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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 - here.
  • 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.
 
How to register with NOOL as well as size of the fees is published here together with registration process.
 
Registration process
 
Beginning in January 2021, the "transitional period" ended, in which the Ministry of Health of the Czech Republic allowed to dispense medicinal products despite an error message, the so-called alert, which shows that the authenticity of the medicinal product was not successfully verified in NSOL. From this date, therefore, each alert needs to be checked and closed, more precisely it must be confirmed by the MAH or end user (or CZMVO for system alerts) that the pack is not a counterfeit. Only then can the pharmacy dispense the medicine to the patient. Rapid and accurate investigation of the resulting alerts is therefore in the interest of all parties - marketing authorization holders, distributors, pharmacies and especially patients.
 

NOOL has been operating since 2020 Czech Alert Management System (CZAMS), where it is possible to quickly and conveniently resolve alerts via an API or web interface. More information about CZAMS functionalities can be found in the attachments below and on the "Alerts Management" section.

You can find the answers to the most frequently asked questions in the "Important Information / Q&A" section.

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