Variation and Renewals Flashcards
what is a variation?
Variation to the terms of marketing authorisation or varation means an amendment to the contents of the particulars and documents refeed to in
Changes not requiring any prior approval are
Design space (no submission required if within an approved designe space) Type 1A (minor variation)
changes requiring prior approval
Type 1B, Type II and Extension
what are catagories of changes?
Administrative changes: Module 1
CMS (quality) changes : Module 3
Saftey, PV, Efficacy: Module 4/5
What are minor variation
variation which has only a minimal impact, or no impact at all, on the quality, safety or efficacy of the MP
Implementation of minor variation
does not require prior approval before implementation
Submission timelines of MV?
can be submitted by the MAH within 12 months after implementation
what is the Variation procedure of type 1A call?
Do and Tell procedure
what is carried out during the assessment of type 1 A variation?
only check for correctioness of application, notification by the authority at the end of the procedure
Examples of Type 1A variation
Change of contact details of the holder
manufacturer or supplier of any starting material, regent, intermediate, active substance
changes in the packaging material not in contact with the finished product
delet
What is procedure of the subclass of type 1A?
this are special case of the Type 1A variation, where it must be notified (submiited) immediately to the national competent authorities or the EMA following implementation.
when is the notification for the subclass type 1A?
no later than 14 days following implementation
Examples for Type 1A subcall variation?
change of the name or address of the marketing authorization holder
Changes in imprints, bossing or other markings
Change in the shape or dimensions of the pharmaceutical form
Variation Type 1B is?
minor variation which ie neither a minor variation of type 1A nor a major variation of typeII nor an extension
Implementation of the Type 1B?
it must be notified to the national competent authority or the EMA before implementation
What is the assessment for the Type 1B procedure?
submission (day 7), the validation process proir to content assessment
start (Day 0-day 30 )assessment after a positive technical validation; with the outcome of acceptance or request for information
Clock stop (max 30 day9
Reassessement process (30days)
How is the assessmet procedure called?
Tell and do procedure
Examples of the Type 1B?
Change in the invented name of the medicinal product for nationally authrized products
change in the batch size of an active substance (10-fold increase)
Change in the immediate packaging of the API
Change in the shape or dimensions
replacement of a single excipeints with comparable excipients with the same functional characteristics
Variation Type II?
a major variation which is not an extension and which may have a siginicant impact on the quality, saftey or efficacy
Implementation of Variation Type II?
it requires approval by the authorities before the chnage can be implemented
Submission timelines for the variation Type II?
30 day and 90 day procedure based on safety risk and complexity
what is the procedure of the Type II variation?
Technical validation prior to content assessment
content assessment start only after positive technical validation
procedure is prolonged in case of a RFI
implementation can only be done after approval by the authority
Examples of Type II variation
Variation related to
- the addition of a new therapeutic indication
- to significant modifications of the SmPC due to new quality, pre-clinical, clinical or pharmacovigilance findings
- changes outside the range of approved specifications, limits or acceptance criteria
- substantial chnages to the manufacturing process
Extensions?
means a variation which is listed in Annex 1 and fulfils the conditions laid down therein
