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Australian regulatory guidelines for OTC medicines (ARGOM) (Nov 2012)
3. The application
The current Australian Regulatory Guidelines for Over-the-counter Medicines (ARGOM) is being reviewed and updated by the TGA.
Selected chapters have been removed and replaced with references to the appendices. This document will remain as the guidance document until it can be fully replaced by the updated ARGOM, i.e. chapters such as Chapter 2, 3, 7, 8, 10 and 11 will remain in effect until such time it is replaced.
This chapter describes the information required to support an application to register an OTC medicine. In general, that information should consist of an application form (accompanied by the prescribed fee) together with a submission containing information and data to support the product's registration. Submissions should be page numbered and include an index. Applications prepared in the European or ICH format are preferred.
The application form is called the New medicine registration application form (OTC). Instructions on how to complete the form are printed opposite the corresponding item in the form. The instructions on the form are additional to the requirements in these guidelines. Contact the OTC Medicines Section if you are unsure as to how to complete any particular item in the form.
Application and evaluation fees are payable for most applications. Full details of the current fees are contained in Schedule 9 to the Regulations. A summary of fees and charges is available on the TGA website. To avoid delay, you should pay the full application and evaluation fees at the time of submitting your application.
In some circumstances, a waiver or reduction of the evaluation fee (but not the application fee) may be possible under the provisions of Regulation 45 of the Therapeutic Goods Regulations (eg. where the TGA has already evaluated relevant data on a related product and the evaluation can be abridged).
If you believe you are eligible for a waiver or reduction of the evaluation fee, include a request with your application. If approved, a refund will be issued by the Business Management Unit (BMU).
The BMU will acknowledge receipt of your application within a few days of its arrival in the TGA. The acknowledgment letter will quote a TGA Identification Number (TGAIN) which uniquely identifies your application. This number should be quoted in any correspondence or enquires concerning the application.
In general, a submission for registration of an OTC medicine should include the following components:
- Specifications and stability data as specified in Chapter 4, Quality;
- Copies of all labelling including package inserts;
- A copy of the Product Information (PI) and Consumer Medicine Information (CMI) documents where relevant (refer Chapter 5, Presentation);
- Efficacy and safety information where relevant (refer Chapters 6A, Efficacy and safety and 6B, New substances)
Instructions for lodging applications are given on the application form. On receipt at the TGA, applications are screened to ensure that they comply with the following criteria:
- correct fees paid;
- form filled correctly;
- all necessary data present (including stability and validation data as detailed in Chapter 4E, Quality - Stability testing);
- all necessary attachments present (eg. labels, PI and CMI documents, where relevant);
- Information on the GMP status of manufacturer(s) provided (usually in the form of a clearance letter from the TGA's Manufacturer Assessment Section).
If any of these factors are absent, the application may be returned to the sponsor on the basis that "An application is not effective unless: the applicant has delivered ... such information ... as will allow the determination of the application" (Section 23 of the Act). In such cases the application fee is not eligible for refund but the evaluation fee may be refunded on the basis that evaluation had not commenced.
The sponsor may also be contacted at this stage (before evaluation commences) if, in the opinion of a senior evaluator, the application is unlikely to be approved. In such cases the sponsor will be given the option of withdrawing the application (with loss of the application fee but not the evaluation fee) or requesting that the application proceed regardless.
Applications which are returned at this screening stage or subsequently withdrawn can be corrected and resubmitted (as a new application with the appropriate fees) at any time. The TGA is willing to provide some general guidance as to what would be required for a future application but for detailed or technical assistance, it is recommended that the services of an appropriately qualified and experienced regulatory affairs consultant be sought (see Consultants below).
Where a product is required to be sterile (eg. eye drops), the sterility and preservative efficacy aspects of the product will be evaluated concurrently by the TGA's Microbiology Section. The microbiology evaluator may contact the sponsor directly if there are any issues relating to this part of the evaluation.
Where a product contains ingredients of animal origin the sponsor must comply with the requirements specified under Ingredients of human or animal origin in Chapter 4B.
Applications for new products may be referred to the Medicines Evaluation Committee (MEC) for assessment and recommendation. However, the delegate may choose to make a decision on the basis of information already to hand without advice from the committee. For example:
- where the new product is a 'clone' (ie. identical in all respects except for the name) of an existing evaluated product (with the consent of the sponsor of the 'parent' product);
- where the new product is similar to products which have been evaluated in the past (eg. a new brand of paracetamol tablet) and bioequivalence data are not required;
- where all issues have been dealt with by the MEC in the past and the Delegate does not require further advice from the committee.
Applications which are precedential or which contain issues that have not been fully addressed in the past will usually be referred to the MEC.
The MEC comprises members with expertise and experience in medicine, paediatric medicine, clinical pharmacology, pharmacy, toxicology, microbiology, regulatory affairs, pharmaceutical chemistry, manufacturing and forensic pharmacy. Its secretariat is provided by the OTC Medicines Section and meetings are held on a two monthly basis. Further details of the composition and terms of reference of the MEC can be found on the TGA website.
An evaluation report is prepared by a TGA evaluator for submission to the MEC. The purpose of the evaluation report is to provide an objective regulatory and scientific assessment and summary of the application to assist the committee in reaching a conclusion about the suitability of the product for registration.
