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Drug Regulatory Affairs > Variation and Renewals > Flashcards

Variation and Renewals Flashcards

1
Q

what is a variation?

A

Variation to the terms of marketing authorisation or varation means an amendment to the contents of the particulars and documents refeed to in

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2
Q

Changes not requiring any prior approval are

A 
Design space (no submission required if within an approved designe space)
Type 1A (minor variation)
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3
Q

changes requiring prior approval

A

Type 1B, Type II and Extension

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4
Q

what are catagories of changes?

A

Administrative changes: Module 1
CMS (quality) changes : Module 3
Saftey, PV, Efficacy: Module 4/5

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5
Q

What are minor variation

A

variation which has only a minimal impact, or no impact at all, on the quality, safety or efficacy of the MP

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6
Q

Implementation of minor variation

A

does not require prior approval before implementation

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7
Q

Submission timelines of MV?

A

can be submitted by the MAH within 12 months after implementation

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8
Q

what is the Variation procedure of type 1A call?

A

Do and Tell procedure

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9
Q

what is carried out during the assessment of type 1 A variation?

A

only check for correctioness of application, notification by the authority at the end of the procedure

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10
Q

Examples of Type 1A variation

A

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

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11
Q

What is procedure of the subclass of type 1A?

A

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.

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12
Q

when is the notification for the subclass type 1A?

A

no later than 14 days following implementation

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13
Q

Examples for Type 1A subcall variation?

A

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

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14
Q

Variation Type 1B is?

A

minor variation which ie neither a minor variation of type 1A nor a major variation of typeII nor an extension

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15
Q

Implementation of the Type 1B?

A

it must be notified to the national competent authority or the EMA before implementation

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16
Q

What is the assessment for the Type 1B procedure?

A

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)

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17
Q

How is the assessmet procedure called?

A

Tell and do procedure

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18
Q

Examples of the Type 1B?

A

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

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19
Q

Variation Type II?

A

a major variation which is not an extension and which may have a siginicant impact on the quality, saftey or efficacy

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20
Q

Implementation of Variation Type II?

A

it requires approval by the authorities before the chnage can be implemented

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21
Q

Submission timelines for the variation Type II?

A

30 day and 90 day procedure based on safety risk and complexity

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22
Q

what is the procedure of the Type II variation?

A

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

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23
Q

Examples of Type II variation

A

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
24
Q

Extensions?

A

means a variation which is listed in Annex 1 and fulfils the conditions laid down therein

25
Q

Implementation of the Extensions

A

Implementation onaly after the relvent authority has amended the decision granting the marketing authorisation in accordnace with the approved extension and notified the holder accordingly

26
Q

Assessment/ approval of the extensions?

A

shall be evaluated in accordance with the same procedure as for the initial marketing authorisation

27
Q

Examples for extensions

A

Replacement of an API by a different salt/ester, with the same therapeutic moiety where the efficay/safety characteristics are not significantly different
Changes or addition of new strength, pharmaceutical form and route of administration

28
Q

How do i know which type of variation applies?

A

Variation classification guideline or the articles 5 database

29
Q

Do i have to submit all variations separately?

A

Some variation can be grouped

30
Q

which variation can be grouped?

A

One Type 1A or 1A (sub) affecting several medicinal products from the sae MAH

Several Type 1A or 1A (sub) affecting several medicinal prodcuts from the same MAH, same for all MP and are submitted to the same relvevant authority

31
Q

Acceptable grouping are?

A

All minor notification of Type 1A and 1A (sub)
New manufacturing site for the finished product and other changes (change in batch size, manufacturing process, batch release

32
Q

Can i group the same variation for several marketing authorization?

A

Worksharing

33
Q

What is worksharing

A

one authority will examine the variation on behalf of the other concered authorities

34
Q

Assessment for the EMA as reference authority

A

Two or more centrally authorized products

One or more centrally authorzed products+ nationally authorized products MRP/DCP

35
Q

Assessment for the National authorities as reference authorities

A

More than one nationally authorized product or MRP/DCP

36
Q

Scope and Advantages of the worksharing?

A

one integrated submission package
Avoidance of duplication of work
Can include many different product

37
Q

what are the types of post approval changes?

A

Minor
Mondereate (CBE 30, CBE-0)
Major (Prior Approval supplement)

38
Q

Implementation of the minor changes

A

the applicant must describe minor changes in its nex Annula Report
Change can be implemented prior to submission of the annual Report

39
Q

submission timelines of the minor changes?

A

submit each ar within 60 days of the date of the U.S approval of application

40
Q

Examples for minor changes?

A

change of Manfacturing site (move to a different site for secondary packaging)
change of manufacturing process ( changes to equipment
change of specification and container closure system

41
Q

Moderate changes, the two types?

A

Change being effected in 30 day

Change veing effected

42
Q

Implementation and Timelines of the moderate change

A

CBE-30 submission at least 30 days before the distribution of the drug product made using the change
CBE-0: distrubtion can occure when FDa receives the supplement

43
Q

Examples for CAE-0?

A

A move to a different manufacturing site for the manufacture or processing of the final intermediate
an addition to a specification that provides increase assurance that the drug product
A change in the size and or shap of a container for a nonstrile drug product, except for solid dosage froms

44
Q

Implementation and Timelines for the Major changes?

A

the submission of a supplement and approval by FDA proi to distribution of the drug product made using the change

45
Q

Assessment by the authority of the major changes?

A

Standard: 6 or 10 months (dpending on the need of proir inspection
Priority: 4 or 8 months

46
Q

Examples for Major change?

A

A move to a different manufacturing site when the new manfacturing site has never been inspected by the FDA for th etype of operation
Changes that may affect the controlled release characteristics of a modified oral dosage form
Delecting part of a specification
A chnage in the primary packaging components

47
Q

Minor changes are?

A

changes does not afeect the quality, safety or efficacy may be implemented prior to submission

48
Q

Moderate chnages when implmented?

A

after a short assessment by the authority

49
Q

Major changes require?

A

an exhaustive assessment and a comprehensive date set

50
Q

what is important of the MAH during submission?

A

the MAH should contain all information required by the relevant legal bais but not more

51
Q

Know the table in slide 48

A

Have you done so?

52
Q

How long is the MA valid and when should a renewal should be submitted?

A

5 years of MA

9 months before the expiry date of the MA

53
Q

Content of the renewal application

A

Module 1 and 2

54
Q

what is the result of a renewal application?

A

Non-Renewal–> may reulst i suspension, withdrawal or revocation of MA

Further renewal
Additional 5-years

55
Q

how to reduced workload and time

A

Shortened renewal (minimum documentation requirements)
Cover letter
Application form
Declaration that full documentation will be available for submission on request

56
Q

Timetable for reduction

A

Submission of the application
Day 0: start of procedure
Day 20 CMS inform about acceptance/non-acceptance
Day 30: End of procedure

Drug Regulatory Affairs (15 decks)

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