For all medicines, registered or listed, before any applications can be considered you need to be sure that the GMP (Good Manufacturing Practice) Certificates for your proposed manufacturers are acceptable to the TGA.

For overseas manufacturers this can be a major issue affecting your budget and time line – for more information go to Applications & Liaison with TGA

The TGA do not recognise the GMP certification issued by all countries. The TGA accepts GMP certificates issued by most EU countries, and countries which have a similar regulatory framework as Australia – such as Canada, USA, Singapore, Sweden, UK – to name a few.

If your manufacturer is in a country that is not recognised by the TGA, then your manufacturer will need to have a GMP licence issued to it by one of the acceptable countries. If that is not the case, you will have no other option  except to organise an inspection by an acceptable authority – that can mean serious delays, usually more than 12 months, as well as a significant investment in cost.

For most medicine applications, the GMP clearance for your overseas manufacturers must be approved before you can proceed.

Once your product is approved you will have to maintain the clearances to ensure they are always valid. Valid clearances are required if you wish to submit any variations that relate to quality. If your GMP expires this can result in cancellation of your product  and restrictions in supply.- find out more in Maintenance & Renewals.

There are 2 types of GMP clearance applications. Regulatory Concepts can access your documentation and determine which application pathway is applicable and the costs and time associated with the pathway.

Applications

An MRA application is a simple application for a manufacturer located in an acceptable country and which has GMP certification from that country.

The second type of application is referred to as a CV application or Compliance Verification or a desk audit. This is an application usually for a manufacturer in a country not recognised by the TGA but who has a GMP certificate issued by an acceptable country.  These CV applications also apply to all manufacturers in the USA. A CV application requires a number of supporting documents from the manufacturer. Regulatory Concepts can assist you in liaising with the manufacturer and reviewing the supporting documents to ensure they are suitable. This is particularly important when a GMP contract is required – refer to Contracts & Agreements.

Regulatory Concepts can assist in coordinating the submission of supporting documents by the manufacturer and the timely submission of the online application.

TGA liaison for New Inspections

If you  end up with no choice other than to organise an inspection with the TGA, we can assist you through the process, setting up the online applications, and coordinating the correspondence with the TGA.

The Maintenance and renewals of GMP clearances can be an onerous task, especially if you have many different products from many different manufacturers. All clearances have an initial tracking number which is associated with the GMP clearance for its lifetime. If the clearance is allowed to expire, this initial tracking number no longer applies and a new application and new tracking number sequence needs to be started. This can add to costs and time so it is imperative to stay on top of expiry dates and ensure that renewals and extensions are submitted on time to enable your clearances to remain valid.

Maintenance & Renewals

Regulatory Concepts has set up a system whereby we review clearances on a regular basis and inform clients/manufacturers of upcoming expiry dates. Depending on whether the GMP clearance is an MRA type or CV type (refer to Applications &Liaison with the TGA) the time frame for renewal actions can vary from 2 months prior to 6 months prior to the expiry date.

If a clearance has expired and a new tracking sequence has been started, this will require an update to your ARTG records- we can manage these updates and prepare the eCTD published dossier in a timely and cost-effective way.

An important aspect of the requirements for GMP is that there needs to be  a GMP Agreement between the Sponsor and the Manufacturer. Sometimes this is called a Technical Agreement or a Quality Agreement

Regulatory Concepts can review your proposed GMP agreements or if there are already agreements in place between your overseas partners and the manufacturers, we can review these and ensure that your interests as the Sponsor are covered off.

Applications & Liaison with TGA

There are 2 types of GMP clearance applications. Regulatory Concepts can access your documentation and determine which application pathway is applicable and the costs and time associated with the pathway.

Applications

An MRA application is a simple application for a manufacturer located in an acceptable country and which has GMP certification from that country.

The second type of application is referred to as a CV application or Compliance Verification or a desk audit. This is an application usually for a manufacturer in a country not recognised by the TGA but who has a GMP certificate issued by an acceptable country.  These CV applications also apply to all manufacturers in the USA. A CV application requires a number of supporting documents from the manufacturer. Regulatory Concepts can assist you in liaising with the manufacturer and reviewing the supporting documents to ensure they are suitable. This is particularly important when a GMP contract is required – refer to Contracts & Agreements.

Regulatory Concepts can assist in coordinating the submission of supporting documents by the manufacturer and the timely submission of the online application.

TGA liaison for New Inspections

If you  end up with no choice other than to organise an inspection with the TGA, we can assist you through the process, setting up the online applications, and coordinating the correspondence with the TGA.

Maintenance & Renewals

The Maintenance and renewals of GMP clearances can be an onerous task, especially if you have many different products from many different manufacturers. All clearances have an initial tracking number which is associated with the GMP clearance for its lifetime. If the clearance is allowed to expire, this initial tracking number no longer applies and a new application and new tracking number sequence needs to be started. This can add to costs and time so it is imperative to stay on top of expiry dates and ensure that renewals and extensions are submitted on time to enable your clearances to remain valid.

Maintenance & Renewals

Regulatory Concepts has set up a system whereby we review clearances on a regular basis and inform clients/manufacturers of upcoming expiry dates. Depending on whether the GMP clearance is an MRA type or CV type (refer to Applications &Liaison with the TGA) the time frame for renewal actions can vary from 2 months prior to 6 months prior to the expiry date.

If a clearance has expired and a new tracking sequence has been started, this will require an update to your ARTG records- we can manage these updates and prepare the eCTD published dossier in a timely and cost-effective way.

Contracts & Agreements

An important aspect of the requirements for GMP is that there needs to be  a GMP Agreement between the Sponsor and the Manufacturer. Sometimes this is called a Technical Agreement or a Quality Agreement

Regulatory Concepts can review your proposed GMP agreements or if there are already agreements in place between your overseas partners and the manufacturers, we can review these and ensure that your interests as the Sponsor are covered off.

Regulatory Concepts

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