TGA certification ensures the safety and efficacy of pharmaceuticals, medical devices, and biological products in Australia. Established in 1989, the Therapeutic Goods Administration (TGA) rigorously enforces stringent regulations for products distributed within the country, whether locally produced or imported.
The regulatory framework mandates that any therapeutic product must be listed in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia.
Under the Therapeutic Goods Act 1989, it is compulsory for every manufacturer of therapeutic goods in Australia to obtain a TGA manufacturing licence application. The article provides a detailed guide to acquiring a license or certification, from the initial inquiry to the final grant.
1: Application
Securing a TGA certificate is done through the TGA’s e-application process. Your application should provide a detailed account of your manufacturing operations and the range of products produced at each site.
When submitting a licence application, especially pertinent for Australian medicine manufacturers, it is essential to include a declaration in line with Section 38(1)(g) of the Act. This declaration confirms that management personnel meet the necessary legal standards. Additionally, it is not only a procedural requirement to nominate individuals for Quality Assurance and Production roles; these roles carry substantial responsibilities under the Act and Regulations.
For those seeking a certification, the process involves the Office of Devices Authorisation (ODA). This includes an inspection of your Quality Management System (QMS) to ensure compliance with TGA’s stringent quality and product standards.
2: Application Review
Once your application, accompanied by the necessary application fee, is received, it enters the pre-assessment stage. During this phase, technical documents are requested and additional document review invoices raised where applicable, followed by the application being placed in a queue.
3: On-Site Inspection
The core objective of a TGA inspection is to verify if a manufacturer’s management systems and practices align with the relevant codes, quality management system standards, and regulations. Inspectors will thoroughly review your actual practices, documentation, and records.
This review process involves a detailed comparison of your operational activities against your stated policies and procedures and the requirements outlined in the Manufacturing Principles.
4: Licensing/Certification Decision
Following the TGA certification process, once any required corrective actions have been addressed—potentially including a follow-up inspection—the inspection report’s findings and recommendations undergo an internal review. This is an essential step before issuing a license or certificate. Once you fulfil all the necessary criteria, you will be officially awarded a TGA licence or certification.
5: Licence/Certificate
As a medicines manufacturer who has successfully achieved licensing or certification, you will receive either a Licence to Manufacture or a GMP Certificate—depending on your specific case. The document you receive is detailed and includes critical information such as the licence or certificate number, your site address, and a description of the types of products and manufacturing steps you are authorised (for licences) or certified (for GMP certificates) to undertake.
Additionally, a Schedule of Conditions may be part of your document, outlining any restrictions on your Licence or Certificate.
Whenever Conformity Assessment Certificates are required, the ODA issues them. You will be given a certificate once the ODA completes any product assessment needed for your operation. This certificate will clearly state your manufacturing facility’s name, address, and the scope of products covered.
Remember, all licences and certificates are the property of the TGA and must be returned if requested. However, you can obtain copies of these TGA certificates on request, albeit with an applicable fee.
6: Displaying a Licence
As a holder of the licence to manufacture therapeutic goods, you must display this licence and its accompanying Schedule of Conditions in a location accessible to the general public. Ensuring the visibility of these documents is a crucial aspect of maintaining transparency and trust in your operations.
Refusal of a Licence or Certificate
Should you fail to meet the necessary standards for TGA GMP or Quality Management Certification, the TGA reserves the right to refuse a licence or certificate grant. In such cases, the decision and the reasons behind the refusal will be formally communicated to you in writing.
Appeals and Complaints
If you wish to appeal against decisions related to licensing or conformity assessment certification made by the TGA, including those concerning TGA approval for medical devices, such appeals are governed by Section 60 of the Act. A letter detailing the outcome of your licensing or conformity assessment certification decision includes detailed instructions on how to appeal.
The TGA takes all legitimate complaints seriously, especially those relevant to products listed on the ARTG and originating from customers of licensed or certified manufacturers. If you are a licensed or certified manufacturer, you must grant TGA representatives access to your premises and records to investigate complaints. As deemed appropriate, the complainant will be kept informed of the outcome.
Confidentiality
The TGA and its staff treat all information of your TGA certificate application or status as a certified manufacturer with the utmost confidentiality. However, it’s important to note that this information may be shared with other regulatory bodies under certain circumstances. Additionally, specifics about your inspection dates and final compliance rating, especially relevant to those holding a TGA licence, may be published on the TGA’s official website.
Obligations of Licensed/Certified Manufacturers
Once you have obtained your licence or TGA certification, you are required to adhere to several managerial responsibilities to maintain your certified status. These obligations are comprehensively outlined in the Act and Regulations. Key responsibilities include:
- Maintaining ongoing compliance with the relevant Code/Standard(s)
- Adhering to the ‘Conditions of licensing/certification’
- Informing the TGA about any significant changes in your manufacturing structure or operations to facilitate an assessment of the impact of these changes.
Timeframes
When planning your journey towards obtaining a manufacturing licence or GMP certification, factoring in the TGA approval time is essential. Adequate planning and anticipation of the
timeframes involved in the licensing or certification process are crucial to ensure a smooth and timely completion.
Obtaining a manufacturing license in Australia and GMP certification for an overseas manufacturing site can take considerable time. From the initial application to the final on-site inspection, it can take up to 12 months for a manufacturing license at an Australian manufacturing site and up to 15 months for GMP certification at an overseas manufacturing facility.
Navigating the TGA certification and licensing process is a detailed and systematic journey crucial for manufacturers in the therapeutic goods industry. Understanding the processes involved, timeframes, and obligations is vital to successfully achieving and maintaining TGA approval— ensuring the safety and efficacy of therapeutic goods in Australia.
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