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. {mospagebreak}
1. Payment of administrative fees
Administrative fees shall be payable for the following applications in the below listed amounts:
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Type of application |
Administrative fee amount |
Comment |
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Application: |
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•· For marketing authorisation of a medicinal product, incl. homeopathic products |
2000.00 CZK |
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•· For variation to marketing authorisation of a medicinal product, incl. homeopathic products |
2000.00 CZK |
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•· For renewal of marketing authorisation of a medicinal product, incl. homeopathic products |
2000.00 CZK |
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Application for a transfer of marketing authorisation of a medicinal product, incl. homeopathic products |
2000.00 CZK |
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Application for authorisation of parallel import of a medicinal product, incl. homeopathic products |
2000.00 CZK |
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Application for revocation of marketing authorisation of a medicinal product, incl. homeopathic products |
1000.00 CZK |
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Application: |
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•· For manufacturing authorisation of a medicinal product or variation thereto |
2000.00 CZK |
|
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•· For authorisation to engage in an activity as a control laboratory or variation thereto |
2000.00 CZK |
|
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•· For authorisation of manufacture in blood centres or variation thereto |
2000.00 CZK |
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Application: |
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•· For authorisation of distribution of medicinal products or variation thereto |
2000.00 CZK |
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•· For extension of distribution authorisation |
2000.00 CZK |
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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. {mospagebreak}
2. Making payments to reimburse the costs of expert services performed upon request
2.1 The payment procedure governing the reimbursement of costs
Pursuant to Section 65 of the Act on Pharmaceuticals, SÚKL charges for the costs of expert services performed upon request. The reimbursement of costs is made prior to the submission of the application by bank transfer, in exceptional cases possibly as cash payment of the amount stipulated in the Pricelist at the cash desk (Annex 2, part A refers).
SÚKL bank details relevant for the bank transfers pertaining to the reimbursements of costs for expert services (pursuant to Section 65 of the Act on Pharmaceuticals):
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Name of the bank |
Česká národní banka |
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Address of the bank |
Na Příkopě 28/3181Praha 1 115 03 Czech Republic |
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Account number |
35-623101 |
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Bank code |
0710 |
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IBAN |
CZ94 0710 0000 3500 0062 3101 |
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BIC (originally SWIFT) |
CNBACZPP |
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Constant symbol |
0308 |
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Variable symbol |
Generated by the below specified procedure in a manner preventing any duplicities in variable symbols. |
The document is automatically generated on the basis of completion of an interactive form which is available from the web site http://www.sukl.cz/0214.htm , section Administrative Fees and Reimbursements - Form (Správní poplatky a úhrady - Formulář).
The applicant shall complete the required data relevant to the application in the interactive form. Following their send-off the document "Proof of payment for reimbursement of costs for expert services performed upon request", which may be printed directly from the internet browser is generated. This document shows a generated variable symbol, which is to be used for the payment of costs associated with the given application. For more detailed instructions please refer to the above specified web site.
If the applicant does not have internet access, the generated document may be obtained from the SÚKL mail room. In this situation the applicant shall complete a substitute form (Annex 3) and shall either hand it directly to the mail room employees or send it to the mail room by post, fax or e-mail together with a request for the generation of the relevant document. On the basis of the details provided by the applicant on the substitute form the employee of the SÚKL mail room shall generate the form "Proof of payment for reimbursement of costs for expert services performed upon request" and shall hand over the document to the applicant as per the instructions provided in the substitute form.
Mandatory attachments to the submitted application shall be as follows:
o The form "Proof of payment of administrative fee" (pursuant to section 1 of the guideline) in one copy;
o Proof of payment for reimbursement of costs as per Pricelist" - for bank transfers this shall be a copy of the payment order certified by the bank or a single copy of a statement of account; for cash payments made at the cash desk this shall be an endorsement issued by the cashier on the document "Proof of payment for reimbursement of costs for expert services performed upon request";
o Document "Proof of payment for reimbursement of costs for expert services performed upon request" in two copies.
Where the applicant fails to submit the specified number of copies of the above-mentioned attachments together with the submitted application, he/she shall be invited to submit them additionally. The procedure shall be suspended upon the invitation. Following the identification of the payment on SÚKL's bank account the applicant shall be sent one endorsed copy of the document submitted together with the application as the proof of payment of the deposit for the reimbursement of costs associated with the conduct of the expert service, which is to be performed upon request. The other copy of the "Proof of payment for the reimbursement of costs for expert services performed upon request" with the particulars of an accounting document shall be sent to the applicant only after the completion of the service.
