The licensing/certification process

Australian medicines manufacturers are required to obtain a licence to manufacture therapeutic goods (sometimes referred to as GMP licence). Overseas medicines manufacturers, where GMP clearance is based on a TGA inspection, obtain GMP Certification when passing a TGA inspection.

Australian and some types of overseas medical device manufacturers, selected by legislation, are required to obtain Conformity Assessment Certification. The following section outlines the usual steps in the licensing or certification from initial enquiry through to the granting of the licence or certificate. The process has been standardised across all the industry streams. The sequence of these steps is as follows:

1. Application received
2. Application review
3. On-site inspection
4. Corrective action if applicable
5. Follow-up
6. Inspection close-out
7. Licensing/certification decision
8. Ongoing inspection activities

The application

The TGA will respond to applications received via the e-application process. As indicated in the application form, full details of the manufacturer including the types of products that are manufactured at each location to be licensed or certified need to be included.

A licence application (for Australian medicines manufacturers) must be accompanied by a declaration that none of the circumstances stated in Section 38(1)(g) of the Act applies to any person involved in the management of the manufacturer. A licence application also requires the nomination of persons responsible for Quality Assurance and Production. These individuals have specific responsibilities under the Act and Regulations, in particular to the Codes of GMP.

Applications for a Conformity Assessment certificates are processed by the Office of Devices Authorisation (ODA), as these certificates attest that product and QMS requirements have been met. Inspection of quality management system requirements is performed when an internal application is made to the TGA by ODA.

Application review

Upon receipt of an application, along with payment of the prescribed fee, an application will be allocated for review. The timing of the inspection may be negotiated at this point.

On-site inspection

The purpose of the inspection is to establish whether a manufacturer has implemented management systems and practices that comply with the relevant code, quality management system standard and regulations. This will be done by examining actual practices, documentation and records and comparing them against the manufacturer's policies and procedures and the relevant Code or QMS Standard requirements, which can be found in the Manufacturing Principles.

For further details regarding the on-site inspection, refer to the section 'The Inspection Process' of this document.

Licensing/certification

Licensing/certification decision

After confirmation that any necessary corrective actions have been taken, which may involve a follow up inspection, the findings and recommendations made in the inspection report are subject to an internal review process prior to a licence or certificate being granted.

Once the manufacturer has achieved the requirements for licensing or certification, the manufacturer will be issued with a Licence or Certificate.

Licence/certificate

When a medicines manufacturer has achieved licensing or certification, the TGA will provide a Licence to Manufacture or GMP Certificate respectively. The document includes important data such as the licence or certificate number, the site address and a description of the types of products and manufacturing steps authorised (for licences) or certified (for GMP certificates). A Schedule of Conditions may be included outlining the restrictions imposed on the Licence or Certificate.

Conformity assessment certificates are issued by the Office of Devices Authorisation (ODA). When ODA has completed any required product assessment, a Certificate indicating the manufacturer's name, site address and scope of products covered by the certificate, will be issued.

All licences and certificates remain the property of the TGA and must be returned upon request. Copies of certificates can be provided upon request and on payment of the applicable fee.

Displaying a licence

The licence to manufacture therapeutic goods and accompanying Schedule of Conditions must be displayed where the general public can view it.

Refusal of a licence or certificate

In the event that the manufacturer is unable to comply with the requirements of the relevant standard, the TGA may refuse to grant a licence or certificate. The decision to refuse licensing or certification, and the grounds for that decision, will be communicated to the manufacturer in writing. (Refer Sections 38 and 41EC of the Act).

Appeals and complaints

Appeals against licensing/conformity assessment certification decisions made by the TGA can be made in accordance with Section 60 of the Act. Instructions on how to make an appeal are provided in the letter advising the outcome of the licensing/conformity assessment certification decision.

Complaints against the service provided by the TGA may be made in writing and should be addressed to:

Head of Office
Office of Manufacturing Quality
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
AUSTRALIA

The TGA will investigate legitimate complaints, relevant to the products on the ARTG, from customers of the licensed or certified manufacturer. Licensed or certified manufacturers shall, at all reasonable times, provide representatives of the TGA with access to its premises and records for the purposes of investigating such complaints. The originator of a complaint will be advised of the outcomes, as appropriate.

Confidentiality

Information relating to an application or licensed/certified manufacturer is treated as confidential information by the TGA and staff, however, information may be released to other regulatory bodies following section 61 of the Act. In addition to that, information on inspection date(s) and final compliance rating may be published on the TGA website.

