ARTG enquiries

A reminder that the ARTG Section and its functions have been devolved to other areas within the TGA.

From 30 November 2002 the old ARTG phone numbers will be disconnected. The following numbers should be used for ARTG queries:

Query	Phone Number
Medical devices	1800 141 144
Non-prescription medicines	02 6232 8465
Prescription medicines	02 6232 8135
AANs and Proprietary Ingredients	02 6232 8465
ELF Help Desk	02 6232 8998
SIME Help Desk	1800 010 624
Requests for batch reports	1800 010 624

ARTG and DEAL now online

The TGA has recently launched two new phases of the SIME project. If you are a Sponsor of a therapeutic good available for sale in Australia or if you are an Agent of a Sponsor, you can now view your Australian Register of Therapeutic Goods (ARTG) records online via the Internet. You can also view your contact details and access the TGA code tables. If you are a Sponsor or Agent wishing to submit an application for entry onto the ARTG against the information requirements of the new medical device legislation, you can now do so online.

Sponsors and Agents are now able to view, via the Internet, all ARTG records to which they are legally entitled. All Sponsors and Agents who currently have a product on the ARTG should have received a letter explaining how to gain access to the online systems. If you are uncertain whether your organisation has received a letter, please contact the TGA SIME Help Desk by email at ebs@tga.gov.au.

The submission of Manufacturer Certificates (Evidence) through the SIME DEAL system has been in place for the past eighteen months. Medical Device Sponsors and Agents have been using the online entry as an alternative to meet GMP pre-clearance requirements for registered and listed ARTG device applications. The second part of the DEAL system was released in October to coincide with new medical device legislation. Sponsors and Agents can now submit both a manufacturer's evidence of conformity and an application for entry onto the ARTG. The manufacturer evidence notification will electronically interface to the ARTG entry application form and pass predetermined information to reduce user keying and to assure data quality. This applies to all Included medical devices other than a Class 1.

If you have any questions, would like to gain access to the online systems or would like further information, please contact the TGA SIME Help desk by email at tga.sime@tga.gov.au.

TGA internationally recognised for criminal investigations

The Therapeutic Goods Administration has been recognised internationally for its efforts in combating pharmaceutical crime.

TGA staff and PFIPC award

At the August 2002 meeting of the Permanent Forum on International Pharmaceutical Crime (PFIPC) in South Africa, Mr Horace Coleman, Deputy Director Investigations, of the United States Food and Drug Administration (FDA), presented the TGA with the "Director's Award". It was "In Appreciation for Exceptional Support and Assistance Provided to the FDA Office of Criminal Investigations".

Mr Stephen Howells, Head of TGA Surveillance, said that although we were focussed on the investigation of crime involving therapeutic goods within Australia, we recognise that the trade in pharmaceuticals is trans-national in nature and as a consequence, so is pharmaceutical crime. "Cooperation between agencies is essential in combating the trade in sub-standard and counterfeit medicines," Mr Howells said.

The Permanent Forum on International Pharmaceutical Crime is an international forum aimed at exchanging information and ideas to foster mutual cooperation in combating pharmaceutical crime.

Member agencies are drug regulatory authorities, police services or other public bodies active in the enforcement of pharmaceutical crime in their respective country. The PFIPC also works in cooperation with a separate Forensic Group, which provides scientific expertise; and with other interested bodies including the World Health Organization, the World Customs Organization, and INTERPOL.

Australia is a member of the PFIPC, represented at the Enforcement Group by the TGA Surveillance Unit, and at the Forensic Group by the TGA Laboratories Branch.

The PFIPC's Director's Award followed the assistance given by the TGA Surveillance Unit, which resulted in an Australian citizen being sentenced to fifteen years imprisonment for illegally offering prescription drugs over the Internet.

The TGA Surveillance Unit was involved in the lengthy US investigation, which was lead by the FDA's Office of Criminal Investigations.

United States District Judge Anthony Alaimo imposed the sentence of 188 months (over 15 years imprisonment) on 23 counts of conspiracy to commit violations of the Federal Food, Drug and Cosmetics Act; conspiracy to commit money laundering; mail fraud; dispensing misbranded drugs; and operating a drug repackaging facility that was not registered with the FDA.

Ms Leura Garrett Canary, United States Attorney for the Middle District of Alabama, said the sentencing in this case demonstrated that unscrupulous business practices on the Internet would not be tolerated. "This case sends a message to those who seek to circumvent the laws protecting the health and safety of consumers," Ms Garrett Canary said. "I commend the investigators and prosecutors for their dedication and hard work in collecting and presenting the evidence to achieve this just result," she said.

Trans Tasman agency

The discussion paper A proposal for a trans Tasman agency to regulate therapeutic products was released in June 2002 and submissions were received up until the end of August 2002. Submissions were received from industry and industry associations covering prescription medicines, OTC medicines, complementary medicines and medical devices; health care professional associations; consumers; and Commonwealth and State government agencies. Forty submissions were received in total, the majority of which included responses to most or all of the questions in the discussion paper.

Subject to final approval by both the Australian and New Zealand governments, the Trans Tasman Project Team will be developing final proposals for a joint agency and preparing drafting instructions for the new legislation over the next few months. In developing final proposals, the project team will take into account the comprehensive stakeholder comments and will continue to consult with stakeholders on detailed elements of the joint scheme.

Further information on the trans Tasman agency is available on the JTA Project website <http://www.anztpa.org>.