Market Authorisation Holders

As from 9th February 2019, MAHs who market medicinal products in Malta that are in scope of the Delegated Regulation are required to certify that all packs released to the Maltese market carry the necessary safety features such as unique identifiers and anti-tamper devices.

Such authorisation holders need to be registered with MaMVO and pay the relevant fees.

Kindly note that for the purposes of registration with the Malta Medicines Verification Organisation, the terms Market Authorisations and Authorisations are considered inclusive of all marketed Centrally Authorised Products, national Marketing Authorisation, 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.

Contribution Fees are applicable to the holders of any authorisation to place a medicinal product for human use bearing the safety features as per Delegated Regulation (EU) 2016/161 on the Maltese market.

The contributions have to be calculated per Marketing Authorisation Holder (MAH) companies who bring medicines on the Maltese market, taking into consideration the number of Marketing Authorisations (MA) covered by each MAH.

MaMVO Contribution Fees for 2021

  • Invoices

    As from this year, invoices will be sent automatically to Authorisation Holders and thus no self-registration process is required. Payment is due within 60 days of date of invoice.

  • Agreement

    Authorisation Holders who have not signed an agreement with MaMVO will be contacted by MaMVO representatives to draw up and electronically endorse the MaMVO agreement.

  • Late Payment Terms

    Failure to settle payment within 60 days from date of invoice shall automatically be regarded as a late payment, and shall render the Authorisation Holder liable towards MaMVO for the payment of Late Payment Fees. After 60 days from date of invoice, a Late Payment Fee equivalent to 30% of the invoice amount shall be added to the contribution to be paid by the Authorisation Holder. After 90 days from date of invoice, a further additional Late Payment Fee equivalent to 30% of the invoice amount shall also be added to the contribution to be paid by the Authorisation Holder. Late Payment terms are applicable from date of invoice. Late payment fees shall be payable for mere delay and shall be deemed to be pre-liquidated damages suffered by MaMVO for such default by the Authorisation Holder, and shall not be subject to abatement by any Court or Tribunal and shall be without prejudice to any other right of MaMVO arising in virtue of law or in terms of the agreement.

  • Exemption Schemes

    An Orphan Drug Fee Exemption scheme is in place for medicinal products holding a central marketing authorisation issued by the European Medicines Agency and that are also included in the Community Register of Orphan Medicinal Products. The difference in fees due to the inclusion of these medicinal products in MaMVO’s fee calculation must be more than 50% of the combined turnover from the medicinal products in Malta (25% if the authorisation holder is listed as a SME in the European Medicines Agency SME Register). Turnover figures are self-certified, but MaMVO reserves the right to request supporting evidence and/or audit the declared turnover. Any approved exclusion of medicinal products from a fee computation will be valid for one financial year only, and renewed applications must be made in subsequent years; these will be considered independently of previous decisions.

GROUP A

Authorisation Holders Uploading Products into the MaMVS

Authorisation holders having at least one Product Code with uploaded packs in the MaMVS are obliged to pay this contribution.

Product Code checks against the MaMVS for authorisation holders will be made in order to establish the respective contribution plan and draw up the contribution invoice.

Contribution Fees

FeeFee Model
€ 9,000Flat rate fee per authorisation holder

Regular Contributor Discount

Market Authorisation Holders that have been regular in the payment of their contribution fees, will in 2021 benefit from a discount.

Discounted FeeFee Model
€ 6,000MAHs with 1 – 2 MAs
€ 6,800MAHs with 3 – 5 MAs
€ 7,500MAHs with more than 5 MAs

GROUP B

Article 126a and Parallel Imports

Authorisation holders having Article 126a (AA) authorisations and/or parallel import (PI) licenced products in the Malta Medicines Authority list, and that have not been uploaded into the MaMVS, whether marketed or not, are obliged to pay this contribution.

Checks to confirm the authorisations/licences listed within the Malta Medicines Authority list will be made to establish the appropriated contribution band.

Contribution Fees

No. of LicensesFeeFee Model
1-9€ 200Per Licence
10-300€ 9,000Flat Fee
> 300€ 10,000*Per 100 licences or part thereof

* Note: a 10% discount will be applied to entities holding more than 500 licences.

Provided that if any Article 126a authorisation or parallel import licence holder, voluntarily or due to regulatory constraints, uploads the pack data of an Article 126a or parallel import licenced product into the MaMVS, said product will be considered as part of the computation in Group A and will not be considered for the purposes of the computation in Group B.

NOTES 

Holders of any authorisation to place on the Maltese market a medicinal product for human use bearing the safety features as per Delegated Regulation (EU) 2016/161 and that have not paid any of the previous years’ Contribution Fees, shall also receive an invoice for the settlement of said fees along with corresponding Late Penalty Fees.

MaMVO Contribution Fees for Previous Years