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Alerts/Letters

Changes to the classification and labelling requirements for codeine-containing products

21 May 2010

Dear Healthcare Professional

Changes to classification and labelling requirements for codeine-containing medicines

The purpose of this letter is to advise you that:

• changes to the classification of analgesic medicines and cough and cold preparations containing codeine will come into effect on 4 October 2010
• new labelling requirements will apply to codeine-containing cough and cold preparations from 1 May 2011.

Changes to classification

In February 2010 Medsafe announced changes to the classification of codeine as a result of recommendations made by the Medicines Classification Committee (MCC). These changes will mean that:

• codeine, when used as an analgesic, will be restricted to sale by a pharmacist
• pack size restrictions will apply to codeine-containing preparations able to be supplied without a prescription.

Currently, any product containing 15 mg or less of codeine per tablet or capsule is a Pharmacy-Only Medicine, with no limit on pack size. Following implementation of the classification changes, codeine-containing analgesics will be either Restricted Medicines or Prescription Medicines, depending on the pack size. Small packs of codeine-containing cough and cold preparations will remain Pharmacy-Only Medicines, while larger packs will become Prescription Medicines.

These classification changes will come into effect on 4 October 2010.

The following table shows the current classification, and the classification from 4 October 2010, for codeine-containing products.

Current classification	Product	Classification from 4 October 2010
Products containing codeine in combination with one or more other active ingredients (Note: Must be formulated in such a way that the codeine is not readily recoverable)
Pharmacy-Only Medicine	Containing not more than 15 mg codeine per dose form (tablet, capsule) or per dose of liquid For use as an analgesic In packs containing up to 5 days of treatment	Restricted Medicine
Pharmacy-Only Medicine	Containing not more than 15 mg codeine per dose form (tablet, capsule) or per dose of liquid For use as an analgesic In packs containing more than 5 days of treatment	Prescription Medicine
Pharmacy-Only Medicine	Containing not more than 15 mg codeine per dose form (tablet, capsule) or per dose of liquid For the treatment of coughs and colds In packs containing up to 6 days of treatment	Pharmacy-Only Medicine
Pharmacy-Only Medicine	Containing not more than 15 mg codeine per dose form (tablet, capsule) or per dose of liquid For the treatment of coughs and colds In packs containing more than 6 days of treatment	Prescription Medicine
Prescription Medicine	Containing more than 15 mg codeine per dose form (tablet, capsule) or per dose of liquid, regardless of pack size or indication	Prescription Medicine
Products containing codeine alone
Only available on prescription	Codeine not in combination with any other active ingredient, regardless of dose form or strength or indication	Only available on prescription

Changes to labelling requirements

The MCC also recommended changes to the labelling requirements for codeine-containing medicines. Those recommendations were that the label of any codeine-containing medicine, including cough and cold medicines, be required to incorporate the following warning statements:

• codeine is an addictive substance
• do not use for more than three days.

Implementation of these new labelling requirements has been deferred so that they can come into effect at the same time as other labelling changes relating to cough and cold preparations arising from a review of the use of cough and cold medicines in children. Submissions from the pharmaceutical industry indicated that medicines intended for the New Zealand market are produced infrequently. The earliest time at which newly-labelled products could be on the shelf in this country would therefore be winter 2011.

These labelling requirements will, therefore, become mandatory from 1 May 2011.

If you have any queries about the changes described in this letter, please contact the MCC Secretary, Andrea Kerridge, on (04) 819 6896.

Yours sincerely

Stewart Jessamine
Group Manager
Medsafe