This content applies to human medicines.
The Regulation (EU) 2024/568 on fees and charges payable to EMA entered into force on 1 January 2025.
Find questions and answers below.
For more information on the 'New fee regulation', see:
Yes, EMA charges a fee for Scientific Advice, including Protocol Assistance (scientific advice for orphan medicinal products).
The amount payable will be calculated at the point of validation of your request. For the applicable fee levels and the scopes applicable for each request, please refer to Annex I, Section 1, to the Fee Regulation and Chapter 1.1 of the Fee Regulation Working arrangements.
There are no differences in the amount of fees between initial requests for Scientific Advice and requests which follow a previous scientific advice (i.e. follow-up requests). In both cases, the fees specified in the above-mentioned Annex I will apply.
There could be one or several fee reductions applicable. Please note that the most favourable reduction to the applicant will be applied, as reductions are not cumulative.
Micro, small and medium sized enterprises (SMEs)
A 90% fee reduction will apply to requests related to non-orphan medicinal products submitted by SMEs while a 100% fee reduction will apply to requests related to designated orphan medicinal products submitted by said entities.
Applicants must be established in the EEA and fulfil the definition of a micro, small or medium-sized enterprise as set out in Commission Recommendation 2003/361/EC of 6 May 2003. To benefit from incentives, SMEs must hold a valid SME status with EMA or have submitted the renewal of the SME status (i.e. before its expiry) at the time of submission of the scientific advice request.
The fee reductions shall not be granted to SMEs acting as applicant for the relevant medicinal product by virtue of a contractual arrangement with a non-SME legal entity.
SME regulatory consultancies may seek to benefit from the provisions of the SME Regulation on behalf of non-EEA based clients only if both they and the client meet the SME criteria (i.e. fall below headcount and financial thresholds). In this case, both the regulatory consultant and the non-EEA based company should submit SME declarations. If successful, the regulatory consultant would receive an SME notification, and the non-EEA based company would be listed in annex to that notification as an SME client company. It is not possible for an SME regulatory consultant to be considered eligible if they are acting on behalf of non-SME clients, as this would be contrary to the objectives of the SME Regulation.
Both the regulatory consultant and the non-EEA based company must hold a valid SME status with EMA or have submitted the renewal of the SME status (i.e. before its expiry) at the time of submission of the scientific advice request.
The invoice will be sent to the company acting as the applicant.
To register as an SME with EMA or renew the SME status, please refer to the Support to SMEs page.
Designated orphan medicinal products
A 75% fee reduction will be applicable to Protocol Assistance requested by non-SME applicants, while SME applicants will benefit from a 100% fee reduction.
To be eligible for orphan fee incentives, a decision of the European Commission granting the orphan designation must have been adopted (product entered in the Community Register of orphan medicinal products) at the time of submission of the scientific advice request. A positive COMP opinion on orphan designation is not sufficient for eligibility to the orphan fee reduction.
Please note that during a transfer of an orphan designation, eligibility for fee incentives lies with the initial sponsor (orphan designation holder) until the transfer is complete. Once the transfer is completed, the new sponsor is eligible to fee incentives. The new sponsor must be a different person/legal entity.
For more information on how to receive an orphan designation for a medicinal product, please refer to the Orphan Designation Overview page.
Medicinal products for paediatric use
A 100% fee reduction is applicable for scientific advice on the development of a medicinal product for the paediatric population, if the advice requested does not include the adult population.
Advanced therapy medicinal products (ATMP)
A 65% fee reduction is applicable for Scientific Advice on ATMPs. SME applicants will receive a 90% fee reduction.
ATMP classification from the CAT is not mandatory for eligibility to the fee incentive.
For more information, refer to the
Entities not engaged in economic activities
A 100% fee reduction is applicable to certain entities and requests for scientific advice. In order to grant the fee reduction, the Agency has to verify compliance with section 1.8 of the Fee Regulation Working Arrangements. Said verification is carried out on request from the applicant, which shall be submitted to the Agency. The verification must be completed with a positive outcome (i.e. compliance verified) by the time of submission of the request for Scientific Advice, at the latest. Therefore, the request for verification has to be submitted at least 5 weeks before the submission of the request for Scientific Advice. Late requests may not be processed in time, in which case will not be taken into consideration when determining the fee for Scientific Advice.
For more information on the above-referred verification, please refer to Academia Overview page.
Pandemic vaccines
A 100% fee reduction is applicable if the request is related to a core dossier for a pandemic vaccine until such a human pandemic situation is duly recognised either by the World Health Organisation or by the Commission in accordance with Article 23(1) of Regulation (EU) 2022/2371 on serious cross-border threats to health and repealing Decision No 1082/2013/EU.
ETF advice during a declared public health emergency
A 100% fee reduction is applicable for accelerated scientific advice on the main aspects of clinical trials and clinical trial protocols related to a declared public health emergency at the time of submission (link to Regulation (EU) 2022/123).
For more information, refer to the public health threat overview page.
In accordance with Article 71 of the Agency’s Financial Regulation and Article 7 of the Fee Regulation and its working arrangements, Scientific Advice services will be provided only after the invoice is paid in its entirety.
Once your request is submitted via the IRIS platform, the request will be validated and the fee will be calculated upon the notification of the validation, including any possible fee reduction.
Upon validation, EMA will issue an invoice to the applicant’s billing address held on file by the Agency.
The invoice shall be paid by the payable date indicated on the invoice (deadline for payment).
For your request of Scientific Advice to be included in the next available start of procedure date (cut-off date), EMA recommends that you pay the invoice promptly upon receipt, as the amount needs to be received by this date.
For information on deadlines’ requests for Scientific Advice including cut-off dates for payments, please refer to the Scientific Advice and Protocol Assistance page.
Should the payment not be received by the deadline specified on the invoice, your request will be considered rejected following the conclusion of the administrative validation and an administrative charge will apply.
For additional information on receiving and paying Agency’s invoices, please refer to the How to pay page.
Yes; however, depending on when you decide to withdraw your request/application, the Agency may apply the administrative charge laid down in section 6.1 of Annex IV to the Fee Regulation, or the fee for the related request/application, or the withdrawal may be free of charge.
