2009 12-12-2009 06-01-2010 25-02-2010 07-03-2010 12-03-2010 29-11-2009 13-12-2009 07-01-2010 26-02-2010 08-03-2010 13-03-2010 30-11-2009 14-12-2009 08-01-2010 27-02-2010 09-03-2010 14-03-2010

Page 20: RECOMMENDATIONS ON SUBMISSION DATES FOR APPLICANTS … · In Annex B the meeting days of the Coordination group are accentuated at day 195 (75) of the European assessment process

Recommendations on submission dates for applicants of the DCP December 2008 Page 20 of 24

Applicant´s submission of

Response

Start of procedure RMS sends

DAR**

CMS comments on

DAR

Possible break-out session

CMS final position

Closure of procedure or

referral to CMD

Day + 106 Day + 120 (0) Day + 145 (25) Day + 195 (75) Day + 205 (85) Day + 210 (90) 01-12-2009 15-12-2009 09-01-2010 28-02-2010 10-03-2010 15-03-2010 02-12-2009 16-12-2009 10-01-2010 01-03-2010 11-03-2010 16-03-2010 03-12-2009 17-12-2009 11-01-2010 02-03-2010 12-03-2010 17-03-2010 04-12-2009 18-12-2009 12-01-2010 03-03-2010 13-03-2010 18-03-2010 05-12-2009 19-12-2009 13-01-2010 04-03-2010 14-03-2010 19-03-2010 06-12-2009 20-12-2009 14-01-2010 05-03-2010 15-03-2010 20-03-2010 07-12-2009 21-12-2009 15-01-2010 06-03-2010 16-03-2010 21-03-2010 08-12-2009 22-12-2009 16-01-2010 07-03-2010 17-03-2010 22-03-2010 09-12-2009 23-12-2009 17-01-2010 08-03-2010 18-03-2010 23-03-2010 10-12-2009 24-12-2009¤ 18-01-2010 09-03-2010 19-03-2010 24-03-2010 11-12-2009 25-12-2009 19-01-2010 10-03-2010 20-03-2010 25-03-2010 12-12-2009 26-12-2009 20-01-2010 11-03-2010 21-03-2010 26-03-2010 13-12-2009 27-12-2009 21-01-2010 12-03-2010 22-03-2010 27-03-2010 14-12-2009 28-12-2009 22-01-2010 13-03-2010 23-03-2010 28-03-2010 15-12-2009 29-12-2009 23-01-2010 14-03-2010 24-03-2010 29-03-2010 16-12-2009 30-12-2009 24-01-2010 15-03-2010**** 25-03-2010 30-03-2010 17-12-2009 31-12-2009 25-01-2010 16-03-2010 26-03-2010 31-03-2010 18-12-2009 01-01-2010 26-01-2010 17-03-2010 27-03-2010 01-04-2010 19-12-2009 02-01-2010 27-01-2010 18-03-2010 28-03-2010 02-04-2010 20-12-2009 03-01-2010 28-01-2010 19-03-2010 29-03-2010 03-04-2010 21-12-2009 04-01-2010 29-01-2010 20-03-2010 30-03-2010 04-04-2010 22-12-2009 05-01-2010 30-01-2010 21-03-2010 31-03-2010 05-04-2010 23-12-2009 06-01-2010 31-01-2010 22-03-2010 01-04-2010 06-04-2010 24-12-2009 07-01-2010 01-02-2010 23-03-2010 02-04-2010 07-04-2010 25-12-2009 08-01-2010 02-02-2010 24-03-2010 03-04-2010 08-04-2010 26-12-2009 09-01-2010 03-02-2010 25-03-2010 04-04-2010 09-04-2010 27-12-2009 10-01-2010 04-02-2010 26-03-2010 05-04-2010 10-04-2010 28-12-2009 11-01-2010 05-02-2010 27-03-2010 06-04-2010 11-04-2010 29-12-2009 12-01-2010 06-02-2010 28-03-2010 07-04-2010 12-04-2010 30-12-2009 13-01-2010 07-02-2010 29-03-2010 08-04-2010 13-04-2010 31-12-2009 14-01-2010 08-02-2010 30-03-2010 09-04-2010 14-04-2010 01-01-2010 15-01-2010 09-02-2010 31-03-2010 10-04-2010 15-04-2010 02-01-2010 16-01-2010 10-02-2010 01-04-2010 11-04-2010 16-04-2010 03-01-2010 17-01-2010 11-02-2010 02-04-2010 12-04-2010 17-04-2010 04-01-2010 18-01-2010 12-02-2010 03-04-2010 13-04-2010 18-04-2010 05-01-2010 19-01-2010 13-02-2010 04-04-2010 14-04-2010 19-04-2010 06-01-2010 20-01-2010 14-02-2010 05-04-2010 15-04-2010 20-04-2010 07-01-2010 21-01-2010 15-02-2010 06-04-2010 16-04-2010 21-04-2010 08-01-2010 22-01-2010 16-02-2010 07-04-2010 17-04-2010 22-04-2010 09-01-2010 23-01-2010 17-02-2010 08-04-2010 18-04-2010 23-04-2010 10-01-2010 24-01-2010 18-02-2010 09-04-2010 19-04-2010 24-04-2010 11-01-2010 25-01-2010 19-02-2010 10-04-2010 20-04-2010 25-04-2010

