Fees in Pharma: 10 tips on how to manage the regulatory fees in Portugal
In our first article on the challenges of managing regulatory fees we spoke about the importance of managing all your assets – not only your medicines but also your marketing authorizations. Key to protecting your assets is knowing how to manage regulatory fees for each national competent authority. After all, missing or incorrect fees are one of the most common reasons why NCAs declare a submission invalid.
In our second article, we would like to share some tips from our Local Regulatory Affairs experts on fee payments in Portugal – another market where fee management can become a challenge for applicants.
- Always check the List of Official fees at Infarmed’s website to calculate regulatory expenses.
- The company must nominate a user to access the different regulatory platforms.
- For Infarmed’s regulatory platforms, always use Internet Explorer v7 or more recent versions in a compatible mode, otherwise pop-ups and options won’t be seen.
- For new marketing authorization applications, the platform to be used is: SMUH-AIM.
- For variation applications to marketing authorization, the platform to be used is SMUH-ALTER.
- Fees need to be paid in advance to the health authority. Once you have selected and completed the type of application, the platform will guide you on how to generate a reference code for payment.
- The fee will be generated according to the information provided. Type of procedure, type of variation and number of dosages all impacts the fee value. Incorrect classification of the procedure or variation can lead to application invalidation and loss of 10% of the total amount paid.
- Fees can be paid by bank transfer, ATM or Visa. Proof of payment must be attached to the submission.
- National Procedures have substantially lower fees and a 40% discount on variations.
- Portugal has one of the lowest regulatory fees in the EU, which can be a good incentive to choose Portugal as a Reference Member State for your submissions.
Nicole Chaves Petronzi, Regulatory Affairs Specialist – Portugal
To learn more about Portugal’s regulatory environment, contact our experts. Click here to find out where we are and how we can support you on your regulatory journey.