-
Advise on the most appropriate course for
the registration process between MRP/DCP and national procedures
for registrations, variations, renewals and transfers.
- Prepare translations of SPCs, labels, leaflets etc in accordance
with the current laws in Italy
- Advise on submission material and any necessary additions that
may be required by the AIFA
-
Preparation of Pricing and reimbursement dossiers,
and obtain reimbursement for products in Italy for MRP/DCP/nation
and Centralised products.
-
Follow procedures from pre submission of MRP/DCP & national
dossiers, assisting during the procedure with any issues and
obtaining the final national MA in Italy.
-
Assisting with requests for meetings with
the AIFA and acting as contact person between the customer and
the AIFA.
-
Services related with pharmacovigilance monitoring
- Arrange for various certificates (Free Sale Certificate, GMP,
Certificate of Importation of dangerous substances, Certificate
of Importation of Samples for clinical trials or other uses)
-
Review of promotional material before publishing
to ensure its compliance with the national legislation
-
Clinical trial applications
- Due diligence
