Published: 22 August 2017

Committees

Agenda for the 171st meeting of the Medicines Adverse Reactions Committee to be held on Thursday 14 September 2017, at 9 am

1.

MATTERS OF ADMINISTRATION

1.1

Welcome and apologies

1.2

Minutes and recommendations of the 170th MARC meeting

1.3

Declarations of potential conflicts of interest

2.

MEDSAFE PHARMACOVIGILANCE ACTIVITIES

2.1

Report on standing agenda items

2.2

Medsafe pharmacovigilance activities

2.3

Prescriber Update

2.4

Quarterly summary of recent safety communications

3.

PHARMACOVIGILANCE REPORTS

3.1

Matters referred to the MARC under section 36 of the Medicines Act 1981

  No items

3.2

Matters referred to the MARC by Medsafe

3.2.1

Use of sodium valproate in pregnancy

3.2.2

Review of immune checkpoint inhibitors in the New Zealand context

3.2.3

Risks of severe depression, anxiety, and suicidal ideation with hormonal contraceptives

4.

MATTERS ARISING FROM THE NZ PHARMACOVIGILANCE CENTRE

4.1

CARM quarterly report

5.

OTHER BUSINESS

5.1

Recommendation from Medicines Classification Committee to review the process for observers at Medsafe expert advisory committee meetings

5.2

New Zealand Formulary (NZF) discussion on risk communication

5.3

Vaccine Safety Expert Advisory Group - Formalising the group and potential to act as an advisory group to MARC

5.4

Therapeutic products regulation project - Update

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