Regulatory Open Forum

 View Only

  • 1.  Windsor Framework Regulation

    Posted 9 days ago

    Dear Colleagues,

    I am seeking confirmation on the following queries regarding the forthcoming Windsor Framework regulation:

    1. Will the regulation require changing the testing and batch release activities currently performed in Ireland to Northern Ireland for the PLGB licenses, or will this be optional?
    2. Will the new regulation prevent testing and batch release of the centralised product in Northern Ireland? Alternatively, if the centralised product is not intended for the Northern Ireland market, will it still be possible for it to be wholesaled, manufactured, and batch-released from Northern Ireland to the EU?

    Thanks for your collaboration!



    ------------------------------
    Zornitsa Angelova
    Dr
    Amicus Therapeutics - ENTERPRISE
    Marlow
    United Kingdom
    ------------------------------


  • 2.  RE: Windsor Framework Regulation

    Posted 9 days ago

    Hello Zornitsa,

    My understanding is that you are referring to medicinal products. You can find some help with your questions here - https://www.hpra.ie/docs/default-source/default-document-library/questions-and-answers-on-the-windsor-framework.pdf?sfvrsn=2

    Q: What will be the situation in relation to medicines moving between the Republic of
    Ireland & Northern Ireland after the implementation of the WF?
    A: Art 7 of Regulation (EU) 2023/1182 introduces a new provision which states that
    medicinal products as referred to in Art 1(1) of that Regulation shall not be moved
    from NI to a Member State or be placed on the market in a Member State. Art 1(1)
    specifies that the scope of the Regulation includes medicinal products intended to be
    placed on the market in NI in accordance with Art 6 of Directive 2001/83/EC. Based
    on this, authorised medicines intended to be placed on the market in NI cannot be
    moved into IE or any other EU MS. We therefore understand that parallel imports
    from NI will not be possible. However, products not intended for or placed on the NI
    market can continue to be wholesaled, manufactured and batch released from NI to
    the EU. 

    Q: Will products manufactured and QP released in Northern Ireland be considered as
    batch released for the EU market?
    A: As indicated in footnote 45 of the Notice to Stakeholders issued by the European
    Commission and the European Medicines Agency, batch release by a Qualified
    person of an importer / manufacturer established in NI is recognised in the EU as per
    the sixth subparagraph of Article 7(3) of the IE/NI protocol. The same subparagraph
    also refers to batch testing. 

    Have a great weekend,

    Olga



    ------------------------------
    Olga Peycheva
    Regulatory and Study Start Up Specialist (Clinical trials)
    Solutions OP Ltd
    https://solutionsop.co.uk/
    United Kingdom
    ------------------------------

    Original Message


Related Content