If your request is withdrawn within 24 hours from your submission in the IRIS portal, the withdrawal will be free of charge.
If your request is withdrawn after 24 hours from its submission and prior to the completion of the administrative validation, an administrative charge will apply. For micro, small or medium sized enterprises, the administrative charge shall be waived.
If your request is withdrawn after the Agency has received the payment of the applicable fee, the amount paid will not be returned to the applicant.
If your request is rejected following the conclusion of the administrative validation, the Agency will issue an invoice for an administrative charge as laid down in section 6.1, Annex IV, to the Fee Regulation.
For registered micro, small or medium sized enterprises, the administrative charge is waived.
For requests validated in 2024, fees and fee reductions will be applied according to Council Regulation (EC) No 297/95 (previous Fee Regulation). The provisions outlined in Regulation (EU) 2024/568 (new Fee Regulation) will apply to all requests validated and starting in 2025.
If the date of your request to withdraw is before 01/01/2025, no administrative fee will be charged for the withdrawal; however, if the date of your request to withdraw your application before the start of the procedure (and 24 hours after its submission) is on or after 01/01/2025, the new Fee Regulation applies with an administrative charge applicable.
Yes, EMA charges a fee for marketing authorisation applications for medicinal products.
The amount payable depends on the legal basis and your claim as to the type of active substance (i.e. new active substance or known active substance) in your application for marketing authorisation. The applicable amount will be calculated after the submission of your application, in conjunction with the related fee reductions.
For the applicable amounts, please refer to Annex I, Section 2, to the Fee Regulation.
It should be noted that for duplicate marketing authorisations, the same fee as described above applies. If, however, the duplicate marketing authorisation is submitted on patent grounds, the lowest fee level set out in Annex I, Section 2.9, to the Fee Regulation applies.
All strengths, pharmaceutical forms and presentations submitted in the same application are covered in the applicable fee.
There could be one or several fee reductions applicable. Please note that the most favourable reduction to the applicant will be applied, as reductions are not cumulative.
Micro, small and medium sized enterprises (SMEs)
A fee deferral will apply to marketing authorisation applications for non-orphan medicinal products submitted by SMEs. A 100% fee reduction will apply to applications for designated orphan medicinal products submitted by SMEs.
A fee deferral for a SME applicant means that the time of payment of the fee for a marketing authorisation (MA) application is deferred until the notification of the final decision (positive or negative outcome) on the MA is issued, or the application is withdrawn. The invoice issued at the time the fee is calculated will inform the applicant that the fee is deferred.
Applicants must be established in the EEA and fulfil the definition of a micro, small or medium-sized enterprise as set out in Commission Recommendation 2003/361/EC of 6 May 2003. To benefit from incentives, SMEs must hold a valid SME status with EMA or have submitted the renewal of the SME status (i.e. before its expiry) at the time of submission of the marketing authorisation application.
The fee reductions shall not be granted to SMEs acting as applicant for the relevant medicinal product by virtue of a contractual arrangement with a non-SME legal entity. For more information, refer to the EMA SME user guide.
A conditional fee exemption of the fee for the evaluation of a MA application may be given where the scientific advice provided by EMA was taken into account by the applicant for the development of the product and a MA is not granted (due to negative outcome or withdrawal of the MA application). To benefit from the conditional fee exemption, SMEs must hold a valid SME status with EMA or have submitted the renewal of the SME status (i.e. before its expiry) at the time of submission of the marketing authorisation application. For additional details, refer to the Support to SMEs page.
A subsequent change to the SME status (i.e. expiration of the SME status) after the applicable fee level date (i.e. at the time of submission of the marketing authorisation application) will not be taken into account for the application of the SME fee incentives. In case of a merger or acquisition impacting the applicant’s SME status, or a product is subject to out-licensing to a non-SME legal entity, after the applicable fee level date, then the deferral will cease to apply from the date on which the merger/acquisition or out-licensing took place, and the applicable fees due will no longer be subject to fee deferral and shall be payable.
To register as an SME with EMA or renew the SME status, please refer to the Support to SMEs page. .
Designated orphan medicinal products
A 10% fee reduction is applicable for a marketing authorisation application for designated orphan medicinal products held at time of submission.
A 100% fee reduction is applicable for marketing authorisation applications for designated orphan medicinal products if the applicant has a valid micro, small or medium-sized enterprise status or has submitted the renewal of the SME status (i.e. before its expiry) at the time of submission.
To be eligible for orphan fee incentives, a decision of the European Commission granting the orphan designation must have been adopted (product entered in the Community Register of orphan medicinal products) at time of submission. A positive COMP opinion on orphan designation is not sufficient for eligibility to the orphan fee reduction.
Please note that during a transfer of the orphan designation from the currently approved sponsor (orphan designation holder) to a new sponsor which is a different person/legal entity, eligibility lies with the initial sponsor until the transfer is completed. Once completed, the new sponsor is eligible to fee incentives.
For more information on how to receive an orphan designation for a medicinal product, please refer to the Orphan Designation Overview page.
Medicinal products for paediatric use
A 50% fee reduction is applicable to a paediatric use marketing authorisation application (PUMA), granted upon eligibility to access the Centralised Procedure.
For more information, refer to the Paediatric overview page.
Pandemic core dossier medicinal products
The applicable fee for an application of a core dossier medicinal product to be used in a pandemic situation is deferred until the pandemic situation is duly recognised by the World Health Organisation or by the European Commission, but it will not exceed 5 years after the date of start of the procedure.
Prior submission of an application for an opinion for compassionate use or for a rolling review
The amount of the fee paid for a previous opinion on compassionate use or for a rolling review will be deducted from the respective fee for a subsequent application for a marketing authorisation for the same product, provided that the applicant remains the same.
EMA will issue an invoice to the applicant’s billing address held on the Agency’s file.
Payments must be made by the payable date indicated on the invoice.
If the applicant changes during an ongoing marketing authorisation application, any fee invoiced since the start of the procedure (i.e. fee for initial marketing authorisation and pre-authorisation inspection fee) will be credited to the original applicant and re-invoiced to the new applicant. This will include changes, if any, relating to micro, small or medium-sized enterprises applicants and orphan medicinal product designation.