Page 21: RECOMMENDATIONS ON SUBMISSION DATES FOR APPLICANTS … · In Annex B the meeting days of the Coordination group are accentuated at day 195 (75) of the European assessment process

Recommendations on submission dates for applicants of the DCP December 2008 Page 21 of 24

Applicant´s submission of

Response

Start of procedure RMS sends

DAR**

CMS comments on

DAR

Possible break-out session

CMS final position

Closure of procedure or

referral to CMD

Day + 106 Day + 120 (0) Day + 145 (25) Day + 195 (75) Day + 205 (85) Day + 210 (90) 12-01-2010 26-01-2010 20-02-2010 11-04-2010 21-04-2010 26-04-2010 13-01-2010 27-01-2010 21-02-2010 12-04-2010 22-04-2010 27-04-2010 14-01-2010 28-01-2010 22-02-2010 13-04-2010 23-04-2010 28-04-2010 15-01-2010 29-01-2010 23-02-2010 14-04-2010 24-04-2010 29-04-2010 16-01-2010 30-01-2010 24-02-2010 15-04-2010 25-04-2010 30-04-2010 17-01-2010 31-01-2010 25-02-2010 16-04-2010 26-04-2010 01-05-2010 18-01-2010 01-02-2010 26-02-2010 17-04-2010 27-04-2010 02-05-2010 19-01-2010 02-02-2010 27-02-2010 18-04-2010 28-04-2010 03-05-2010 20-01-2010 03-02-2010 28-02-2010 19-04-2010**** 29-04-2010 04-05-2010 21-01-2010 04-02-2010 01-03-2010 20-04-2010 30-04-2010 05-05-2010 22-01-2010 05-02-2010 02-03-2010 21-04-2010 01-05-2010 06-05-2010 23-01-2010 06-02-2010 03-03-2010 22-04-2010 02-05-2010 07-05-2010 24-01-2010 07-02-2010 04-03-2010 23-04-2010 03-05-2010 08-05-2010 25-01-2010 08-02-2010 05-03-2010 24-04-2010 04-05-2010 09-05-2010 26-01-2010 09-02-2010 06-03-2010 25-04-2010 05-05-2010 10-05-2010 27-01-2010 10-02-2010 07-03-2010 26-04-2010 06-05-2010 11-05-2010 28-01-2010 11-02-2010 08-03-2010 27-04-2010 07-05-2010 12-05-2010 29-01-2010 12-02-2010 09-03-2010 28-04-2010 08-05-2010 13-05-2010 30-01-2010 13-02-2010 10-03-2010 29-04-2010 09-05-2010 14-05-2010 31-01-2010 14-02-2010 11-03-2010 30-04-2010 10-05-2010 15-05-2010 01-02-2010 15-02-2010 12-03-2010 01-05-2010 11-05-2010 16-05-2010 02-02-2010 16-02-2010 13-03-2010 02-05-2010 12-05-2010 17-05-2010 03-02-2010 17-02-2010 14-03-2010 03-05-2010 13-05-2010 18-05-2010 04-02-2010 18-02-2010 15-03-2010 04-05-2010 14-05-2010 19-05-2010 05-02-2010 19-02-2010 16-03-2010 05-05-2010 15-05-2010 20-05-2010 06-02-2010 20-02-2010 17-03-2010 06-05-2010 16-05-2010 21-05-2010 07-02-2010 21-02-2010 18-03-2010 07-05-2010 17-05-2010 22-05-2010 08-02-2010 22-02-2010 19-03-2010 08-05-2010 18-05-2010 23-05-2010 09-02-2010 23-02-2010 20-03-2010 09-05-2010 19-05-2010 24-05-2010 10-02-2010 24-02-2010 21-03-2010 10-05-2010 20-05-2010 25-05-2010 11-02-2010 25-02-2010 22-03-2010 11-05-2010 21-05-2010 26-05-2010 12-02-2010 26-02-2010 23-03-2010 12-05-2010 22-05-2010 27-05-2010 13-02-2010 27-02-2010 24-03-2010 13-05-2010 23-05-2010 28-05-2010 14-02-2010 28-02-2010 25-03-2010 14-05-2010 24-05-2010 29-05-2010 15-02-2010 01-03-2010 26-03-2010 15-05-2010 25-05-2010 30-05-2010 16-02-2010 02-03-2010 27-03-2010 16-05-2010 26-05-2010 31-05-2010 17-02-2010 03-03-2010 28-03-2010 17-05-2010**** 27-05-2010 01-06-2010 18-02-2010 04-03-2010 29-03-2010 18-05-2010 28-05-2010 02-06-2010 19-02-2010 05-03-2010 30-03-2010 19-05-2010 29-05-2010 03-06-2010 20-02-2010 06-03-2010 31-03-2010 20-05-2010 30-05-2010 04-06-2010 21-02-2010 07-03-2010 01-04-2010 21-05-2010 31-05-2010 05-06-2010 22-02-2010 08-03-2010 02-04-2010 22-05-2010 01-06-2010 06-06-2010

