Latest Contribution Fees

Authorisation Holders who market medicinal products in Malta that are in scope of the Delegated Regulation 2016/161 need to be onboarded with MaMVO. Contribution fees are applicable to all Authorisation Holders who have completed the Onboarding Process. The contributions are calculated per Authorisation Holder (AH) entity placing medicines on the Maltese market, taking into consideration the number of authorisations held by each AH.

MaMVO splits medicinal products into two classes:

Class I products: These are products that are subject of Central or National Authorisations, or Parallel Distribution Notices held by the European Medicines Agency.

Class II products: These are products that are subject of an Article 126a or Article 126c authorisation, or a Parallel Import licence.

MaMVO Contribution Fees (2023 and 2024)

Authorisation Holders are classified into one of three groups for the purposes of computation of the contribution fees.

Group A: Authorisation Holders of Class I and/or Class II medicinal products, where the data of the unique identifiers of all the products has been uploaded into Active batches in the MaMVS.

Group B: Authorisation Holders of Class II medicinal products, where none of the data of the unique identifiers of the products has been uploaded into the MaMVS.

Group A+B: Authorisation Holders of Class I and/or Class II medicinal products where the data of the unique identifiers of some of the products has been uploaded into Active batches in the MaMVS.

	Group A	Group A+B	Group B
Active batches of Class I and/or Class II medicinal products present in the MaMVS	Yes	Yes	No
Active batches of Class II medicinal products not present in the MaMVS	No	Yes	Yes

GROUP A

Contribution Fees

No. of Licenses	Fee	Fee Model
1-15	€ 500	Per Licence
16-200	€ 7,500	Flat Fee
> 200	€ 37.50	Per Licence

GROUP A+B

Contribution Fees

No. of Licenses	Fee	Fee Model
1-30	€ 500	Per Licence
31-200	€ 15,000	Flat Fee
> 200	€ 75	Per Licence

GROUP B

Contribution Fees

No. of Licenses	Fee	Fee Model
1-50	€ 500	Per Licence
51-200	€ 25,000	Flat Fee
> 200	€ 125	Per Licence

Important Notes

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.
Checks are made against data held in the MaMVS and in publicly accessible databases on the 1st of January of the applicable contribution year, in order to establish the appropriate contribution plan, and draw up the contribution invoice.
Payment is due within 60 days of date of invoice.
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.

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 15% of the invoice amount shall be added to the contribution to be paid by the Authorisation Holder. After 120 days from date of invoice, a further additional Late Payment Fee equivalent to 35% 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 any applicable agreement.