Fees on medicinal products, medical devices, cosmetic products, and personal care products, in accordance with current legislation, must be paid by the persons or entities that request the Spanish Agency for Medicines and Medical Devices (AEMPS) to carry out activities or provide services within its competence. These fees are indicated in Article 123 of Royal Legislative Decree 1/2015, of 24 July, which approves the consolidated text of the Law on Guarantees and Rational Use of Medicinal Products and Medical Devices.
In January 2023, the AEMPS reported on legislative changes affecting fees on medicinal products, medical devices, cosmetic products, and personal care products. Law 38/2022, of 27 December, introduces changes to applying fees on these products. This law was published for the establishment of temporary energy levies and levies on credit institutions and financial credit institutions; it creates the temporary solidarity tax on large fortunes and amends certain tax rules.
In addition, it includes in its sixth final provision the amendment of the consolidated text of the Law on guarantees and rational use of medicinal products and medical devices, approved by Royal Legislative Decree 1/2015, of 24 July, giving a new wording to Title XI on fees.
As of 28 June 2023, these amendments came into force, whereby clinical studies that meet the following characteristics will be exempt from the payment of fees:
The sponsor is a university, hospital, public scientific organization, non-profit organization, patient organization, or individual investigator.
The ownership of the research data belongs to the sponsor from the beginning of the study.
There are no agreements between the sponsor and third parties that allow the use of the data for regulatory or proprietary uses.
The design, conduct, recruitment, data collection, and reporting of research results remain under the control of the sponsor.
By their nature, these studies cannot be part of a development program for a marketing authorization for a product. Therefore, a declaration signed by the sponsor with these considerations must be included and uploaded in the “Proof of payment” section of CTIS. In addition, in these cases it will be essential to indicate the IEC assessing the application in the cover letter.