Application for a Variation to a Parallel Import Licence
For details of the requirements, please see the Guide to Parallel
Imports – Human Medicines. (For addition of a source country, use the
form, Application for Addition of a Source Country to a Parallel Import
Licence.)
1
Name and address of the parallel
import licence holder:
2
PPA Number:
FOR HPRA USE ONLY
CRN:
Name and address of the applicant, if
different:
Name of product:
Active substance(s):
Pharmaceutical form:
Strength(s):
3
Change description
1
2
3
4
Change in source country authorisation number
(changes to a number of source country authorisation
numbers for a single parallel import licence can be made
under one Type 1A variation)
Change in source country authorisation holder’s
name/address
Change in parallel import licence holder’s name/address
5
Change in PA number of originator product on the Irish
market
Deletion of a source country
6
Change in the name of the active substance
7
Change in the product name
8
Replacement or addition of a manufacturer of the
product in a source country
Deletion of a manufacturer of the product in a source
country
9
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Fee code
classification
IA
IB
II
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10
12
Change of the name/and or address of the manufacturer
of the product in a source country where the actual
manufacturing site remains unchanged.
Change of re-packager/assembler information if there is
no change in the site but change in the name or address
Addition of a new re-packager/assembler
13
Deletion of a re-packager/assembler
14
Change in product composition as stated in the SPC,
labelling or package leaflet
Change in product description (including tablet markings
and score-lines)
Change to re-box the product
11
15
16
17
20
Change to the method of sale and supply or to method of
promotion (following an approved change to the Irish
reference product)
Amend to add a new pack size (if within the currently
approved range for the PPA)
Amend to add a new pack size (if outside the currently
approved range for the PPA)
Replacement or addition of a new pack presentation
21
Deletion of a pack size / pack presentation
22
Change to the labels and/or package leaflet of the PPA
product which does not affect the approved SPC
Amend to bring the SPC, labelling and/or package leaflet
in line with the reference product
Amend to bring SPC, labelling and/or package leaflet in
line with EU Commission decision
Update to any section of the SPC that is not covered by
one of the previous categories
Other (please specify):
18
19
23
24
25
26
*
*
The HPRA reserves the right to request an unforeseen variation to be upgraded to a
Type II variation if the proposed changes are considered to be significant
Background (Please give brief background explanation for the proposed change to the
product import licence)
Specify the precise present and proposed details, using additional pages if necessary. If
the change affects the SPC, labelling or package leaflet, the changed words should be
indicated by underline, strikethrough or highlight, and a clean version should be
attached. Colour mock-ups need to be provided where the change affects the labelling
or leaflets.
PRESENT
PROPOSED
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4
I hereby apply to vary the parallel import licence. I confirm that no changes have been
made to the product particulars other than those approved by the Health Products
Regulatory Authority. I declare that all changes have been identified and that there are
no other changes in the amended documentation.
I declare that fees have been/will be paid. If fees have been paid, attach proof of
payment.
Signature of applicant:
Date:
Capacity in which signed:
Print/type name:
Fax number:
Telephone number:
E-mail address:
Send to: Receipts and Validation, Health Products Regulatory Authority, Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2.
Tel. No. +353 1 676 4971 Fax No. +353 1 676 7836
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