Application Form for Variation to an MIA or
Wholesaler's Authorisation
See guidance document ‘Guide to Applications to Vary an MIA or Wholesaler’s Authorisation’
for instructions on completing this form and details of the supporting documents required. This
document is available on the ‘Publications and Forms’ section of www.hpra.ie.
1
TYPE OF AUTHORISATION / LICENCE REQUESTED TO BE
VARIED
(Tick as appropriate.)
For internal use only
Licensing register ref no.:
Manufacturer’s authorisation for medicinal products for
human use
2
Manufacturer’s authorisation for medicinal products for
veterinary use
Endorsement no.:
Manufacturer’s authorisation for investigational
medicinal products
Fee codes:
Wholesaler’s authorisation
CWS reference no.:
APPLICANT DETAILS
Legally registered name of authorisation/licence holder:
Legally registered address of the authorisation/licence holder:
Company Registration Office number:
Address of manufacturing or wholesaling premises (if different from that of the holder):
Name and address of applicant to whom correspondence should be addressed:
Licence/authorisation number:
Contact telephone:
Contact fax:
E-mail address of contact:
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3
PROPOSED VARIATION TO THE AUTHORISATION
(Tick as appropriate)
Manufacturing/importation authorisation:
1 General information
1.1 Minor corrections/typographical errors to authorisation
1.2 Change in the name of authorisation holder
1.3 Change in the legally registered address of the authorisation holder
1.4 Change in the main address of the manufacturing site
If any of the changes from 1.2 to 1.4 affect your API facility, please provide details in
Section 5 (Background).
2 Schedule 2, Annex 1, (Scope of authorisation), Part 1 – Manufacturing operations
2.1 Addition to the currently approved manufacturing operations
2.2 Deletion of currently approved manufacturing operations
2.3 Change in the address at which manufacturing operations are carried out
3 Schedule 2, Annex 1 (Scope of authorisation), Part 2 – Production activities
3.1 Addition to the currently approved manufacturing operations in relation to a
product type
3.2 Deletion of currently approved manufacturing operations in relation to a dosage
form or deletion of a general product class / dosage form and the associated
manufacturing operations from this section.
4 Schedule 2, Annex 1, (Scope of authorisation) Part 3 – List of product dosage
forms
4.1 Addition to the list of imported products from a new contract manufacturer or, for a
contract manufacturer which is already approved on the authorisation, the addition of a
new product class and/or dosage form (e.g. tablets already listed but sterile small
volume liquids to be added from the same contract manufacturer)
4.2Addition to the list of imported products where manufacturer is already approved on
authorisation for manufacture of the same dosage form (e.g. addition of another tablet
product sourced from a contract manufacturer which has already been authorised for
supply of tablets)
4.3 Deletion of an imported product
5 Schedule 2, Annex 2 – Contract manufacturing site/contract storage site
5.1 Addition of contract manufacturing site
5.2 Change in the name of a contract manufacturing site
5.3 Change in the address of a contract manufacturing site
5.4 Addition of production activities at an approved contract manufacturing site
5.5 Deletion of operations carried out at a contract manufacturing site or deletion of a
contract manufacturer
6 Schedule 2, Annex 3 – Contract laboratories
6.1 Addition of a new contract laboratory
6.2 Change in the name of a contract laboratory
6.3 Change in the address of a contract laboratory
6.4 Addition of activities at an approved contract laboratory
6.5 Deletion of testing activities carried out at a contract laboratory or deletion of a
contract laboratory
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7 Schedule 2, Annex 4 - Qualified Person(s)
7.1 Addition of Qualified Person (primary or deputy)
7.2 Removal of Qualified Person
7.3 Change Deputy Qualified Person named on authorisation or licence to Primary
Qualified Person (or vice versa)
7.4 Update to qualifications for Qualified Person or Deputy Qualified Person
7.5 Addition of product/s for Batch Release by an approved Qualified Person
8 Schedule 2, Annex 5 – Key personnel
8.1 Addition of a person responsible for production (or deputy)
8.2 Addition of a person responsible for quality control (or deputy)
8.3 Addition of a person responsible for biological testing (or deputy)
8.4 Removal of person responsible for production (or deputy)
8.5 Removal of person responsible for quality control (or deputy)
8.6 Removal of person responsible for biological testing (or deputy)
8.7 Update to qualifications for personnel
Wholesaler’s authorisation:
1 General information
1.1 Minor corrections/typographical errors to authorisation
1.2 Change in the name of authorisation holder
1.3 Change in the legally registered address of the authorisation holder
1.4 Change in the name of the wholesale site
2 Premises
2.1 Change in address of wholesaling premises
3 Category of medicinal products
3.1 Addition of a category of medicinal product
3.2 Removal of a category of medicinal product
4 Responsible Person
4.1 Addition of Responsible Person or deputy Responsible Person
4.2 Removal of Responsible Person or deputy Responsible Person
4.3 Change of Responsible Person to deputy Responsible Person or deputy
Responsible Person to Responsible Person
5 Wholesale distribution operations
5.1 Addition of wholesale distribution operations
5.2 Removal of wholesale distribution operations
6 Contract wholesale distribution site
6.1 Addition of contract wholesale distribution site
6.2 Removal of contract wholesale distribution site
6.3 Change in name or authorisation number of contract wholesale distribution site
6.4 Change in address of contract wholesale distribution site
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4
PROPOSED WORDING
Please specify the precise present and proposed wording underlining or highlighting the
changed words.
Present Wording
5
Proposed Wording
BACKGROUND
Please give a brief background explanation for the proposed changes to your
authorisation/licence (attach additional supporting data as necessary).
6
FEES
An application fee must be submitted with each request for variation to an
authorisation/licence.
Please refer to the ‘Guide to Fees’ Section 3 / ‘Guide to Fees (Veterinary)’ Section 2 on the
‘Publications and Forms’ section of www.hpra.ie. Complete and submit only the relevant
section of the fee application form.
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7
DECLARATION
I hereby make application for the above authorisation/licence to be varied in accordance
with the proposals given above, and certify that the changes will not adversely affect the
quality, efficacy or safety of any medicinal product tested. I declare that amended
documents have been supplied and that the supporting information is correct. I declare
that all changes have been identified and that there are no other changes in the amended
documentation.
Signature: ______________________________________
Date:
Print name:
Title/position:
Send to:
E-mail: compliance@hpra.ie
Compliance Department
Health Products Regulatory Authority,
Earlsfort Centre, Earlsfort Terrace, Dublin 2.
Tel:
+ 353 1 676 4971
Fax:
+ 353 1 676 7836
Please do not submit applications more than once.
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