Additional information on receiving and paying Agency’s invoices can be found below:
Yes; however, depending on when you decide to withdraw your request/application, the Agency may apply the administrative charge laid down in section 6.1 of Annex IV to the Fee Regulation, or the fee for the related request/application, or the withdrawal may be free of charge.
If your request/application is withdrawn within 24 hours from your submission, the withdrawal will be free of charge.
If your request/application is withdrawn after 24 hours from its submission and prior to the completion of the administrative validation, an administrative charge will apply. For micro, small or medium sized enterprises, the administrative charge is waived.
If your request is withdrawn after the start of the procedure, the applicable fee as per invoice issued at the start of the procedure is to be paid.
If your application is rejected following the conclusion of the administrative validation, the Agency will issue an invoice for an administrative charge laid down in section 6.1, Annex IV, to the Fee Regulation.
For registered micro, small or medium sized enterprises, the administrative charge is waived.
If the end of the administrative validation, that is the day before the procedure starts, is before 01/01/25, the applicable fee will be under Council Regulation (EC) No 297/95 (please refer to the published procedural timetables to determine the date).
If the start of procedure date is in 2025, the fees according to Regulation (EU) 2024/568 apply.
If the date of your request to withdraw your application before the start of procedure is before 01/01/2025, no administrative fee will be charged for the withdrawal; however, if the date of your request to withdraw your application before the start of the procedure (and 24 hours after its submission) is on or after 01/01/2025, the new Fee Regulation applies with an administrative charge applicable.
Yes, EMA charges a fee for a scientific opinion on a medicinal product for compassionate use pursuant to Article 83 of Regulation (EC) No 726/2004 and for an assessment on an on-going basis of data packages of particulars and documents submitted to the Agency by a prospective applicant prior to a formal submission of an application for a marketing authorisation falling within the scope of Regulation (EC) No 726/2004 (rolling review).
The amount payable depends on the legal basis and your claim as to the type of active substance (i.e. new active substance or known active substance) in your application. The amount of the fee referred to in Section 2, Annex I, to the Fee Regulation will apply.
For rolling review, the fee related to the legal basis and the type of active substance of your application is increased of 15%.
Yes; however, depending on when you decide to withdraw your request/application, the Agency may apply the administrative charge laid down in section 6.1 of Annex IV to the Fee Regulation, or the fee for the related request/application, or the withdrawal may be free of charge.
If your request/application is withdrawn within 24 hours from your submission, it is free of charge.
If your request/application is withdrawn after 24 hours from its submission and prior to the completion of the administrative validation, an administrative charge will apply. For micro, small or medium sized enterprises, the administrative charge is waived.
If your request is withdrawn after the start of the procedure, the applicable fee as per invoice issued at the start of the procedure is to be paid.
If your application is rejected following the conclusion of the administrative validation, the Agency will issue an invoice for an administrative charge laid down in section 6.1, Annex IV, to the Fee Regulation.
For micro, small or medium sized enterprises, the administrative charge is waived.
If the end of the administrative validation, which is the day before the procedure starts, is before 01/01/25, the applicable fee will be under Council Regulation (EC) No 297/95.
If the start of procedure date is in 2025, the fees according to Regulation (EU) 2024/568 apply.
If the date of your request to withdraw your application before the start of procedure is before 01/01/2025, no administrative fee will be charged for the withdrawal; however, if the date of your request to withdraw your application before the start of the procedure (and 24 hours after its submission) is on or after 01/01/2025, the new Fee Regulation applies with an administrative charge applicable.
Yes, EMA charges a fee for the extension of a marketing authorisation.
The amount payable depends on the content of your extension request and legal basis of your application. The applicable amount will be calculated after the submission of your application, in conjunction with the related fee reductions.
The fee shall cover a single pharmaceutical form with a single associated strength.
For the applicable fee levels, determined at submission, please refer to Annex I, Section 4, to the Fee Regulation.
There could be one or several fee reductions applicable. Please note that the most favourable reduction to the applicant will be applied, as reductions are not cumulative.
Micro, small and medium sized enterprises (SMEs)
A 40% fee reduction is applicable for small or medium-sized enterprises.
A 100% fee reduction is applicable for a micro sized enterprise.
A 100% fee reduction is applicable for designated orphan medicinal products if the applicant is a micro, small or medium-sized enterprise. This is applicable up to the first anniversary date of the Commission decision granting the marketing authorisation.
Applicants must be established in the EEA and fulfil the definition of a micro, small or medium-sized enterprise as set out in Commission Recommendation 2003/361/EC of 6 May 2003. To benefit from incentives, SMEs must hold a valid SME status with EMA or have submitted the renewal of the SME status (i.e. before its expiry) at the time of submission of the application.
The fee reduction shall not be granted to SMEs acting as applicant for the relevant medicinal product by virtue of a contractual arrangement with a non-SME legal entity.
To register as an SME with EMA or renew the SME status, please refer to
Orphan medicinal products
A 100% fee reduction is applicable for an extension of the marketing authorisation for a designated orphan medicinal product if the applicant is a micro, small or medium sized enterprise. This is applicable up to the first anniversary date of the Commission decision granting the marketing authorisation.
To be eligible for orphan fee incentives, a decision of the European Commission granting the orphan designation must have been adopted (product entered in the Community Register of orphan medicinal products) at time of submission. A positive COMP opinion on orphan designation is not sufficient for eligibility to the orphan fee reduction.
Please note that during a transfer of the orphan designation from the currently approved sponsor (orphan designation holder) to a new sponsor which is a different person/legal entity, eligibility lies with the initial sponsor until the transfer is completed. Once completed, the new sponsor is eligible to fee incentives.
For more information on how to receive an orphan designation for a medicinal product, please refer to
Medicinal products for paediatric use
A 50% fee reduction is applicable for extension of a marketing authorisation related to a paediatric use marketing authorisation (PUMA) submitted in the first year from granting of the marketing authorisation. Please refer to Annex V, Section 4.c, to the Fee Regulation.
