TGA News Issue 56 (July 2008) - Medicines
Adverse drug reactions bulletin
The June 2008 issue of the Australian Adverse Drug Reactions Bulletin is available <http://www.tga.gov.au/adr/aadrb.htm>.
Articles in the June 2008 issue include:
- Severe skin reactions and venous thromboembolism with strontium ranelate (Protos)
- Statins and muscle disorders - be careful with the dose
- Hepatic toxicity with nitrofurantoin
Alerts & advisory statements
Since the last issue of TGA News, the following information has been issued or updated by the TGA.
These are all available on the TGA website.
- Human papillomavirus vaccine (Gardasil)
<http://www.tga.gov.au/alerts/medicines/gardasil.htm> - Recall of blood-thinning medicine - Clexane (enoxaparin)
<http://www.tga.gov.au/alerts/medicines/clexane.htm> - The use of cough and cold medicines in children
<http://www.tga.gov.au/media/2008/080409cold.htm>
The following guidelines are available on the Australian Government Department of Health and Ageing website.
- Consensus Guidelines for Australian Clinicians for the use of anti-coagulants during heparin-based product shortages
Australian Government Department of Health and Ageing, 16 May 2008
<http://www.health.gov.au>
Extemporaneous medicines
During April and May 2008, comments were sought on the discussion paper Regulation of Extemporaneously Prepared Medicines in Non-hospital Pharmacies <http://www.tga.gov.au/meds/extempcomp2.htm>. Although the consultation is now closed, the document is still available.
The discussion paper is the work of the National Co-ordinating Committee on Therapeutic Goods (NCCTG) and is part of the continuing development of an appropriate regulatory response to the changes in the practice of pharmacy that have occurred over recent years. These changes have included increases in the scale of preparation and the variety of ingredients and formulations of extemporaneously compounded medicines.
Listed medicines
Therapeutic Goods (Listing) Notice 2008 (No.3) was registered in the Federal Register of Legislative Instruments (FRLI) on 8 July 2008 <http://www.tga.gov.au/legis/tgnlist0803.htm>.
This listing notice relates to preparations containg Arabinogalactan - Larix.
Medicines committees updates
- ADEC: meeting dates for 2009
<http://www.tga.gov.au/docs/html/adec/adec.htm> - CMEC: public recommendation summaries for meetings 66 (April 2008) & 67 (June 2008) and extracted ratified minutes for meetings 65 (February 2008) & 66 (April 2008)
<http://www.tga.gov.au/docs/html/cmec/cmecminu.htm>
Medicines labelling
TGO69B
Therapeutic Goods Order No. 69B Amendment to Therapeutic Goods Order No. 69 General requirements for labels for medicines <http://www.tga.gov.au/legis/tgo/tgo69b.htm> was registered with Federal Register of Legislative Instruments (FRLI) on 6 June 2008.
This amendment updates the definition of 'Required Advisory Statements for Medicine Labels' in TGO69.
RASML
The Required Advisory Statements for Medicine Labels (RASML) was updated in April 2008. The current version and historical versions are available <http://www.tga.gov.au/meds/rasml.htm>.
Also available is a consultation document Required Advisory Statement for Medicine Labels - proposed update 4 <http://www.tga.gov.au/meds/drrasmlupd4.htm>, advising stakeholders of proposed changes to the current (April 2008) edition of the Required Advisory Statements for Medicine Labels.
Stakeholders are requested to review and comment on the proposed changes.
Responses should include:
- Whether or not you support the proposed changes. If you do not support a change, you may make suggestions for an alternative acceptable to you.
- An assessment of how the proposed change will impact on you. That is, what do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits.
This consultation closes on 31 July 2008.
Orphan drugs
Orphan drug products are drugs, vaccines or in vivo diagnostic agents which physicians use to treat, prevent or diagnose rare diseases. The Australian Orphan Drug Program encourages sponsors to market orphan drugs in Australia by reducing costs through waiving fees.
Since the last issue of TGA News, six additions have been made to the list of drugs designated as orphan drugs <http://www.tga.gov.au/docs/html/orphand2.htm>.
Product changes in ELF3
The document Guidance on product changes in ELF3 <http://www.tga.gov.au/cm/elf3productchanges.htm> has been updated.
Following the inclusion of a product as a Listed medicine in the ARTG, sponsors may wish to change certain details previously advised to the TGA. Factors such as product stability, manufacturer changes and developing marketing strategies may require changes to product details that were entered at the time of the product's inclusion in the ARTG. This guidance document has been developed to provide assistance to sponsors so that they are able to determine if a change to their ARTG entry for a particular product is necessary and the regulatory impact that making certain changes to currently Listed products may have.
This guidance applies only to medicines Listed in the ARTG for supply in Australia. It does not apply to Registered medicines or medicines Listed in the ARTG for Export Only.
All changes required to be made to existing Listed complementary medicines are to be undertaken via the Electronic Listing Facility Version 3 (ELF 3) system.