Update: In March 2019, we posted on the “MHRA’s extensive no-deal guidance updates for pharma and medtech“.

Following on from the MHRA’s published guidance on ‘grandfathering’ and managing the lifecycle changes of medicinal products (see here), the MHRA has released an update in regards to the time period companies must submit the relevant information.

The MHRA will allow companies a period of:

  • 12 months after the UK officially leaves the EU to submit to the MHRA information on their CAPs; and
  • 33 months after exit day to implement changes to the MA numbers and MAH name and address in packs in order that these changes do not have to be made in isolation but can be made when other changes become necessary.

The full notice on updates can be found here

Author

Julia Gillert is a Senior Associate in the Corporate Department of Baker & McKenzie's London office and is a key member of the Healthcare industry group within the London office and European and Global networks. Julia advises both domestic and international companies in the med-tech, pharma and healthcare sectors on a wide range of regulatory and general compliance matters. Julia has contributed to a variety of regulatory healthcare related publications and practice handbooks and co-edits the firm's European Healthcare Newsletter. Julia sits on the ABHI's Legal Issues Committee.

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