In order to carry out an application for a fee refund, it is essential to submit all the necessary documentation.
- In the case of a legal entity, the AEMPS will carry out consultations of powers of attorney through the Electronic Register of Powers of Attorney (Apodera). If the interested party objects to the telematic consultation, a certified photocopy of the powers of attorney of the legal entity requesting the return or a simple notarized copy of the same must be provided. In the case of an individual, an authenticated photocopy of the DNI must be provided.
- In general, photocopy of the receipt(s) of the self-assessment form(s) 317 (copy(s) of the interested party) accrediting the income for which the refund is being claimed. In the case that the refund of the totality of the payment is requested, this photocopy will be substituted by the original(s).
- Optionally, photocopy of the bank transfer made in favor of the Spanish Agency of Medicines and Health Products.
The return request document, duly completed and signed. The document includes, among others, the following sections:
- Return request document (English version), duly completed and signed. This English version includes both a section describing the facts and the corresponding Spanish translation of the description of the facts.
- A sworn translation into Spanish of the powers of attorney (with Hague apostille) of the person(s) signing the application.
- In general, a photocopy of the receipt(s) of the self-assessment form(s) 317 (copy(s) of the interested party) accrediting the income for which the refund is claimed. In the case that the refund of the totality of the payment is requested, this photocopy will be substituted by the original(s).
- Optionally, photocopy of the bank transfer made in favor of the Spanish Agency of Medicines and Health Products.
- Return request document (English version), duly completed and signed. This English version includes both a section describing the facts and the corresponding Spanish translation of the description of the facts.
- A sworn translation into Spanish of the powers of attorney (with Hague apostille) of the person(s) signing the application.
- In general, a photocopy of the receipt(s) of the self-assessment form(s) 317 (copy(s) of the interested party) accrediting the income for which the refund is claimed. In the case that the refund of the totality of the payment is requested, this photocopy will be substituted by the original(s).
- Optionally, photocopy of the bank transfer made in favor of the Spanish Agency of Medicines and Health Products.
If the request for a refund is submitted by a resident legal entity, the AEMPS may carry out consultations of the proxies through the Electronic Register of Proxies (Apodera) provided that such proxies are registered in the platform and the interested party does not oppose the carrying out of the consultations.
To request the return they have to send the documentation by the means admitted in law (Law 39/ 2015, of October 1, of the Common Administrative Procedure of the Public Administrations, given the obligation to relate by electronic means established in article 14):
For residents in Spain:
- Single electronic registry (with electronic certificate)
For non-residents in Spain:
- Postal mail:
Spanish Agency of Medicines and Medical Devices
Accounting and Fees Service
Campezo 1, Edificio 8. 28022 Madrid – Spain - Administration Registries
For doubts and queries please contact tasasydevoluciones@aemps.es
1. The refund of income from fees shall be applicable in the cases contemplated in Article 221 of Law 58/2003, of December 17.
The procedure for the recognition of the right to the refund of undue income will be initiated ex officio or at the request of the interested party, among others, in the following cases:
– When there has been a duplicity in the payment of fees.
– When the amount paid has exceeded the amount to be paid as a result of a self-assessment or liquidation act.
2. When, having paid the fee, the taxpayer does not submit the request for the provision of the corresponding service or performance of the activity within the period granted in Article 125.2, provided that this is for reasons not attributable to the taxpayer and accredited in a reliable manner, the refund will be of the total amount paid.
When the taxpayer withdraws the application, provided that this is for a reason not attributable to the taxpayer and which is reliably proven, the refund shall be seventy percent of the amount paid.
3. When, in the procedures for the authorization and/or registration of a medicinal product for human use or a veterinary medicinal product and for the modification of the authorization and/or registration, the application submitted is rejected in the validation phase, or the Administration cannot process the corresponding procedure, or the interested party withdraws from the procedure, seventy percent of the total amount of the fee will be refunded. This procedure will be initiated ex officio by the Spanish Agency of Medicines and Medical Devices.
For the purposes of the provisions of this Act, validation is understood to be the administrative action carried out for the purpose of verifying that the application meets all the necessary requirements for the provision of the service or administrative activity.
4. The self-assessments submitted by the taxable persons may be subject to verification and checking by the Spanish Agency of Medicines and Medical Devices, which will practice, where appropriate, the corresponding settlement and will return the amount of the self-assessment submitted and paid by the taxable person.