CRED ERP 25

and specific obligations and answers questions from CHMP. The company position should focus on relevant scientific evidence submitted in relation to the issues identified by the Committee and is followed by a Questions & Answers session. The CHMP then discusses the applicant’s responses and takes a formal vote. In case of a positive trend – applicant is de-briefed on proposed amendments to SmPC. In case of a negative trend – possible options are discussed with the applicant.

Step 5 Applicant provides final draft product information and CHMP adopts Opinion.

Things to consider • Employ a small delegation team to address the specific questions asked. External experts/KOLs can be helpful if there are specific questions on medical practice/unmet need

• Prepare extensively but don’t be surprised if the OE is cancelled at last minute

• Have sufficiently senior people available on site who are able to make immediate decisions on “conditions of approval” such as; a restricted indication/further obligations/RMP, etc. This is where a good risk mitigation and planning strategy is invaluable (minimally commercially viable labelling wording and fall-back positions)

• Have a pre-prepared strategic plan with regards to a withdrawal of the application if it is likely to go to negative opinion (plus consider the possibility of a re-examination of the opinion) at this stage.

Further reading and guidance on oral explanations: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-applicants/marketing- authorisation-holders-oral-explanations-european-medicines-agency_en.pdf

7. Re-examination of an Opinion

• Applicant must notify EMA in writing of its intent to request a re-examination of the opinion within 15 days of CHMP Opinion o Detailed grounds for the re-examination request to be provided within 60 days of the CHMP Opinion o Request for oral hearing should be part of request o May request that the CHMP consult a Scientific Advisory Group (SAG) • Carefully consider the timing of your detailed request for re-examination in relation to CHMP meeting dates in order to optimise the time available to you and to the rapporteurs. For example, if the next CHMP meetings for a new opinion are 35 and 65 days away then the opinion must be taken at the earlier meeting therefore reducing the available assessment time considerably) • New Rapporteur appointed by EMA and new Co-Rapporteur (if involved in the initial application) • Re-examination may only deal with grounds for re-examination initially identified by applicant • Re-examination may only be based on the scientific data available when the CHMP adopted the original opinion • CHMP may consult a SAG • Within 60 days of receipt of detailed request for re-examination, the CHMP will re-examine its opinion o If oral hearing required, it will be conducted within this timeframe • No clock stops are possible.