Producers - MAH - Parallel Distributors

Marketing authorisation holders (MAHs) or Parallel distributors who market products in the Czech Republic must ensure that prescription-only medicine packs released for the Czech market from 9th February 2019 carry unique identifiers and anti-tamper devices according to the EU Directive 2011/62/EU - also called the Falsified Medicines Directive (FMD) and the data for the products are uploaded in the system.

Companies can start to get ready and update their packaging and releasing serialised packs to the market well ahead of that date.
 
The main duties/steps to be done to meet the FMD requirements include:
  • Identifying what products are in scope of the new requirements and require safety features (as defined in Article 2 of the Commission Delegated Regulation 2016/161/EU -https://www.czmvo.cz/file.php?id=23).
  • Changing packaging to include safety features and having it approved by the regulatory authority.
  • Upgrading production lines to apply the unique identifiers and anti-tamper device.
  • On-boarding to the EU Hub which is managed by EMVO – see https://emvo-medicines.eu/pharmaceutical-companies/ for details of on-boarding process.
  • Uploading unique identifier data that has been placed on packs to the EU Hub. The data will then transfer from the EU Hub to the national repository for the market where the packs are intended to be sold.
  • Registering with NOOL and paying the relevant registration and user fees.
NOOL sent out a large amount of letters in March 2018 to MAHs. The aim of the letter was to provide basic information about FMD project in the Czech republic, but also to clarify contacts for each MAH prior to registration with NOOL and signing the contract. We have received a lot of answers and we are now handling them. If you have not received a letter please contact info@czmvo.cz. If you have answered the letter you should receive an update about registration process.
 
How to register with NOOL as well as MAH contract and size of the fees is published here together with registration process.
 
Registration process
 
 

NOOL ALERT MANAGEMENT SYSTEM

The alert management system operated by NOOL is a support system for the CZMVS (NSOL). The purpose of this support system is to facilitate the administration associated with alert investigations and to help automate the entire investigation process.

Alerts can be managed in several ways:

A. Response to the NOOL's "clickable" email.

Existing system - can continue to be used. However, it will not be further developed.

B. NOOL web interface for alert management

For users who do not have their own alert management system or do not allow direct integration of their organization rules, access to the NOOL alert management system is available via a user-friendly web interface.

C. Direct NOOL API communication

Integration of user's own alert management system with alert management system operated by NOOL via API communication.

REGISTRATION:

Request to join the NOOL web interface or NOOL API should be sent to registrace@czmvo.cz

Please note: the test environment will be available to the interested person first and afterwards (after the MAHA e-mail confirmation) the production environment will be switched on - at that moment the sending of “clickable” e-mails will be turned off. You cannot use both systems at the same time!

DOCUMENTATION:

User manual for web interface for MAHs

Technical documentation for developers - API description


Documents

Founding members

Associate members

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