Page 22: RECOMMENDATIONS ON SUBMISSION DATES FOR APPLICANTS … · In Annex B the meeting days of the Coordination group are accentuated at day 195 (75) of the European assessment process

Recommendations on submission dates for applicants of the DCP December 2008 Page 22 of 24

Applicant´s submission of

Response

Start of procedure RMS sends

DAR**

CMS comments on

DAR

Possible break-out session

CMS final position

Closure of procedure or

referral to CMD

Day + 106 Day + 120 (0) Day + 145 (25) Day + 195 (75) Day + 205 (85) Day + 210 (90) 23-02-2010 09-03-2010 03-04-2010 23-05-2010 02-06-2010 07-06-2010 24-02-2010 10-03-2010 04-04-2010 24-05-2010 03-06-2010 08-06-2010 25-02-2010 11-03-2010 05-04-2010 25-05-2010 04-06-2010 09-06-2010 26-02-2010 12-03-2010 06-04-2010 26-05-2010 05-06-2010 10-06-2010 27-02-2010 13-03-2010 07-04-2010 27-05-2010 06-06-2010 11-06-2010 28-02-2010 14-03-2010 08-04-2010 28-05-2010 07-06-2010 12-06-2010 01-03-2010 15-03-2010 09-04-2010 29-05-2010 08-06-2010 13-06-2010 02-03-2010 16-03-2010 10-04-2010 30-05-2010 09-06-2010 14-06-2010 03-03-2010 17-03-2010 11-04-2010 31-05-2010 10-06-2010 15-06-2010 04-03-2010 18-03-2010 12-04-2010 01-06-2010 11-06-2010 16-06-2010 05-03-2010 19-03-2010 13-04-2010 02-06-2010 12-06-2010 17-06-2010 06-03-2010 20-03-2010 14-04-2010 03-06-2010 13-06-2010 18-06-2010 07-03-2010 21-03-2010 15-04-2010 04-06-2010 14-06-2010 19-06-2010 08-03-2010 22-03-2010 16-04-2010 05-06-2010 15-06-2010 20-06-2010 09-03-2010 23-03-2010 17-04-2010 06-06-2010 16-06-2010 21-06-2010 10-03-2010 24-03-2010 18-04-2010 07-06-2010 17-06-2010 22-06-2010 11-03-2010 25-03-2010 19-04-2010 08-06-2010 18-06-2010 23-06-2010 12-03-2010 26-03-2010 20-04-2010 09-06-2010 19-06-2010 24-06-2010 13-03-2010 27-03-2010 21-04-2010 10-06-2010 20-06-2010 25-06-2010 14-03-2010 28-03-2010 22-04-2010 11-06-2010 21-06-2010 26-06-2010 15-03-2010 29-03-2010 23-04-2010 12-06-2010 22-06-2010 27-06-2010 16-03-2010 30-03-2010 24-04-2010 13-06-2010 23-06-2010 28-06-2010 17-03-2010 31-03-2010 25-04-2010 14-06-2010 24-06-2010 29-06-2010 18-03-2010 01-04-2010 26-04-2010 15-06-2010 25-06-2010 30-06-2010 19-03-2010 02-04-2010 27-04-2010 16-06-2010 26-06-2010 01-07-2010 20-03-2010 03-04-2010 28-04-2010 17-06-2010 27-06-2010 02-07-2010 21-03-2010 04-04-2010 29-04-2010 18-06-2010 28-06-2010 03-07-2010 22-03-2010 05-04-2010 30-04-2010 19-06-2010 29-06-2010 04-07-2010 23-03-2010 06-04-2010 01-05-2010 20-06-2010 30-06-2010 05-07-2010 24-03-2010 07-04-2010 02-05-2010 21-06-2010**** 01-07-2010 06-07-2010 25-03-2010 08-04-2010 03-05-2010 22-06-2010 02-07-2010 07-07-2010 26-03-2010 09-04-2010 04-05-2010 23-06-2010 03-07-2010 08-07-2010 27-03-2010 10-04-2010 05-05-2010 24-06-2010 04-07-2010 09-07-2010 28-03-2010 11-04-2010 06-05-2010 25-06-2010 05-07-2010 10-07-2010 29-03-2010 12-04-2010 07-05-2010 26-06-2010 06-07-2010 11-07-2010 30-03-2010 13-04-2010 08-05-2010 27-06-2010 07-07-2010 12-07-2010 31-03-2010 14-04-2010 09-05-2010 28-06-2010 08-07-2010 13-07-2010 01-04-2010 15-04-2010 10-05-2010 29-06-2010 09-07-2010 14-07-2010 02-04-2010 16-04-2010 11-05-2010 30-06-2010 10-07-2010 15-07-2010 03-04-2010 17-04-2010 12-05-2010 01-07-2010 11-07-2010 16-07-2010 04-04-2010 18-04-2010 13-05-2010 02-07-2010 12-07-2010 17-07-2010 05-04-2010 19-04-2010 14-05-2010 03-07-2010 13-07-2010 18-07-2010

