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The new variations legislation Overview Helen Vella Director

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The new variations legislation Overview Helen Vella Director Licensing 21 January 2011 Medicines Authority 203,Level 3, Rue D Argens, Gzira,GZR 1368 – PowerPoint PPT presentation

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Title: The new variations legislation Overview Helen Vella Director


1
The new variations legislation
Overview
  • Helen Vella
  • Director Licensing
  • 21 January 2011

2
New variations legislation
Regulation 1234/2008
  • All changes subsequent to their placing on the EU
    market, e.g. changes to the production process,
    product packaging or the address of the
    manufacturer, are considered in legal terms as
    'variations', and must be handled in accordance
    with a complex legislative framework the
    'Variations Regulation'.
  • This lack of harmonisation had negative
    consequences in terms of the administrative
    burden, both for industry and national regulatory
    authorities, and the overall functioning of the
    internal market.
  • Better regulation of pharmaceuticals towards a
    simpler, clearer and more flexible framework on
    variations

3
New variations legislation
Regulation 1234/2008
  • The objective of the revision of the Variations
    Regulation (Commission Regulation (EC) No
    1234/2008 ) is to simplify the legislative
    framework governing 'variations'. The Regulation
    applies to variations from 1 January 2010 (for
    centrally authorised products and products
    authorised through the mutual recognition and
    decentralised procedure).
  • Repeals regulations 1084/2003/EC and 1085/2003/EC
  • Applies from 1 January 2010 (MRP/DCP and
    Centralised)

4
(No Transcript)
5
New variations legislation
Directive 2009/53/EC
  • Directive 2009/53/EC
  • Start of implementation by Member States at the
    latest by 20 January 2011
  • Amends Directive 2001/83/EC with regards to
    variations
  • For the first time the submission requirements
    and processing of national variations is being
    harmonised
  • Applicable for all nationally authorised
    medicinal products authorised after 1998

6
New variations legislation
Directive 2009/53/EC state of implementation in
2010
7
New variations legislation
Main changes DO AND TELL
  • Introduction of a do and tell system for type
    IA notifications allows the MA holder to
    implement minor changes prior to informing the
    competent authority of such changes. In some
    cases the MA holder will only be required to
    notify the Medicines Authority within 12 months
    of implementation in one single periodic report
  • However some Type IA changes will require
    immediate notification following implementation
    These changes are listed as Type IAIN changes in
    the classification guideline published by the
    Commission

8
  • .

New variations legislation
Main changes TYPE IB BY DEFAULT
  • Change of default category for variations from
    type II to type IB Where the classification of a
    change is not defined in the annexes to
    Regulation 1234/2008, the classification
    guideline as published by the Commission, or via
    a recommendation on the classification of an
    unforeseen variation issued by EMA or CMD, it
    will be considered as type IB.

9
New variations legislation
Main changes GROUPING
  • Introduction of a grouping system for
    variations by the same MA holder resulting in a
    reduction in the number of submissions
  • E.g. same minor variations of type IA to the
    terms of one
  • or several marketing authorisations can be
    notified
  • at the same time as a group.

10
New variations legislation
Main changes - GROUPING
  • Several variations to the terms of the same
    marketing authorisation submitted at the same
    time, can also be submitted in one application,
    provided that the variations fall within one of
    the cases listed in Annex III of the regulation
    or if it is allowed by the RMS (in MRP and DCP)
    or EMA (in the case of centralised procedures).

10
11
New variations legislation
Definition of a Marketing Authorisation More
than one pharmaceutical form or strength can be
grouped for variations MT/H/0123/001 MT/H/012
3/002 MT/H/0123/003
Main changes - GROUPING
11
12
New variations legislation
Main changes - GROUPING
Submission type value for mixed groups, should
be the highest variation or extension
type For example, a group consisting of a Type
IA and a Type IB variation should use the
submission type value var-type1b A group
consisting of a Type II variation and an
extension should use the submission type value
extension.
12
13
New variations legislation
Main changes WORKSHARING
  • Introduction of a worksharing procedure
  • this will allow more efficient assessment of a
    single change (type IB or Type II) or multiple
    changes (type IB, type II or grouped variations)
    to a series of MAs held by the same MA holder.
    This may include changes to MAs issued through
    the centralised, mutual recognition or
    decentralised procedures a single competent
    authority will act as the reference authority.

