New Guidelines about Administrative fees in the Czech Republic 

As of December 1 2007 this new guideline for admistraive fees supersedes guideline UST 29 published in January 2007.

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UST- 29 version 2 Administrative fees, reimbursement of costs for expert services performed upon request, reimbursements for services associated with the provision of information, and reimbursements of other services

Effective date: December 1 2007

As of December 1 2007 this guideline supersedes guideline UST 29 published in January 2007, guideline UST 6 published in January 2001 and repeals guideline UST 25 published in January 2007.

Introduction

The guideline is being published in compliance with the provisions of Act No 79/1997 Coll., on Pharmaceuticals and on Amendments to Some Related Acts, as amended (hereinafter referred to as the "Act on Pharmaceuticals"), Act No 634/2004 Coll., on Administrative Fees, as amended (hereinafter referred to as the "Act on Administrative Fees"), and Act No 106/1999 Coll., on Free Access to Information, as amended (hereinafter referred to as the "Act on Free Access to Information"), and Act No 218/2000 Coll., on  Budgetary Rules, as amended (hereinafter referred to as the "Act on Budgetary Rules").

The State Institute for Drug Control (hereinafter referred to as „SÚKL") has, as part of the UST 29, UST 6 and UST 25 guideline revision, conducted the following changes, specifications, and amendments:

o    For comprehension and clarity reasons the guidelines have been merged into a single overview guideline (the original guideline UST 29 referenced guidelines UST 6 and UST 25);

o    Pricelist items have been supplemented and the amounts of reimbursements for expert services performed upon request have been amended:

Ø  The original amounts of reimbursements for expert services have been calculated on the basis of the amounts of SÚKL expenses in 2003, and for this reasons it has been necessary to update the calculations to reflect the costs incurred by SÚKL for its activities at present,

Ø  The newly established amounts of reimbursements have been based upon the calculation of planned expenses for 2007, and, moreover, upon the review and specification of the times necessary for the conduct of certain expert services, in particular with respect to the adoption of the EU legislation, experience obtained from practical implementation (e.g. Mutual Recognition Procedure), and changes to the approach to certain procedures (e.g. consultations),

Ø  The expected inflation for 2007 has been reflected;

o    The items of the Pricelist for reimbursements of laboratory analyses of pharmaceuticals and excipients, reimbursements associated with the provision of information, and reimbursements for other services  have been  updated and, furthermore, the amounts of reimbursement for individual services have been amended to reflect the costs incurred (the original calculation of reimbursements of services has dated back to 2001);

o    The requirements for the completion of data by the applicant (e.g. applicant's identification details) have been specified in the forms.