RE:P2 Out licensing 2 years away
WRONG. Its 277 days as follows per EMA: https://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000023.jsp&mid=WC0b01ac0580022714 Once the application is validated, the EMA starts the procedure at the monthly starting date published on the EMA website. The submission deadlines and full procedural detailed timetables are published on the EMA website (see, 'submission deadlines and full procedural timetables'). The EMA shall ensure that the opinion of the CHMP is given within 210 days (less any clock-stops for the applicant to provide answers to question from the CHMP) in accordance with the below standard timetable, which can be shortened in exceptional cases (see, Request for accelerated assessment). DAY ACTION 1* Start of the procedure 80 Receipt of the Assessment Report(s) from Rapporteur and Co-Rapporteur(s) by CHMP members (which includes the peer reviewers) and EMA. The CHMP Rapporteur will focus his evaluation of the RMP on the safety specifications. EMA sends Rapporteur and Co-Rapporteur Assessment Report to the applicant making it clear that it only sets out their preliminary conclusions and that it is sent for information only and does not yet represent the position of the CHMP. 94 PRAC Rapporteur circulates the RMP assessment report, focusing on the prospective planning aspects: pharmacovigilance plan and risk minimisation measures, and proposed RMP LoQ. EMA sends also the PRAC Rapporteur AR to the applicant. 100 (Co-)Rapporteurs, other PRAC and CHMP Committee members and EMA send comments (including peer reviewers). 101-104 (step exceptionally applicable) PRAC adopts PRAC RMP Assessment Overview and Advice for D120 LoQ (PRAC discussion and adoption of advice during the 1st assessment phase is only envisaged for a minority of applications such as ATMP, PUMA or products assessed under accelerated assessment). 107 The updated PRAC RMP AR & LOQ is circulated to the CHMP (Co)-Rapporteurs, peer reviewer, PRAC and EMA. 115 Receipt of draft list of questions (including the CHMP recommendation and scientific discussions), from CHMP (Co-)Rapporteurs, as discussed with the peer reviewers, together with the PRAC RMP Assessment Overview and Advice by CHMP members and EMA 120 CHMP adopts the LoQ as well as the overall conclusions and review of the scientific data to be sent to the Applicant by the EMA. Clock stop. At the latest by Day 120, adoption by CHMP of request for GMP/GLP/GCP inspection, if necessary (Inspection procedure starts). 121* Submission of the responses, including revised SmPC, labelling and package leaflet texts in English. Restart of the clock. * Target dates for the submission of the responses are published on the EMA website CHMP meeting After receipt of the responses, the CHMP will adopt a timetable for the evaluation of the responses. In general the following timetable will apply: DAY ACTION 157 Joint Response Assessment Report from CHMP (Co-) Rapporteurs and PRAC Rapporteur received by CHMP, PRAC members and the EMA. There is no standalone PRAC Rapporteur AR on the RMP circulated at this stage. EMA sends this joint Assessment Report to the applicant making clear that it is sent for information only and does not yet represent the position of the CHMP. Where applicable inspection to be carried out. EMA/QRD sub-group meeting for the review of English product Information with participation of the applicant (optional) around day 165. 160 PRAC and CHMP Committee members and EMA send comments on the RMP assessment. 166 The PRAC Rapporteur presents the assessment on the prospective planning aspects of the RMP and the members comments received at the PRAC plenary. The PRAC Rapporteur will then liaise with the CHMP (Co)-Rapporteurs to reflect the members comments and the PRAC plenary discussion in the joint Assessment Report. PRAC adopts PRAC RMP Assessment Overview and Advice for D180 LoOI. 170 Deadline for comments from CHMP Members to Rapporteur and Co-Rapporteur, EMA and other CHMP members. The CHMP Rapporteur will integrate the various contributions and views in the draft List of outstanding issues. 180 CHMP discussion and decision on the need for adoption of a list of outstanding issues (LoOI) and/or an oral explanation by the Applicant. Submission of final inspection report to the EMA, Rapporteur and Co-Rapporteur by the inspection team (at the latest by day 180). CHMP adopts the LoOI as well as the overall conclusions and review of the scientific data to be sent to the Applicant by the EMA. Clock stop. 181 Restart of the clock with submission of responses or oral explanation (if needed). Day 194 The CHMP (Co)-Rapporteurs/ PRAC Rapporteur assess the applicants responses including the RMP aspects in a joint assessment report. A PRAC discussion is not foreseen at this stage. 200 PRAC and CHMP Committee members and EMA send comments on the assessment report. 204 The updated AR is circulated to the PRAC and CHMP Committee members and EMA. By 210 Adoption of CHMP Opinion + CHMP Assessment Report. Adoption of a timetable for the provision of product information translations After adoption of a CHMP opinion, the preparation of the annexes to the Commission Decision is carried out in accordance with the following timetable: DAY ACTION 215 at the latest Applicant provides to the EMA the product information and Annex A in the 25 languages (all EU languages including Icelandic and Norwegian) and the QRD Form 1 by Eudralink* 229 Member States will send linguistic comments on the product information by e-mail to the applicant with a copy to the EMA product shared mailbox together with QRD Form 1 235 at the latest Applicant provides EMA with final translations of SmPC, Annex II, labelling and package leaflet, and Annexes IV and 127a if applicable; in the 25 languages (+ QRD Form 2 and PDF checklist) by Eudralink 237 Transmission of Opinion and Annexes in all EU languages to applicant, Commission, and Members of the Standing Committee, and Norway and Iceland. 239-261 Draft Commission Decision Standing Committee Consultation By 277 Finalisation of EPAR in consultation with Rapporteur, Co-Rapporteur, CHMP and Applicant (the latter for confidentiality aspects) 277 Final Commission decision *By e-mail: qrd@ema.europa.eu References Regulation (EC) No 726/2004External link icon 'Centralised Procedure', the Rules governing Medicinal Products in the European Community, Volume 2A, Notice to ApplicantsExternal link icon, Chapter 6 The linguistic review process of product information in the centralised procedure - human (EMEA/5542/02)