Details of the inspection are not released to sponsors who may have requested the inspection. The information is considered to be confidential between the manufacturer on the application and the TGA.

Post licensing/certification activities

Obligations of licensed/certified manufacturers

Following licensing or certification, there are a number of managerial responsibilities which the manufacturer will need to observe to maintain a licence or TGA certification. These are detailed in the Act and Regulations and include:

• Continued compliance with the relevant Code/Standard(s).
• Compliance with 'Conditions of licensing/certification' (see next section).
• Notification to the TGA of any significant changes in the structure and operations of the manufacturer to enable the impact of such changes to be evaluated.

Conditions associated with ongoing licensing/certification

The Act and Regulations contain details on the conditions associated with the licensing or conformity assessment certification of Australian manufacturers of medicines and medical devices.

The following sections contain the relevant requirements.

Medicines

Section	Section number
Granting a licence	Section 38
Term of the licence	Section 39
Conditions of the licence	Section 40/regulation 20
Variations by the Secretary	Section 40A
Variations by the licence holder	Section 40B
Revocation or suspension of licence	Section 41

Medical devices

Section	Section/Division number
Granting a conformity assessment certificate	Section 41EE
Refusal of application	Section 41EH
Conditions of the certificate	Division 2 of Part 4-4
Suspension of the certificate	Division 3 of Part 4-4
Revocation of the certificate	Division 4 of Part 4-4

The following conditions apply to the GMP certification issued to overseas medicines manufacturers as well as to certification of medical devices manufacturers:

• The certified manufacturer shall not in any way use the fact that certification has been granted to provide customers with misleading information regarding applicability of the certification outside the scope for which certification has been granted.
• Certificates of GMP Compliance issued to Australian medicines manufacturers are given a 3 years expiry. Other Certificates have an expiry period which reflects the intended re-inspection frequency and is based on the risk category of the products manufactured and the compliance rating determined at the close-out of the inspection.

For continuance of certification the TGA shall be satisfied that the following conditions are met:

• Continued compliance with these conditions of certification
• Continued compliance of the manufacturer with the relevant standard against which certification is held
• Payment by a Medicine sponsor, or a Medical Device manufacturer (or authorised representative), by the prescribed dates of all fees set by the TGA for continuance of certification.

Following certification, the certified manufacturer must:

• Maintain the facility and manufacturing operations in accordance with the applicable standard(s)
• Make personnel, records and facilities available for inspection by the TGA on the dates and at the times agreed and confirmed in writing by the TGA
• Provide the TGA with access to premises, facilities and records at any reasonable time for the conduct of inspections and periodic reinspections.

Following certification, the TGA will:

• Conduct inspections of the certified manufacturer's manufacturing facility at approximately 1 to 3 year intervals (depending on the risk of the products manufactured and the compliance level determined)
• Consider requests from the certified manufacturer for changes to the scope of the certification and evaluate such requests during inspections subject to payment of any additional costs associated with this evaluation process
• Notify the certified manufacturer in writing of any changes in the scope of certification
• Notify the certified manufacturer in writing of any inspection findings that require corrective action to maintain certification.

The licensed or certified manufacturer shall, in a time frame agreed with the TGA, rectify any deficiencies found during inspections that impact on the scope of the licence or certification of compliance with the relevant standard.

When a manufacturer's scope of licence, conditions or certification is reduced, the TGA shall issue revised licences, conditions and certificates and the manufacturer shall return all superseded licences, conditions or certificates.

Inspection and review activities

After licensing or certification the TGA conducts periodic on-site inspections of the manufacturer's facility. The frequency of these inspections may vary depending on the level of compliance demonstrated at the previous inspection(s) and the level of risk of the products manufactured.

For medical device manufacturers, surveillance inspections are conducted on a 12 monthly basis, with a full triennial inspection conducted in which the full management system is reviewed for continued compliance with the relevant Standard(s).

Inspections are scheduled within the TGA and the manufacturer is only advised shortly before the inspection is to be conducted. Unannounced inspections may be conducted if deemed necessary.

Any changes required to the manufacturer's scope of licence or certification can be processed within the ongoing inspection program. If the manufacturer wants to change or add to the products it is licensed to manufacture, an on-line application is completed.

General arrangements

Fees and charges

All fees and charges associated with licensing/certification and conduct of inspections can be found on the TGA website.

Performance measures and targets

The performance of the OMQ Licensing/Certification Inspection Program is published annually. The performance measures and targets for the program are provided in Appendix 1.