Authorisation Holders who market medicinal products in Malta that are in scope of the Delegated Regulation 2016/161 need to be onboarded with the Malta Medicines Verification Organisation (MaMVO).
For the purposes of registration with MaMVO, the terms “Market Authorisations” and “Authorisations” are considered inclusive of all marketed Centrally Authorised Products, National Marketing Authorisations, Parallel Import Licences, and Article 126a Authorisations, and the terms “Market Authorisation Holders (MAH)” and “Authorisation Holders (AH)” are considered inclusive of any and all holders of any such authorisations to market medicinal products in Malta.
Authorisation Holders who do not have a Contract Agreement with MaMVO signed in 2021 or later (version 4) are expected to follow the Onboarding Process below.
The Onboarding Process that MaMVO has put in place for MAHs and AHs as part of the process for fulfilling the requirements of Delegated Regulation 2016/161 involves the following 2 phases:
Authorisation Holders are required to provide:
- The AH entity details as well as the details of the Applicant and the Signatory necessary to engage the contractual phase of the AH Onboarding Process through the following online AH Contract Agreement Form.
- A number of contact details to enable communication between the AH and MaMVO on various matters related to activities under the Delegated Regulation through the following online AH Representatives Form.
Completion of the Registration Phase provides the Authorisation Holder with the means to electronically sign a contract with MaMVO.
Re-signing of the Contract Agreement will only be necessary in the event of any change in the Terms of the Contract Agreement, but will not otherwise need to be re-signed on a yearly basis.
- Checks are made against data held in the MaMVS and in publicly accessible databases in order to establish the Authorisation Holders who are expected to have onboarded with MaMVO and signed a Contract Agreement accordingly.
- Authorisation Holders who have not signed an AH Contract Agreement with MaMVO, in 2021 or later (version 4), and who have not filled in the AH Representatives Form, will be contacted by MaMVO representatives to draw up and electronically endorse the MaMVO Contract Agreement, and/or fill in the AH Representatives Form, as necessary.
- Any queries or requests for further clarifications may be sent to MaMVO Website AH Onboarding Query/Request.