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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 to provide you with LOA, by e-mail not later than four 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 20 business days, 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;
|
|
Dossier type (number) |
Products |
|
US FDA
|
Type III (n° 011321) |
Bulk: vials, syringes, cartridges, ampoules |
|
Type III (n° 021723) |
EZ-fill® vials and syringes |
|
|
Type III (n° 030397) |
EZ-fill® cartridges |
|
|
Type III (n° 033620) |
EZ-fill® Alba® Products |
|
|
Health Canada
|
Type II (n° MF 2003-095) |
Bulk: vials, syringes, cartridges, ampoules |
|
Type II (n° MF 2008-122) |
EZ-fill® vials and syringes |
|
|
Type II (n° MF 2024-081) |
EZ-fill® Alba® Products |
|
|
Type II (n° MF 2020-190) |
EZ-fill® cartridges |