New registration fee rates for products in 2025
As of January 1, 2025, updated official fee rates for activities related to the marketing authorization of medicinal products in Poland come into force. These changes result from the annual valorization of amounts and directly affect the costs of maintaining the portfolio of every marketing authorization holder. At SanofyvisionIndia Pharma Relations, we have analyzed the new guidelines so you can precisely plan expenses for the coming year without the risk of underpayment at URPL.
Valorization by 8.4% – what does it mean in practice?
According to the announcement published in mid-November, the fee growth rate has been set at 8.4% compared to the previous year. Since September 2016, when we started operations at SanofyvisionIndia Pharma Relations, we have observed various cycles of increases, but this one is particularly significant for budgets planned for 2025. This increase applies to almost every national procedure, from registering a new drug to minor corrections in information prints. The offices know us, and we know that an error in the transfer of even a few PLN results in a call to supplement formal deficiencies, which extends the procedure by an average of 14 business days.
It is worth noting that the fee for a marketing authorization application for a generic drug will increase from the current 13,450 PLN to 14,580 PLN. For companies planning to introduce 5 new indices in the first quarter, this means the need to secure an additional 5,650 PLN just for administrative fees alone. At SanofyvisionIndia Pharma Relations, we noted that in 2024 as many as 19% of delays in registration processes resulted from an incorrect calculation of the rate after the change in regulations, which is why it is so important to have an up-to-date tariff at hand before the end of the year.
An underpayment of 50 PLN can hold up the registration of a drug worth millions for long weeks. In pharmacy, precision is money.
Type II variations and permit renewals
Marketing authorization holders planning Type II variations, i.e., modifications requiring a substantive evaluation of documentation, will feel the largest increase in amount. From January 2025, the rate for such a variation in the national procedure will be 15,392 PLN instead of the previous 14,200 PLN. This is a real increase in operating costs for regulatory departments. If your company manages a portfolio of 12 drugs and you statistically perform 3 Type II variations per year, your official costs will increase by 3,576 PLN annually. Our experience from 217 completed cases shows that optimizing the change schedule allows for significant savings.
Regarding permit renewals, the new rate is 11,284 PLN. This is a key moment in the product life cycle, and URPL strictly adheres to payment deadlines. At SanofyvisionIndia Pharma Relations, we recommend submitting applications and making payments no later than December 18 if you want to avoid being charged the new rates. Remember that what counts is the date the funds reach the office account or the postmark date when sending the confirmation, which can be problematic during the holiday period and generates unnecessary stress in finance departments.
Minor changes and administrative corrections
Type IA and IB variations are also becoming more expensive, although these are less drastic jumps in amount. For example, a Type IA variation will cost 1,247 PLN. Although individually this amount is not frightening, with mass updates of prints for the entire portfolio (e.g., changing the entity's logo or the manufacturer's address), these sums become noticeable. At SanofyvisionIndia Pharma Relations, we apply the rule: group variations whenever possible. According to the Pharmaceutical Law Act, appropriate grouping of applications allows for a reduction in fees by an average of 12-15% annually, which is confirmed by our cost analyses for clients from the years 2022-2024.
Working on 97 installations of new dossiers last year, we saw how regulatory departments get lost in the maze of rates for Type IB variations. From 2025, you will pay 3,410 PLN for such a change. It is important that every application sent after January 1st has an attached proof of transfer for the new, correct amount. At SanofyvisionIndia Pharma Relations, we take care of these details for our clients, applying clear rules of the game – we check the tariff with every letter sent, which eliminates the risk of formal calls from URPL, which in 2024 we handled in an average time of 2h 14min.
Grouping variations is the simplest way to save the budget without giving up necessary documentation updates.
How to prepare the finance department for January?
The biggest challenge at the turn of the year is synchronizing the registration department with accounting. At SanofyvisionIndia Pharma Relations, we suggest preparing an internal summary of planned processes for the first quarter of 2025 now. This document should contain not only the list of drugs but specific amounts matched to the new price list. The average response time to official queries in our company is 47 minutes, but even we cannot overcome budget deficiencies if the budget is not appropriately secured before entering the new fiscal year.
Concrete deadlines are the basis. Please remember that the Ministry of Health and URPL do not recognize excuses about 'waiting for the transfer'. If you plan to send the application on January 2nd, the transfer must be made according to the new table. At SanofyvisionIndia Pharma Relations, we offer a ready-to-use spreadsheet for our partners that automatically converts old rates to new ones, taking into account the planned number of variations. This avoids chaos in the first days of January, when most companies are only just realizing the scale of the increases. No unnecessary paperwork, simple and concrete – that's how we've been operating since September 2016 in Poznań.