It is advisable to make the bank transfer several days before the submission of the application, as the fee may be considered paid only after the identification of the payment on SÚKL's bank account. Where the application is being submitted at the beginning of the year, it is not advisable to make the payment in the preceding year because of payment reconciliation with accounting documents and with accounting books. Applicants are advised that where the payment is made via a bank transfer, it is necessary to ensure that the full amount specified by SÚKL Pricelist is transferred to SÚKL's account (the amount is provided on the automatically generated document "Proof of payment for reimbursement of costs of expert services performed upon request" depending on the type of application). For this purpose it is necessary to state the symbol "OUR" on the payment order.
Important notification:
If the amount transferred to the above specified SÚKL's bank account is less than the amount established in the Pricelist (e.g. because the bank deducts processing fees from the amount), the reimbursement of costs shall not be considered paid until the remaining portion of the amount established by the Pricelist is paid (possible methods of making additional payments are defined in item 2.2).
Each payment has to be made separately, as a single item on the payment order, so that a unique identification of the payment according to the variable symbol is feasible, hence it is not possible to make several partial payments as a single summed amount. For batch release, where the applicant applies for a release of several batches within a single application, it is, however, possible to use a single variable symbol for several batches and to make the payment on the basis of a joint proof of payment for reimbursement of costs associated with the conduct of an expert service. {mospagebreak}
2.2 Making additional payments - types and methods
2.2.1 Additional payment where the applicant has made a payment for the reimbursement of costs for a type of application other than actually requested
Recommended methods of making the additional payment:
o Bank transfer from the applicant's account - the applicant shall again complete the interactive form (as per item 2.1), shall obtain a new document with a variable symbol, under which he/she shall pay the outstanding amount, and shall attach two copies of the payment order presented to the bank or two copies of the account statement (i.e. original and new), as well as a written notification of this method of payment giving both variable symbols and the paid amounts, to the new document "Proof of payment for reimbursement of costs of expert services performed upon request" in two copies.
o Cash payment made at the cash desk - on the basis of the submitted newly generated document (with a newly generated variable symbol), the applicant shall pay the outstanding amount at the cash desk and shall submit this new document "Proof of payment for reimbursement of costs of expert services performed upon request" in two copies together with the original document with the original variable symbol to the mail room once the cash desk endorses the payment.
2.2.2 Additional payment where the applicant has made the reimbursement of costs for the required type of application, but the reimbursement has not been made in full amount (e.g. because the bank has deducted its processing fees from the amount, etc.)
Recommended methods of making the additional payment:
o Bank transfer from the applicant's account - additional payment made by a payment order where the applicant uses the same generated variable symbol as for the original payment. The applicant shall submit a copy of the payment order certified by the bank or a copy of the account statement to the relevant Regulatory Affairs section.
o Cash payment made at the cash desk - on the basis of the submitted "Proof of incomplete payment" (received by the applicant if the reimbursement of costs as per the Pricelist has not been made in full for the application) the applicant shall make the additional payment at the cash desk. {mospagebreak}
2.3 Other procedures pertaining to making the reimbursements of costs
2.3.1 Applications for Certificate of Compliance with GMP Requirements, with the conduct of an inspection at a foreign manufacturer's premises ("Certificate")
Where applications for a GMP inspection in a third country* are concerned, the applicant shall make in advance the reimbursement of costs of the required inspection in compliance with the Pricelist (Annex No 2, part A). Furthermore, an agreement shall be made in writing with the applicant under which he/she shall undertake to cover, apart from the reimbursement of costs, also related travel costs of the inspectors. These consist of the following:
- Reimbursement of air travel to the destination at the nearest proximity of the site of inspection in the "Economy" class where flights in Europe are concerned, and in the "Business" class where overseas flights outside Europe are concerned;
- Reimbursement of the costs of standard-category hotel stay for the necessary number of days;
- Reimbursement of the costs of the stay (daily allowance and local transport) stipulated by the relevant implementing regulation of Act No 262/2006 Coll., Labour Code, as amended. The arrival of the inspector at the site of inspection is normally anticipated one day prior to the commencement of the inspection, and departure on the last day of inspection or the day after;
- Reimbursement of travel insurance, and, in relevant cases, reimbursement of the costs of necessary vaccination and health prevention pertaining to the trip in question.
