This procedure provides a mechanism for the pharmaceutical industry to resolve any issues informally and is intended to provide a clear hierarchy for escalation if required. The procedure is independent to the Agency's Complaints Procedure which only covers complaints about administrative decisions and does not cover complaints relating to regulatory decisions. Please select the subject area of your issue from the buttons below.
  What type of licence is needed? Consistency of definitive advice |
Is this a medicine?
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 Failing to consult appropriately or effectively on proposals for change |
 Accuracy of information on Sentinel Packaging/patient information leaflets (PILs) not consistent with brand leads |
Charging issues
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Email Telephone number |
 Importation or distribution of unlicensed medicines Export certificates Defective medicines reporting |
 Wholesale dealing Manufacturing Clinical trials inspections Pharmacovigilance inspections Blood establishments Control laboratories |
Accuracy of press statement |
Lost data/approval letter Delays in picking up the application Delays in assessment |
Pharmacovigilance requirements |
RAMA How to do an electronic submission Problems with Portal |
Issues during the assessment process Clinical trials
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Whistle blower information |
Download the full escalation procedure
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