14
New variations legislation
Definitions of variations
Variation categories are defined Minor
variation type IA variation which has only a
minimal or no impact, on the quality, safety or
efficacy of the product Major variation type
II variation which is not a line extension, but
may have a significant impact on the quality,
safety or efficacy of the medicinal product
Minor variation type IB variation which is
neither a minor type IA, nor a major type II nor
an extension Extension of a marketing
authorization a variation which is listed in
Annex I and fulfils the conditions therein
14
15
New variations legislation
New timelines for national variations Type IA
Type IA notifications Type IA not requiring
immediate notification up to 12 months
following the implementation and can be submitted
as one report including all the variations
together. Type IAIN require submission
immediately after the implementation important
for the continuous supervision of the medicinal
product concerned. Simultaneous submission to
all relevant authorities a notification
containing the elements listed in Annex IV. This
notification must be submitted within twelve
months following implementation of the variation.
The notification must be immediately submitted
after the implementation of the variation in
special cases where minor variations require
immediate notification for the continuous
supervision of the medicinal product
concerned. Within 30 days following receipt of
the notification, the RMS will inform finally if
the decision is accepted or rejected
12
16
New variations legislation
New timelines for national variations Type IB
Simultaneous submission to all relevant
authorities a notification containing the
elements listed in Annex IV. If the notification
fulfils the requirements the RMS shall, after
consulting the other Member States concerned
(CMS), acknowledge receipt of a valid
notification. If within 30 days of
acknowledgement, no unfavourable opinion is
received, the notification is considered
accepted. The RMS will inform finally if the
decision is accepted or rejected.
16
17
New variations legislation
New timelines for national variations Type II
Simultaneous submission to all relevant
authorities an application containing the
elements listed in Annex IV. If the application
fulfils the requirements the RMS will acknowledge
receipt of a valid application, the procedure
will start from this acknowledgement
date. Within 60 days the RMS will prepare an
assessment report and a decision on the
application, which shall be communicated to the
CMS. If urgent the period may be shortened, or
extended to 90 days for variations listed in Part
1 of Annex V. Within 30 days following receipt
of the decision and the RMS assessment, the CMS
will recognize the decision and inform RMS. No
disagreement from the CMS will be considered as
recognition of the decision. The RMS will inform
finally if the decision is accepted or rejected.
17
18
New variations legislation

Out of scope of Regulation (EC) 1234/2008
homeopathic and traditional herbal medicinal
products which have not been granted a marketing
authorisation but are subject to a simplified
registration procedure should remain excluded
from the scope of the Regulation. transfers
of a marketing authorisation from one
marketing authorisation holder to another.
19
(No Transcript)
20
  • The European Commission has published a
    guideline
  • Communication from the Commission Guideline on
    the details of the various categories of
    variations to the terms of marketing
    authorisations for medicinal products for human
    use and veterinary medicinal products
  • (2010/C 17/01)
  • This guideline describes
  • Classification of minor variations of type IA, IB
    and major variations of type II
  • These in turn are also classified as
  • Administrative changes
  • Quality changes
  • Safety, Efficacy and Pharmacovigilance changes
  • Specific changes to Plasma Master Files and
    Vaccine Antigen Master Files

New variations legislation

21
New variations legislation
  • The CMDh has also published several guidelines
    http//www.hma.eu/96.html
  • Best Practice Guides for the Submission and
    Processing of Variations in the Mutual
    Recognition Procedure (Revision 11, November
    2010)
  • EMA/CMDh explanatory notes on Variation
    Application Form Examples for acceptable and not
    acceptable groupings for MRP/DCP products
    (October 2010)
  • Position paper on common grounds seen for
    invalidation/delaying day 0 for Variations
    (December 2010)
  • Cover letter for Variation Applications in the
    Mutual Recognition Procedure (December 2009)
  • Questions Answers - List for the Submission of
    Variations according to Commission Regulation
    (EC) 1234/2008 (October 2010)


21
22
New variations legislation
FEES - Current scenario - Legal Notice 315/2006

23
New variations legislation
Current scenario - Legal Notice 315/2006


24
New variations legislation
  • Fees scenario for variations
  • MRP/DCP
  • Malta as Concerned Member State no fees (fees
    covered by annual fee)
  • Malta as Reference Member State National fees
    supplementary 20
  • Bulk fees apply for identical variations
    submitted at the same time for one marketing
    authorisation (not for groups)
  • National variations
  • On submission of a valid approval from another
    Member State for the same variation with the
    application form no fees (fees covered by annual
    fee)
  • No valid approval submitted full fees as per
    legal notice
  • Bulk fees apply for identical variations
    submitted at the same time for one marketing
    authorisation (not for groups)


25
New variations legislation
  • Fees scenario for variations
  • Majority of variations have been submitted with a
    valid approval from another Member State.
  • The situation is changing slowly due to new
    timeline requirements which may not allow for
    waiting for an approval before submission in
    Malta and implementation.
  • Fees for grouped variations are still not
    included in the current legal notice bulk fee
    concept may not be applicable to the grouping
    scenario new fees required.


25
26
Questions?
  • prelicensing.mru_at_gov.mt

26
27
Discussion way forward
27
28
Thank You
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    by experts in their field and
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    are free to re-use the resources
  • for non-profit use, as long as you do not
    infringe the Authoritys rights. If you are
  • unsure whether you can use or re-use the material
    presented or their parts,
  • please contact
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