In the event of a recall of a batch, withdrawal of a product from the market or a case of stolen packages, the marketing authorisation holder (MAH) should perform appropriate decommissioning transactions in the EMVS system for the affected markets, reminds the Latvian Medicines Verification Organization (LZVO).
It is crucial to decommission in the verification system the medicine that has been withdrawn or recalled from the market. The MAH must mark the affected batch(es) as recalled for the Latvian market in the EMVS as soon as possible after the wholesalers are notified, to minimize the risk for potential harmful products being dispensed to patients. If a product is withdrawn from the Latvian market, the MAH must mark the product as withdrawn for the Latvian market in the EMVS the same day as the marketing authorization cancellation takes effect.
The procedure for medicine recalls and the flow of information in Latvia is determined by the Cabinet of Ministers Regulation No. 416 "Procedures for the Distribution and Quality Control of Medicines." Similarly, MAHs must also adhere to the Delegated Regulation (EU) 2016/161, which regulates the operation of the verification system and the manufacturers' obligations concerning the recall, withdrawal from the market, or theft of medicines.
Article 40 of the Delegated Regulation stipulates that MAH’s “ensure the decommissioning of the unique identifier of a medicinal product which is to be recalled or withdrawn, in every national or supranational repository serving the territory of the Member State or Member States in which the recall or the withdrawal is to take place.” The same obligation also applies in cases of stolen medicines if the unique identifier of the stolen medicines is known.
EMVO would like to remind once more that the withdrawal of a product and batch recall within the EMVS are irreversible actions.
Data quality in the verification system is a crucial prerequisite for effective operation. Every MAH who uploads the medicine data to the national medicines verification system through the EU HUB and distributes their medicines for human use must take care of it.