Fees in Pharma - Spain

Marketing authorizations are one of the most important assets for any pharmaceutical company, next to its products. Why is that the case? You can have the most life-changing medicine in your pipeline, but without marketing authorization, you won’t be able to sell it anywhere in the world.

But getting and keeping your assets on the market doesn’t come easily or cheaply. The health authorities charge fees for marketing authorization applications, as well as for variations, renewals, and annual fees for authorized medicines. Any company that wishes to put medicinal products on the market must know the costs of product submissions and product maintenance across the board to avoid any unforeseen expenses during the product lifecycle.

One of the many activities that a regulatory affairs department must manage is staying on top of regulatory fees, which is both complex and time-consuming. First, requirements from the national competent authorities are continuously changing, and secondly, the methods of payment are different for every member state.

An internal database or Excel file may be helpful, though it would be very time consuming to continuously look at each NCA’s website to stay up to date. For example, for each submission, you need to check the required fees for the application. Missing or incorrect fees are one of the most common reasons why  NCAs declare a submission invalid. These payment errors result in delays to starting the authorization and lead to additional costs for the company, since further paperwork is needed when requesting a refund or correcting a payment.

These challenges can be avoided with the right partner to guide you through any exemptions or reductions that could decrease the costs of the regulatory fees. Our Local Regulatory Affairs experts have this information readily available, ensuring your marketing authorization assets are properly managed.

We would like to share some tips from our Local Regulatory Affairs experts on fee payments in Spain, where fee management can become a challenge for  applicants.

Spain

1. Always check the List of Official fees at AEMPS Website to calculate regulatory expenses.
2. Fees need to be paid in advance on the health authority website: Where to request the fees at AEMPS web
3. New Marketing Authorization Application for National Procedure fees expire 10 days from the payment date.
4. New Marketing Authorization Application for Mutual Recognition Procedure and Decentralised Procedure fees expire 3 months from the payment date.
5. Variations of existing Marketing Authorization Application for National Procedure, Mutual Recognition Procedure and Decentralised Procedure fees expire 3 months from the payment date.
6. When fees are paid by bank transfer, the reference code of the fee (13 digit numbers starting 317) must be included in the reference field of the transfer for agency reconciliation of the payment and acceptance.
7. Reference code (13 digits numbers in the form 3.01.7) should be included in the payment file of the electronic application form, and must always include a copy of the proof of payment in eCTD-Module 1.
8. The payer of the transfer shall be the same as the payer stated on the fee payment form receipt.
9. Ensure the amount entered in AEMPS account (in EUR) coincides exactly with the amount on the payment form.
10. Make sure your procedure type, variation type, dosage and presentation are correct before the fee payment. Any mistake will invalidate the application, and fee transfers take time to process.

Authors

Laura Fernandez, Senior Regulatory Affairs Specialist – Spain

To learn more about Spain’s regulatory environment contact our experts. Click here to find out where we are and how we can support you on your regulatory journey.