The reimbursement of the above specified costs may be shared by several applicants, if it is possible to conduct more than one inspection during a single trip.
2.3.2 Applications for laboratory analyses
In the application for a laboratory analysis the applicant shall provide a control regulation (a pharmacopoeia article, MA dossier), on the basis of which the analysis is to be conducted, or shall specify individual control methods, where applicable. The reimbursement for the required analysis which shall be calculated by the applicant himself/herself from the individual items of SÚKL's Pricelist (Annex No 2, parts B and C) shall be made by the applicant in advance (for procedure please refer to item 2.1). Where unclarities arise it is possible to obtain information on the amount of reimbursement also from the manager of the relevant Regulatory Affairs section. The proof of payment for the reimbursement shall be submitted by the applicant together with the application for the analysis. Where the conduct of special control methods requires a purchase of reference substances or expensive chemicals or kits, and the total costs of the conduct of the analysis thus exceed the amount of reimbursement stipulated in the Pricelist, the applicant shall be notified in writing to this effect immediately after the submission of the application, incl. the specification of additional costs. Applicants are notified that the required analysis shall be conducted only after a written approval of the reimbursement of these additional costs on the part of the applicant. The procedure shall apply likewise to applications for re-testing of batches of medicinal products prior to release onto the market, where no batch certificate issued by an EU Member State has been provided.
In exceptional cases, in epidemiological emergencies (epidemics, floods, etc.), the Institute may release batches of the product also without prior payment, and the payment, incl. its proof, shall be made additionally.
2.3.3 Applications for professional consultations and lectures
a) Professional consultations
SÚKL gives consultations associated with the operation of the Institute in the sphere of human pharmaceuticals and medical devices. The purpose of the consultations is to allow applicants to discuss specific issues to obtain SÚKL's position on the issue in question. Outputs of individual consultations shall be considered confidential and shall serve for the purposes of generalisation of SÚKL's position and ensuring an analogous handling of cases of similar nature. SÚKL shall, in its activities, reflects the conclusions from the given consultations; these, however, shall not be binding for the party seeking advice - it may choose a solution different from the recommended one to achieve the required objective, and, equally, it may not be considered absolutely binding for SÚKL employees, either, as it is impossible to rule out that due to new information the application of the conclusions from consultations may be, to a certain degree, limited. It is always necessary to take into consideration the date when the consultation has been given, and reflect any legislative, legal or professional changes that might have been applied since.
SÚKL charges for the costs of consultations provided upon request. The amount of costs is stipulated in the Pricelist (Annex No 2, part A.). No reimbursement of costs is required for a consultation given as part of the running expert services rendered by SÚKL as per the Pricelist (Annex No 2, part A) and previously paid for (i.e. within the scope of a previously submitted application), for consultations on cases where the reimbursement of costs has been waived (please refer to SÚKL guideline UST-24 Waivers and refund of costs reimbursement) and for consultations associated with medical devices. Meetings with the representatives of regulated entities, to which SÚKL employees have been invited, shall not be considered consultations.
In terms of the intensity and focus of consultations the following categorisation has been made:
- Consultations in regulatory issues - oral consultations or an issuance of a written position in the area of pharmaceuticals, irrelevant of a previously submitted application, which pertain especially to procedural issues (e.g. the conduct of a marketing authorisation procedure);
- Scientific consultations - oral consultations or an issuance of a written position in the area of pharmaceuticals irrelevant of a previously submitted application, which pertain especially to expert issues, i.e. those for which scientific background has been provided in advance.
b) Expert lectures
Upon request, SÚKL gives expert lectures associated with the operation of SÚKL in the sphere of pharmaceuticals. The purpose of these lectures is to disseminate educational activities for the issues in question among regulated entities. SÚKL charges for the costs of giving experts lectures upon request. The amounts of reimbursement of costs are stipulated in the Pricelist (Annex No 2, part A.).
c) Procedures applicable to the submission of application and to making the payment (applicable to consultations as well as lectures)
The applicant shall send a signed written binding application for a consultation or an expert lecture (an application sent electronically via e-mail either directly to the consultant, lecturer or to the e-mail address This e-mail address is being protected from spambots. You need JavaScript enabled to view it shall be considered binding only if electronically signed; otherwise it shall be considered a preliminary request which shall be considered binding and handled only after the delivery of a written signed application).