For more information, refer to
Pandemic core dossier vaccines
A 100% fee reduction is applicable to an extension of a marketing authorisation of a pandemic core dossier vaccine until the human pandemic situation is duly recognised, either by the World Health Organization or by the Commission. Please refer to Annex V, Section 3.2 (c), to the Fee Regulation.
Bioterrorism health threat related medicinal products
A 50% fee reduction is applicable for extension of a marketing authorisation related to marketing authorisations for medicinal products for human use that are used for stockpiling in preparation of a bioterrorism health threat. For further details on applying for such fee reduction, please refer to Chapter 3.2 of the Fee Regulation working arrangements.
For more information, refer to
Yes; however, depending on when you decide to withdraw your request/application, the Agency may apply the administrative charge laid down in section 6.1 of Annex IV to the Fee Regulation, or the fee for the related request/application, or the withdrawal may be free of charge.
If your request/application is withdrawn within 24 hours from your submission, it is free of charge.
If your request/application is withdrawn after 24 hours from its submission and prior to the completion of the administrative validation, an administrative charge will apply. For micro, small or medium sized enterprises, the administrative charge is waived.
If your request is withdrawn after the start of the procedure, the applicable fee as per invoice issued at the start of the procedure is to be paid.
If your application is rejected following the conclusion of the administrative validation, the Agency will issue an invoice for an administrative charge laid down in section 6.1, Annex IV, to the Fee Regulation.
For registered micro, small or medium sized enterprises, the administrative charge is waived.
If the end of the administrative validation, which is the day before the procedure start, is before 01/01/2025, the applicable fee will be under Council Regulation (EC) No 297/95 (please refer to the published procedural timetables to determine the date).
If the start of procedure date is in 2025, the fees under Regulation (EU) 2024/568 apply.
If the date of your request to withdraw your application before the start of procedure is before 01/01/2025, no administrative fee will be charged for the withdrawal; however, if the date of your request to withdraw your application before the start of the procedure (and 24 hours after its submission) is on or after 01/01/2025, the new Fee Regulation applies with an administrative charge applicable.
Yes, EMA charges a fee for each major variation of type II and a charge for work-sharing applications.
The amount payable depends on the scope of the variation of Type II. There are two levels of fees for an application for a major variation of type II. The applicable amount will be calculated after the submission of your application, in conjunction with the related fee reductions. Variations of Type II grouped in a single application will attract a fee for each scope.
The charge for a work-sharing shall apply to each variation of the second and subsequent centrally authorised product included in the application.
For the applicable fee levels, determined at submission, please refer to Annex I, Section 5, to the Fee Regulation and the Appendix to the Fee Regulation Working arrangements.
There could be one or several fee reductions applicable. Please note that the most favourable reduction to the applicant will be applied, as reductions are not cumulative.
Micro, small and medium sized enterprises (SMEs)
A 40% fee reduction is applicable for small or medium-sized enterprises.
A 100% fee reduction is applicable for a micro sized enterprise.
A 100% fee reduction is applicable for designated orphan medicinal products if the applicant is a micro, small or medium-sized enterprise. This is applicable up to the first anniversary date of the Commission decision granting the marketing authorisation.
Applicants must be established in the EEA and fulfil the definition of a micro, small or medium-sized enterprise as set out in Commission Recommendation 2003/361/EC of 6 May 2003. To benefit from incentives, SMEs must hold a valid SME status with EMA or have submitted the renewal of the SME status (i.e. before its expiry) at the time of submission of the application.
The fee reductions shall not be granted to SMEs acting as applicant for the relevant medicinal product by virtue of a contractual arrangement with a non-SME legal entity.
The SME fee reductions are not applicable to the charge for each variation of the second and subsequent centrally authorised product included in the work-sharing application.
To register as an SME with EMA or renew the SME status, please refer to
Orphan medicinal products
A 100% fee reduction is applicable for designated orphan medicinal products when the applicant is a micro, small or medium-sized enterprise at the time of submission. This is applicable up to the first anniversary date of the Commission decision granting the marketing authorisation.
To be eligible for orphan fee incentives, a decision of the European Commission granting the orphan designation must have been adopted (product entered in the Community Register of orphan medicinal products) at time of submission. A positive COMP opinion on orphan designation is not sufficient for eligibility to the orphan fee reduction.
Please note that during a transfer of the orphan designation from the currently approved sponsor (orphan designation holder) to a new sponsor which is a different person/legal entity, eligibility lies with the initial sponsor until the transfer is completed. Once completed, the new sponsor is eligible to fee incentives.
For more information on how to receive an orphan designation for a medicinal product, please refer to
Medicinal products for paediatric use
A 50% fee reduction is applicable for major variations of Type II related to a paediatric use marketing authorisation (PUMA) submitted in the first year from granting of the marketing authorisation. Please refer to Annex V, Section 4.d, to the Fee Regulation.
For more information, refer to
Pandemic core dossier medicinal products
A 100% fee and charge reduction is applicable for major variations of Type II related to a pandemic core dossier vaccine until the human pandemic situation is duly recognised, either by the World Health Organization or by the Commission. Please refer to Annex V, Section 3.2 (d), to the Fee Regulation.
Bioterrorism health threat related medicinal products
A 50% fee and charge reduction is applicable for major variations of Type II related to a marketing authorisation of medicinal products for human use that are used for stockpiling in preparation of a bioterrorism health threat. For further details on applying for such fee reduction, please refer to Chapter 3.2 of the Fee Regulation working arrangements.
For more information, refer to
Yes; however, depending on when you decide to withdraw your request/application, the Agency may apply the administrative charge laid down in section 6.1 of Annex IV to the Fee Regulation, or the fee for the related request/application, or the withdrawal may be free of charge.
If your request/application is withdrawn within 24 hours from your submission, it is free of charge.
If your request/application is withdrawn after 24 hours from its submission and prior to the completion of the administrative validation, an administrative charge will apply. For micro, small or medium sized enterprises the administrative charge is waived.
If your request is withdrawn after the start of the procedure, the applicable fee as per invoice issued at the start of the procedure is to be paid.
