Update for the 2017/18 Invitation to Tender

23 November 2017

There are some clarifications and changes to the 2017/18 Invitation to Tender that was issued on 2 November 2017. These changes have been uploaded to the webpage and e-portal as relevant.

Tender e-portal modifications

During the period of 7:30-8:30 NZT on Thursday 23^rd November, modifications were made to the tender product list. The changes made are as detailed below.

Whilst testing showed that these modifications would not have an impact on submitted or drafted tender bids, it is recommended suppliers thoroughly check all bids and the bid report/bid report summary before submitting any final tender bids. All tender bids received at the tender closing, 5pm Friday 15 December 2017, will be considered final and binding.

Product additions to the 2017/18 ITT

PHARMAC has made the decision to add 2 new line items to the 2017/18 Invitation to Tender:

Varenicline tartrate (current access) – Tab 0.5 mg x 11 and 1 mg x 42
Varenicline tartrate (widened access) – Tab 0.5 mg x 11 and 1 mg x 42

Amendment to usage data estimates

Usage data has been updated to present a more accurate representation of units used within the 2017 FYR for the following items:

Community Usage data:

Chemical name and line item	Usage
Zopiclone – Tab 7.5 mg	24,239,622

Hospital Usage data:

Chemical name and line item	Usage
Zopiclone – Tab 7.5 mg	349,853 (UOM tab)
Povidone Iodine – Antiseptic 10% (pack size 15 ml or less)	495 (UOM ml)
Povidone Iodine – Antiseptic 10% (pack size greater than 100 ml)	947,000 (UOM ml)
Povidone Iodine – Antiseptic 10% (pack size greater than 15 ml but less than 100 ml)	2,352,700 (UOM ml)

Please note these units remain approximate and indicative only, PHARMAC makes no representation as to the accuracy of these unit volumes or to the level of sales or likely sales of any tender items. PHARMAC accepts no liability for any errors or omissions in this information.

As previously advised, in order to be fair to all suppliers, we are unlikely to provide any further data requested by individual suppliers relating to tender items while the 2017/18 ITT remains open.

Proposed scheduling of zopiclone to become a controlled drug

The Expert Advisory Committee on Drugs recommended at its October 2015 meeting that zopiclone be scheduled as a Class C5 controlled drug under the Misuse of Drugs Act 1975. The recommendation will be presented to Cabinet to decide any new scheduling.

If zopiclone is scheduled as a controlled drug, it is likely that this change will take effect by the end of 2018. Following Cabinet’s decision, Medsafe will be able to give an indication of the commencement date at least 2-3 months in advance. However, Medsafe will not be able to confirm the exact commencement date until at least 28 days before the change takes effect.

Controlled drugs that are also medicines must meet the requirements of both the Misuse of Drugs legislation and the Medicines legislation. Where there is any inconsistency between the two sets of legislation, the Misuse of Drugs legislation takes precedence over the Medicines legislation.

Labelling requirements

If zopiclone is scheduled, product labels will need to be changed to include a CONTROLLED DRUG C5 classification statement.

A Changed Medicine Notification (CMN) under change category: Labelling – Grade 2 must be submitted to Medsafe to obtain approval for changed labels.

CMN forms can be found at: http://www.medsafe.govt.nz/regulatory/forms.asp#cmn(external link).

If zopiclone is scheduled, from the date the scheduling commences, no zopiclone products can be supplied to pharmacies unless they are labelled as C5 controlled drugs. If Cabinet agrees to schedule zopiclone under the Misuse of Drugs Act, we will contact you to inform you of the decision and keep you up to date on the progress of the scheduling.

General requirements

Requirements for Class C5 controlled drugs under the Medicines Regulations and Misuse of Drugs Regulations would apply to zopiclone:

	Requirements
Manufacturers, Suppliers (wholesalers), Importers	Must have correctly labelled stock (labels must state ‘CONTROLLED DRUG C5’). Labelling must be consistent with the Misuse of Drugs Act 1975. Labelling must comply with the Medicines Act 1981 and the Medicines Regulations 1984. Must have a Licence to Deal in Controlled Drugs. Must have export licences for each consignment. An export licence will be required from the date the scheduling commences. Must have import licences for each consignment. An import licence will be required from the date the scheduling commences. Must not advertise to the public (practitioners and pharmacists only).

Requirements

Manufacturers, Suppliers (wholesalers), Importers

Must have correctly labelled stock (labels must state ‘CONTROLLED DRUG C5’).
Labelling must be consistent with the Misuse of Drugs Act 1975.
Labelling must comply with the Medicines Act 1981 and the Medicines Regulations 1984.
Must have a Licence to Deal in Controlled Drugs.
Must have export licences for each consignment. An export licence will be required from the date the scheduling commences.
Must have import licences for each consignment. An import licence will be required from the date the scheduling commences.
Must not advertise to the public (practitioners and pharmacists only).

2017/18 Annual Tender

Zopiclone – tab 7.5 mg and tab 3.75 have been included in the recently released 2017/18 Invitation to Tender (released 2^nd November 2017).

Please note that should this change take effect, any supplier who has been awarded a sole supply contract as a result of the 2017/18 ITT will be required to comply with the changes as detailed above.

Further information

If you have any questions, please contact Medsafe at eacd@moh.govt.nz.

More information

If you have any queries regarding the tender, please contact the tender analysts at tender@pharmac.govt.nz