Mandatory parts of the application shall be as follows:
•· Specific questions or areas for the required consultation or lecture;
•· Required time scope of the consultation or lecture;
•· Name of the contact person and its contact details (address, telephone, and e-mail where applicable);
•· In the event of a reimbursed consultation or lecture other details shall be specified: business name of the entity, address of the entity, and company reg. no. (IČO);
•· In the event of a scientific consultation the above mentioned details shall be accompanied by scientific background.
With a view to applications for consultations please be advised that SÚKL does not provide consultations in general issues and that the consultations do not serve as a substitute for training to complete basic knowledge, be they associated with regulatory, expert, or legislative issues (this purpose may be fulfilled e.g. by an expert lecture). The consultant shall suggest a date for the consultation to the applicant, or shall refuse the consultation, where applicable, or request additional specification of the topic of the consultation. The refusal of a consultation shall always be made in writing and shall contain a reason for the rejection (e.g. an advice on publicly available information, which provides adequate answer to the submitted questions).
Reimbursement of costs as per the Pricelist (Annex 2, part A) for giving a consultation or lecture shall be made by the applicant either after the consultation or lecture has been given, by means of an invoice sent by the Institute for the amount to be paid by bank transfer, or the reimbursement of costs may be required in advance. The method of payment (beforehand of after the service has been provided) shall be specified for the applicant after the submission of the application by a SÚKL employee handling the relevant application. Where an advance payment is concerned, the applicant shall make the bank transfer on the basis of the variable symbol stated on the generated document "Proof of payment for reimbursement of costs of expert services performed upon request" (the procedure governing this method of payment is described in item 2.1 of this guideline).
In order to document the conclusions from oral consultations, each oral consultation shall be concluded with a brief written summary of the conclusions arrived at for the questions asked (in the Czech language, in the English language, or in German, where applicable, after an agreement with the consultant), which shall be provided to the consultant by the contact person of the applicant within 5 working days. If necessary, the consultant shall amend the minutes, endorse its final version and send it to the applicant; for paid consultations within 5 working days of having received a proof of payment of the invoice (payment identification on SÚKL's bank account). The minutes shall also mean an agreed layout plan. The above mentioned due dates for preparing the minutes may be agreed differently during the consultations. Any conclusions from consultations which have not been endorsed in writing by the Institute shall not be deemed SÚKL's official positions and shall not be considered relevant in the work of the Institute. References to oral communications of individual employees of the Institute in particular shall bear no relevance.
2.3.4 Applications for services associated with the provision of information and other services
The amounts of reimbursements for services associated with the look-up of information and the amounts of reimbursements for other services are provided in the Pricelist (Annex No 2, parts D and E). These services shall be conducted on the basis of a written binding application signed by the applicant (an electronically submitted application by e-mail to the address This e-mail address is being protected from spambots. You need JavaScript enabled to view it shall be considered binding only if an electronic signature is attached thereto; otherwise it shall be considered a preliminary application which shall become binding and be handled only after the delivery of a written signed application) giving the specific required service associated with the provision of information or another service. Once the service is rendered, SÚKL will issue and send to the applicant an invoice the amount of which shall be based upon the Pricelist or an advance payment shall be requested. The method of payment (in advance or after the service is rendered) shall be specified for the applicant, after the application is lodged, by the SÚKL employee who handles the relevant application. The advance payment may be made either in cash at the SÚKL cash desk or by a bank transfer. Where the applicant makes the advance payment by means of a bank transfer, the SÚKL employee who handles the relevant application shall notify the applicant after the submission of the application of the details necessary for the bank transfer (variable symbol, bank details for SÚKL).
2.4 Waivers and refunds of reimbursement
The procedure governing those instances when waivers or partial refunds may be applicable is stipulated in SÚKL guideline UST-24 - Waivers and refund of costs reimbursement for expert services performed upon request.
This situation pertains to countries who are not members of the EU or of the European Economic Area (EEA), and who have not signed an agreement on the mutual recognition of results of good manufacturing practice inspections with the EU (Mutual Recognition Agreement, MRA). Information about effective MRAs is available from the following internet address: http://ec.europa.eu/enterprise/pharmaceuticals/mra/index.htm.
