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 fees (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 is 4,856 EUR (+VAT).
- 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.
This fee is reviewed every year as part of NOOL’s annual budgeting process and is published in advance minimum 4 months before end of the current year.
The annual user fee for the year 2020 is 6,600 EUR (+VAT) and will be payable by each MA holder.
The annual user fee for the year 2021 is 5,800 EUR (+VAT) and will be payable by each MA holder.
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.
- Reduction of the user fee
Based on the NOOL Board’s proposal a reduction of the user fee for the year 2020 for MAHs with very small or zero revenues was approved by General Meeting. The reduced user fee was set at 1,800 EUR*.
For 2021, the General Meeting of NOOL approved a reduced user fee of EUR 1,580 *.
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 the year preceding the year for which the annual user fee is to be paid a written request to NOOL; a request can also be send by e-mail to email@example.com.
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 the previous year. 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).
In the event of a very first approval of the Annual User Fee discount, execution of an amendment to the Cooperation Agreement between the registration holder and NOOL shall follow.
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).