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London, insert full date insert Doc.Ref.EMA/91958/2015 Committee for Medicinal Products for Human Use (CHMP) DRAFT CHMP day 120 list of questions product name International non-proprietary name: INN Procedure No. EMEA/H/C/XXX Applicant: Table of contents 1. Recommendations 5 2. Executive summary 7 2.1. Problem statement 7 2.2. About the product 7 2.3. The development programme/compliance with CHMP guidance/scientific advice 7 2.4. General comments on compliance with GMP, GLP, GCP 7 2.5. Type of application and other comments on the submitted dossier 7 3. Scientific overview and discussion 7 3.1. Quality aspects 7 3.2. Non clinical aspects 8 3.3. Clinical aspects 8 4. Orphan medicinal products 12 5. Benefit risk assessment 12 5.1. Conclusions 13 6. CHMP list of questions 13 6.1. Quality aspects 13 6.2. Non clinical aspects 14 6.3. Clinical aspects 15 7. Recommended conditions for marketing authorisation and product information 15 7.1. Conditions for the marketing authorisation 15 7.2. Summary of product characteristics (SmPC) 15 7.3. Labelling 15 7.4. Package leaflet (PL) 15 8. Appendix (as appropriate) 16 Administrative information Invented name of the medicinal product: INN (or common name) of the active substance(s): Applicant: Applied Indication(s): Pharmaco-therapeutic group (ATC Code): Pharmaceutical form(s) and strength(s): Rapporteur contact person: Co-Rapporteur contact person: EMA Product Lead: Procedure Manager: Name: Tel: Fax: Email: Name: Tel: Fax: Email: Name: Tel: Fax: Email: Name: Tel: Fax: Email: Names of the Rapporteur assessors (internal and external): Quality: Name(s) Tel: Fax: Email: Non-clinical: Name(s) Tel: Fax: Email: Clinical : Name(s) Tel: Fax: Email: Names of the Co-Rapporteur assessors (internal and external): Quality: Name(s) Tel: Fax: Email: Non-clinical: Name(s) Tel: Fax: Email: Clinical: Name(s) Tel: Fax: Email: List of abbreviations Recommendations Based on the