Art. 5(3) referral on nitrosamines in human medicinal products
How should "Step 2 responses" be submitted for products authorised in Austria (nationally, MRP and DCP)?
Step 2 responses for products nationally authorised in Austria (including MRP / DCP) should be uploaded in the respective procedure ("Risikoevaluierung") of the concerned product via eServices only.
Detailed instructions can be found under this link.
Step 2 responses should not be submitted via e-mail. If step 2 responses have already been submitted via e-mail, then the respective documents should be uploaded as soon as possible via eServices too.
Further inquiry note
Page last modified: 15/12/2022