Authorisation holders of medicinal products placed on the market in Malta are required to complete and submit this form.

In order to complete the form, the contact information for the below listed roles need to be supplied.

Local Representative
The authorisation holder’s contact person in Malta (if applicable).

Billing / Finance
The authorisation holder’s contact person for matters regarding invoicing and payment of contributions due to MaMVO by the authorisation holder.

Legal
The authorisation holder’s contact person for legal matters, such as contracts, and changes thereto, between the authorisation holder and MaMVO.

Regulatory Affairs
The authorisation holder’s contact person on matters related to pharmaceutical regulatory affairs, such as national and central marketing authorisations, and the placing on the market of the products that are the subject of such authorisations.

Supply Chain Alert Management
The authorisation holder’s contact person for the investigation of alerts where the pack audit trail concerns events that may have occurred through the pack’s supply chain from the manufacturing site to the local market.

Serialisation Alert Management
The authorisation holder’s contact person for the investigation of alerts, where the root cause of the alert concerns issues with the serialisation of packs and/or the absence/presence of serial numbers in the OBP’s serialisation database.

OBP Product / Pack Data
The authorisation holder’s contact person for the investigation of issues concerning the upload of product and pack data into the MaMVS and/or other markets in the case of intermarket alerts.

Alert Management SPOC (Single Point of Contact) for National Alert Management System (AMS)
The contact details of the authorisation holder’s SPOC for input by MaMVO into the national AMS, NMVS Alerts.


Note: The same individual may be assigned different roles.