Medicines verification begins on 9th February 2019
In accordance with Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use, as of 9 February 2019 medicines must be verified before being dispensed to patients. In the Czech Republic the National Medicines Verification Organization (NOOL, CZMVO) is responsible for implementing and operating the system for verifying the authenticity of medicines. More detailed information is available at www.czmvo.cz
Czech medicines verification system (NSOL, CZMVS) is technically ready and functional. NOOL has published a dossier for the procedure, which will be regularly updated based on ongoing experience.
As of 7th February, 1,338 pharmacies and distributors (end users) are connected to the system, while the unique codes of 21,209,260 medicinal products of 186 marketing authorization holders (manufacturers) have been entered into the system.
According to the Chairman of the Board of Directors of NOOL, Jakub Dvořáček, MHA, the current likelihood of falsified medicines appearing in the official Czech distribution network is negligible. If for any reason pharmacists are unable to verify the unique code, then they will proceed at their own discretion.
The availability of medicines was also emphasized by Czech Minister of Health Adam Vojtěch, as a priority. He said: “Until the end of this year neither the Ministry of Health nor the State Institute for Drug Control will sanction pharmacists for dispensing medicines to patients even if they are not able to verify and check the identifier of the medicinal product in the data repository, if in good faith they are reasonably sure such medicinal product is authentic. This good faith may stem from experience to date, as well as the system of risk management that has been implemented, including measures such as accepting medicinal products only from established and proven distributors of medicinal products, visual inspection of packaging integrity, etc.”