Registration process

How to register with CZMVO?

The registration process for Marketing Authorisation Holders (MAHs) with CZMVO consists of 3 steps:

1. Fill in the registration details in CZMVO IS.

Registration serves to enter the identification data of the Marketing Authorization Holder (MAH) and leads to the conclusion of the Cooperation Agreement. 

To register you need the access to CZMVO IS. Please send a request to registrace@czmvo.cz and provide your name and e-mail address to which an invitation with access data will be sent.

2. Conclude and sign the "CZMVO-MAH Cooperation Agreement".

There are five versions of the agreement:

• MAH concludes a separate agreement with CZMVO (ver_1).
• MAH authorizes a third party to conclude a contract with CZMVO on its behalf (ver_2).
• Several MAHs conclude a contract with CZMVO (ver_3a).
• Several MAHs instruct one of them to enter into a contract with CZMVO on their behalf (ver_3b).
• Several MAHs instruct a third party to enter into a contract (ver_3c).

Depending on your role in the contract process select the appropriate version of the contract. The cooperation agreement is concluded by the signature by the authorized person(s).

If the agreement is signed by a representative, it is necessary to attach a signed power of attorney (a draft power of attorney is available for download below together with the sample of agreements). 

The cooperation agreement can be signed electronically, via DocuSign, or by signing the paper version. After printing the agreement and arranging signatures on your side, please send two originals of the Agreement to the CZMVO office (address below). After CZMVO signs the contract, one copy of the Agreement will be sent back to you.

In order to prove the authority of the individual to act for the company, we require an extract from a foreign commercial register or similar register showing this authority. If the contract is signed on behalf of the company by a person other than the person named in the extract, the signatory must provide a power of attorney granted by the person who is authorized to act for the company according to the extract. You can use a sample of power of attorney available here.

Please send the contracts, including attachments in paper form, to:

Narodni organizace pro overovani pravosti leciv, z.s.

IBC, Pobrezni 620/3

186 00 Praha 8 - Karlín

Czech Republic

3. Pay CZMVO fees

CZMVO uses a "flat fee" model, i.e. the same fee for each registration holder.

The flat fee model was defined by EMVO stakeholders: the European Medicines Verification Organization including EFPIA (representing the innovator industry), Medicines for Europe (representing the generic industry) and EAEPC (representing co-distributors) and is used across Europe (see EMVO for more details).

MAH pays a one-off Registration Fee + Annual User Fee.

• Registration Fee

The purpose of the registration fee is to cover the implementation costs of the Czech medicines verification system (CZMVS). It is currently set at EUR 4 856 (excluding VAT).

• Annual user fee

The annual user fee is paid by MAH each year during the use of the CZMVS system. This fee is used to cover the ongoing costs associated with the operation of CZMVS. The amount of this fee is reviewed each year at the same time as the CZMVO budget planning for the next period, and is published at least 4 months before the end of the current year.

For the year 2024, the annual user fee is set at EUR 4 250* (excluding VAT) for each MAH.For

2025, the annual user fee is also set at EUR 4 250* (excluding VAT) for each MAH.

Note: If the recipient of the invoice/MAH is required to provide an order number on the invoice, we request that this is sent by the end of October of the year preceding the year for which the annual user fee is payable.

The invoice for the user fee may be issued to a company designated by MAH as the payer or recipient of the invoice. It need not therefore be issued directly to the holder of the decision to which the fee relates. Please notify the change of billing information in writing or by e-mail (info@czmvo.cz).

Both fees can also be paid in Czech crowns* according to the payment terms specified in the contract. The fees are payable on the basis of the invoice. We do not offer the option of invoicing the representing MAH (or third parties) instead of issuing an invoice to the represented MAH, who is the actual recipient of the service, as a standard, as this may affect the correctness of the application of VAT. If the actual recipient of the service is a foreign MAH, the invoice from CZMVO should be exclusive of VAT, with the tax to be paid by the recipient under the reverse charge regime. If the invoice were instead invoiced to a Czech MAH with Czech VAT (i.e. VAT would be incorrectly applied), the MAH would not be entitled to deduct VAT on the invoice. The VAT paid would therefore be an additional cost to the MAH being represented.

• Discount on the annual user fee

Based on the proposal of the CZMVO Board of Directors, the General Assembly of the association has approved a reduction of the user fee for the year 2024, the reduced user fee is therefore EUR 1,150*.

For the year 2025, the annual reduced user fee is also set at EUR 1 150* (+VAT) for each MAH.

The lower user fee is intended to enable new companies or marketing authorisation holders with very low revenues to enter or continue to operate in the Czech market for medicinal products.

A MAH which in the previous year achieves sales for all medicinal products on the Czech market of not more than 500 thousand EUR. The MAH shall be entitled to a reduced fee provided that the MAH applies for the discount to CZMVO; no later than 15 October of the year preceding the year for which the annual user fee is payable, in writing to CZMVO or by e-mail to info@czmvo.cz.

The amount of sales to be documented by the MAH when requesting the rebate should be expressed for regulated products at the originator's price at which the product was actually marketed, and for non-regulated products at the purchase price, in accordance with the wording of the DIS - 13 guideline, excluding all mark-ups and VAT. Due to the expected date of invoicing of the fee, sales in the previous completed year will be considered. CZMVO is entitled to request additional documentation for the purpose of verifying compliance with the condition for obtaining the reduced fee.

In the first year of operation, i.e. MAHs with no previous history can apply for a reduction in the annual user fee; this does not apply to MAHs newly established due to re-registration (e.g. due to Brexit).

If this is the first time that a reduction in the annual user fee has been approved, an amendment to the Cooperation Agreement between the registration holder and CZMVO must be signed (within 14 days of the application being approved).

If it is subsequently determined that the discount was obtained in violation of the set terms and conditions, CZMVO will request a refund up to the full amount of the annual user fee.

The amount of this fee will be reviewed each year at the same time as CZMVO 's budget planning for the next period and will be published at least 4 months before the end of the current year.

 *The amount of the fee has been approved in EUR; for the determination of the equivalent in CZK (for invoicing in CZK) it is converted at the CNB rate on the 1st day of the month in which the invoice is issued.

**The amount of revenue to be considered for the application for a reduced user fee has been approved in EUR; the official exchange rate of the CNB on the date of application is used to determine the CZK equivalent.

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4. Amendments/termination of the cooperation agreement

If there is a change of representative in an already signed agreement, please follow this process.

If there is a need for termination of the cooperation agreement by MAH, a sample termination notice can be downloaded here.