This guidance is for sponsors of prescription medicines. It describes the process for registering new medicines with new trade names that are 'clones' of currently registered prescription medicines ('parent medicines').
When applying for additional trade names, you may not include unrelated changes in your application.
The statutory time frame for prescription medicine applications is 45 working days when Regulation 16G of the Therapeutic Goods Regulations 1990 applies.
Steps in the application process
The additional trade name application process consists of the following steps:
- Determining the regulatory pathway
- Choosing trade names
- Checking the ARTG records of parent medicines
- Checking GMP and manufacturing sites and steps
- Preparing:
- Making your application
- Paying your fees
- Evaluating your additional trade name applications (TGA processing time)
- Providing patent certification or notification
- Printing your ARTG certificate
- Lodging the Product Information and CMI
- Sending us the certified product details
Step 1. Determining the regulatory pathway
You have three pathways for applying for a different trade name for your prescription medicine:
- the additional trade name pathway: continue following these instructions
- the minor variation pathway for the replacement of trade names, see:
- the prescription medicine registration process, for when you combine additional trade names with extensions of indication or other types of application.
These pathways have different application forms, different guidance and different fees.
For registered medicines, a different name means a separate and distinct good with a new ARTG entry [Section 16(1) of the Therapeutic Goods Act 1989 (the Act)]. Whether you add trade names or replace an existing trade name, your application is made under section 23 of the Act and our decisions are made under section 25 of the Act.
Step 2. Choosing trade names
For information on choice of product names see medicine labels: Guidance on TGO 91 and TGO 92.
Step 3. Checking the ARTG records of parent medicines
Your new ARTG entries will be based on the ARTG records of a parent medicine.
- Check that the ARTG record of the parent medicine is complete and correct. In particular, check:
- container type
- materials
- shelf life
- storage conditions
- quantitative formulation
- manufacturing sites
- manufacturing steps
- visual identification
- indications (which should be the same as in the Product Information).
- Submit 9D(1) request to correct an ARTG entry form if the ARTG entry is incomplete or incorrect.
- Make one of the following declarations in section 6 of the application form, either:
- the ARTG entries are complete and correct
- you have submitted 9D(1) request(s) to complete or correct ARTG entries.
Differences between new and parent medicines
Apart from the trade name, a new medicine can only differ from a parent medicine in a few aspects.
For a new medicine, the following must be different from the parent medicines, but only to a limited extent:
- Labels, which may differ in:
- trade name
- design
- logos
- Product Information - see guidance on Product Information
- Consumer Medicine Information.
The markings on oral dosage forms such as tablets can only differ from the parent medicine when this is necessary for the presentation to be acceptable. You need to provide dissolution data in Module 3 if you change the markings.
The new medicines can differ from the parent medicine in having a subset of the parent medicine's:
- manufacturing sites
- manufacturing steps
- container materials
- pack sizes - defined on page 87 of Minor variations to registered prescription medicines: Chemical entities. Remember that certain pack sizes are required to ensure adequate adherence to the prescribed dosage regimes.
Step 4. Checking GMP and manufacturing sites and steps
Good manufacturing practice (GMP)
Provide all relevant manufacturing licence number (for Australian manufacturers) and GMP clearance numbers (for overseas manufacturers) along with the expiry dates in Module 1.7.
We need this information because we are obliged to check whether you have met the requirements regarding manufacture in section 25(1)(g) and (h) of the Therapeutic Goods Act 1989.
Manufacturing sites
You may not add manufacturing sites beyond the sites already registered to the parent medicine. However, for the new ARTG entries you do not need to include a manufacturing site of the parent medicine, provided that:
- all the relevant manufacturing steps will be registered for another manufacturing site
- AND
- this manufacturing site is already registered to perform these steps for the parent medicine.
On the application form, provide information about manufacturing sites that are registered to the parent medicine and will not be sought for registration for the new medicines.
Manufacturing steps
You may not add manufacturing steps beyond the steps already registered to be performed by the manufacturing site registered to the parent medicine. However, for the new ARTG entries you do not need to include a manufacturing step registered for a manufacturing site of the parent medicine, provided that:
- the manufacturing step relates to a material or pack size that is not going to be used for the new medicine
- OR
- another manufacturing site will be registered to perform the manufacturing step and this manufacturing site is already registered to perform this step for the parent medicine.
On the application form, provide information about manufacturing steps that are registered to the parent medicine and will not be sought for registration for the new medicines.
Step 5a. Preparing Module 1
Make sure your application, complies with the general dossier requirements.
Follow the general guidance about CTD Module 1 to complete all relevant sections of Module 1.
We are moving towards the eCTD. Where numbering in Module 1 differs between CTD and eCTD, both numbers have been used.
Module 1.0. Cover letter
Place your cover letter in Module 1.0.1.
In your letter, include:
- the name of the new medicines and the active ingredient(s)
- the type of application (additional trade name).
Module 1.1. Comprehensive table of contents
If you are using the CTD, provide a comprehensive table of contents.
