End Users

The Falsified Medicines Directive and the Delegated Regulation specify the verification of safety features and the deletion of unique identifiers by the wholesalers and the entities that are authorised or have the right to supply medicines to the population. According to the Regulation and applicable Latvian regulatory acts, the companies that are authorised or have the right to supply medicines in Latvia are pharmacies, hospitals, clinics, outpatient clinics, health centres, dental clinics and practices. 

The Latvian Medicines Verification System includes application programming interfaces that wholesalers, pharmacies, hospitals, clinics, outpatient clinics, health centres and medical practices use to send requests to this system, by using their IT software, to verify the authenticity of unique identifiers and to decommission them from the repository system.

From 9th February 2019, pharmaceutical wholesalers across Europe will be required to verify medicines bearing safety features that pass through their warehouses in specific circumstances as set out in the Commission Delegated Regulation (EU) 2016/161. They will also have to decommission packs in certain circumstances, including when they are being supplied to specific customers as per Article 23 of the Delegated Regulation.

A wholesaler must verify the authenticity of medicines on a risk approached basis. This means the wholesaler must verify the unique identifier of at least those products that are returned to him by pharmacies or other wholesalers. Also, products the wholesaler receives from another a wholesaler who is neither the manufacturer nor the wholesaler holding the marketing authorisation nor a wholesaler who is designated by the marketing authorisation holder, must be verified.

Article 20(b) of the Commission Delegated Regulation (EU) 2016/161 relieves wholesalers from the requirement to verify packs if received from the manufacturer or MAH or a wholesaler designated by the MAH, by means of a written contract, to store and distribute products covered by his MA on his behalf (i.e. ‘Designated Wholesaler’). MAHs (including parallel importers / parallel distributors) are obliged to upload to the EU Hub a list of ‘Designated Wholesalers’ for each product placed on the market. For detailed guidance on Designated Wholesalers, please see Appendix 5 of the EMVO Master Data Guide which is available on the EMVO website.

The IT system of each company can be set up by its internal IT employees or outsourced partners. Each company may choose either to integrate the functions of medicines verification and unique identifier deletion into its own IT system or to use them separately. It is a matter to be decided in each company internally.

The LZVO is responsible for developing and supervising the national medicines verification system that receives and stores the information about the safety features of the medicines from the European central database. The LZVO introduces procedures that ensure that only users with a verified identity, role and legitimacy can access the repository or upload information to it.

The competent authorities of Latvia – the State Agency of Medicines and the Health Inspection – supervise the repository to ensure that the requirements of the Delegated Regulation are fulfilled.

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