Data on bioavailability trials 1.5 Swissmedic Form: Information on bioequivalence trials or information according to EMA/CHMP/600958/2010/Corr.* 1.5.1 IV of the Guideline on the Investigation on „Appendix Bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1)” Documents on the reference product for the foreign 1.5.2 comparator product Environmental Risk Assessment 1.6 Decisions by foreign authorities 1.7 Responses to Questions (always incl. LoQ) Answer to day 180 LoOI (incl. day 180 LoOI) EMA 1.7.1 CP: Answer to day 120 LoQ (incl. day 120 LoQ) All other countries: Answer to LoQ (incl. LoQ) Assessment Reports (=AR) Day 210 AR EMA CP Day 80 AR EU Day 70 Preliminary AR (for DCP) DCP / Day 90 RMS AR (for MRP) MRP EU Final AR (MRP = day 90, DCP day 105) ≥ DCP / If arbitration to CHMP-> Opinion of the EMA MRP AR EU / 1.7.2 EFTA Assessment report Final AR (= Standard or Priority Review) FDA Summary Basis of Approval (if available) Final AR Canada Summary Basis of Decision (if available) Review Report PMDA (translated) Japan Review Summary (translated) Overall Summary Basis of Decision (translated) All other countries: Final AR (translated if applicable) EU Decision by reference authority CxMP/HMPC Opinion EMA CP Decision by the EU Commission (submit as soon 1.7.3 as available) EU DCP/MRP: Marketing Authorisation by the RMS EU/EFTA: Marketing Authorisation FDA Decision: Approval Letter 1.7.4 Decision by other foreign authorities: Canada: Notice of Compliance (NOC) 1.7.5 All other countries: Marketing Authorisation Paragraph 13 Additional Documentation 1.7.6 Tracking overview table 1.8 Information on pharmacovigilance
1.5 Data on bioavailability trials 1.5.1 Swissmedic Form: Information on bioequivalence trials or information according to EMA/CHMP/600958/2010/Corr.* „Appendix IV of the Guideline on the Investigation on Bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1)” 1.5.2 Documents on the reference product for the foreign comparator product 1.6 Environmental Risk Assessment 1.7 Decisions by foreign authorities 1.7.1 Responses to Questions (always incl. LoQ) EMA CP: Answer to day 180 LoOI (incl. day 180 LoOI) Answer to day 120 LoQ (incl. day 120 LoQ) All other countries: Answer to LoQ (incl. LoQ) 1.7.2 Assessment Reports (=AR) EMA CP Day 210 AR Day 80 AR EU DCP / MRP Day 70 Preliminary AR (for DCP) Day 90 RMS AR (for MRP) EU DCP / MRP Final AR (MRP = day 90, DCP ≥ day 105) If arbitration to CHMP-> Opinion of the EMA EU / EFTA AR Assessment report FDA Final AR (= Standard or Priority Review) Summary Basis of Approval (if available) Canada Final AR Summary Basis of Decision (if available) Japan Review Report PMDA (translated) Review Summary (translated) Overall Summary Basis of Decision (translated) All other countries: Final AR (translated if applicable) 1.7.3 EU Decision by reference authority EMA CP CxMP/HMPC Opinion Decision by the EU Commission (submit as soon as available) EU DCP/MRP: Marketing Authorisation by the RMS EU/EFTA: Marketing Authorisation 1.7.4 FDA Decision: Approval Letter 1.7.5 Decision by other foreign authorities: Canada: Notice of Compliance (NOC) All other countries: Marketing Authorisation 1.7.6 Paragraph 13 Additional Documentation Tracking overview table 1.8 Information on pharmacovigilance
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