Download EMEA User Guide for SMEs

TABLE OF CONTENT
1. INTRODUCTION............................................................................................................................................. 4
1.1 OBTAINING A MARKETING AUTHORISATION WITHIN THE EUROPEAN UNION .................................................. 5
1.2 OVERVIEW OF (DATA) REQUIREMENTS FOR OBTAINING MARKETING AUTHORISATION IN THE EU .................. 7
1.3 EU LEGISLATIVE FRAMEWORK FOR PHARMACEUTICALS ................................................................................. 7
2. SME INITIATIVE ............................................................................................................................................ 9
2.1 OBJECTIVE .................................................................................................................................................... 9
2.2 DEFINITION OF AN SME ................................................................................................................................ 9
2.3 INCENTIVES FOR SMES (EU PROVISIONS AND NATIONAL PROVISIONS)....................................................... 10
2.4 ROLE OF THE SME OFFICE.......................................................................................................................... 12
2.5 HOW TO REQUEST SME STATUS .................................................................................................................. 12
3. SCIENTIFIC ADVICE................................................................................................................................... 14
3.1 SCIENTIFIC ADVICE/PROTOCOL ASSISTANCE .............................................................................................. 14
3.2 SCIENTIFIC GUIDELINES AND POSITION PAPERS ........................................................................................... 16
3.3 ADVANCED THERAPIES AND TECHNOLOGIES ............................................................................................... 16
4. MEDICINAL PRODUCT DEVELOPMENT (HUMAN) ........................................................................... 18
4.1 QUALITY ...................................................................................................................................................... 19
4.2 NON-CLINICAL DEVELOPMENT ................................................................................................................... 23
4.3 CLINICAL DEVELOPMENT ............................................................................................................................ 25
4.4 GMP/GCP/GLP ....................................................................................................................................... 28
4.5 MEASURES FOR ORPHAN MEDICINES AND PAEDIATRICS ............................................................................... 29
5. MEDICINAL PRODUCT DEVELOPMENT (VETERINARY)................................................................ 34
5.1 MAXIMUM RESIDUE LIMITS (MRL) .............................................................................................................. 34
5.2 QUALITY ...................................................................................................................................................... 35
5.3 SAFETY ........................................................................................................................................................ 35
5.4 EFFICACY .................................................................................................................................................... 36
5.5 IMMUNOLOGICALS ...................................................................................................................................... 37
5.6 GMP/GLP/GCP ....................................................................................................................................... 37
6. APPLICATION FOR CENTRALISED MARKETING AUTHORISATION .......................................... 38
6.1 ACCESS TO THE CENTRALISED PROCEDURE ................................................................................................. 38
6.2 SELECTION OF RAPPORTEUR/CO-RAPPORTEUR .......................................................................................... 38
6.3 (INVENTED) NAME OF PRODUCTS EVALUATED VIA THE CENTRALISED PROCEDURE ..................................... 39
6.4 EMEA CONTACT POINT IN THE CENTRALISED PROCEDURE ......................................................................... 40
6.5 EMEA PRE-SUBMISSION MEETING ............................................................................................................. 40
6.6 COMPILATION OF THE APPLICATION DOSSIER .............................................................................................. 41
6.7 SUBMISSION AND VALIDATION OF THE APPLICATION DOSSIER...................................................................... 42
6.8 EVALUATION OF THE APPLICATION .............................................................................................................. 42
6.9 RE-EXAMINATION OF THE CHMP/CVMP OPINION .................................................................................... 44
6.10 DECISION-MAKING PROCESS ..................................................................................................................... 44
6.11 EARLY ACCESS TO THE EU MARKET ........................................................................................................... 45
6.12 MARKETING OF THE MEDICINAL PRODUCT IN THE COMMUNITY ................................................................ 47
6.13 RISK MANAGEMENT AND PHARMACOVIGILANCE ....................................................................................... 47
7. OTHER USEFUL INFORMATION ............................................................................................................. 49
7.1 INFORMATION ON MEDICINAL PRODUCTS .................................................................................................... 49
7.2 LIST OF ABBREVIATIONS .............................................................................................................................. 50
7.3 CONTACT POINTS AT THE EMEA ................................................................................................................ 51
ANNEX 1 ............................................................................................................................................................. 52
© EMEA 2009
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