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Home / Industry / Fees Guideline and Q&A

Fees Guideline and Q&A

Guideline on fees for authorisation and post-authorisation procedures

 

Please refer to the Guideline on fees for useful information on the relevant fees to be paid for registration of new products and other authorisation procedures related to medicinal products.

Questions and Answers on Fees to be paid for authorisation and post-authorisation procedures

Question 1: Where do I find the fees to be paid to the Medicines Authority for registration and post-authorisation procedures of medicinal products?

The fees are laid out in Legal Notice 315 of 2006 (Subsidiary Legislation S.L.458.46), as amended. More information is also found in the Guideline on fees payable to the Medicines Authority in relation to medicinal products in accordance with Legal Notice 315 of 2006 - Medicines Authority Fees. 

Question 2: How and when do I make the payment for licensing and post-licensing procedures?

Fees must be paid to the Medicines Authority bank account details of which are the below:

Bank HSBC Malta plc.
Gżira Branch
Malta
Account No. 039-011176-002
Swift Code MMEBMTMT
IBAN MT78MMEB44392000000039011176002

Please use this account only to effect payments to the Medicines Authority.

Please also note that whenever a payment is effected in respect of an application which is submitted to the Medicines Authority, the following details need to be submitted to finance.medicinesauthority@gov.mt.

  • The name of the company effecting payment
  • The name of the company on behalf of which the payment is effected (when applicable)
  • The amount paid
  • Date of payment
  • Payment details e.g., type of application and reference no.; invoice no., etc.

A copy of the proof of payment should accompany the submission.

Question 3: What happens if the fee paid is incorrect?

If the fees paid are more than those that are due, credit is given and the applicant is informed.

If the fees paid are less than those that are due, the applicant is informed to pay the correct fee. 

Question 4: Are refunds given if the application is not successful?

This depends on the type of application.  Refunds are given for fees paid for Mutual Recognition and Decentralised procedures where Malta is the Reference Member State - 90% of the total fees paid are refunded if the application is withdrawn during the validation period or is invalid.  Following day 0, once the assessment is started, no refunds are issued.

For applications in accordance with article 126(a) the amount required to be paid upon submission is 25% of the relevant fee. The remaining balance is requested by the Medicines Authority upon completion of the process for granting of the authorisation in case of a positive outcome.

If the full fee is paid upon submission of the application, and the application is refused, 75% of the fee is credited to the company. A 90% refund of the fees paid may be given only in the case where the application is considered invalid because a marketing authorisation already exists for the product in Malta, and the application is refused on this basis. 

For parallel import applications that are refused because there is no valid marketing authorisation to be used as reference product, a 90% refund of the fees paid may be given.

Refunds are always given at the discretion of the Medicines Authority.

Question 5: How do I apply for the relevant discount for the third application for DCP procedure with Malta as Reference Member State?

Please refer to the Fees Guideline.  Please use the appropriate form to be able to apply for the discount, which should be applied for with submission of the 3rd application.

Question 6: How do I pay the annual maintenance fees?

Annual fees can be paid directly into the bank account of the Medicines Authority (Answer to Question 2 refers).  Furthermore, an invoice is also issued by the Finance and Administration Unit on a yearly basis based on the authorisation issue date of each particular product.

Question 7: Is it possible to group the fees for a number of submissions into one single payment?

Yes, a single payment for more than one application can be made, provided that a description clearly states what the payments are for.

Question 8: What happens if I submit a variation and it is invalid or non-approvable and I need to re-submit it?  Can I use the fees paid for the first submission for the re-submission?

No, once an application is invalid, non-approvable or partially approved, the fees for the variation must be paid when it is re-submitted. 

Question 9: When a variation has already been approved for a lead procedure where Malta is the Reference Member State, are the fees for the same variation for parallel procedures still due?

Yes, each variation application must be accompanied by the relevant fees. 

Updated: February 2020