If your application is rejected following the conclusion of the administrative validation, the Agency will issue an invoice for an administrative charge laid down in section 6.1, Annex IV, to the Fee Regulation.
For registered micro, small or medium sized enterprises, the administrative charge is waived.
If the end of the administrative validation, which is the day before the procedure start, is before 01/01/2025, the applicable fee will be under Council Regulation (EC) No 297/95 (please refer to the published procedural timetables to determine the date).
If the start of procedure date is in 2025 the fees under Regulation (EU) 2024/568 apply.
If the date of your request to withdraw your application before the start of procedure is before 01/01/2025, no administrative fee will be charged for the withdrawal; however, if the date of your request to withdraw your application before the start of the procedure (and 24 hours after its submission) is on or after 01/01/2025, the new Fee Regulation applies with an administrative charge applicable.
Yes, EMA charges a fee for certain types of referrals, while for other types of referrals (the ones laid down in Article 13 of Regulation (EC) No 1234/2008 and Article 29(4) of Directive 2001/83/EC) and for scientific opinions pursuant to Article 5(3) of Regulation (EC) No 726/2004 the fee is waived.
For the referral procedures for which a fee shall be paid, the amount payable depends on the legal basis of the referral. There are 7 level of fees linked to either the legals basis and/or the number of active substances and number of Marketing Authorisation holders included in the referral. This will be determined after the start of the referral based on the total number of chargeable units included in the referral and the number of Marketing Authorisation holders involved in the referral.
An advice note will be sent to the QPPV at the start of the referral with the list of chargeable units in scope.
For the applicable fee levels, please refer to Annex I, Section 6, to the Fee Regulation and the Appendix to the Fee Regulation Working arrangements.
Micro, small and medium sized enterprises (SMEs)
A 40% fee reduction is applicable for small or medium-sized enterprises.
A 100% fee reduction is applicable for a micro sized enterprise.
Applicants must be established in the EEA and fulfil the definition of a micro, small or medium sized enterprise as set out in Commission Recommendation 2003/361/EC of 6 May 2003. To benefit from incentives, SMEs must hold a valid SME status with EMA or have submitted the renewal of the SME status (i.e. before its expiry) at the time of notification of referral.
The fee reduction shall not be granted to SMEs acting as marketing authorisation holder for the relevant medicinal product by virtue of a contractual arrangement with a non-SME legal entity.
To register as an SME with EMA or renew the SME status, please refer to
Other fee reductions or exclusions
No other fee reductions are envisaged for these types of procedures. They are also excluded from the possibility to request ad-hoc fee reduction in accordance with Article 6.5 of the Fee Regulation.
A “chargeable unit” in relation to medicinal products for human use means a unit defined by a unique combination of the following dataset:
Any variation in one of the fields will result in an additional chargeable unit.
For more information, please refer to the document: calculating chargeable units
The advice note provides information on the chargeable units that have been identified for validation at a given point in time within the ‘Article 57 database’. In order to have a reliable and complete list of medicinal products and related chargeable units, the QPPV is requested to review (and, if necessary, amend or add) the data directly in the ‘Article 57 database’ for the relevant product(s) authorised for each marketing-authorisation holder.
This should be performed in liaison with the marketing-authorisation holder at the earliest opportunity and no later than 10 calendar days from the date of the advice note for pharmacovigilance-related referrals.
In absence of any action by the given deadline, the Agency will regard the information in the ‘Article 57 database’ as agreed by the marketing-authorisation holder and consistent with the marketing authorisation holder's obligations as defined in Article 57 (2) of Regulation (EC) No 726/2004.
To support marketing authorisation holders, an advice note will be generated and sent out to the designated marketing-authorisation holder’s Qualified Person for Pharmacovigilance (QPPV) after the start of the procedure.
As this is an automated process, the Agency is not able to send the advice note to any additional e-mail address or any other contact point other than the QPPV provided in ‘Article 57 database’ for the respective product entry.
Please note that changing the QPPV (i.e.: different person taking the respective role) in Eudravigilance registration system does not lead to an automatic update of the respective authorised medicinal product entries in the Article 57 database. A dedicated update of product entries must be made to amend the QPPV referenced in each individual entry. However, changes of details for a particular QPPV (e.g.: amendments of contact details) will be automatically updated without any other further changes required at product level.
There are several reasons why an advice note might not have been generated, for example:
The advice note is provided as an additional support to the marketing authorisation holder; the non-receipt of an advice note does not exempt from the receipt of an invoice or the proactive review of data in Article 57 database. Marketing authorisation holders are obliged to maintain up to date the submitted medicinal product information in Article 57 database and notify the EMA of any newly authorised medicines or variations to the terms of the marketing authorisation according to the requirements introduced by Article 57(2) of Regulation No 726/2004.
If the start date of the referral procedure, following notification of the referral, is before 01/01/2025, the applicable fee will be under the Pharmacovigilance Fee Regulation or the previous general fee regulation.
If the start date of the referral procedure, following notification of the referral, is after 01/01/2025, the applicable fee will be under Regulation (EU) 2024/568 (new Fee Regulation).
The data submission obligation and the related deadlines for marketing authorisation holders in accordance with Article 57 (2) of Regulation (EC) 726/2004 remain unchanged.
Yes, EMA charges a fee for the evaluation of traditional herbal medicinal products.
The amount payable is mentioned in Section 7, Annex I, to the Fee Regulation. The applicable amount will be calculated after the submission of your application, in conjunction with the related fee reductions.
Micro, small and medium sized enterprises (SMEs)
A 40% fee reduction is applicable for small or medium-sized enterprises.
A 100% fee reduction is applicable for a micro sized enterprise.
Applicants must be established in the EEA and fulfil the definition of a micro, small or medium-sized enterprise as set out in Commission Recommendation 2003/361/EC of 6 May 2003. To benefit from incentives, SMEs must hold a valid SME status with EMA or have submitted the renewal of the SME status (i.e. before its expiry) at the time of submission of the application.
The fee reductions shall not be granted to SMEs acting as applicant for the relevant medicinal product by virtue of a contractual arrangement with a non-SME legal entity.
