1

Welcome

2

Apologies

3

Confirmation of the minutes of the 102nd meeting held on Tuesday 29 September 2015

4

Declaration of conflicts of interest

5

Applications for consent to distribute a new medicine under section 20 / 23 / 24 of the Medicines Act 1981 (referred by the Minister of Health under section 22(2))

5.1

Oncentin, 125 mg/5mL and 250 mg/5mL, powder for oral suspension (TT50-9615, a) Actavis New Zealand Limited

Oncentin is a powder for oral suspension containing 25 mg/mL or 50 mg/mL amoxicillin trihydrate. Amoxicillin is indicated for the treatment of infections due to susceptible organisms. Amoxicillin is also used for:

• instituting therapy prior to bacteriology; however bacteriological studies to determine the causative organisms and their sensitivity to amoxicillin should be performed.
• prophylaxis for endocarditis: amoxicillin may be used for the prevention of bacteraemia associated with procedures such as dental extraction, in patients at risk of developing bacterial endocarditis.

The applicant has not satisfactorily addressed the issues and concerns raised during the assessment. Medsafe is unable to recommend that the benefits of using the medicine Oncentin outweigh the risks presented by the unresolved issues.

The application is being referred to the Committee for independent advice as to whether the Minister of Health should grant consent.

This application has now been withdrawn.

6

Review of evaluation reports

6.1

List of medicines for potential review in 2016

The Committee will be provided with a list of all medicines which evaluations were conducted in 2015.

The Committee will discuss which medicines should be reviewed (a maximum of eight will be chosen) and by which member of the Committee. Completed reviews will be brought back to the next meeting in November 2016.

6.2

Feedback from Medsafe on any process changes made following the expert advice provided by the Committee on the quality of the risk-benefit assessments that have been completed

7

General business

7.1

Updating the Medicines Assessment Advisory Committee Handbook to include a Deputy Chair

The Medicines Assessment Advisory Committee Handbook is a document for members to refer to regarding their responsibilities and meeting protocol.

It is proposed to update the Medicines Assessment Advisory Committee Handbook to include a Deputy Chair for times when the Chair is unavailable.

7.2

Update on the new protocol for meetings with observers

In March 2013, the MAAC agreed to trial applicants attending meetings to increase the transparency of the Committees deliberations. Medsafe received feedback from observers who had attended meetings and found that applicants were unclear of their role at the meeting.

With the extension of the trial period for applicants to attend meetings, the Chair has adopted a new protocol for observers. The Medicines Assessment Advisory Committee Handbook and letter to the applicant template has been updated to reflect this change.

7.3

Update on Prochymal (remestemcel-L) 100 million cells in 15 mL solution for injection (TT50-8843) Osiris Therapeutics Incorporated

At the 99th meeting on 1 July 2014, the following recommendation was made:

"that if the medicine Prochymal (remestemcel-L) 100 million cells in 15 mL solution for injection was not used in New Zealand over the next two years its approval should lapse when the provisional consent expires on 14 June 2016."

The MAAC will be updated on the activity and registration status of Prochymal.

7.4

Any other business

8

Date of next meeting