Guidance published on joint labelling for veterinary medicines
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Guidance from the Veterinary Medicines Directorate for the
veterinary pharmaceutical industry on how to apply for and maintain
a joint-label for use on veterinary medicines placed on the market
in the UK and Ireland. Joint-label following a new MA procedure For
new EU procedure MAs, it will be assumed that you want a
joint-label if both NI and Ireland are involved in the...Request free trial
Guidance from the Veterinary Medicines Directorate for
the veterinary pharmaceutical industry on how to apply for
and maintain a joint-label for use on veterinary medicines
placed on the market in the UK and Ireland.
Joint-label following a new MA procedure For new EU procedure MAs, it will be assumed that you want a joint-label if both NI and Ireland are involved in the procedure. If not, you should make this clear when submitting the mock-ups. Following the end of a new MRP or DCP, you should submit mock-ups to the VMD and HPRA within 20 days of procedure ending. For new MA applications submitted in parallel to GB and the EU, or for national MA applications submitted to the UK (or part of) and IE, you can request joint-labelling as part of these applications. However, as the procedures will be assessed separately, we cannot guarantee that joint-labelling will be achieved at the end of the assessment.
See Timetables, below, for more information on the
procedure. Mock-ups for Centrally Authorised Products (CAPs) submitted to IE and NI are not assessed by national competent authorities; however they must reflect the agreed QRD text and observe “blue box” requirements.
Mock-ups submitted in support of a parallel GB national
application will be assessed by the VMD in accordance
with our national requirements and standard 20 day
timetable. You may also get a joint-label as a stand-alone procedure by submitting a joint-labelling variation to both the VMD and HPRA, whether authorised by EU or national procedures.
For nationally authorised products, the SPC for the
products involved will not be the same, so these will
need to be harmonised first before a joint-label can be
agreed. You cannot make any changes to the SPC that
requires data to be assessed. In this case, you should
submit the appropriate variation(s) and wait for these
to be approved before submitting the joint-label
variation. If such changes are identified during
assessment, the joint-label variation will be refused,
and you will be asked to resubmit once the changes have
been made.
You should submit the joint-labelling variation to the
VMD and HPRA. You
should make it clear in your application that the
purpose of the variation is to get a joint-label for a
mutually recognised product. See Timetables, below, for
more information on the procedure once the application
has been validated. You should submit the joint-labelling variation to the VMD and HPRA. You should make it clear in your application that the purpose of the variation is to obtain a joint-label for nationally authorised products. During the first timetable the SPC will be discussed and agreed. Once this is complete the lead country will request mock-ups and the timetable process starts again.
See Timetables, below, for more information on the
procedure once the application has been validated.
Following a procedure that changes your mutually
recognised product SPC or
Label/leaflet, it will be assumed that you want to
maintain your joint-label if both NI and Ireland are
involved. If not, you should make this clear when
submitting the mock-ups to the VMD and HPRA,
which should be within 20 days of procedure ending. You must submit any future applications that affect the SPC or label/leaflet to the VMD and HPRA at the same time. You should make it clear in your application that the product is joint-labelled. Normal application timescales may be suspended during these applications to allow the Agencies to liaise with each other.
If you are submitting a variation to simply make
changes to the mock-ups that do not affect the approved
label text, such as C.II.6(b) variation, this will be
run on the same timetable as a joint-labelling
variation. Do not submit mock-ups under a C.1(z)
category. See Variations to a veterinary MA, Submission of applications to an animal medicines and SPC and Product Literature for further guidance. You should also refer to the HPRA guidance.
You should include in the application a clear, concise
description of the variation under ‘scope of
change’.
Using the variation Unforeseen ‘Type IB Category C.1.z’
in the UK and ‘Type IB Category C.II.6(b)’ in Ireland,
you must provide the current mock-ups for the UK and
Ireland with the proposed joint mock-ups. Using the variation Unforeseen ‘Type IB Category C.1.z’ in both the UK and Ireland you must provide current SPCs for the UK and Ireland, and a proposed joint SPC. Revised QRD text will also be required for the UK. You must also confirm that none of the proposed changes to the SPC require data to be assessed.
Mock-ups are not required at this stage and will be
requested once the joint SPC has
been agreed. Once an application has passed validation, you will be sent an invoice for the fee by email so you must provide a valid email address in your application.
See Application fees
for animal medicines. You submit mock-ups to NI and IE within 20 days of the procedure ending. The VMD and HPRA will decide who will take the lead. The lead country draws up timetable and emails it to you and the other country.
If there are no comments, or the mock-ups can be approved with minor annotations, the application goes into the national phase where each country issues the authorisation documentation including the agreed joint-label.
If mock-ups are not submitted on time or the revised
mock-ups are still incorrect, the MA will be issued
with a condition that you must submit a variation to
approve mock-ups (Type IB - C.II.6(b)) prior to placing
the product on the market for sale and supply. You must submit the QRD agreed as part of the counter procedure. If the QRD text is not the same then during an initial 20 days, the VMD and HPRA will consider the differences and if alignment of the text can be reached. If changes are required to the agreed QRD text and assessment of data is needed, you must submit the necessary variation(s) before the joint-labelling variation can proceed. If alignment is not possible you can continue with GB and/or NI only labelling or close the existing procedure without approved packaging. If/once the QRD text is aligned, you must provide mock-ups for assessment. The VMD and HPRA will decide who will take the lead. The lead country draws up timetable and emails it to you and the other country.
How to ‘undo’ a joint-label
If you no longer wish to have a joint-label, please
send an email to the VMD and HPRA and
we will update our records. |