On this page: Overview | Summary of requirements | Module 1.6.1 Relevant external sources | Module 1.6.2 Applicant's declaration | Module 1.6.3 Letters of access
Overview
This section of Module 1 holds multiple documents relating to the use of drug master files (DMFs), plasma master files (PMFs) and Certificates of Suitability of Monographs of the European Pharmacopoeia (CEPs) to establish the quality of active substances in the medicine, novel excipients and excipients of animal and human origin.
Summary of requirements
| Section | Description | Category 1/COR report-based | Variations to quality only (e.g. Category 3) | ||
|---|---|---|---|---|---|
| New registration | Variation | New registration | Variation | ||
| 1.6.1 | Relevant external sources | requirement defined by the regulatory activity | requirement defined by the regulatory activity | requirement defined by the regulatory activity | requirement defined by the regulatory activity |
| 1.6.2 | Applicant's declaration | requirement defined by the regulatory activity | requirement defined by the regulatory activity | requirement defined by the regulatory activity | requirement defined by the regulatory activity |
| 1.6.3 | Letters of access | requirement defined by the regulatory activity | requirement defined by the regulatory activity | requirement defined by the regulatory activity | requirement defined by the regulatory activity |
Module 1.6.1 Relevant external sources
When to include information about external sources
Include this document when the application makes reference to one or more:
- drug master files (DMFs)
- plasma master files (PMFs)
- Certificate(s) of Suitability of Monographs of the European Pharmacopoeia (CEPs).
How to prepare information about external sources
Obtain the relevant DMF/PMF/CEP details from the active substance manufacturer, including the eSubmission Identifier and any other TGA reference numbers.
Where a DMF, PMF or CEP is referenced, download and complete the relevant part/s of the DMF/PMF/CEP details form. Include the completed form(s) in Module 1.6.1.
Note:
Declaration(s) and Letter(s) of access are required—see Module 1.6.2 and Module 1.6.3.
The applicant's (open) part of the DMF must be included in Module 3.2.S of the quality documentation in the dossier.
The active substance manufacturer's restricted (closed) part is supplied to the TGA directly by the active substance manufacturer.
Ensure that the active substance manufacturer's part of the DMF/PMF has been submitted to the TGA before lodging the application dossier.
New registrations
For medicines that contain either a raw material or an excipient that is derived from plasma a PMF must be included in Module 3 or have been previously approved by the TGA.
Variation applications
For variations to a registered medicine involving a modified DMF/PMF/CEP it is not necessary to provide this document again, unless a new DMF/PMF/CEP is to be provided.
Where a PMF is referenced
- Prepare the PMF in accordance with EU guideline: EMEA/CPMP/BWP/3794/03 Rev 1: Guideline for the scientific data requirements for a plasma master file and its annex.
- .
- Provide the epidemiological data for the previous calendar year in accordance with the EU guideline: EMA/CHMP/BWP/548524/2008: Guideline on epidemiological data on blood transmissible infections.
- Ensure the PMF complies with the Transmissible Spongioform Encephalopathies (TSE): TGA approach to minimising the risk of exposure.
Related information and guidance
European Union Guidelines adopted in Australia.
Module 1.6.2 Applicant's declaration
When to include the applicant's declaration
Include when the application makes reference to one or more:
- drug master files (DMFs)
- plasma master files (PMFs) from a third party
- Certificate (s) of Suitability of Monographs of the European Pharmacopoeia (CEPs).
How to prepare the applicants declaration
Establish a formal agreement with the active pharmaceutical ingredient manufacturer to ensure the manufacturer communicates any changes to the applicant and the TGA before any significant change is made to the drug substance. This agreement is independent of the TGA.
Once the agreement has been established, download the Applicant declaration form
- complete and sign the form
- include the completed form(s) in Module 1.6.2.
Note:
The declaration must be signed by an authorised officer of the company.
Subsequent regulatory activities
For regulatory activities subsequent to the initial registration application involving the same DMF/PMF/CEP it is not necessary to provide the declaration again, unless a new DMF/PMF/CEP is to be provided or there has been a change in sponsor.
Module 1.6.3 Letters of access
When to include a Letter of access
Include when the application makes reference to one or more:
- drug master files (DMFs)
- plasma master files (PMFs) from a third party
- Certificate(s) of Suitability of Monographs of the European Pharmacopoeia (CEPs).
How to prepare a Letter of access
Applicant
- establish a formal agreement with the active substance manufacturer.
Manufacturer
Each manufacturer providing a DMF/PMF for the application:
- completes the relevant part/s of the Letter of access to DMF/PMF/CEP.
Each manufacturer providing a CEP for the application:
- completes the parts relevant to the CEP in the Letter of access to DMF/PMF/CEP, and
- authorises the TGA to access relevant European Directorate for the Quality of Medicines & HealthCare (EDQM) reports.
All manufacturers:
- provide the applicant with the completed and signed letter for inclusion in Module 1.6.3.
Note:
The finished product applicant must have written permission from the manufacturer to access their DMF/PMF/CEP to enable the TGA to proceed with the evaluation.
Where reference is made to a CEP, the finished product applicant must provide to the TGA a copy of the certificate and any annexes (see Module 3.2.R).
Subsequent regulatory activities
For regulatory activities subsequent to the initial registration application involving the same DMF/PMF/CEP it is not necessary to provide the declaration again, unless a new DMF/PMF/CEP is to be provided or there has been a change in sponsor.
Legislation
Applications are made under either section 23 (new registrations) or section 9D(3) (requests for variations) of the Therapeutic Goods Act 1989 (the Act) and where the relevant legislative and business requirements are met, are approved under section 25 or section 9D(3), respectively.
Section 25(1)(d) of the Act requires that the TGA determine whether the quality, safety and efficacy of the goods for the purposes for which they are to be used have been satisfactorily established.
Section 9D(3)(c) requires that 'the Secretary is satisfied that the variation requested does not indicate any reduction in the quality, safety or efficacy of the goods for the purposes for which they are to be used'.
Assessing the quality of the goods includes establishing the quality of the active substance.
Where quality relating to the active substance cannot be established solely by the information provided by the applicant in Module 3.2.S, the applicant may make reference to external sources to establish the quality.
Acceptable external sources are a drug master file, plasma master file or an EDQM Certificate of Suitability of Monographs of the European Pharmacopoeia.
As a condition of registration it is a requirement that, apart from specified variations, no changes are made to the active substance without the prior approval of the TGA.
To receive approval for some changes, revised and/or new DMFs, PMFs and/or CEPs need to be provided to the TGA and assessed, by reference to section 9D(3) of the Act.