Application for a Variation for a Laboratory Approval
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APPLICANT DETAILS
Name and address of approval holder:
For internal use only:
Licensing register ref no.:
Endorsement no:
Fee codes:
CWS reference no.:
Legally registered address of the approval holder (if different from above):
Company office registration number:
Name and address of quality control laboratory (if different to that of the holder):
Name and address of applicant (if different from the proposed approval holder):
Date of application:
Approval number:
Name and address of contact person:
Contact telephone:
Contact fax:
E-mail address of contact:
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PROPOSED VARIATION TO THE APPROVAL
(tick as appropriate)
Change in the name and / or address of the approval holder
Change in name of quality control laboratory or actual site of laboratory
Addition to currently approved testing operations
Deletion of currently approved testing operations
Addition in personnel responsible for operations in current approval
Removal of personnel responsible for operations in current approval
Change in special conditions of current approval
Other:
3. PROPOSED WORDING
Please specify the precise present and proposed wording underlining or highlighting the
changed words
Present Wording
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Proposed Wording
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PROPOSED WORDING CONTINUED
Please specify the precise present and proposed wording underlining or highlighting the
changed words
Present Wording
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Proposed Wording
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BACKGROUND
Please give a brief background explanation for the proposed changes to your approval
(attach additional supporting data as necessary)
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FEES
An application fee must be submitted with each request for variation to a laboratory
approval.
Please refer to the ‘Guide to Fees’ / ‘Guide to Fees (Veterinary)’ on the ‘Publications and
Forms’ section of www.hpra.ie and complete the fee application form.
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DECLARATION
I hereby make application for the above approval 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:
The Compliance Department
Health Products Regulatory Authority
Earlsfort Centre, Earlsfort Terrace, Dublin 2
Tel:
+ 353 1 676 4971
Fax:
+ 353 1 676 7836
E-mail: compliance@hpra.ie
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