Brexit: Two-year implementation period for name and address change on released drug packages for sale

The Danish Medicines Agency (DMA) has established a two-year implementation period starting 29 March 2019 in which it is permitted to sell released drug packages indicating a UK-owner of the marketing authorization or representative.

Released packages may be sold during the implementation period if, prior to 30 March 2019, the DMA has received and approved a request for variation change of the name or address of the owner of the marketing authorization or representative from the UK to an owner or representative within the EEA, and upon upload of an updated patient information leaflet no later than 3 months after the variation approval. Further, after 29 March 2019, a Qualified Person is prohibited from releasing batches indicating a UK-based owner of the marketing authorization or representative.

The two-year implementation period ends on 29 March 2021.

During this period, both new and old packages may be sold on the market, whereas only new packages may be released after 29 March 2021.

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