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In brief

The Spanish Agency for Medicines and Medical Devices (AEMPS) has implemented a new system for the payment of clinical trial fees in Spain.


In more detail

The Spanish Agency for Medicines and Medical Devices (AEMPS) has implemented a new application form for the payment of clinical trial fees in Spain (“Application“). The Application, which is available on the AEMPS website, facilitates the payment process and eliminates payment errors that existed in the previous system.

This new method of payment of fees has been developed in accordance with the provisions of Royal Legislative Decree 1/2015, of 24 July, approving the revised text of the Law on Guarantees and Rational Use of Medicines and Medical Devices (“Law on Guarantees“), which provides for the payment of the fees to be made in electronic form, granting the AEMPS the collection management of these fees, among other particularities.

In this sense, the payers will be able to make the payment through the Application by:

  • Electronic payment
  • Downloading the 317 form for self-assessment
  • Bank transfer
  • In cash

The AEMPS has also prepared a manual for users, which contains a series of instructions on how to use the Application.

For more information or in case you need individual advice for your company, please contact our team of experts in this field.

Author

Montserrat has extensive experience in pharmaceutical and health law, as well as in compliance, contract law, licensing, competition law and acquisitions in the pharmaceutical sector. She is the coordinator of the healthcare practice in the Barcelona office.
She assists healthcare companies throughout the life cycle of healthcare products (drugs, IVD and medical devices, combination products, cosmetics and food supplements), from R&D to commercialization and more specifically in the areas of clinical trials (agreements, regulatory procedures, processing of personal data), market access (pricing and reimbursement), products and companies regulations (MA/CE-marking, vigilances, required licenses, product classification, labelling), commercial relations between healthcare industries (distribution, (co)promotion, manufacturing, supply, licensing, partnership agreements), relations with healthcare professionals and/or patients including compliance (anti-gift and transparency laws); communication and advertising, e-health (connected devices, telemedicine, hosting of health data) and product liability. Her practice encompasses both advisory and litigation matters.
She also has considerable experience in the drafting of codes of professional ethics and conducting compliance audits, and advising on advertising and promotion of medicines and medical devices, including via the internet, online advertising and social media. Montserrat advises on a wide range of agreements related to the pharmaceutical industry, such as license and distribution agreements, clinical trial agreements, and supply and manufacturing agreements.

Author

Damià Triay is an Associate in Baker McKenzie, Barcelona office.