How to register with NOOL?
There are three steps in NOOL’s registration/onboarding process for MAHs:
Complete a Registration form so we have all your details, including invoicing requirements. The form is prepared to collect information from MAH, local affiliates and even company authorized to sign the contract on behalf of MAH (form allows add additional MAHs). All these options are reflected in contract forms as well. It is MAH’s decision to choose, which option is preferred. Please make sure that even if you choose to sign one contract for more than 1 subject, you have filled in invoicing details for each MAH. Form can be completed by the local affiliate as well.
All data from registration form should be uploaded into NOOL database directly; no need to send a copy of the form.
Click on the icon shown to open the registration form.
Sign the “NOOL-MAH Agreement”. There are 5 options available how to sign a contract with NOOL:
- MA holder signs a separate agreement with NOOL (ver_1).
- MA holder authorizes 3rd party to sign a contract with NOOL on its behalf (ver_2).
- Few MA holders authorize sign a contract with NOOL (ver_3a).
- Few MA holders authorize one of them to sign a contract with NOOL on their behalf (ver_3b).
- Few MA holders authorize 3rd party to sign a contract with NOOL on their behalf (ver_3c).
Based on preferred option please choose one of 5 attached contract forms. Please do not forget to provide signed power of attorney, if you choose a different option than the first one. 3rd party or MAH who represents other subjects needs to sign as a representative, but also put signature for represented parties. Both parts of the agreement must be fulfilled (Czech as well as English).
2 signed Agreements (+signed power of attorney – based on the form you choose) please send via mail to NOOL address below.
Narodni organizace pro overovani pravosti leciv, z.s.
IBC, Pobrezní 620/3
Praha 8 – Karlín
Click on the icon shown to download the Agreement.
To be able to issue the invoice for registration or user fee the registration must be completed by fulfilling the registration form as well as signed contract between MAH and NOOL.
Pay the NOOL MA holder registration fee (this should be paid after the Agreement is signed).
What is the model for fees to be paid by MA holders to NOOL?
NOOL is applying a flat fee per MAH model where each MAH whose product data is held in the Czech system pays the same fees to NOOL. If the contract is concluded for more than one MAH, separate fees are payable by each of the MAHs.
The flat fee per MA holder model was developed by the stakeholders in European Medicines Verification Organisation including EFPIA (representing the research-based industry), Medicines for Europe (representing the generic / biosimilars industry) and EAEPC (representing parallel distributors) and is being rolled out across Europe. Information on how this model was selected is available on the EMVO website.
What fees are payable to NOOL by MA holders?
Model used in the Czech Republic consists from Registration fee (one-off) + User fee (annual).
- Registration fee
Purpose of the registration fee is to cover implementation costs of Czech Medicines Verification System. A one-off registration fee of 4 047 EUR (+VAT) is payable by all MA holders who will have in-scope products on Czech market on 9th Feb 2019 (‘existing MA holders’) and by all new MA holders joining the Czech Medicines Verification System after that date.
Early bird discounts are available if the fee is paid in 2018 - see table below for details. Surcharges will be levied on existing MA holders if the registration fee is not paid by 30th June 2019 (see table for details). NOOL is dependent on budgeted income from registration fees and the surcharge will be used to defray additional costs to NOOL associated with late payment of the fee.
|Registration fee variations||EUR||
Date of payment
|20% discount||3 237||invoice till 31/08/2018*)|
|10% discount||3 642||payments till 31/12/2018|
|without discount||4 047||payments from 01/01/2019|
|15% up||4 653||payments from 01/07/2019|
|20% up||4 856||payments from 01/01/2020|
*) Issuing the invoices started in the end of August due to the accounting company changes (delay compared with original expectations), this should not affect proposed discount on registration fee. All subjects with complete registration, signed Cooperation Agreement with NOOL and invoice issued no later than 31st August 2018 are entitled to 20% discount from regsitration fee provided that the due date on the invoice is met.
- Annual user fees
An annual user fee will be payable by MA holders from 2019 onwards when the system goes live. This fee will cover the ongoing costs of the Czech Medicines Verification System. The annual user fee is 7 361 EUR (+VAT) per annum and will be payable by each MA holder. This fee will be reviewed each year as part of NOOL’s annual budgeting process and will be published in advance minimum 4 months before end of the current year.
It is possible to pay fees in Czech crowns according to the payment terms mentioned in the contract,too. Fees to be paid on the basis of issued invoice. Invoices should be issued directly to each registered MAH (not the 3rd party representatives) – those who are the actual beneficiary of the transaction because of the impact on the application of the VAT. Foreign MAH who is actual recipient of the services should receive an invoice from NOOL without VAT and it is MAH’s responsibility to pay a tax under the reverse charge procedure, while invoice issued to Czech MAH’s representative should include Czech VAT and there is no possibility for foreign MAH to apply tax deduction. Paid VAT increases the costs for MAH in this case.
Based on the NOOL Board’s proposal a reduction of the User fee for 2019 for MAHs with very small or zero revenues was approved by General Meeting on 23rd August 2018. The reduced user fee was set at € 2,000 *.
A lower user fee should allow newly emerging companies or marketing authorization holders with very low revenues to enter or continue to operate on the market of medicinal products in the Czech Republic.
The Marketing Authorization Holder (MAH), which in the previous year achieved sales for all medicinal products on the Czech market of up to 500,000. EUR * (or CZK 13 million, the rate of 26 CZK/EUR was used when determining the amount of the discount and terms of its application) is entitled to request a reduced fee, provided that the MAH asks for a discount by sending no later than by 15th October of this year a written request to NOOL; a request can also be send by e-mail to firstname.lastname@example.org .
The amount of sales receipted by the MAH in the application for a discount should be expressed for regulated products at the producer's price for which the product was actually marketed, unregulated at purchasers' prices, in accordance with DIS-13, without any surcharges, and without VAT. Due to the expected date of issuing the invoice, judged revenues should be for 2017. NOOL is entitled to request additional documentation to verify compliance with the condition to obtain a reduced fee.
In the first year of operation, a MAH without previous history, it may request a reduction in the annual user fee; does not concern newly created MAHs related to over registration (due to Brexit).
The approval of the NOOL user fee discount will then be accompanied by the signature of an addendum to the current cooperation agreement between the MAH and NOOL (the wording of the contract addendum is currently being prepared).
If it is discovered additionally that the discount was obtained in violation of the conditions set, NOOL will demand payment of the full amount of the annual user fee.
The amount of this fee will be revised each year along with the NOOL budget planning for the next period, and its size will be published at least 4 months before the end of the current year.
* The amount of the fee and the revenue to be assessed for its approval has been approved in EUR; to determine the equivalent in CZK, the CNB exchange rate is decisive at the time of the application (in the case of sales in CZK), respectively 1st day of the month when the invoice will be issued (at the amount of user fee in CZK).