Regulatory services

ESR’s Pharmaceutical Programme specialises in the provision of regulatory services to support clients within a range of sectors:

Medicines regulation

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.

  • 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

Providing 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

Providing advice and assistance on the requirements for these products as defined under the current Dietary Supplements Regulations 1985.

Natural health products

Assisting 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

Providing advice and assistance on the requirements for these products as defined under the current Cosmetics Group Standard 2006.