Fees connected with marketing authorizations in MR/DC procedures
where Poland acts as CMS:
The complete information concerning fees connected with marketing authorisations for
veterinary medicinal products, can be found in the Regulation of Minister of Health of 29
October 2008, on the method of establishing payment amounts and performing payments
connected with marketing authorisations for veterinary medicinal products (O.J. No. 195, item
1211), amended by regulation of Minister of Health of 21 March 2011 (O.J. No. 77, item 426) - in
force from 27th April 2011
This guidance reflects the most frequently asked questions. For more information, please refer to
the regulation or contact the following coordinators:
National procedures: jolanta.drzewinska@urpl.gov.pl
MRP/DCP procedures: anna.kucharska@urpl.gov.pl
National variations: anna.kicinska@urpl.gov.pl
MRP/DCP variations: joanna.kubisa@urpl.gov.pl
The fees have been calculated based on the basic quota: 1 600 PLN
Fee amount (pln)
1A. Application fees (products not mentioned in point B-I) for:
1. MA for original veterinary medicinal product
56 000
2. MA for original veterinary medicinal product for food producing animals: fishes, 15 000
insects, animals bred for fur, pigeons
3. MA for well established veterinary medicinal product
40 000
4. MA for well established veterinary medicinal product for food producing animals: 9 600
fishes, insects, animals bred for fur, pigeons
5. MA for generic veterinary medicinal product
21 600
6. MA for generic veterinary medicinal product for food producing animals: fishes, 7 200
insects, animals bred for fur, pigeons
7. MA for hybrid veterinary medicinal product
32 000
8. MA for hybrid veterinary medicinal product for food producing animals: fishes, 8 800
insects, animals bred for fur, pigeons
9. Type IA Variation
3 680
10. Type IB Variation
3 680
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11. Type II Variation
15 200
12. Type II Variation – for veterinary medicinal product for food producing animals: 6 800
fishes, insects, animals bred for fur, pigeons
13. Renewal for veterinary medicinal product
10 000
14. Type IA Variation – Worksharing procedure
3 680
15. Type IB Variation – Worksharing procedure
3 680
16. Type II Variation – Worksharing procedure
15 200
17. Type II Variation – Worksharing procedure - for veterinary medicinal product for 6 800
food producing animals: fishes, insects, animals bred for fur, pigeons
18. Renewal for veterinary medicinal product for food producing animals: fishes, 5 000
insects, animals bred for fur, pigeons
1E Application fees (products for hobby animals, especially aquarium fish, ornamental birds, small
rodents, ferrets, rabbits) for:
19. MA for veterinary medicinal product
2 000
20. Type I Variation
400
21. Type II Variation
1 600
22. Renewal for veterinary medicinal product
1 000
1HApplication fee for transfer of marketing authorization to a new holder
4 000
1I Application fee for other administrative changes
400
1J Application fee for changes to an existing pharmacovigilance system
400
For each additional pharmaceutical form, submitted at the same time as the initial application for
authorisation, the fee is 70% of the first application fee.
For each additional strength, submitted at the same time as the initial application for
authorisation, the fee is 30% of the first application fee.
In case of applications for grouping of variations submitted according to Commission Regulation
(EC) No 1234/2008 the fee for submission of application is a sum of fees for each change
enclosed in application.
For grouping of variations submitted in connection with art. 7 sec. 2 letter a of (EC) No
1234/2008, in case of submission of the same changes in several MA’s, the fee for each change in
first MA enclosed in application is 100% of fee for single variation. The fee for changes in each
following MA enclosed in application is 80% of fee for single variation.
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For grouping of variations submitted in connection with art. 7 sec. 2 letter b of (EC) No
1234/2008, the fee for all changes concerning one MA is 200% of fee for change, for which the
fee is the highest, but no more then the sum of fees for all submitted changes. In case when the
fees for all submitted changes concerning one MA are equal, the fee is 200% of fee for single
variation.
The fees have to be paid in Polish zlotys, before submitting the application. Proof of payment
should be submitted with the application.
Each payment should be made on an individual form and described. The description should
include the procedure number, product name, pharmaceutical form and MAH.
The payment must be net of bank charges and performed before the submission (payment details
should be given to enable identification). The proof of payment should be included in the
dossier.
Please enquire directly before the submission of the dossier about additional fiscal payments
connected with letter of authorisation/power of attorney.
Bank accounts for payment of fees for registration of medicinal products, medical
devices and biocidal products and fees for entry in the Central Register of Clinical Trials
(CEBK)
Bank account for international payments:
Bank: Narodowy Bank Polski, Plac Powstańców Warszawy 4, 00-950 Warszawa, POLAND
Account No.: PL30 1010 1010 0094 1022 3100 0000
NBP BIC Code: NBPLPLPW
Bank account for domestic payments:
Bank: NBP O/O Warszawa
Account No.: 30 1010 1010 0094 1022 3100 0000
Bank account for payment of treasury fees (power of attorney) for issue of medical device
and other certificates:
Bank account for international payments:
Payee: Urząd Miasta Stołecznego Warszawy Dzielnica Praga Północ
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Account No.: PL 96 1030 1508 0000 0005 5002 6074
Bank: Bank Handlowy w Warszawie S.A.
kod SWIFT - CITIPLPX
Bank account for domestic payments:
Payee: Urząd Miasta Stołecznego Warszawy Dzielnica Praga Północ
Account No.: 96 1030 1508 0000 0005 5002 6074
Bank: Bank Handlowy w Warszawie S.A.
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