Notice to applicants for Temporary Authorisation for Use
55
pages
English
Documents
2007
Le téléchargement nécessite un accès à la bibliothèque YouScribe Tout savoir sur nos offres
55
pages
English
Documents
2007
Le téléchargement nécessite un accès à la bibliothèque YouScribe Tout savoir sur nos offres
Publié par
Publié le
15 novembre 2007
Nombre de lectures
70
Langue
English
Drugs
15/11/2007
Voir
15/11/2007
Publié par
Publié le
15 novembre 2007
Licence :
Paternité, pas d'utilisation commerciale, pas de modification
Langue
English
EVALUATION OF MEDICINAL PRODUCTS AND BIOLOGICAL PRODUCTS Department of the Evaluation of Medicinal Products with Special Status and Clinical Trials Notice to applicants for Temporary Authorisation for Use (ATU)
November 2007 Contact: Afssaps/Unité ATU Tel: 33 (0) 1 55 87 36 11 Fax: 33 (0) 1 55 87 36 12 E-mail: atu@afssaps.sante.fr
1
I.
II.
SUMMARY
ATU : GENERAL PRINCIPLES .................................................................................................................5
REGULATION............................................................................................................................................5
2.1 Legislative relating to ATU ........................................................................................................................5
2.2 Provisions relating to ATU ........................................................................................................................6
2.3 Provisions relative to the import of medicinal products which are the object of ATU .......................6 2.4 Provisions concerning pharmacovigilance .............................................................................................6
2.5 Regulatory provisions relating to the conditions of prescription, supply and retrocession .............6
2.6 Provisions relative to the cost of ATU......................................................................................................7
2.7 Supply and responsibility for medicinal products..................................................................................7
2.8 European provisions..................................................................................................................................7
III. MEDICINAL PRODUCTS CONCERNED BY ATU AND CONDITIONS OF PRESCRIPTION, SUPPLY AND RETROCESSION..............................................................................................................................8
3.1 Medicinal products concerned..................................................................................................................8
3.2 Conditions of prescription, supply and retrocession.............................................................................8
IV. IDENTITY OF THE APPLICANT FOR ATU...............................................................................................8
V. SHOULD APPLICATIONS FOR ATU BE ADDRESSED? .........................................................9WHERE
VI. ....U.ATE IVATINMON................................................................................................................................9 6.1 Application file for nominative ATU..........................................................................................................9 6.2 Evaluation of applications for nominative ATU and Afssaps decision ................................................9
6.3 Procedure for obtaining nominative ATU medicinal product and importing the medicinal products10
6.4 Duration of the nominative ATU and continuations of treatment .......................................................10
6.5 Information for patients in the case of nominative ATU.......................................................................10 6.6 Role of the prescribing physician in the case of nominative ATU ......................................................10
6.7 Information for prescribing physicians concerning nominative ATU medicinal products ..............11
6.8 Role of the hospital pharmacist in the case of nominative ATU .........................................................11
6.9 Labelling of the medicinal product for nominative ATU.......................................................................11
6.10 Protocol for therapeutic use and information collection ...................................................................11
6.11 Role of the exploitant of the medicinal product in nominative ATU .................................................11
6.12 List of nominative ATU medicinal products ........................................................................................11 2
VII. CATT OROH......U....................................................................................................................................11
7.1 Application file for cohort ATU ...............................................................................................................11
7.2. Protocol for therapeutic use and information collection....................................................................12 7.3. Assessment of cohort ATU applications..............................................................................................13
7.4. Patient information in the context of a cohort ATU.............................................................................13 7.5. the prescribing physician in the context of a cohort ATU ....................................................13Role of 7.6. of the hospital pharmacist in the context of a cohort ATU........................................................13Role 7.7. of a cohort ATU and treatment initiationProcedure to obtain a medicinal product in the context procedure.................................................................................................................................................14
7.8. Role of the exploitant of the medicinal product with a cohort ATU ..................................................14
7.9. Periodic ATU reports in the context of a cohort ATU .........................................................................14
7.10. Importing medicinal products in the context of a cohort ATU ........................................................14
7.11. Labelling of a medicinal product in the context of a cohort ATU.....................................................15
7.12. List of medicinal products with a cohort ATU ....................................................................................15
7.13 Duration of cohort ATU and renewal ....................................................................................................15
VIII. PHARMACOVIGILANCE AND ATU ........................................................................................................16
8.1 Role of healthcare professionals ............................................................................................................16 8.2 Role of the exploitant of the medicinal product with an ATU ..............................................................17 8.3. Role of Afssaps........................................................................................................................................18
8.4 Role of Regional Pharmacovigilance Centres (CRPV) .........................................................................18
IX. WITHDRAWAL AND SUSPENSION OF ATU.........................................................................................19
X. APPROVAL OF ATU MEDICINAL PRODUCTS FOR HOSPITAL USE.................................................19
XI. ................................................................CHANGING FOR MTA UOTM .A..................................91...........
XII. ........20..................................................................................................................................NGSITIERDVA
XIII. SITE .............................................................20 INTERNETINFORMATION AVAILABLE ON AFSSAPS ’
XIV. FINANCING OF ATU MEDICINAL PRODUCTS .....................................................................................20
ANNEXS...........................................................................................................................................................21
ANNEX A..........................................................................................................................................................22
Nominative ATU Cerfa application form.......................................................................................................22
http://www.sante.gouv.fr/cerfa/autotemp/atu.pdf........................................................................................22
3
ANNEX B..........................................................................................................................................................23
Cerfa form for the notification of an adverse reaction likely to be due to a medicinal product or a product mentioned in Article R.5121-150 .............................................................................................23
ANNEX C..........................................................................................................................................................24
“Roles of the various parties ......................................................................................................................42
ANNEX D..........................................................................................................................................................25
Application form for cohort ATU...................................................................................................................25
ANNEX E..........................................................................................................................................................30
Template Protocol for therapeutic use and information collection .......................................................30
ANNEX F..........................................................................................................................................................46
Template for drafting of Periodic ATU Report .............................................................................................46
ANNEX G.........................................................................................................................................................50
Application form for renewal of cohort ATU................................................................................................50
4
