Annex I APPLICATION DOSSIER FOR THE INITIAL APPLICATION

United Kingdom

1. AINTRODUCTION AND GENERAL PRINCIPLES
2. BCOVER LETTER
3. CEU APPLICATION FORM
4. DPROTOCOL
5. EINVESTIGATOR'S BROCHURE (IB)
6. FDOCUMENTATION RELATING TO COMPLIANCE WITH GOOD MANUFACTURING PRACTICE (GMP) FOR THE INVESTIGATIONAL MEDICINAL PRODUCT
7. GINVESTIGATIONAL MEDICINAL PRODUCT DOSSIER (IMPD)
8. HAUXILIARY MEDICINAL PRODUCT DOSSIER
9. ISCIENTIFIC ADVICE AND PAEDIATRIC INVESTIGATION PLAN (PIP)
10. JCONTENT OF THE LABELLING OF THE INVESTIGATIONAL MEDICINAL PRODUCTS
11. KRECRUITMENT ARRANGEMENTS (INFORMATION PER MEMBER STATE CONCERNED)
12. LSUBJECT INFORMATION, INFORMED CONSENT FORM AND INFORMED CONSENT PROCEDURE (INFORMATION PER MEMBER STATE CONCERNED)
13. MSUITABILITY OF THE INVESTIGATOR (INFORMATION PER MEMBER STATE CONCERNED)
14. NSUITABILITY OF THE FACILITIES (INFORMATION PER MEMBER STATE CONCERNED)
15. OPROOF OF INSURANCE COVER OR INDEMNIFICATION (INFORMATION PER MEMBER STATE CONCERNED)
16. PFINANCIAL AND OTHER ARRANGEMENTS (INFORMATION PER MEMBER STATE CONCERNED)
17. QPROOF OF PAYMENT OF FEE (INFORMATION PER MEMBER STATE CONCERNED)
18. RPROOF THAT DATA WILL BE PROCESSED IN COMPLIANCE WITH UNION LAW ON DATA PROTECTION