To register as an SME with EMA or renew the SME status, please refer to
Yes; however, depending on when you decide to withdraw your request/application, the Agency may apply the administrative charge laid down in section 6.1 of Annex IV to the Fee Regulation, or the fee for the related request/application, or the withdrawal may be free of charge.
If your request/application is withdrawn within 24 hours from your submission, it is free of charge.
If your request/application is withdrawn after 24 hours from its submission and prior to the completion of the administrative validation, an administrative charge will apply. For micro, small or medium sized enterprises the administrative charge is waived.
If your request is withdrawn after the start of the procedure, the applicable fee as per invoice issued at the start of the procedure is to be paid.
If your application is rejected following the conclusion of the administrative validation, the Agency will issue an invoice for an administrative charge laid down in section 6.1, Annex IV, to the Fee Regulation.
For registered micro, small or medium sized enterprises the administrative charge is waived.
If the end of the administrative validation, which is the day before the procedure start, is before 01/01/2025, the applicable fee will be under Council Regulation (EC) No 297/95.
If the start of procedure date is in 2025, the fees under Regulation (EU) 2024/568 apply.
If the date of your request to withdraw your application before the start of procedure is before 01/01/2025, no administrative fee will be charged for the withdrawal; however, if the date of your request to withdraw your application before the start of the procedure (and 24 hours after its submission) is on or after 01/01/2025, the new Fee Regulation applies with an administrative charge applicable.
Yes, EMA charges fees for the certification of compliance with Union legislation for a plasma master file.
There are four types of fees/charges for certifications of compliance with Union legislation for a PMF. The applicable amount will be calculated after the submission of your application, in conjunction with the related fee reductions.
For the applicable fee amounts, determined at submission, please refer to Annex I, Section 8, to the Fee Regulation:
Micro, small and medium sized enterprises (SMEs)
A 40% fee and charge reduction are applicable for small or medium-sized enterprises.
A 100% fee and charge reduction are applicable for a micro sized enterprise.
Applicants must be established in the EEA and fulfil the definition of a micro, small or medium-sized enterprise as set out in Commission Recommendation 2003/361/EC of 6 May 2003. To benefit from incentives, SMEs must hold a valid SME status with EMA or have submitted the renewal of the SME status (i.e. before its expiry) at the time of submission of the application.
The fee reductions shall not be granted to SMEs acting as applicant by virtue of a contractual arrangement with a non-SME legal entity.
To register as an SME with EMA or renew the SME status, please refer to
Yes; however, depending on when you decide to withdraw your request/application, the Agency may apply the administrative charge laid down in section 6.1 of Annex IV to the Fee Regulation, or the fee for the related request/application, or the withdrawal may be free of charge.
If your request/application is withdrawn within 24 hours from your submission, it is free of charge
If your request/application is withdrawn after 24 hours from its submission, an administrative charge will apply. For micro, small or medium sized enterprises the administrative charge is waived.
If your request is withdrawn after the start of the procedure, the applicable fee as per invoice issued at the start of the procedure is to be paid.
If your application is rejected following the conclusion of the administrative validation, the Agency will issue an invoice for an administrative charge laid down in section 6.1, Annex IV, to the Fee Regulation.
For registered micro, small or medium sized enterprises, the administrative charge is waived.
If the end of the administrative validation, which is the day before the procedure start, is before 01/01/2025, the applicable fee will be under Council Regulation (EC) No 297/95.
If the start of procedure date is in 2025, the fees under Regulation (EU) 2024/568 apply.
If the date of your request to withdraw your application before the start of procedure is before 01/01/2025, no administrative will be charged fee for the withdrawal; however, if the date of your request to withdraw your application before the start of the procedure (and 24 hours after its submission) is on or after 01/01/2025, the new Fee Regulation applies with an administrative charge applicable.
Yes, EMA charges fees for the certification of compliance with Union legislation for a vaccine antigen master file.
There are four types of fees/charges for certifications of compliance with Union legislation for a VAMF. The applicable amount will be calculated after the submission of your application, in conjunction with the related fee reductions. For the applicable fee amounts, determined at submission, please refer to Annex I, Section 9, to the Fee Regulation:
For each major variation of type II that is grouped in a single application, a separate fee shall be levied per scope.
Micro, small and medium sized enterprises (SMEs)
A 40% fee and charge reduction is applicable for small or medium-sized enterprises.
A 100% fee and charge reduction is applicable for a micro sized enterprise.
Applicants must be established in the EEA and fulfil the definition of a micro, small or medium-sized enterprise as set out in Commission Recommendation 2003/361/EC of 6 May 2003. To benefit from incentives, SMEs must hold a valid SME status with EMA or have submitted the renewal of the SME status (i.e. before its expiry) at the time of submission of the application.
The fee reductions shall not be granted to SMEs acting as applicant by virtue of a contractual arrangement with a non-SME legal entity.
To register as an SME with EMA or renew the SME status, please refer to
Yes; however, depending on when you decide to withdraw your request/application, the Agency may apply the administrative charge laid down in section 6.1 of Annex IV to the Fee Regulation, or the fee for the related request/application, or the withdrawal may be free of charge.
If your request/application is withdrawn within 24 hours from your submission, it is free of charge.
If your request/application is withdrawn after 24 hours from its submission, an administrative charge will apply. For micro, small or medium sized enterprises the administrative charge is waived.
If your request is withdrawn after the start of the procedure, the applicable fee as per invoice issued at the start of the procedure is to be paid.
If your application is rejected following the conclusion of the administrative validation, the Agency will issue an invoice for an administrative charge laid down in section 6.1, Annex IV, to the Fee Regulation.
For registered micro, small or medium sized enterprises, the administrative charge is waived.
If the end of the administrative validation, which is the day before the procedure start, is before 01/01/2025, the applicable fee will be under Council Regulation (EC) No 297/95.
If the start of procedure date is in 2025, the fees under Regulation (EU) 2024/568 apply.
If the date of your request to withdraw your application before the start of procedure is before 01/01/2025, no administrative fee will be charged for the withdrawal; however, if the date of your request to withdraw your application before the start of the procedure (and 24 hours after its submission) is on or after 01/01/2025, the new Fee Regulation applies with an administrative charge applicable.
