Published: 8 May 2015
Closing date: 22 June 2015
The consultation document is titled:
Addition of warning statements on labels of OTC oral and topical diclofenac medicines (Adobe pdf document, 2 pages 19 KB)
Addition of warning statements on labels of OTC oral and topical diclofenac medicines (Microsoft Word document, 2 pages 21 KB)
This document is intended to:
Medsafe is seeking comments and input from interested parties on the proposed warning and advisory statements for OTC diclofenac medicines.
Document released for consultation on 8 May 2015. Interested parties should respond by close of business 22 June 2015. Feedback will be released following consideration of submissions (see What will happen).
Diclofenac is a member of the class of non-steroidal anti-inflammatory drugs (NSAIDS). Warning statements are mandated for ibuprofen, which is a member of this class. Concerns have been raised recently over the cardiovascular safety of NSAIDS, particularly diclofenac.
Medsafe proposes warning and advisory statements to be placed on the labels of OTC diclofenac medicines, as provided by regulation 13(1)(i) of the Medicines Regulations 1984.
Most of these proposed warning and advisory statements are consistent with the warnings already required on labels of ibuprofen medicines and on labels of NSAIDs in Australia. The additional warning and advisory statements recognise the risks identified from the safety review conducted by the Medicines Adverse Reactions Committee.
Medsafe proposes an implementation date for the changes described above of 12 December 2015.
Comments are sought on the proposed requirement for warning and advisory statements to be placed on the labels of OTC oral and topical diclofenac medicines. Submissions may address any or all of the statements for oral or topical diclofenac, or the target date for implementation.
Please complete the Medsafe consultation submission form:
diclofenac label statements consultation submission form
(Adobe pdf document, 3 pages, 59 KB)
OTC diclofenac label statements consultation submission form
(Microsoft Word document, 3 pages 54 KB)
Submissions must include full personal or organisational contact details (including address, telephone number or email address).
Electronic submissions are preferred and should be emailed to firstname.lastname@example.org, and include ‘Diclofenac warning statements’ in the subject line of the email.
Alternatively, hard copy submissions may be posted to:
PO Box 5013
Submissions will be reviewed by Medsafe and feedback on submissions will be provided through the Medsafe website. Input from submitters on the consultation draft will help inform the wording of the warning and advisory statements for OTC diclofenac medicines.
All submissions may be placed on the Medsafe website unless
marked confidential. Any confidential material contained within your
submission should be clearly marked 'IN CONFIDENCE'. Reasons for a
claim of confidentiality must be included in the space provided on
the submission coversheet. These reasons must meet Official
Information Act 1982 requirements if the submission (or part
thereof) is not to be displayed. For Official Information Act
For submissions made by individuals, all personal details other than your name will be removed from your submission before it is published on the Medsafe website. In addition, a list of parties making submissions may be published.
If you do not wish to be identified with your submission, or if you do not wish your submission to be associated with a party, you must specifically request this in the space provided on the submission coversheet.
Any questions relating to submissions should be directed by email to email@example.com