Market Authorisation Holders

As from 9th February 2019, MAHs who market in-scope products in Malta 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 updates to packaging and releasing serialized packs to the market will happen before this date.

Below are the key steps to be followed in order to comply with the new regulations:

  1. Categorizing the products which require safety features and are in scope of the new requirements (as defined in Article 2 of the Commission Delegated Regulation (EU) 2016/161).
  2. Making the necessary changes to packaging to include safety features and having it approved by the regulatory authority.
  3. Upgrading production lines so as to apply the anti-tamper device and unique identifiers.
  4. On-boarding to the EU Hub. This process is managed by EMVO and details pertaining to this process (which includes both technical and contractual obligations) can be found on their website.
  5. Uploading the unique identifier data placed on packs to the EU Hub. The data will then be transferred from the EU Hub to the national repository for the market where the packs are planned to be sold.
  6. Registering with MaMVO and paying 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 and Authorisation Holders are considered inclusive of all holders of any such authorisations to market medicinal products in Malta.

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.

It is important to highlight that failure to transfer payment by the stipulated yearly deadline will automatically be regarded as a late payment. An additional penalty equivalent to 25% of the total amount due per AH would be added to the total contribution to be paid by the AH, in case the payment is done from one day to three months after the deadline. An additional penalty equivalent to 50% of the total amount due per AH would be added to the total contribution to be paid by the AH, in case the payment is done from three months and one day to six months after the deadline. An additional penalty equivalent to 100% of the total amount due per AH would be added to the total contribution to be paid by the AH, in case the payment is done from six months and one day to twelve months after the deadline.

MaMVO Contribution Fees for 2020

The MaMVO Board has approved the new Contribution Fees structure for 2020. 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.

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.

Checks for the presence/absence of product codes in the MaMVS will be made at the time of application, subject to the submission of a valid application by the 31st January, 2020. Product Code checks against the MaMVS for authorisation holders submitting a late application will be made against a snapshot taken on the 31st January 2020.

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 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 at the time of application, subject to the submission of a valid application by the 31st January 2020. Checks for late application will be made against a snapshot taken on the 31st January 2020.

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

The following contribution payment scheme applies for 2020

Payment SubmissionLate Payment Fee
by 31st January 20200%
by 30th April 202025%
by 31st July 202050%
After 31st July 2020100%

Registration will be available shortly.

MaMVO Contribution Fees for 2019

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 in 2019 are obliged to pay the 2019 Contribution Fee.

MAs per MAHContribution per MAH
1-5€ 1,050
6-25€ 2,675
26-50€ 6,800
51-300€ 20,250
300+€ 57,500

MaMVO Contribution Fees for 2018

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 in 2018 are obliged to pay the 2018 Contribution Fee.

MAs per MAHContribution per MAH
1-5€ 650
6-25€ 1,650
26-50€ 4,200
51-300€ 12,500
300+€ 35,500

NOTES 

  1. 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 in 2018 and/or 2019 that have not paid the 2018 and/or 2019 Contribution Fees, should also submit a registration and pay the respective year Contribution Fees.
  2. The deadline for the settlement of the 2019 Contribution Fee has been extended till the 15th July 2019. Registrations and payments beyond this date are subject to a late payment fee.