As a general rule, for major variations of Type II, a 60-day
evaluation period will apply. This period may be reduced by
the reference Member State having regard to the urgency of the
matter, particularly for safety issues, or may be extended by the
reference Member State to 90 days for variations listed in Part I
of Annex V or for grouping of variations in accordance with
Article 7(2)(c) of the Variations Regulation. For variations for
veterinary medicinal products listed in Part 2 of Annex V of the
Variations Regulation a 90-day period will apply.
The reference Member State will prepare a draft assessment
report and a decision on the application according to the
communicated timetable and will circulate them to the
concerned Member States for comments as well as to the
holder for information. The concerned Member States will
send to the reference Member State their comments within
the deadlines set out in the timetable.
Within the evaluation period, the reference Member State may
request the marketing authorisation holder to provide supple
mentary information. The request for supplementary
information will be sent to the holder together with a
timetable stating the date by when the holder should submit
the requested data and where appropriate the extended
evaluation period. In general, a suspension of 1 month will
typically apply. For longer suspension the holder should send
a justified request to the reference Member State for agreement.
The procedure will be suspended until the receipt of the supple
mentary information. The evaluation of responses may take up
to 30 or 60 days depending on the complexity and amount of
data requested to the holder.
After receipt of the holder’s response, the reference Member
State will finalise the draft assessment report and the decision
on the application and will circulate them to the concerned
Member States for comments as well as to the holder for
information.
2.3.3. Outcome of Type II variations assessment for mutual recog
nition procedure
By the end of the evaluation period, the reference Member State
will finalise and submit the assessment report and its decision
on the application to the concerned Member States.
Within 30 days following receipt of the assessment report and
the decision, the concerned Member States will recognise the
decision and inform the reference Member State accordingly,
unless a potential serious risk to public health or a potential
serious risk to human or animal health or to the environment
(in the case of veterinary medicinal products) is identified that
prevents a Member State from recognising the decision of the
reference Member State. The Member State that, within 30 days
following receipt of the assessment report and the decision of
the reference Member State, identifies such a potential serious
risk must inform the reference Member State and give a detailed
statement of the reasons for its position.
The reference Member State will then refer the application to
the corresponding coordination group for application of
Article 33(3), (4) and (5) of Directive 2001/82/EC or
Article 29(3), (4) and (5) of Directive 2001/83/EC to the
matter of disagreement and will inform the holder and the
concerned Member States accordingly. The holder is not
entitled to trigger a referral.
Where an application concerning a grouping of variations that
includes at least a variation Type II is referred to the coor
dination group, the decision on the variations not subject to
the referral will be suspended until the referral procedure has
concluded (including, where relevant, the referral to the
Committee for Medicinal Products for Human Use under
Articles 32 to 34 of Directive 2001/83/EC, or the Committee
for Veterinary Medicinal Products pursuant to Articles 36 to 38
of Directive 2001/82/EC). However, only the variation(s) in
respect of which a potential serious risk to human or animal
health or to the environment has been identified will be
discussed by the coordination group and eventually by the
Committee for Medicinal Products for Human use or the
Committee for Veterinary Medicinal Products, not the whole
group.
The reference Member State will inform the concerned Member
States and the holder about the approval or rejection of the
variation(s) (including the grounds for the unfavourable
outcome). Where several Type II variations, or a group of
Type II variation(s) with other minor variations have been
submitted as one application, the reference Member State will
inform the holder and the concerned Member States which
variation(s) have been accepted or rejected. The holder may
withdraw single variations from the grouped application
during the procedure (prior to the finalisation of the assessment
of the reference Member State).
After a positive decision is communicated regarding variations
with changes to the summary of product characteristics,
labelling or package leaflet, the holder should submit, within
7 days, translations of the product information texts to all
Member States concerned.
After approval of the variation(s), the competent authorities of
the Member States concerned will, where necessary, amend the
marketing authorisation to reflect the variation(s) within 2
months, provided that the documents necessary for the
amendment of the marketing authorisation have been
submitted to the Member States concerned.
The accepted major variation(s) of Type II can be implemented
30 days after the holder has been informed about the
acceptance of the variation(s) by the reference Member State,
provided that the necessary documents to amend the marketing
authorisation have been submitted to the Member State
concerned. In those cases where the application has been the
object of a referral, the variation(s) must not be implemented
until the referral procedure has concluded that the variation(s) is
accepted. However, the variations in the group not subject to
the referral may be implemented if so indicated by the reference
Member State.
Variations related to safety issues must be implemented within a
time-frame agreed between the reference Member State and the
holder.
EN
C 223/10 Official Journal of the European Union 2.8.2013