Notice to applicants for Temporary Authorisation for Use

Afssaps

Description

Drugs
15/11/2007

Sujets

• DRUGS

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• Publié par: ansm-drugs
• Publié le: 15 novembre 2007
• Nombre de lectures: 99
• Licence : En savoir +
  Paternité, pas d'utilisation commerciale, pas de modification
• Langue: English

Extrait

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: [phone]  Fax: [phone]  E-mail: [e-mail] 

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  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  

 

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  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     

 

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