No. The fee for the certification of quality and/or non-clinical data relating to ATMPs shall be waived in full.
Yes, you can withdraw your request.
The administrative charge referred to in Section 6.1, Annex IV, to the Fee Regulation is waived.
If your application is rejected following the conclusion of the administrative validation, the administrative charge referred to in Section 6.1 of Annex IV to the Fee Regulation is waived.
If the end of the administrative validation, which is the day before the procedure start, is before 01/01/2025, the applicable fee will be under Council Regulation (EC) No 297/95.
If the start of procedure date is in 2025, the fees under Regulation (EU) 2024/568 apply.
No. The fee for any paediatric applications shall be waived in full.
Yes, however depending on when you decide to withdraw your request/application, the Agency may apply the administrative charge laid down in section 6.1 of Annex IV to the Fee Regulation, or the withdrawal may be free of charge.
If your request/application is withdrawn within 24 hours from your submission, it is free of charge.
If your request/application is withdrawn after 24 hours from its submission and prior to the completion of the administrative validation, an administrative charge will apply. For micro, small or medium sized enterprises, the administrative charge is waived.
If your application is rejected following the conclusion of the administrative validation, the Agency will issue an invoice for an administrative charge laid down in section 6.1, Annex IV, to the Fee Regulation.
For registered micro, small or medium sized enterprises, the administrative charge is waived.
For procedures starting in 2024, there are no fees or charges to be applied according to Council Regulation (EC) No 297/95.
For procedures starting in 2025, the provisions of Regulation (EU) 2024/568 (new Fee Regulation) will apply.
If the date of your request to withdraw your application before the start of procedure is before 01/01/2025, no administrative fee will be charged for the withdrawal; however, if the date of your request to withdraw your application before the start of the procedure (and 24 hours after its submission) is on or after 01/01/2025, the new Fee Regulation applies with an administrative charge applicable.
No. The fee for an application, or for reassessment, for the designation of an orphan medicinal product, shall be waived in full.
Yes, however depending on when you decide to withdraw your request/application, the Agency may apply the administrative charge laid down in section 6.1 of Annex IV to the Fee Regulation, or the withdrawal may be free of charge.
If your request/application is withdrawn within 24 hours from your submission, it is free of charge.
If your request/application is withdrawn after 24 hours from its submission and prior to the completion of the administrative validation, an administrative charge will apply. For micro, small or medium sized enterprises, the administrative charge is waived.
If your application is rejected following the conclusion of the administrative validation, the Agency will issue an invoice for an administrative charge laid down in section 6.1, Annex IV, to the Fee Regulation.
For registered micro, small or medium sized enterprises, the administrative charge is waived.
For procedures starting in 2024, there are no fees or charges to be applied according to Council Regulation (EC) No 297/95 (previous Fee Regulation).
For procedures starting in 2025, the provisions of Regulation (EU) 2024/568 (new Fee Regulation) will apply.
If the date of your request to withdraw your application before the start of procedure is before 01/01/2025, no administrative fee will be charged for the withdrawal; however, if the date of your request to withdraw your application before the start of the procedure (and 24 hours after its submission) is on or after 01/01/2025, the new Fee Regulation applies with an administrative charge applicable.
Yes, EMA charges a fee for an application for a scientific opinion following the evaluation of a medicinal product for human use intended exclusively for markets outside the Union pursuant to Article 58 of Regulation (EC) No 726/2004.
The applicable amount will be calculated after the submission of your application.
Please refer to Section 13, Annex I, to the Fee Regulation, and the relevant sections of Annexes I and IV, for the applicable amount.
Yes, please refer to the Q&A of the applicable procedure.
Please refer to the Q&A of the applicable procedure.
Please refer to the Q&A of the applicable procedure.
Yes, EMA charges a fee per procedure for the assessment of Periodic Safety update reports referred to in Articles 107e and 107g of Directive 2001/83/EC and in Article 28 of Regulation (EC) No 726/2004 as per EURD list. Please refer to Section 14, Annex I, to the Fee Regulation for the applicable amount.
Periodic Safety Update Reports, PSURs, shall be submitted with known frequencies. The frequency of these reports can be found in the ‘List of Union reference dates and frequency of submission of PSURs’, also known as the EURD list. The EURD list consists of a list of active substances and combinations of active substances for which PSURs shall be submitted in accordance with the EU reference dates and frequencies.
Based on number of marketing authorisation holders that are subject to the obligation to submit a periodic safety update report, the amount payable by each marketing authorisation holder shall be calculated by the Agency in two steps, as follows:
Micro, small and medium sized enterprises (SMEs)
A 40% fee reduction is applicable for small or medium-sized enterprises.
A 100% fee reduction is applicable for a micro sized enterprise.
Applicants must be established in the EEA and fulfil the definition of a micro, small or medium sized enterprise as set out in Commission Recommendation 2003/361/EC of 6 May 2003. To benefit from incentives, SMEs must hold a valid SME status with EMA or have submitted the renewal of the SME status (i.e. before its expiry) at the time of the EURD Data Lock Point (DLP) date.
The fee reductions shall not be granted to SMEs acting as applicant for the relevant medicinal product by virtue of a contractual arrangement with a non-SME legal entity.
To register as an SME with EMA or renew the SME status, please refer to
Other fee reductions or exclusions
No other fee reductions are envisaged for this procedure. It is also excluded from the possibility to request ad-hoc fee reduction in accordance with Article 6.5 of the Fee Regulation.
A ‘chargeable unit’ for medicinal products for human use means a unit defined by a unique combination of the following dataset:
Any variation in one of the fields will result in an additional chargeable unit.
For more information, please refer to the document: calculating chargeable units
The advice note provides information on the chargeable units that have been identified for validation at a given point in time within the ‘Article 57 database’. In order to have a reliable and complete list of medicinal products and related chargeable units, the QPPV is requested to review (and, if necessary, amend or add) the data directly in the ‘Article 57 database’ for the relevant product(s) authorised for each marketing-authorisation holder.