Page 23: RECOMMENDATIONS ON SUBMISSION DATES FOR APPLICANTS … · In Annex B the meeting days of the Coordination group are accentuated at day 195 (75) of the European assessment process

Recommendations on submission dates for applicants of the DCP December 2008 Page 23 of 24

Applicant´s submission of

Response

Start of procedure RMS sends

DAR**

CMS comments on

DAR

Possible break-out session

CMS final position

Closure of procedure or

referral to CMD

Day + 106 Day + 120 (0) Day + 145 (25) Day + 195 (75) Day + 205 (85) Day + 210 (90) 06-04-2010 20-04-2010 15-05-2010 04-07-2010 14-07-2010 19-07-2010 07-04-2010 21-04-2010 16-05-2010 05-07-2010 15-07-2010 20-07-2010 08-04-2010 22-04-2010 17-05-2010 06-07-2010 16-07-2010 21-07-2010 09-04-2010 23-04-2010 18-05-2010 07-07-2010 17-07-2010 22-07-2010 10-04-2010 24-04-2010 19-05-2010 08-07-2010 18-07-2010 23-07-2010 11-04-2010 25-04-2010 20-05-2010 09-07-2010 19-07-2010 24-07-2010 12-04-2010 26-04-2010 21-05-2010 10-07-2010 20-07-2010 25-07-2010 13-04-2010 27-04-2010 22-05-2010 11-07-2010 21-07-2010 26-07-2010 14-04-2010 28-04-2010 23-05-2010 12-07-2010 22-07-2010 27-07-2010 15-04-2010 29-04-2010 24-05-2010 13-07-2010 23-07-2010 28-07-2010 16-04-2010 30-04-2010 25-05-2010 14-07-2010 24-07-2010 29-07-2010 17-04-2010 01-05-2010 26-05-2010 15-07-2010 25-07-2010 30-07-2010 18-04-2010 02-05-2010 27-05-2010 16-07-2010 26-07-2010 31-07-2010 19-04-2010 03-05-2010 28-05-2010 17-07-2010 27-07-2010 01-08-2010 20-04-2010 04-05-2010 29-05-2010 18-07-2010 28-07-2010 02-08-2010 21-04-2010 05-05-2010 30-05-2010 19-07-2010**** 29-07-2010 03-08-2010 22-04-2010 06-05-2010 31-05-2010 20-07-2010 30-07-2010 04-08-2010 23-04-2010 07-05-2010 01-06-2010 21-07-2010 31-07-2010 05-08-2010 24-04-2010 08-05-2010 02-06-2010 22-07-2010 01-08-2010 06-08-2010 25-04-2010 09-05-2010 03-06-2010 23-07-2010 02-08-2010 07-08-2010 26-04-2010 10-05-2010 04-06-2010 24-07-2010 03-08-2010 08-08-2010 27-04-2010 11-05-2010 05-06-2010 25-07-2010 04-08-2010 09-08-2010 28-04-2010 12-05-2010 06-06-2010 26-07-2010 05-08-2010 10-08-2010 29-04-2010 13-05-2010 07-06-2010 27-07-2010 06-08-2010 11-08-2010 30-04-2010 14-05-2010 08-06-2010 28-07-2010 07-08-2010 12-08-2010

Page 24: RECOMMENDATIONS ON SUBMISSION DATES FOR APPLICANTS … · In Annex B the meeting days of the Coordination group are accentuated at day 195 (75) of the European assessment process

Recommendations on submission dates for applicants of the DCP December 2008 Page 24 of 24