Nitrosamines – Step 2: Nitrosamine detected

Questions and answers on how to correctly fill in this webform

* Mandatory field

Surname and first name

E-mail

Marketing Authorisation Holder name

Marketing Authorisation Holder address

Name of medicinal product

Type of product

Active pharmaceutical ingredient (API)/intermediate

Marketing Authorisation Number

Procedure Number (DCP, MRP, NAT)

For DCPs and MRPs use the country code + product counter of maximum four numbers, for example BE-106. For NATs use NAT + product counter of maximum four numbers, for example NAT-1125

API manufacturer name

API manufacturer address

Finished product manufacturer name

Finished product manufacturer address

Product risk classification (from risk evaluation)

Product/API batch analysed

Root cause of identified (from the investigation performed)

Proposed next steps

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