LZVO shares with European partners the experience on medicines verification system implementation in Latvia

01.10.2019

European Medicines Verification Organization (EMVO) on September 27 has published the latest EMVO Newsletter. Inese Erdmane, Chair of the Board of the Latvian Medicines Verification Organization (LZVO), shares with European partners experience on the medicines verification system implementation in Latvia.

A new medicines safety verification system has been successfully implemented in Latvia. It is operational already for 7 months with the aim to prevent the risk of patients receiving falsified medicines. Since 9th February 2019 end-users in Latvia have decommissioned from the system more than 4.6 million medicine packages.

End-users connected to the Latvian system:

1188

Total users

822

ALL pharmacies

ALL hospitals

205

Healthcare institutions

Wholesalers

Dispensing doctors (dental institutions/ practices and general practitioners) have been less active. They started onboarding mainly after 9th February. They have alternative to buy medicine in pharmacy where the package is decommissioned.

There are almost 40 million active packs in the Latvian repository. Every week there are in average 0.5 million transactions done. Dispensing activity is steadily increasing. 245 Marketing Authorization Holders (MAH) have uploaded more than 3,900 products into the repository.

In Latvia the average number of L5 alerts generated in the system are 1,200 per week. All current alerts are related to technical and procedural issues. Around 40% of alerts are coming from MAHs (including Parallel Distributors) through EU HUB. The number of alerts created by end-users are only 0.1% of the total number of verified medicine packages.

Main reasons for L5 alerts in August 2019:

Upload of incorrect products and its batches in EU HUB by MAHs;
Verify packages that are not fully equipped with safety features;
Attempt to decommission an already decommissioned pack;
Scanner and IT system configuration issues;
Indian packages.

In case of an alert, LZVO contacts both end-users and producer's representatives to check the causes of the alert message, their actions and outcome. In majority of cases the reason is identified within 2-3 days. In more than 10 cases also national competent authorities (NCA) are involved to clarify the situation.

There is no stabilization or grace period in Latvia. All involved stakeholders must comply with Delegated Regulation and fulfil their tasks. Transitional period does not apply for products which were released before 9th February 2019 with a unique identifier. The unique identifiers for such products must be uploaded to the European system before distribution to the market.
LZVO regularly reports to its NCA – Department of Pharmaceuticals of Ministry of Health, Health Inspectorate and State Agency of Medicines. The Health Inspectorate undertake regular inspections to pharmacies, healthcare institutions and wholesalers and control distribution of medicines and decommissioning is a part of the control. LZVO provide the necessary information to authorities to fulfil their tasks. The current focus is to those end-users who have not connected to national system and who do not use the system.

See more: https://emvo-medicines.eu/new/wp-content/uploads/EMVO-Newsletter-20190927.pdf

Documents

EMVO newsletter