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Division 33 If the investigational medicinal product is not authorised, and does not have a marketing authorisation from a third country that is party to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and is not manufactured in the Union, the following documentation shall be submitted:

United Kingdom

Original text. Later amendments are not shown.

  1. (a)

    a copy of the authorisation referred to in Article 61; and

  2. (b)

    certification by the qualified person in the Union that the manufacturing complies with GMP at least equivalent to the GMP in the Union, unless there are specific arrangements provided for in mutual recognition agreements between the Union and third countries.