This should be performed in liaison with the marketing-authorisation holder at the earliest opportunity and no later the day before the start of the procedure.
In absence of any action by the given deadline, the Agency will regard the information in the ‘Article 57 database’ as agreed by the marketing-authorisation holder and consistent with the marketing authorisation holder's obligations as defined in Article 57 (2) of Regulation (EC) No 726/2004.
To support marketing authorisation holders, an advice note will be generated and sent out to the designated marketing-authorisation holder’s Qualified Person for Pharmacovigilance (QPPV) after EURD Data Lock Point (DLP) date.
As this is an automated process, the Agency is not able to send the advice note to any additional e-mail address or any other contact point other than the QPPV provided in ‘Article 57 database’ for the respective product entry.
Please note that changing the QPPV (i.e.: different person taking the respective role) in Eudravigilance registration system does not lead to an automatic update of the respective authorised medicinal product entries in the Article 57 database. A dedicated update of product entries must be made to amend the QPPV referenced in each individual entry. However, changes of details for a particular QPPV (e.g.: amendments of contact details) will be automatically updated without any other further changes required at product level.
There are several reasons why an advice note might not have been generated, for example:
The advice note is provided as an additional support to the marketing authorisation holder; the non-receipt of an advice note does not exempt from the receipt of an invoice or the proactive review of data in Article 57 database. Marketing authorisation holders are obliged to maintain the submitted medicinal product information in Article 57 database and notify the EMA of any newly authorised medicines or variations to the terms of the marketing authorisation according to the requirements introduced by Article 57(2) of Regulation No 726/2004.
If the start date of the PSUR assessment and the Data Lock Point (DLP) are before 01/01/2025, the applicable fee will be under Regulation (EU) 658/2014 (the Pharmacovigilance Fee Regulation).
If the start date of the PSUR assessment is after 01/01/2025 and the Data Lock Point (DLP) is before 01/01/2025, the applicable fee will be under Regulation (EU) 2024/568 (the New Fee Regulation).
If the start date of the PSUR assessment and the Data Lock Point (DLP) are both after 01/01/2025, the applicable fee will be under Regulation (EU) 2024/568 (the New Fee Regulation).
The data submission obligation and the related deadlines for marketing authorisation holders in accordance with Article 57(2) of Regulation (EC) 726/2004 remain unchanged.
Yes, EMA charges a fee for an assessment carried out under Articles 107n to 107q of Directive 2001/83/EC and Article 28b of Regulation (EC) No 726/2004 of post-authorisation safety studies as referred to in Article 21a, point (b), or Article 22a(1), point (a), of Directive 2001/83/EC, or in Article 9(4), point (cb), or Article 10a(1), point (a), of Regulation (EC) No 726/2004, that are conducted in more than one Member State.
Please refer to Section 14, Annex I, to the Fee Regulation for the applicable amounts.
The fee is paid in two parts:
An additional fee will not be applicable when amendments are made to the draft protocol or for the submission of interim study reports.
In principle, a PASS protocol should involve a single study report and therefore, would trigger a single fee.
However, in cases whereby several study reports are submitted separately, the different study reports may be subject to a separate fee, depending on the nature of the study and the description of the protocol.
When several marketing authorisation holders have the obligation to conduct a joint post-authorisation safety study, the amount of the fee shall be divided equally amongst the marketing authorisation holders involved.
Furthermore, marketing authorisation holders who have paid a fee for the assessment of a post-authorisation safety study are exempted from any additional fee which can be charged by the Agency or a national competent authority for the submission of these studies.
The applicable amount will be calculated after the submission of the draft protocol (for the first fee instalment) or of your final study report (for the second fee instalment) in conjunction with the related fee reductions.
Micro, small and medium sized enterprises (SMEs)
A 40% fee reduction is applicable for small or medium-sized enterprises.
A 100% fee reduction is applicable for a micro sized enterprise.
Applicants must be established in the EEA and fulfil the definition of a micro, small or medium sized enterprise as set out in Commission Recommendation 2003/361/EC of 6 May 2003. To benefit from incentives, SMEs must hold a valid SME status with EMA or have submitted the renewal of the SME status (i.e. before its expiry) at the time of submission of the application.
The fee reductions shall not be granted to SMEs acting as applicant for the relevant medicinal product by virtue of a contractual arrangement with a non-SME legal entity.
To register as an SME with EMA or renew the SME status, please refer to
Other fee reductions or exclusions
No other fee reductions are envisaged for this procedure. It is also excluded from the possibility to request ad-hoc fee reduction in accordance with Art 6.5 of the Fee Regulation)
In principle, an application for an assessment of a non-interventional post-authorisation safety study protocol and final study results could be withdrawn, but you may wish to consider enquiring the Agency about your specific case. Depending on when you decide to withdraw your application, the Agency may apply the administrative charge laid down in section 6.1 of Annex IV to the Fee Regulation, or the fee for the related application, or the withdrawal may be free of charge.
If your request is withdrawn within 24 hours from your submission, the withdrawal will be free of charge.
If your request is withdrawn after 24 hours from its submission and prior to the completion of the administrative validation, an administrative charge will apply. For micro, small or medium sized enterprises, the administrative charge shall be waived.
If your request is withdrawn after the Agency has received the payment of the applicable fee, the amount paid will not be returned to the applicant.
If your application is rejected following the conclusion of the administrative validation, the Agency will issue an invoice for an administrative charge laid down in section 6.1, Annex IV, to the Fee Regulation.
For registered micro, small or medium sized enterprises, the administrative charge is waived.
If the start date of the PASS procedure is before 01/01/2025, the applicable fee will be under Regulation (EU) 658/2014 (the Pharmacovigilance Fee Regulation).
If the start date of the PASS procedure is after 01/01/2025, the applicable fee will be under Regulation (EU) 2024/568 (the New Fee Regulation).
If the date of your request to withdraw your application before the start of procedure is before 01/01/2025, no administrative fee will be charged for the withdrawal; however, if the date of your request to withdraw your application before the start of the procedure (and 24 hours after its submission) is on or after 01/01/2025, the new Fee Regulation applies with an administrative charge applicable.