Hi Judy,
While I'm not in the UK, I did go through this process for the first time last year in New Zealand and would like to share my experience...
Suggest that you have someone handling company taxes make the initial enquiry for you to identify the appropriate staff to handle your request.
I initially submitted the FDA form to the general correspondence address for our IRD department no less than 3 times last year- each time it was lost. As I'm not an authorized individual on our company's tax account, phone calls weren't at all successful. So, I finally asked our Finance department to intervene - they found the right people to manage the request and get the form signed.
Before you submit to FDA, make sure that all fields are populated, check that the name on form 3602A Section I, line 1 exactly matches the name in the UserFees System, and don't forget your Organization ID. The SBD staff at FDA are quite nice and very helpful, so they'll let you know if anything needs correction.
I'm happy to have an offline chat if I can be of further assistance.
Tina
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Tina O'Brien RAC, MS
Director of Regulatory Affairs
Aroa Biosurgery
Auckland
New Zealand
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Original Message:
Sent: 25-Oct-2017 07:09
From: Judy Calt
Subject: Small Business Decision Number - FDA MDUFA IV
Hi all,
I would like to submit an application with FDA for qualification as a Small Business so that we are eligible for the reduced user fee / waiver for PMA application.
In order to do so, as a foreign business, I need to obtain a National Taxing Authority Certificate for my company, and any affiliates. My question relates specifically to obtaining a National Taxing Authority Certificate from HM Revenue and Customs in the United Kingdom.
Would appreciate if anyone having been through this process with HMRC (UK Government) could provide any insights; how long did it take for HMRC to provide the necessary certification; is there a particular division within HMRC to which the application should be sent; any general recommendations? It seems that HMRC are not accustomed to such requests so I would value any experience that could be shared.
Although FDA quotes a 60 day review time, I understand that these applications are processed pretty quickly assuming all required documents are filed.
Kind regards,
Judy Calt
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Judy Calt,
Regulatory Affairs Director
Veryan Medical
Galway
Ireland
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