ESR | Keeping people safe and healthy through science

Breadcrumbs

Pharmaceutical, natural health product and cosmetic regulatory services

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ESR’s Pharmaceutical team specialises in the provision of regulatory services to support clients from a range of sectors including local manufacturers and importers, biotechnology companies and clinical trial organisations.

Medicines

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:

  • Product categorisation advice.
  • Support for the preparation and maintenance of product registration dossiers for submission in Australia and New Zealand (new medicines (all categories), changes to approved medicines (all categories), DMF applications).
  • Management of application processes for pre-market assessment (Australia and New Zealand).
  • Management of post-marketing activities.
  • Evaluation of labelling and other supporting materials (e.g. CMI, data sheets).
  • Assessments of quality control of the manufacturing and testing of medicines, and stability trial data.

Classification issues

ESR provides advice about classification and scheduling of substances under the following legislation:

  • Medicines Act 1981 and Medicines Regulations 1984
  • Misuse of Drugs Act 1975
  • Psychoactive Substances Act 2013

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:

  • General understanding of the proposed scheme and what it will mean
  • What you can do to get ready for the changes
  • Assistance understanding the notification process requirements
  • Labelling requirements
  • Permitted ingredients and allowable health claims lists
  • Code of manufacturing practice

Cosmetics

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)