CRED Managing Variations Effectively

Definition of Classifications

– Type IA – “Do and tell” for changes implemented in previous 12 months – Type IA IN - “Do and tell” and requires immediate notification after implementation – Type IB – “Tell, wait and do” and requires notification before implementation (wait 30 days after notification) – Type II – More detailed changes (“Tell and do”) and requires approval before implementation (usually 60 day review; range 30-90 days) – Extension applications – e.g. additional strengths, pharmaceutical form and route of administration (up to 1 year review)