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Administrative Fees - The Czech R.

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Administrative Fees - The Czech R.
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1. Payment of administrative fees

Administrative fees shall be payable for the following applications in the below listed amounts:

Type of application	Administrative fee amount	Comment
Application:
•· For marketing authorisation of a medicinal product, incl. homeopathic products	2000.00 CZK
•· For variation to marketing authorisation of a medicinal product, incl. homeopathic products	2000.00 CZK
•· For renewal of marketing authorisation of a medicinal product, incl. homeopathic products	2000.00 CZK
Application for a transfer of marketing authorisation of a medicinal product, incl. homeopathic products	2000.00 CZK
Application for authorisation of parallel import of a medicinal product, incl. homeopathic products	2000.00 CZK
Application for revocation of marketing authorisation of a medicinal product, incl. homeopathic products	1000.00 CZK
Application:
•· For manufacturing authorisation of a medicinal product or variation thereto	2000.00 CZK
•· For authorisation to engage in an activity as a control laboratory or variation thereto	2000.00 CZK
•· For authorisation of manufacture in blood centres or variation thereto	2000.00 CZK
Application:
•· For authorisation of distribution of medicinal products or variation thereto	2000.00 CZK
•· For extension of distribution authorisation	2000.00 CZK
Application for the issue of a counterpart, copy, photocopy or extracts from official documents, indexes and registries, books, records, documentary files or other written and picture documentation	50.00 CZK	For each, even incomplete, page

Administrative fees shall be paid using a revenue stamp of the relevant value which is to be pasted on the "Proof of payment of administrative fee" form which forms part of the application and is provided in Annex 1. In order to ensure a smooth take-over of applications it is advisable to get the revenue stamps in advance. In exceptional cases, revenue stamps may be purchased in limited quantities also at the cash desk of SÚKL, located at Šrobárova 48, Praha 10 (hereinafter referred to as the "cash desk"). Where applications for which the administrative fee fails to be paid are concerned, the applicant shall be sent a reminder to pay the fee within 15 days, as stipulated by the Act on Administrative Fees. Should the applicant fail to do so, the administrative procedure may be stopped. Due to the fact that administrative fees are paid for the submission of the application, the fees may not be refunded with the exception of those cases where the complete or partial refund of the fee is explicitly allowed by the Act on Administrative Fees. When applying for the refund of the administrative fee the applicant shall submit an "Application for Refund of an Administrative Fee" (Annex 4), SÚKL shall decide upon the application and shall communicate its decision in writing to the applicant.

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