CRED Managing Variations Effectively

 Be concise  Be specific : state PL number(s) related to the query  Provide brief explanation of:- Advice on the submission of queries to MHRA Do:-

 FIRST: refer to the CMDh guideline “acceptable and not acceptable groupings”. SECOND: refer to MHRA practical examples  NEW THEN ask only if complex/grey area

  why the change is needed   how the changes are related   provided tabulated current vs proposed (changes highlighted) Don’t:-  submit the full application form, supporting data, Type IA/B checklist  submit the QOS, Clinical Overview  request advice when the UK is a CMS  request grouping numbers:-   for purely National MAs (not needed)   a European MA other than Type IA affecting >1 MA  submit “vague, non-specific or theoretical” queries

MHRA Regulatory Information Service (RIS):

148