2001 edition of the Uniform Recall Procedure for Therapeutic Goods (URPTG)

A new edition of the Uniform Recall Procedure for Therapeutic Goods (URPTG) has been produced by the TGA to reflect changes in the responsibilities of sponsors reporting incidents in relation to product tampering. A new section has been included explaining the procedures that will be followed during the management of a crisis.

The responsibilities of the State and Territory Recall Coordinators now include the additional requirement to maintain a current Rapid Alert System to facilitate communication of urgent safety-related information to all public and private hospitals in an emergency. There is also a new requirement for recalls of human blood and tissues.

The TGA introduced requirements for the regulation of fresh blood in August 2000. This included a new code of Good Manufacturing Practice for Human Blood and Tissues. The Code includes a requirement for the Australian Red Cross Blood Service and tissue banks to report all recalls of human blood and tissues that have been issued to external customers.

The 2001 edition of the URPTG <http://www.tga.gov.au/docs/html/urptg.htm> is available from the TGA website or can be purchased from the TGA Publications Office (tel 1800 020 653). A list of the current contact details for Recall Coordinators will be available from the TGA website as a separate attachment.

ARTG contact numbers

The ARTG Section and its functions have been devolved to other areas within the TGA. The following numbers should now be used for ARTG queries:

Query	Phone Number
Medical device	02 6232 8048
Non-prescription medicine	02 6232 8634
Prescription medicine	02 6232 8135
ELF Help Desk	02 6232 8657
AANs and Proprietary Ingredients	02 6232 8465

For general enquiries, use the numbers in the contact list <http://www.tga.gov.au/contact.htm> on the TGA website.

British Pharmacopoeia 2001

The TGA is currently consulting with peak medicines and medical device industry bodies on the proposed adoption in Australia of the British Pharmacopoeia 2001 (BP 2001) as the edition of the British Pharmacopoeia defined under the Therapeutic Goods Act 1989, with effect from 1 December 2001. This consultation is part of the normal procedures undertaken following the publication of each new edition of the British Pharmacopoeia.

The views of industry on this issue will be considered by the Therapeutic Goods Committee at its November 2001 meeting. Adoption in Australia of BP 2001 will maintain parity in standards for therapeutic goods and prevent the introduction of unique Australian requirements arising from Australia retaining a superseded standard.

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Enforcement news

Prosecutions

TGA investigators seizing unlawfully imported goods

Recent prosecutions by the Surveillance Unit have resulted in the convictions of:

• a Sydney man and a Sydney company in relation to multiple counts of exporting large quantities of both prescription and non-prescription medicines in tablet form;
• two Melbourne men in relation to multiple counts of importing and supplying complementary medicine in oral liquid form;
• a Cairns man and a Cairns company in relation to multiple counts of importing and exporting large quantities of prescription medicines in tablet, capsule and injectable form;
• a Melbourne company in relation to several counts of manufacture and supply of non-prescription medicines in tablet and capsule form.

UN in East Timor

Brett is pictured above (at rear) with
other UN police and five officers of
the new East Timor police (front right)

Surveillance Unit Principal Investigator Brett Irwin is currently serving with the United Nations peacekeeping contingent in East Timor.

Brett is attached to the Australian Federal Police, as a Senior Sergeant serving with the UN Civil Police contingent at Viqueque, a western province of about 60,000 in population.

International training

Surveillance Unit investigations, particularly in relation to counterfeiting, often involve international trade in the goods. The Unit regularly conducts investigations in conjunction with drug regulatory authorities from overseas.

Investigators from Australia, New Zealand and Thailand recently completed specialist investigator training conducted by the TGA in Australia.

The Unit also represents Australia on the Permanent Forum on International Pharmaceutical Crime and the World Health Organization Anti-Counterfeit Pharmaceuticals Network.

This joint agency liaison has served Australia well and has proved most effective in combating the international illicit trade in therapeutic goods, particularly in relation to sub-standard and counterfeit goods.

Anti-counterfeiting law

Australia's therapeutic goods legislation now provides specific criminal offences for dealing in counterfeit goods. These laws apply to medicines and medical devices, and goods for use in humans and in animals.

Specific offences have been created for the import, export, manufacture or supply of counterfeit therapeutic goods.

These offences carry a maximum penalty if committed by a person, of five years imprisonment, a fine of $55,000 or both; and if committed by a corporation, a fine of $275,000; in respect of each offence.

The Surveillance Unit is currently investigating a number of matters under these provisions.

This legislation affords the industry strong protection against counterfeiters and aids in combating the significant public health risk posed by counterfeit goods.

Inside a smuggler's warehouse

Sea container containing starting materials and
machinery imported into Melbourne for use in
the manufacture of counterfeit goods

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Fees and charges increase

A summary of TGA fees and charges <http://www.tga.gov.au/docs/html/feesach.htm> as at 1 July 2001 is available.

NATA accreditation of TGA Laboratories

The National Association of Testing Authorities, Australia (NATA) has recently audited several individual areas of the TGA Laboratories (TGAL). As a result, TGAL has maintained its accreditations in these key areas for Chemical and Biological testing. TGAL is now preparing for corporate accreditation to the ISO 17025 standard.

