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Quality Commitment
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REM SYSTEMS Limited is registered as a medicines wholesaler in New Zealand and is therefore audited annually by the Ministry of Health before the issue of each year’s licence. We maintain a quality system as specified in the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods Parts 4 and 5. This GMP Code requires documented procedures for the effective, safe and efficient handling, storage and distribution of Medicines and Medical Devices, whilst they are moving between their site of manufacture and the end-user.
The medicines we sell in New Zealand have undergone assessment and received consent to market from the Ministry of Health. We import and distribute products from manufacturers who maintain internationally accepted GMP quality systems such as the ISO 9000 series, ISO 13485 or the EN46000 series of standards and all products are registered with the relevant regulatory body in their country of origin.
In Australia, REM SYSTEMS Pty Limited operates to the same GMP quality system standard as REM SYSTEMS Limited in New Zealand. All of our products sold in Australia have received consent to market from the Therapeutic Goods Administration and in New Zealand comply with the requirements of the Medical Device WAND notification system currently being implemented by the Ministry of Health. From July 2005 these registrations and notifications will be transitioned to comply with the requirements of the Joint Regulatory Authority for New Zealand and Australia.
Our staff undergo an induction session with our Regulatory Affairs Manager to ensure familiarity with our quality system and what is required of them to maintain continued compliance. Each staff member has their own copy of our company Policies and Procedures manual at their workstation and on our network and they are expected to follow the specified requirements at all times.
REM SYSTEMS is committed to maintaining quality above and beyond the requirements stipulated by law. We regularly review our policies and procedures with a goal of continuing improvement. Our commitment to excellence is reflected by the positive comments we receive from our clients. Should you have any quality-related concerns or comments, please e-Mail our Regulatory Affairs Manager, Tony Edmonds, at: tedmonds@remsystems.co.nz.
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