Good Clinical Practice Guide
Results 1 to 3 of 3

Thread: IV IMP labelling requirements

  1. #1

    IV IMP labelling requirements

    Dear all
    Does anyone know if IV IMPs are exempt from requiring 'use as directed' or similar directions if they are administered by nurses within the hospital? All our trial specific prescription proformas have the specific administration details that the nurses follow.
    The labelling section of annex 13 guidance does state the information should be included on labels unless its absence can be justified - does inclusion of admin details on the prescription justify its absence?
    Thanks
    Vicky

  2. #2
    Forum Member
    Join Date
    Jan 2012
    Location
    Dundee
    Posts
    3
    I would venture to say that the requirements of Annex 13 are still required to be met. I don't consider separate instructions on doing provided to nurses as adequate. The main exemption being health care provider and hospital based is only that re-packaging does not require QP release.

    HTH
    Graham

  3. #3
    Forum Member
    Join Date
    Nov 2011
    Location
    Manchester
    Posts
    5
    HI Vicky
    If it is an IMP then Annex 13 should still be met - if there was a justification for absence then this needs to be detailed in the CTA application.
    Susie

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •