Coordination Unit

Fees:

• If you are unsure of the fees you will need to pay for your notifications/applications for drugs processed by Drug Safety and Evaluation Branch (DSEB), please contact DSEB.
• New fees: Please note that there will be a fee increase on 1 July 1995. New applications/notifications received by the TGA on or after that date will be charged the increased fees.
• Application fees: Application to register fees (currently $1,200; $560; $420 and $210) apply to all applications which result in a new entry on the Australian Register of Therapeutic Goods under Section 16 of the Therapeutic Goods Act - for example, applications for extension of indications. Applications to vary, that do not result in a new register entry, attract the lower application fee, also known as the processing fee, this is currently $340.
• Evaluation fees for Category One Applications: Please do not pay your 75 per cent evaluation fee with your application. Wait for the invoice from the Business Management Unit. Too many fees are being calculated incorrectly. This results in more work for the Coordination Unit in organising the correct recording of the fees with the Business Management Unit, as well as organising invoices for additional money or refunds for overpayments. Waiting for an invoice ensures that the correct fees are paid. This also helps when it is necessary to request the 25 per cent at the time of the Delegate's decision. No advantage is gained by sending the 75 per cent evaluation fee with the application. The application proceeds while awaiting payment of the invoice for the 75 per cent.
• Fee calculations: It has become clear from the applications being received from sponsors, that staff within the same regulatory area have a different understanding of fee calculation. The Coordination Unit has received similar applications from a sponsor which have been prepared by different people within the same regulatory area. Each person has calculated the fees differently, therefore causing delays in their applications while fees are checked and invoices are sent for any outstanding money. There has also been the need for refunds where overpayments have occurred. It is suggested that sponsors implement procedures to ensure that all staff are aware of the fee schedule and how to calculate the correct fees in a consistent manner.
• Cheques: When sending cheques to the Business Management Unit clearly identify what the payment is for. The Unit has received cheques without covering letters, application forms or any identification of what the cheque is for. Cheques should be attached to a covering letter, application form or an invoice which clearly identifies the purpose of the cheque. Sponsors have also paid several applications with the one cheque. The Business Management Unit then has to play a guessing game to determine what money has been received for which application. If you pay for more than one application with one cheque, please clearly identify what the money is for.

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Notifications:

Self-assessable

• Don't send application forms with these notifications. The only form you need to fill out and send is the proforma No. DEB/pce:93/4.
• Attach a covering letter and cheque for the application/processing fee, currently $340, to the DEB/pce:93/4 proforma. The fee must be attached.
• Send original proforma, covering letter and cheque to the Business Management Unit. Don't send copies or facsimiles to the Drug Safety and Evaluation Branch, the multiple copies cause confusion and are unnecessary.
• If you are making a change common to several products with different active ingredients, that is change of site of manufacture of these products, only one fee is payable and one proforma. If there are too many products to include on page one of the proforma, attach a list of the products including all the details as set out on page one.

Safety related changes to product information

• Only changes under Section 32(4) of the Therapeutic Goods Act 1989 are acceptable by notification. Don't include any other changes with these notifications as it will be necessary to reject the correspondence with a request that it be resubmitted as two separate matters.
• The notification must take the form of submitting a copy of the approved product information on which the changes have been made and are clearly identified and an accompanying letter that should state that no other changes have been made and the changes are supported by data in the sponsor's possession. Supporting data should not be submitted at the time of notification, but may be requested later.
• Don't send application forms with these notifications.
• Don't use the proforma number DEB/pce:93/4, this is for a notification of self-assessable changes to Part II information in accordance with Appendices 7 and/or 8 of the AGRD Volume 1.
• Send the originals to the Business Management Unit. Don't send copies or facsimiles to the Drug Safety and Evaluation Branch, the multiple copies cause confusion and are unnecessary.
• Each notification must have the application/processing fee, currently $340, attached.

Category 3 Applications:

• The application fee and 100 per cent of the evaluation fee should accompany the application. The Coordination Unit is still receiving applications with incorrect fees, ie application fees and no evaluation fees. These applications cannot be processed until the correct fees are received.
• If an application to vary covers several products, same change, only one application fee is payable. However, where evaluation fees are concerned, you need to request a reduction under Regulation 45 to reduce the evaluation fee to one.

