1.-2. Purpose and scope

1. Purpose

The purpose of this document is to describe the processes and procedures for handling alerts caused by the medicines verification system from the perspective of different user groups. The document can be used to further develop users' IT systems so that the user can quickly and easily see the content of the verification inquiry, the response from the FiMVS system, and can also distinguish whether it is an error message or an alert.

The medicines verification system is based on the requirements of EU legislation (Falsified Medicines Directive (2011/62/EU) and the Commission Delegated Regulation (EU) 2016/161). The aim is to prevent falsified medicines entering the legal supply chain for medicinal products and to improve safety.

The medicines verification system applies to almost all prescription medicines. They are equipped with 2D codes that include the unique identifiers for the packs. When dispensing a serialized medicine, the information on the pack is compared to the data in the medicines verification system database. If the information is consistent, we can be assured this is not a falsification. In some cases, however, the pack may cause an alert.

2. Scope

The scope of this document includes the activities in the medicines verification system and the processes and procedures for handling alerts caused by the medicines verification system. However, each user of the verification system will have to resolve the final process for their part.

Medicines verification system alerts must always be investigated before the pack is dispensed. If the alert is caused by a false alert and/or if falsification is not suspected, the pack can be dispensed to the customer. N.B. The pack should not be returned to the wholesaler before the cause of the alert is resolved and/or return has been agreed with the marketing authorization holder.

This document has been drafted in co-operation with stakeholders in the pharmaceutical supply chain. The document will be updated as necessary, possible suggestions can be sent to FiMVO at nmvs@fimvo.fi