More than 3,100 users are included in the system in our country, and coverage of COVID-19 vaccines is forthcoming
Over 3,100 pharmacies, hospital pharmacies and wholesalers are connected to the Bulgarian Medicines Verification System. All Bulgarian producers perform serialization and upload their products data in the European Hub. The system has been operating steadily in all EU countries for 2 years, announced Mrs. Illiana Paunova, Executive Director of Bulgarian Medicines Verification Organization (BgMVO), on the anniversary of the implementation of the European Medicines Verification System.
As of February 9th, 2019, all prescription medicines are manufactured with a unique identification code and contain an anti-tampering evidence. This is an obligation of the EU countries under European Directive 2011/62/EU and Delegated Regulation 2016/161, aiming to guarantee the origin and quality of prescribed medicines.
The national systems are connected in the Unified European medicines verification system. The codes of all manufactured packages are registered by the producers in the European Hub, and from there are distributed into the national systems.
Approximately 70 mln packs of medicines have been verified during 2020 in Bulgaria. This is a large volume of transactions, but at the same time it represents only 25% of our prescription medicines market, said Illiana Paunova.
In 2020 the changes in Bulgarian legislation, related to the verification of medicines were adopted and are already in force. They set out the obligations regarding medicines verification of all stakeholders in the pharmaceutical supply chain, as well as the penalties for non-compliance. So far, 83% of Bulgarian pharmacies are connected, but there are still approximately 630 pharmacies that are about to start working with the verification system.
From April 1st, 2021, the requirements for serialization and verification will also cover the COVID-19 vaccines, for which an initial grace period was given by the European Commission to facilitate the organization of their distribution, said Illiana Paunova. After this date, the vaccines will also be produced with a unique identification code that proves their origin, as is the requirement for all prescription medicines. Interpol has issued a warning of an increased risk of counterfeit medicines, medical devices, vaccines, and tests for COVID-19, due to increased demand in the context of global crisis. Through the unique identification code and the application of verification requirements, COVID-19 vaccines shall be scanned throughout the supply chain up to the moment of application at the immunization points, thus being protected from falsification attempts.