While Brexit uncertainty remains, European and national regulators continue to provide information for the animal health industry

Cyton Brexit news update for November 2018
19 November, 2018

The uncertainty of Brexit for industry makes forwards planning extremely difficult for the animal health and other industries, so the regulators are maintaining strong communication to keep industry as well informed as possible.

Latest advice from the EU regulators

The CMDv has developed a practical guidance document (Link) for procedures related to Brexit for VMPs approved through the Mutual Recognition and Decentralised procedures (MRP/DCP). This document has been prepared to complement the Q & A document and has been based on the equivalent EMA document relating to centrally authorised VMPs. In addition, the CMDv has updated its ongoing Brexit Q & A document (Link). New answers have been added relating to the deputy QPPV (Q3a) and inspections (Q17) - Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and pharmacovigilance.

Meanwhile, the EMA’s Brexit plans include a further three industry stakeholder meetings confirmed to take place in 2019 (Link).

Updates from the national regulators

Danish regulator, DKMA, has clarified that there will be a two-year implementation period during which medicines with packaging indicating a UK marketing authorisation holder will not need to be recalled (Link). There will be no need to withdraw packs with old labelling before the end of the implementation period.

The Austrian regulator BASG has also updated its Brexit information page (Link – Austrian only).


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