Freedom of Information request on Micralax Micro-enema (PL 00039/0368) (FOI 21/733)
Published 29 December 2021
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7th July 2021
FOI 21/733
Dear
Thank you for your email dated 11 June 2021, in which you requested the clinical assessment report for the original licence Micralax Micro-enema (PL 00039/0368), following on from our response to FOI 21/528.
The marketing authorisation for Micralax Micro-enema (PL 00039/0368) was granted on 28 June 1991, as an abridged simple (Regulation 56 of the Human Medicines Regulation 2012, as amended, previously Article 10c of Directive 2001/83/EC, as amended) application, cross-referring to the reference product Micralax Micro-enema (PL 00002/5037R). Please note that as Micralax Micro-enema (PL 00039/0368) was granted as an abridged simple application, we accepted Module 1 and Module 3 data only; no clinical data would have been submitted or required for such an application and therefore a clinical assessment report was not generated.
Micralax Micro-enema (PL 00002/5037R), to which Micralax Micro-enema (PL 00039/0368) refers, was granted a product licence on 08 November 1990. We have searched our records for Micralax Micro-enema (PL 00002/5037R ) and have not found the information you have requested. Therefore, having exhausted all the usual avenues in our search for this information, we have concluded that, it is no longer on our systems in a retrievable form.
We now consider this FOI request closed. If you have a query about this letter, please contact the MHRA FOI Licensing mailbox using the email address listed below.
If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within 2 months of the date you receive this response and addressed to: info@mhra.gov.uk, quoting reference FOI 21/733.
If you are not content with the outcome of the internal review, you have the right to apply directly to the Information Commissioner for a decision. The Information Commissioner can be contacted at:
Information Commissioner’s Office,
Wycliffe House,
Water Lane,
Wilmslow, and Cheshire,
SK9 5AF
Yours sincerely,
The FOI Licensing Team