Authorisation holders of medicinal products placed on the market in Malta are required to follow a three-step process in order to register with the Malta Medicines Verification Organisation (MaMVO), as part of the process for fulfilling the requirements of Delegated Regulation 2016/161.

Registration of the Authorisation Holder
In the online registration process, applicant authorisation holders provide the details necessary to engage the contractual and financial steps of the process. The authorisation holder also provides a number of contact details to enable communication between the parties on various matters related to activities under the Delegated Regulation.

Contractual phase
Completion of the details of the registration process enables the provision to the authorisation holder of a contract to be signed between the authorisation holder and MaMVO.

Financial phase
At the beginning of each year, MaMVO issues, to all authorisation holders that are in a contractual relationship with MaMVO, an invoice for settlement of their dues towards MaMVO under the Delegated Regulation 2016/161. The fees for the current year are available on the MaMVO website at https://mamvo.org/mahs/contribution-fees/