CRED Managing Variations Effectively

Type IA Variations – Tips

• MHRA recently (August 2013) published feedback on these common reasons for rejection along with specific examples and advice on getting it right first time http://webarchive.nationalarchives.gov.uk/20141205150130/http://ww w.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Mark etingauthorisations/Variationstolicences/Experiencetodate/index.htm • Deficiencies are largely administrative and can be readily avoided with training, careful planning and suitable quality checks prior to submission • If errors are identified in the critical documents of the licence and you have evidence that the correct information was submitted please contact DataReviewTeam@mhra.gsi.gov.uk

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