Module 1.2.1. Application form
Place your application form in Module 1.2. (See Step 6: Making your application for more information.) In the application form you will make a number of declarations, including:
- the use of human embryos or embryonic material [See regulation 9B in the Therapeutic Goods Regulations 1990] (previously required in Module 1.3.3)
- the completeness and accuracy of the parent medicines ARTG records, (previously required to be in Module 1.5.4).
- that the new medicines are identical to the parent medicines, with the exception of nominated differences (previously required to be in Module 1.5.4)
- in relation to the Product Information (previously required to be placed in Module 1.5.4).
If you are planning on using a name or livery owned by another company, provide a letter of authorisation from the owner company in Module 1.2.1.
Module 1.2.3. Patent certification or notification
We will need your patent certification or notification form before we can create your ARTG entries.
You do not have to do this at the same time as your application: see Step 9: providing patent certification or notification.
Module 1.3. Medicine information documents, packaging and labelling
You need to provide us with:
- Product Information (Module 1.3.1)
- Consumer Medicine Information (Module 1.3.2)
- Label mock ups and specimens (Module 1.3.4 in the CTD, Module 1.3.3 in the eCTD).
Only make changes to the Product Information and Consumer Medicine Information that are necessary:
- because of the new name
- in order to make the format of the medicine information meet current requirements.
Do not make minor editorial changes to the Product Information that are not necessary to meet current requirements.
Module 1.5.4.
Do not place any information in Module 1.5.4. The declarations previously required in Module 1.5.4 are now part of the additional trade name application form.
Module 1.7. Good manufacturing practice
Provide all relevant manufacturing licence number (for Australian manufacturers) and GMP clearance numbers (for overseas manufacturers) along with the expiry dates in Module 1.7.
See Step 4 Checking GMP and manufacturing sites and steps for more information.
Step 5b. Preparing Module 3
Module 3 contains information about the quality of the medicine. The only quality changes allowed for additional trade name applications are changes to the markings of an oral dosage form when this is necessary for the presentation to be acceptable (usually when markings on the parent medicine are related to the trade name of the parent medicine).
If the markings on the tablets have changed, place in Module 3:
- dissolution data
- justification for changing markings.
Guidance on the dissolution data required when markings on prescription medicines are changed is provided on pp 89-90 of Minor variations to registered prescription medicines: Chemical entities.
Step 6. Making your application
Complete the application form
Use the Additional trade names: application form for prescription medicine sponsors. If you do not provide us with all of the information we ask for in the application form, we may be unable to process your submission.
Do not combine applications for additional trade names of prescription medicines with other types of application in the one submission.
All medicines contained in the submission must contain the same active ingredient (see clause 1(3) in Part 1 of Schedule 9 to the Therapeutic Goods Regulations 1990).
What to send to us
Send us:
- Module 1
- Module 3 (if applicable)
- additional documentation required by the form
- other supporting documentation.
Check the TGA general dossier requirements for information on how to submit your application.
Step 7. Paying your fees
To pay your invoice, follow the guidance at payment options.
There are two fees, an application fee and an evaluation fee. We recommend that you pay 100% of your invoice in the one payment.
For applications to be included in one submission with one application fee and one evaluation fee, all the medicines contained in the submission must contain the same active ingredient (see clause 1(3) in Part 1 of Schedule 9 to the Therapeutic Goods Regulations 1990).
Step 8. Evaluating your additional trade name applications
Once you have paid your application fee and we have received your applications and the supporting data, we will evaluate your applications.
We may ask you for more information under section 31 of the Therapeutic Goods Act 1989 (the Act).
We have a statutory time frame of 45 working days for prescription medicine trade name applications (when Regulation 16G of the Therapeutic Goods Regulations 1990 is applied). However, the clock (that records TGA working days) does not start until you have paid your application fee and stops when we send you a request under section 31 of the Act.
Each application may be:
If your submission consists of more than one application, we may approve some of your applications and reject others.
Approved applications
If an application is approved, you will receive a letter outlining the decision to register the new medicines and the conditions of registration.
You will be able to go to Step 9: Patent certification and notification.
Rejected applications
If an application is rejected, you will receive a letter:
- explaining the reasons for not registering the new medicines
- providing you with an explanation of your rights to request a review of the decision.
Step 9. Providing patent certification or notification
If you have not already done so, send us a patent certification or notification form according to section 26B of the Therapeutic Goods Act 1989. We need to receive this before we can create your ARTG entries.
Step 10. Printing your ARTG certificate
Although the public can view ARTG entries and public ARTG summaries, these are not the same as ARTG certificates.
You can view and print your ARTG certificate the day following ARTG registration.
Step 11. Lodging the Product Information and CMI
In TGA Business Services lodge:
- the approved Product Information within 2 weeks of registration as a text-searchable pdf document
- the Consumer Medicine Information (CMI) before you supply the medicine using the new trade name.
Step 12. Sending us the certified product details
If you have not already done so, send us the certified product details within one month of the decision letter.
Version history
| Version | Description of change | Author | Effective date |
|---|---|---|---|
| V1.0 | Original publication | Scientific Evaluation and Special Product Access Branch with the Regulatory Guidance Team | July 2015 |