GROUP A
Authorisation Holders Uploading Products into the MaMVS
Authorisation Holders that have uploaded data into the MaMVS in respect of medicinal products that are the subject of Central or National Authorisations, or Parallel Distribution Notices held by the European Medicines Agency, are considered in this category.
Contribution Fees
| Fee | Fee Model |
|---|---|
| € 8,000 | Flat rate fee per authorisation holder |
Discounts
Authorisation Holders may be eligible for a (cumulative) number of 15% discounts on their contribution fee as per the following criteria:
- The Authorisation Holder is a regular contributor, that is, it is deemed by MaMVO to be in good standing with regards to the regular settlement of contribution fees owed.
- The Authorisation Holder has uploaded data into the MaMVS in respect of medicinal products that are the subject of only 1 – 5 Central or National authorisations.
- The product being marketed in Malta by the Authorisation Holder is listed in the Community Register of orphan medicinal products or has been authorised by the European Medicines Agency or the Malta Medicines Authority for the treatment of a rare disease.
- The Authorisation Holder is registered as a micro, small or medium-sized enterprise (SME) with the European Medicines Agency.
GROUP B
Authorisation Holders Placing Medicinal Products on the Maltese Market but Uploading Data to Another National Repository
Authorisation holders placing medicinal products on the market in Malta under an Article 126a (AA) authorisation and/or a Parallel Import (PI) licence without the need for reserialisation may have uploaded their data into another National Repository. The packs marketed in Malta are authenticated by Intermarket Transactions (IMT), with the MaMVS as the originating system. These Authorisation Holders are required to pay this contribution, irrespective of whether the product is being actually marketed.
Contribution Fees
| No. of Licenses | Fee | Fee Model |
|---|---|---|
| 1-33 | € 265 | Per Licence |
| 34-300 | € 9,000 | Flat Fee |
| > 300 | € 10,000* | Per 100 licences or part thereof |
* 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, and is already paying a Group A contribution in respect of other products, the uploaded products will be considered as covered by the Group A contribution and will not be considered for the purposes of the computation in Group B.
Important Notes
- 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.
- 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.
GROUP A
Authorisation Holders Uploading Products into the MaMVS
Authorisation Holders that have uploaded data into the MaMVS in respect of medicinal products that are the subject of Central or National Authorisations, or Parallel Distribution Notices held by the European Medicines Agency, are considered in this category.
Contribution Fees
| Fee | Fee Model |
|---|---|
| € 9,000 | Flat 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.
| Fee | Fee Model |
|---|---|
| € 6,000 | MAHs with 1 – 2 MAs |
| € 6,800 | MAHs with 3 – 5 MAs |
| € 7,500 | MAHs with more than 5 MAs |
GROUP B
Authorisation Holders Placing Medicinal Products on the Maltese Market but Uploading Data to Another National Repository
Authorisation holders placing medicinal products on the market in Malta under an Article 126a (AA) authorisation and/or a Parallel Import (PI) licence without the need for reserialisation may have uploaded their data into another National Repository. The packs marketed in Malta are authenticated by Intermarket Transactions (IMT), with the MaMVS as the originating system. These Authorisation Holders are required to pay this contribution, irrespective of whether the product is being actually marketed.
Contribution Fees
| No. of Licenses | Fee | Fee Model |
|---|---|---|
| 1-9 | € 200 | Per Licence |
| 10-300 | € 9,000 | Flat Fee |
| > 300 | € 10,000* | Per 100 licences or part thereof |
* 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, and is already paying a Group A contribution in respect of other products, the uploaded products will be considered as covered by the Group A contribution and will not be considered for the purposes of the computation in Group B.
Important Notes
- 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.
- 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 30% of the invoice amount for 2021 shall 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.
GROUP A
Authorisation Holders Uploading Products into the MaMVS
Authorisation Holders that have uploaded data into the MaMVS in respect of medicinal products that are the subject of Central or National Authorisations, or Parallel Distribution Notices held by the European Medicines Agency, are considered in this category.
Contribution Fees
| Fee | Fee Model |
|---|---|
| € 9,000 | Flat rate fee per authorisation holder |
Early Bird Contribution Fees
An early bird contribution fee structure was valid until the 29th February 2020 against proof of payment submitted to MaMVO as specified within the payment instructions section on the registration cover sheet.
| Fee | Fee Model |
|---|---|
| € 6,000 | MAHs with 1 – 2 MAs |
| € 7,500 | MAHs with 3 – 5 MAs |
| € 9,000 | MAHs with more than 5 MAs |
GROUP B
Authorisation Holders Placing Medicinal Products on the Maltese Market but Uploading Data to Another National Repository
Authorisation holders placing medicinal products on the market in Malta under an Article 126a (AA) authorisation and/or a Parallel Import (PI) licence without the need for reserialisation may have uploaded their data into another National Repository. The packs marketed in Malta are authenticated by Intermarket Transactions (IMT), with the MaMVS as the originating system. These Authorisation Holders are required to pay this contribution, irrespective of whether the product is being actually marketed.
Contribution Fees
| No. of Licenses | Fee | Fee Model |
|---|---|---|
| 1-9 | € 200 | Per Licence |
| 10-300 | € 9,000 | Flat Fee |
| > 300 | € 10,000* | Per 100 licences or part thereof |
* 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, and is already paying a Group A contribution in respect of other products, the uploaded products will be considered as covered by the Group A contribution and will not be considered for the purposes of the computation in Group B.
Important Notes
- 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.
- 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
Any payment that has not been settled by an Authorisation Holder in respect of contributions owed to MaMVO in 2020 is automatically regarded as a late payment, and the Authorisation Holder is liable towards MaMVO for the payment of a Late Payment Fee equivalent to 10%, which shall be included within the invoice amount. 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 this agreement.
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 MAH | Contribution per MAH |
|---|---|
| 1-5 | € 1,050 |
| 6-25 | € 2,675 |
| 26-50 | € 6,800 |
| 51-300 | € 20,250 |
| 300+ | € 57,500 |
Important Notes
- 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.
- 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
Any payment that has not been settled by an Authorisation Holder in respect of contributions owed to MaMVO in 2019 is automatically regarded as a late payment, and the Authorisation Holder is liable towards MaMVO for the payment of a Late Payment Fee equivalent to 25%, which shall be included within the invoice amount. 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 this agreement.
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 MAH | Contribution per MAH |
|---|---|
| 1-5 | € 650 |
| 6-25 | € 1,650 |
| 26-50 | € 4,200 |
| 51-300 | € 12,500 |
| 300+ | € 35,500 |
Important Notes
- 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.
- 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
Any payment that has not been settled by an Authorisation Holder in respect of contributions owed to MaMVO in 2018 is automatically regarded as a late payment, and the Authorisation Holder is liable towards MaMVO for the payment of a Late Payment Fee equivalent to 25%, which shall be included within the invoice amount. 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 this agreement.
Postal Address
Groundfloor, Mayflower Court,
St Louis Street,
Msida, MSD1465 MALTA
Registered Address
36, Archbishop Street,
Valletta, VLT 1447 MALTA