Miscellaneous:

• Page counts: Please list the part, volume, copies and page count in the covering letter. The Coordination Unit has experienced several problems sorting out exactly what has been submitted with applications. Covering letters differ from the application form and these can differ from what is received. This makes fee calculation extremely difficult and time consuming when you have conflicting page counts;
• Additional data: Clearly identify additional data. It should be bound and clearly labelled with the company name, drug name, part, volume number, copy number and include page numbers;
• S.31 responses: Facsimiles and originals must be clearly identified as such, including the S.31 number, and addressed to the Section 31 Officer. The Coordination Unit is still receiving responses addressed to Evaluation Sections which do not reach the Section 31 Officer, who is responsible for re-starting the clock. Please note: These responses must be addressed to the Section 31 Officer only and not include any officer's name or evaluation area. If the Section 31 Officer is not clearly identified and addressed, the clock does not re-start until it is identified as such, that is five working days; and
• Application forms: Application forms must accompany Category 1, 2 and 3 applications. As much information as possible should be supplied to enable accurate identification of each application.

Remember: if unsure - please ring DSEB.

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In brief

AUST R numbers

When you are lodging an application or notification of a variation to an existing product (including self-assessable changes and safety related notifications), please make sure you list the AUST R numbers for all the products affected by the change.

Pre-ADEC responses

Please make sure all responses resulting from pre-ADEC (Australian Drug Evaluation Committee) consultation are addressed to: The Drug Safety and Evaluation Branch, PO Box 100, Woden ACT 2606. The original plus one copy must be provided, and they must be received direct to the DSEB (and not be delivered to other areas of the Department). Original documents, not facsimiles, are required.

Concern has been expressed that Product Information (PI) documents submitted in draft form prior to consideration by ADEC may be further amended following review by ADEC. This is of course a legitimate function of ADEC and it is not possible to guarantee that a PI can be finalised prior to ADEC. In particular, a Delegate may need to consult ADEC about the contents of a PI and this will inevitably result in further negotiations following the ADEC meeting.

The Australian Pharmaceutical Manufacturers Association (APMA) has written to the Drug Safety and Evaluation Branch (DSEB) expressing the concern that such negotiations might cause delays in the registration of the product. As a general rule, Delegates will do everything possible to develop as near to a final draft as possible and as required by Baume (Rec. 48). However, it is the duty and prerogative of ADEC to review such documents and to recommend amendments to the delegate. If sponsors are experiencing unreasonable delays they should contact the Director of DSEB, Malcolm Wright.

Current import permits

The Branch has recently identified cases where sponsors were importing products that required import clearance under the Customs (Prohibited Imports) Regulations and/or under quarantine legislation. In these cases, old import clearances had not been kept current. Please ensure that, even if your imported product is registered in Australia on the ARTG, you have all clearance/import approvals current. Failure to keep these clearances current could lead to prosecution.

Special therapeutic products

Last year amending legislation was passed to regulate the contract manufacture of therapeutic products for a hospital or like institution. Full details of the amendment were contained in the previous issue of TGA News. One provision was that any sponsor engaged in contract manufacture of these special therapeutic products must regularly report the level of activity to the TGA. The TGA understands that there are a number of companies engaged in contract manufacture of special therapeutic goods that have not yet sent in the first mandatory report. The format for these reports is available from the Drug Safety and Evaluation Branch.

CTN (Clinical Trial Notification Scheme for Drugs) forms

Maurice Merritt also reports that recently there have been a number of CTN forms that have had a number of errors in the notified data. Sponsors of CTN trials are requested to ensure that the data provided on the notification form is complete and accurate. Forms with evident errors may mean the trial has not been legally and properly notified to the TGA, and will generally be returned to the trial sponsor.

Addressing correspondence

Please note that mail addressed personally to the Director of DSEB, Malcolm Wright, is delivered to the Director's office first. If your mail is not for the personal attention of the Director, please do not address it to Dr Wright by name.