CONSULTATION  BY A NOTIFIED BODY ON AN ANCILLARY MEDICINAL SUBSTANCE  INTEGRATED IN A MEDICAL DEVICE

Application Form

This application form is to be used for an application for a scientific opinion on an ancillary medicinal substance used in a medical device submitted to the Afssaps in accordance with Directives 93/42/CE and 90/385/CEE as amended.

A combined form is acceptable for a range of strengths or concentrations of the ancillary medicinal substance and for a range of similar devices (e.g. a range of catheters made of the same material) incorporating the same medicinal substance from the same manufacturer (give information successively, where appropriate).

To be submitted to: ANSM DMTCOS – DMCHIR (172), Procédure d’avis sur substance médicamenteuse ajoutée à un Dispositif Médical, 143/147 bd Anatole France F-93285 Saint-Denis cedex- France

DECLARATION and SIGNATURE

Name of device:			
     

Ancillary medicinal substance(s)			
     

Strength/Concentration of medicinal substance(s) 	
     

Notified body:			
     

Person authorised for communication,on behalf of the notified body : 
     
	
Applicant for device approval:			
     

I hereby request a consultation with the ANSM concerning the medicinal substance(s) integrated in the above mentioned device. I declare that, for this product no application for consultation has been submitted to any other medicinal authority and no consultation procedure is ongoing.

It is hereby confirmed that all existing data which are relevant to the quality, safety and usefulness of the ancillary medicinal substance(s) have been supplied in the dossier and that all required headings have been filled.

On behalf of the notified body
     ___________________________________________
		 				Signature(s)

Name                                        Function 	     		

Place and date  (dd-mm-yy)     

NB For the admissibility of the request (step 1 of the consultation) only items 1 to 16 must be completed

1. Name of product
Proposed (Invented) name of the medical device 
If different (Invented) names are proposed, these should be listed by Member State
	2.  Consultation reference number
(Insert number allocated by ANSM)
	
     
     	     
     	
3 Name of the ancillary medicinal substance 
Note only one name should be given in the following order of priority : INN, Ph. Eur, National Pharmacopia, common name, scientific name; the active substance should be declared by its recommended INN, accompanied by its salt or hydrate form if relevant
	
     
     	
4 Type of application	

4.1 Initial advice for a new medical device 

	Initial consultation on an ancillary new medicinal substance (i.e. the medicinal substance does not have a MA in France)			 

	Initial consultation on an ancillary new medicinal substance (i.e. the medicinal substance does not have a  MA in France for the purpose of the integration into the medical device) 

	Initial consultation on a known ancillary medicinal substance from a known source (i.e. the medicinal substance have a MA in France for the purpose of the integration into the medical device) 

4.2  Modification for a class 3 rule 13 medical device already marked CE

	Follow-up consultation: variation on an ancillary medicinal substance due to an amendment to the documentation.

Date and reference of previous consultation procedure 
     
     	
5 Claims made in product information (only for initial advice, for complementary advice see section 6)	

Not applicable

Please state claims as made in product information, including any additional claims relating to added substance 

5.1 Claim
     
     

5.2 Additional claims
 none
 Yes : 
     
     	
6 Background on change to substance (Only for complementary advice on variation, for initial see section 5)	

Not applicable or initial ANSM’ reference number      

Please explain the background to proposed change in relation to substance

6.1 Background on change
     
     

6.2 Impact on claims

Specify the exact current and proposed text (if changing claim)

Not applicable
Modifications proposed

Current claims
     
     
Current additional claims
     
     
Proposed new claims
     
     
Proposed additional new claims
     
     
	
7  Notified Body
(Insert name, address, e-mail, telephone, fax and name of contact person)	
     
     
     
	
8  Device manufacturer seeking device approval
(Insert name and address and contact details  for person authorised for communication throughout the consultation)	
     
     
	
9 Manufacturer of device (if different from section 8)
(Insert name and address)	
Not applicable
     
     
     
	
10  Manufacturer(s) of intermediate products
(Insert name, address, telephone and  fax numbers) attach flow chart.	
     
     
     
	
11  Manufacturer(s) of the active substance
(Insert name, address, telephone and  fax numbers of each supplier)	
     
     
     
	
12  Pharmacotherapeutic classification
Use ATC classification system,: WHO ATC weblink : http://www.whocc.no/atcddd	
     
     
     
	
13  Ph Eur Certificate of Suitability
(Insert reference number if applicable)	
Not applicable
     
     
	
14  Active Substance Master File
(Insert reference if applicable)	
Not applicable
     
     
     
	
15  Description of device with ancillary medicinal substance
(Enter amount of active substance in each device, also concentration per unit volume/area as appropriate, description of device, packaging components, shelf-life details and recommended storage conditions.     
A single form may be used for a group of products where the active substance is qualitatively and quantitatively identical.)Attach the instruction for use of medical device.	

Description of device and intended purpose
     
     
     
	
Ancillary medicinal substance(s)	Quantity	Unit		Reference / Monograph standards e.g. PhEur	
a.     	     	     	     	
b.     	     	     	     	
c.     	     	     	     	
Packaging components and pack size
     

Proposed Shelf-life (unopened)
     	Proposed Shelf-life (in use)
     

Recommended storage conditions
     
     
	
16  Intended purpose of the ancillary medicinal substance as incorporated into the device with scientific explanation that the action of the medicinal substance is only ancillary to that of the device.	
     
     
     
     
     
	
17  Utility of the ancillary medicinal substance as incorporated into the device. Summary of Notified Body evaluation	
     
     
     
     
     
	
18  Checklist  of data submitted : to be completed only at step 2 consultation when  the complete dossier is submitted	
Application form		
Application Dossier 
(according to MEDDEV
formatted in accordance with Annex 1 or 2 of ANSM guideline)		
Attachments 		
Notified Body report on usefulness of the ancillary medicinal substance		
Letter of authorisation for communication on behalf of the notified body		
Flow chart indicating the different sites involved in the manufacturing process of the ancillary medicinal substance as incorporated into the device		
Good Manufacturing Procedure inspection certificate / ISO 9001 certificate for manufacturing sites		
Letter(s) of access to Active Substance Master Files or copy of Ph. Eur. Certificate of Suitability		
Copy of written confirmation from the manufacturer of the ancillary medicinal substance to inform the applicant in case of modification of the manufacturing process or specifications according to Annex 1 of Directive 2001/83/EC as amended		
TSE Statement and supporting documentation where the ancillary medicinal substance is manufactured using materials of animal origin 		
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