Published: 8 May 2015
Consultations
Addition of warning statements on labels of OTC oral and topical diclofenac medicines
Closing date: 22 June 2015
Consultation documents
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:
- propose labelling requirements for over-the-counter (OTC) medicines containing diclofenac
- provide a contact point for queries or feedback on the proposed changes.
Invitation to comment
Medsafe is seeking comments and input from interested parties on the proposed warning and advisory statements for OTC diclofenac medicines.
Timetable
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).
Background
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.
About the consultation
- This consultation seeks feedback on the proposal to mandate warning and advisory statements on the labels of OTC medicines containing diclofenac as the active ingredient.
- Medsafe has reviewed warnings required in other jurisdictions and considers that the proposed warning statements are consistent with the pharmaceutical industry’s desire to harmonise labelling whenever possible.
Content of submissions
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.
How to respond
Please complete the Medsafe consultation submission form:
OTC 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 askmedsafe@health.govt.nz, and include ‘Diclofenac warning statements’ in the subject line of the email.
Alternatively, hard copy submissions may be posted to:
Product Regulation
Medsafe
PO Box 5013
Wellington 6145
What will happen
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.
Confidentiality
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 criteria,
see
http://www.legislation.govt.nz/act/public/1982/0156/latest/DLM64785.html?search=qs_act_official+
information+act_resel_25_hp=3sr=1
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.
Enquiries
Any questions relating to submissions should be directed by email to askmedsafe@health.govt.nz
