Current Affairs
September - October 2010 Issue 102 Published by Robert Forbes & Associates Pty Ltd
http://www.robert-forbes.com/
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RFA News
RFA offers new training on GMP responsibilities
RFA is offering a ½ day (4 hours) training session at our Glebe office on the new manufacturing principles that became mandatory 1st July for Australian medicines after the adoption of the PIC/S Guide to GMP for Medicinal Products 2009. The agenda will cover:

product quality reviews
ongoing stability programs
how to review your contractual arrangements
reference and retention samples
complaints and product recalls

Training sessions are conducted for up to four people, from one company only at a time. For further information please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

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Medicines
TGA News

Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 & 8
Wholesaling forms part of the supply chain for medicines in Schedules 2, 3, 4 and 8. Wholesalers are responsible for the effective, efficient and safe handling, storage and distribution of those medicines. Medicines in Schedules 2, 3, 4 and 8 need to be stored and distributed in accordance with the label requirements of the sponsor, State and Territory legislation and this Code. Although it is a Code of Practice and not legislation, compliance with it may be made mandatory in States and Territories.
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TGA internet site redevelopment
Consultation is underway with interested parties on options for the redevelopment of the TGA website and their preferred methods of receiving communications from the TGA.
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2010-11 annual charges - low value turnover exemption applications by new date
Sponsors wishing to apply for an exemption from an annual charge in relation to therapeutic goods entered in the ARTG on the grounds of ?low value turnover? must apply before the 31 October 2010.
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Sibutramine (Reductil) ? withdrawal in Australia
Following discussions with the TGA, Abbott Australasia ceased supply of sibutramine (Reductil) in Australia from 9 October 2010. Sibutramine, marketed in Australia as Reductil, is a prescription medicine indicated for weight loss. Marketing of sibutramine in Europe has already been suspended by the European Medicines Agency (EMA). These regulatory actions follow an analysis of the results of a major study known as the Sibutramine Cardiovascular OUTcomes (SCOUT) study, which showed a higher rate of cardiovascular events in obese and overweight patients using sibutramine than in patients managing their weight through exercise and diet alone.
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Technical working groups
Technical working groups (TWG) have been established by the TGA's Office of Manufacturing Quality (OMQ) to bring together manufacturing technical expertise from industry and the regulator to address the grey areas or vagaries of the cGMP as it relates to manufacturing. Updated technical guidance documents on the interpretation of manufacturing standards are available for:
On-going stability testing for listed complementary medicines
Product quality reviews for listed complementary medicines
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Australian regulatory guidelines for GMP clearance for overseas manufacturers
The TGA invites sponsors and manufacturers to comment on a revision of the guidance document provided by the TGA for the assessment of GMP compliance for overseas manufacturing sites. The main changes to the current guidance document include:
clarification of assessment requirements and processes for getting GMP clearance for overseas manufacturing sites;
the addition of a list of sponsor responsibilities in obtaining and maintaining those clearances;
amended evidential requirements to address difficulties experienced by sponsors in obtaining particular documents from regulators and manufacturers (including delays in the release of inspection reports);
a description of the criteria used for granting clearance approval and determining its duration;
the addition of TGA performance timeframes for the assessment of applications;
new provisions describing the circumstances in which an application will be rejected or lapse; and
the addition of procedures for the review of GMP clearance assessments.
Comments on the draft guidance should be submitted by 15 November 2010.
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Australian state and territory variations from part 4 of the poisons standard
Part 4 of the Poisons Standard is a record of decisions regarding the classification of medicines and chemicals into schedules. States and territories can refer to the Poisons Standard as published or enact state or territory variations to the Poisons Standard. Variances in each state and territory from part 4 of the Poisons Standard is updated annually.
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Invitation for public comment - ACMS and joint ACMS/ACCS meetings
Public comment is invited under on proposed amendments to the Poisons Standard which will be referred to an expert advisory committee for scheduling advice. The notice includes references to rescheduling cough and cold medicines, including sodium lauryl sulfate in appendix E with appropriate labelling statements and including triclosan in schedule 6. The closing date for submissions is Friday 29 October 2010.
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Scheduling of medicines and poisons - delegate's decisions (Aug 2010)
A summary of reasons for amendments to the Standard for the Uniform Scheduling of Medicines and Poisons is available. There is a new schedule 4 entry for omega-3-acid ethyl esters (excluding salts and derivatives) for human therapeutic use, for the treatment of post-myocardial infarction and / or hypertriglyceridaemia.
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Consultation on draft compositional guidelines
Currently consultation on two draft compositional guidelines is underway:
Caralluma adscendens var. fimbriata (due 5 Nov 2010)
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Wheat dextrin (due 9 Nov 2010)
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Questions and answers on the code of good manufacturing practice
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Contact details for uniform recall procedure for therapeutic goods (URPTG) updated
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Membership of national coordinating committee on therapeutic goods (NCCTG) updated
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Medicines safety update No5 2010
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Foods
FSANZ (Food Standards Australia New Zealand) update

Food standards gazette ? amendment 118 and 119
Amendment 118 was gazetted on 2 September 2010. The applications under which these amendments are made are:
Application A1029 ? food derived from drought-tolerant corn line MON87460
Application A1035 ? food derived from insect-protected soybean line MON87701

Amendment 119 was gazetted on 30 September 2010. The application and proposal under which these amendments are made are:
Application A1036 ? lipase derived from Aspergillus niger as a processing aid
Proposal M1005 ? maximum residue limits (April?September 2009)
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Food standards news - spring edition 74
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Cosmetics
NICNAS News

Chemical gazette October 2010
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Conferences & Meetings
ASMI Conference & AGM ? Bringing Self Care to Life
November 18, Australian Technology Park, Redfern, Sydney
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Natural Products Expo West
March 11 ? 13, 2011 Anaheim Convention Centre, Anaheim, CA, USA
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Natural & Organic Products Europe
April 3 - 4, 2011 Olympia, London
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Vitafoods International
May 10 ? 12, 2011 Geneva Palexpo, Switzerland
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GMP Management Course
ASMI in partnership with the Advanced Manufacturing Centre and the University of NSW has created a course on GMP management which culminates in a graduate certificate. This course is open to members and non-members of ASMI.
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RFA Training Courses
New half-day course now available:
Overview of GMP responsibilities ? including product quality reviews, stability, GMP contract agreements

Half day (4 hour) courses
Overview of the food/therapeutic/cosmetic interface
Cosmetic regulation
Medicines - advertising code
Medicines - product claims and indications
Listed complementary medicines - TGA eBS online applications
Medicines ? the sponsor's finished product specifications
Overview of advertising regulations for foods, cosmetics and medicines, for marketing executives

Full day course
Food Standards

For more information visit the RFA website

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