Bulgaria: managing alerts during verification and decommissioning of medicines

Bulgaria: managing alerts during verification and decommissioning of medicines

After February 9th 2019 the EU drug verification system (established by the Falsified Medicines Directive (Directive 2011/62/EU) and further detailed by Commission Delegated Regulation (EU) 2016/161) became applicable.

The Bulgarian Drug Agency (BDA) and the Bulgarian Medicines Verification Organisation (BGMVO) published the first Guidelines for managing alerts during verification and decommissioning of medicines. The document has been coordinated with the national competent authorities and professional organizations of all stakeholders in the medicines supply chain at national level and aims at providing instructions to manufacturers of medicinal products, wholesale traders and pharmacies.

Although the guidelines do not expressly define a stabilization or use & learn period, the document provides some information on handling technical errors and dispensing medicinal products in the initial phase of implementing the verification system. Technically, the Bulgarian Medicines Verification System has been in production and functioning since April 2018. However, the occurrence of technical errors during the initial period of operation of the new system after February 9th 2019, should not disrupt the normal supply of medicines to patients.

It is recommended that pharmacies perform verification of serialized medicinal products at the time of their receipt from the wholesalers to prevent possible technical problems when the actual dispensing to patients takes place. Special attention is paid to alerts due to errors in product data (e.g. serial number is unknown, batch identifier mismatch or expiry date mismatch). These alerts might occur as a result of data upload errors, encoding errors, errors in the barcode scanner setup or software errors. These technical errors should not prevent the supply of medicinal products to patients during the initial period of use of the system.