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CTD Module 1

3 August 2020

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1.8 Information relating to pharmacovigilance

Overview

This section of Module 1 holds documents relating to the pharmacovigilance activities for a new medicine, or significant changes to a registered medicine.

Summary of requirements

Documentation
Section Description Category 1/COR report-based Variations to quality only (e.g. Category 3)
New registration Variation New registration Variation
1.8.1 Pharmacovigilance systems mandatory requirement defined by the regulatory activity mandatory not required
1.8.2 Risk management plan for Australia requirement defined by the regulatory activity requirement defined by the regulatory activity not required not required

Module 1.8.1 Pharmacovigilance systems

When to include information about pharmacovigilance systems

Include in all regulatory activities which result in one or more new ARTG entries under section 16 of the Act, for example:

  • new chemical entity
  • change in formulation
  • additional trade name
  • change in trade name
  • new container type.

How to prepare information about pharmacovigilance systems

The summary of the pharmacovigilance system should be provided in Module 1.8.1 of the application and includes the following elements:

  • The contact details of the Australian pharmacovigilance contact person.
  • A statement signed by the applicant to the effect that the applicant has the necessary means to fulfil the tasks and responsibilities listed in Pharmacovigilance responsibilities of medicine sponsors - Australian recommendations and requirements.
  • A reference to the location where where the adverse reaction and post-market safety data for the medicinal product is kept, if known.
  • A statement that the applicant has at their disposal a qualified person responsible for pharmacovigilance in Australia, if available at the time of submission.

Module 1.8.2 Risk management plan for Australia

When to include a risk management plan

Include in all regulatory activities for:

  • a new chemical entity
  • a similar biological medicinal product
  • a generic medicinal product where a safety concern with the reference medicinal product requires additional risk minimisation activities.

Unless TGA has agreed that it is not required, include a risk management plan (RMP) for regulatory activities involving:

  • a similar biological medicinal product (biosimilar)
  • a significant new registration (for example, new dosage form, new route of administration, significant change in indications, extension of paediatric population).

In some circumstances products which do not fall into the above categories may require a RMP. These may include, but are not limited to:

  • known active substances
  • literature-based submissions
  • fixed combination applications.

It is strongly recommended that discussions with the TGA on the need for, and content of, an RMP take place in advance of PPF lodgement, especially for situations where the submission of a RMP is not mandatory but may nevertheless be required.

Where a RMP waiver has been given by the Pharmacovigilance and Special Access Branch, include the relevant document from TGA in this module (see Risk management plans for medicines and biologicals).

How to prepare a risk management plan

Provide a detailed description of a risk management system in the form of a RMP, as outlined in:

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