Medicines regulation
ESR provides full regulatory affairs services for pre- and post-marketing activities for products that meet the definition of therapeutic products as defined under the Medicines Act 1981 and the Medicines Regulations 1984.
Our services include:
Classification issues
ESR provides advice about classification and scheduling of substances under the following legislation:
Dietary supplements
ESR provides advice and assistance on the requirements for these products as defined under the current Dietary Supplements Regulations 1985.
Natural health products
ESR assists manufacturers and suppliers of natural health products (including herbal products and complementary medicines) to prepare for the changes in regulatory requirements proposed by the Natural Health Products Bill currently before Parliament, particularly with regard to the following:
ESR provides advice and assistance on the requirements for these products as defined under the current Cosmetics Group Standard 2006.
ESR’s Pharmaceutical programme is certified by the Ministry of Health (Medsafe) in compliance with the New Zealand Code of Good Manufacturing Practice (GMP)(external link) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S)(external link).
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