The following NATA accreditations were assessed and renewed:

7.56 Drugs and pharmaceuticals

• Qualitative identification of active ingredients and other components by IR and UV spectrometric, GC, GC-MS, HPLC, LC-MS and TLC techniques
• Quantitative analysis by AAS, classical, GC, HPLC, polarimetry and UV-vis spectrophotometric techniques
• Physical tests
• Dissolution; disintegration; particle sizing; pH; specific gravity; uniformity of weight by the methods of:
  - AS, BP, EP, USP, Manufacturer's Standards and TGAL
  .01 Drugs
  .02 Medicinal and veterinary preparations
  .03 Vitamins
  .04 Antibiotics
  .08 Chemicals used in compounding pharmaceuticals

8.01 Tests on human pharmaceutical and biological products

• .14 Bioassays of hormones
• .17 Bioassay of enzymes
• .18 Assay of blood products
  - Anticoagulants, clotting factors, heparin, plasma expanders, products with haematological actions
• .19 Physiochemical tests
  Hormones
• .20 Potency
  - Cytokines, immunoglobulins
• .10 Endotoxin tests
• .13 Bioassays of immunological products
  - Viral and bacterial vaccines
• .20 Potency of immunological products
  - Viral and bacterial vaccines

8.06 Microbiological tests on veterinary products

• .24 Microbioassay of antibiotics

8.07 Microbiological tests on pharmaceuticals

• .24 Microbioassay of antibiotics

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New email address for TGA Recalls

The TGA has established a general email address for recalls and medicine problem reports. This new email address is TGA.Recalls@tga.gov.au.

The address has been established to assist health care professionals, sponsors and members of the public to report defects that affect the quality, safety or efficacy of therapeutic goods that may require either recall action or to initiate a medicine problem investigation.

In accordance with current protocols, reports relating to Adverse Drug Reactions should continue to be directed to adrac@tga.gov.au and those relating to a Medical Device Incident Report referred to the Device Incident Reporting and Investigation Scheme at iris@tga.gov.au.

Report on the 18th Therapeutic Goods Committee meeting

The 18th meeting of the Therapeutic Goods Committee (TGC) was held on 14 June 2001. The main outcomes of the meeting were:

1. Commencement of consultation with peak therapeutic goods industry associations on the adoption of the British Pharmacopoeia 2001 (BP 2001) for the purposes of the edition of the British Pharmacopoeia defined under the Therapeutic Goods Act 1989. It is proposed that the BP 2001 be adopted from 1 December 2001. A formal recommendation on this will be made at the Committee's next meeting.
2. Ongoing action by the TGA to progress the harmonisation of the names of approximately 200 substances included in the Australian Approved Names Chemical Substances List with the names of the British Pharmacopoeia which have been amended to correspond with International Nonproprietary Names.
3. Resolution of final issues relating to the draft of Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69) and a recommendation that this new Order be adopted. (See related article on TGO 69 under Medicines <http://www.tga.gov.au/docs/html/tganews/news36/med.htm#tgo>).
4. A recommendation for revocation of the following TGOs created prior to 1990 which are no longer current in terms of best practice or the current regulatory framework:
   • TGO 9 Standard for B. abortus. Rose-Bengal Antigen;
   • TGO 10 Standard for B. abortus. Milk Ring Test Antigen;
   • TGO 12 Standard for Sterility of Intramammary Injections;
   • TGO 21 General Standard for Live Avian Viral Vaccines; and
   • TGO 30 Standards Adopted from the British Pharmacopoeia (Veterinary) 1985, the British Pharmacopoeia (Veterinary) 1977 and the British Veterinary Codex 1965, Supplement 1970.
5. A recommendation for adoption in Australia of the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients as a Manufacturing Principle for active pharmaceutical ingredients used in prescription medicines. (See related article under Manufacturing <http://www.tga.gov.au/docs/html/tganews/news36/manuf.htm#api>).
6. The endorsement of a range of medical device standards appropriate for gazettal in Australia as Medical Device Standards or Conformity Assessment Standards under the new Medical Device Regulatory System.

Tamper evident packaging guidelines

Therapeutic goods industry associations, in cooperation with the TGA, State and Territory Health Departments and consumers, have developed the Guidelines for the Tamper-Evident Packaging of Medicines, Complementary Healthcare Products and Medical Devices.

Tamper evident packaging systems introduce an indicator or barrier to entry which, if breached or missing, can reasonably be expected to provide visible or audible evidence to consumers that tampering has occurred. The visual indications are required to be accommodated by appropriate precautionary label statements that describe the tamper-evident feature(s) to the consumer and to warn that the absence of or damage to such feature(s) at the time of purchase is an indication of possible tampering with the product.

The guidelines reflect world best practice, drawing from previous Australian requirements and the most recent developments in the United States, the United Kingdom, Canada and New Zealand. Currently, application of the guidelines by industry is voluntary, although a number of industry organisations require use of the Guide by their membership.

A phase-in period of three years has been agreed to before the requirements become mandatory for therapeutic goods in Australia.

Copies of the guidelines may be obtained from the TGA or from the following industry organisations: Australian Self-Medication Industry Inc. (ASMI), Australian Pharmaceutical Manufacturers Association (APMA), the Complementary Healthcare Council of Australia (CHC), the Medical Industry Association of Australia (MIAA) or the Consumers Health Forum (CHF).