Applications for variation of existing products are generally not referred to the MEC unless the advice of the committee is specifically required. Circumstances where this may occur include:
- new indications, directions for use or claims for an existing product;
- a chemistry, quality control or labelling issue which is precedential; or
- where the delegate requires technical or policy advice from the committee.
Where the product is to be referred to the MEC, the sponsor will be sent a copy of the TGA's evaluation report at least ten days before the cut-off date for the meeting at which the application is to be considered. Comments from the sponsor will be given to the MEC. In general, comments must be limited to three pages and should only address substantial issues raised in the evaluation report. Minor and administrative issues can be dealt with separately by the evaluator. Additional data will not be accepted at this stage.
Where an application is recommended by the MEC for rejection, the committee will usually offer the sponsor the opportunity to appear before a future meeting in support of the application. If the sponsor chooses to accept this invitation, the following considerations will apply:
- The sponsor should contact the OTC Medicines Section as soon as possible to arrange a suitable meeting;
- The sponsor is allocated half an hour (usually towards the end of the meeting) to present their case;
- New data that require evaluation are not usually accepted at this stage;
- Presentation aids (eg. PowerPoint, overhead projector) will be available on request;
- The committee may ask questions at the end of the presentation.
This procedure has been accepted as a long-standing custom of the MEC. It is not a formal appeal and does not affect the sponsor's appeal rights under Section 60 of the Therapeutic Goods Act 1989. Refer also to Chapter 7, Review of decisions.
The term 'clone' is used in relation to OTC medicines that are identical in all respects to an existing evaluated medicine, apart from the product name and identifying details on the product label.
Where a product is accepted as a 'clone', no supporting data are required (apart from the proposed labelling, PI and CMI) and the evaluation fee will be reduced to the amount of the variation evaluation fee.
If the application is approved, the 'clone' will be registered in its own right in the ARTG. From the time of registration onwards, the 'clone' will bear no legal relationship to the 'parent' product. The sponsor of the 'clone' will be fully responsible for that product.
In general, 'clone' applications must comply with the following requirements:
- The application should be accompanied by a letter from the sponsor of the 'parent' product authorising the TGA to access information on the 'parent' to support the 'clone' application.
- The 'parent' product must have been fully evaluated (ie. not a grandfathered product).
- The sponsor must provide an assurance that all quality aspects of the proposed 'clone' product are identical to the 'parent' product, and that the sponsor will ensure that the 'clone' product will comply with all applicable regulatory requirements.
- The application should be accompanied by copies of all labels, PI and CMI (where applicable) of the 'parent' product and the 'clone'.
The TGA will closely compare the labels, PI and CMI of the 'parent' and 'clone' products. If there are changes beyond the product name and identifying details, the label, PI and CMI will be fully evaluated without regard to the 'parent'. In such cases, the full new product evaluation fee will apply.
Applications are treated on a commercial-in-confidence basis. Details of an application will only be discussed with the sponsor or the sponsor's appointed agent. All TGA committees operate under a strict code of confidentiality. Members of committees must declare any conflict of interest in matters to be considered at a meeting and are excluded from taking part in any final determination of those matters.
The Act is written in terms of two parties – 'the sponsor' and 'the Secretary'. In practice, where the Act specifies that decisions are to be made by 'the Secretary', those decisions are usually made by an officer of the TGA to whom the Secretary's authority has been formally delegated. Delegations of this nature are generally restricted to senior officers.
When an evaluation has been completed, the delegate makes a decision on whether the product is suitable for entry in the ARTG on the basis of the application and accompanying data, advice from evaluation committees, other relevant sources and his or her own professional judgement. Decisions made under the Act may be appealed – information on appeal rights is given in Chapter 7, Review of decisions.
If your application for registration of a product is approved it will be entered in the Australian Register of Therapeutic Goods (ARTG). You will be sent a letter asking you to check the accuracy of all details of the ARTG entry using your on-line access to the SIME ARTG and confirm it is correct (or advise any amendment required). A certificate of registration will be issued following receipt of your confirmation that all details are correct. The registration of the goods will commence on the day specified for the purpose in the certificate of registration. The goods may not be supplied before this date.
The Certificate of Registration will include a number of conditions of registration. Read the conditions carefully as they must be complied with in order to retain your product in the register.
The target times for the various types of applications are set out in the table below.
|Application type||Target time (working days)|
Variations referred to the MEC
|Variation processed through TGA only||32|
|Variation – notification only||20|
These targets are set by agreement between the TGA and industry representative bodies and are exclusive of 'company response time' (ie. time taken for the sponsor to respond to issues raised during the evaluation).
The TGA's goal is to finalise all applications within the target time. To help achieve these goals, the following procedures are followed:
- applications not meeting acceptance criteria (see above) are returned to the sponsor without evaluation;
- where possible, applications are assessed by the evaluator and evaluation committee only once;
- in general, applications are dealt with on the basis of the submitted information – deficiencies can be corrected by the sponsor in a new application rather than by a process of iterative submissions.
Specific information on the requirements for changes to existing products is given in Chapter 11, Changes to OTC medicines.
Sponsors who are not experienced in preparing registration applications may find it to their advantage to engage the services of an appropriately qualified and experienced regulatory affairs consultant.
Information on how to locate consultants is available on the TGA website.