Letter of Authorization (LOA) for Master Files

Dear Customer,

Please fill out one (1) LOA request form for each drug product submission. The requested LOA(s) will be sent to you by e-mail. A LOA request needs to list only one targeted health authority.

The LOA provides authorization to health authorities to review Ompi Master Files in parallel to the Marketing Authorization Holder (MAH) application. Upon receiving your request, Ompi will proceed providing you with LOA, by e-mail not later than 15 working days from the day of request, if otherwise not indicated or requested with urgency.

Once LOA is signed, DMF update and LOA will be forwarded to competent Regulatory Authority by 1 month, if otherwise not requested.  

Note: * = Required fields

Stevanato group SpA and Nuova Ompi S.r.l. unipersonale owns several types of Master File submitted to US FDA and Health Canada;

 

DMF type (number)

Products

US FDA

Type III (n° 11321)

Bulk: vials, syringes, cartridges, ampoules

Type III (n° 21723)

EZ-fill vials and syringes  

Type III (n° 030397)

EZ-fill cartridges

Health Canada

Type II (n° DMF 2003-095)

Bulk: vials, syringes, cartridges, ampoules

Type II (n° DMF 2008-122)

EZ-fill vials and syringes  

 


Your Contact Details:
Contact details of the person who should receive the LOA:
Ompi's product information:
Customer's Submission Information: