The Australia New Zealand Therapeutic Products Authority Newsletter 2

The Australia New Zealand Therapeutic Products Authority Project
Newsletter No 2, August 2006

This newsletter aims to provide regular information and updates to New Zealand industry and other stakeholders about the proposal to establish a trans-Tasman regulator for therapeutic products.

Update from the State Services Minister, Hon Annette King

As you will be aware, the first set of consultation documents on the proposed joint regulatory scheme was released for comment and feedback in May. There is just over a week to go until submissions close on the draft Rules for medicines, medical devices and administrative matters, along with the discussion paper on the proposals for fees and charges.

Consultation with industry and consumers on these proposals is crucial in ensuring the new regulatory scheme is workable and meets the overall objective of safeguarding public health and safety. This is your opportunity to provide input into how the scheme will operate. I want your feedback about the proposals and I am committed to ensuring that comments made as part of submissions are taken into account and reflected in the final Rules.

Many of your views have been heard, such as those raised by the medical devices industry about the recognition of third party conformity assessments under the joint Authority. I would like to take this opportunity to reassure you that this will be a reality under the scheme. In addition, I am prepared to look at options to assist industry in stepping up into the scheme. It is also important to remember that the paper on the proposed fees and charges is a discussion paper and your views and input into the development of this proposal is needed.

As part of the consultation process a number of stakeholder meetings have been held around the country. One of these was a consultation hui held in Rotorua. There is a lot of incorrect and misleading information being circulated about the joint therapeutic products regulatory scheme and it is important that discussion about these proposals is well informed, particularly around areas such as practitioners, traditional healers and Rongoa Māori. If you have heard that practitioners, traditional healers or Rongoa Māori would be affected – this is not true. None of these will come under the joint scheme and nor will they regulated by it. In addition, the views tabled with officials at the hui have been passed onto my office for consideration.

I look forward to providing you, from time to time, with updates as part of this regular newsletter.

Further details about the current consultation phase

The consultation documents on the draft Rules for medicines, medical devices and administrative matters, along with the discussion paper on the proposals for fees and charges can be found on the Australia New Zealand Therapeutic Products Authority (ANZTPA) website at: http://www.anztpa.org.nz/consult/consdocs1.htm

Submissions on these documents close at the end of business on Tuesday, 15 August 2006.

Making a submission

When making a submission it would be helpful to clearly state the consultation document that the submission relates to and includes specific references to the part or division of the draft Rule that is being commented on.

Including a completed cover form with each submission will also help with the process of efficiently analysing submissions. The cover form, which includes information such as name or company name and contact details, is available on the ANZTPA website at: http://www.anztpa.org.nz/consult/consdocs1.htm

If there information provided as part of a submission that you would like to keep confidential, please indicate this where appropriate. For submissions on the discussion paper on the proposed fees and charges there is a separate cover form and submission template available on the website at: http://www.anztpa.org.nz/consult/dr-fees-subform.rtf and http://www.anztpa.org.nz/consult/dr-fees-subtemplate.rtf

Submissions can either be emailed to:
consultation@anztpa.org

Or sent by post in New Zealand to:
C/- Joint Authority Establishment Group
Medsafe, Ministry of Health
PO Box 5013
Wellington

Submissions will be analysed jointly by New Zealand and Australian officials from Medsafe, the Ministry of Health, the Therapeutic Goods Administration and the Department of Health and Ageing and recommendations will then be made to the Ministers on the Therapeutic Products Interim Ministerial Council. A summary of submissions will be published and is expected to be available around November.

Consultation on the Microbiological Standards for Medicines

A paper on the proposed joint microbiological standards for medicines has been released for consultation. The consultation paper seeks stakeholder input into the microbiological standards for medicines under the proposed joint regulatory scheme.

The principal issues under consideration include how the preservative efficacy of sterile and non-sterile multidose medicines, and the microbial attributes of non-sterile medicines, can be assured. Submissions close on 15 September 2006.

Further details, along with copies of the consultation paper can be found online at: http://www.anztpa.org/consult/microbiological.htm

Hui presentation

The presentation from the consultation hui is available on the ANZTPA website at. http://www.anztpa.org/consult/060710pres-hui.htm

The hui, which was held at the beginning of July in Rotorua, provided an opportunity for members of the Māori community, traditional healers and those with a special interest in the traditional medical system, Rongoa Māori, to find out more about the proposed joint regulatory scheme for prescription and over-the-counter medicines, complementary medicines and medical devices. It also provided an opportunity to reinforce some important messages around areas that will not be covered by the joint scheme such as practitioners and Rongoa Māori. Traditional Māori healers and Rongoa Māori will not come under the joint scheme and will not be regulated by the proposed joint Authority.

Homoeopathic and anthroposophic medicines

Workshops to clarify the proposed approach to the regulation of homoeopathic and anthroposophic medicines, and essences were recently held in Auckland and Sydney. Topics discussed included an overview of the proposed regulatory scheme and processes along with discussion around the summary of the outcomes from the consultation on homoeopathic and related medicines, which was released for consultation in January 2005.

Further information, including the presentation can be downloaded from the ANZTPA website at: http://www.anztpa.org/cm/0607pres-is-hae.htm

Workshops on fees and charges proposals

Four focus workshops have been held with the peak industry body groups for complementary medicines, medical devices and prescription and non-prescription medicines. These provided a forum for the main groups and bodies representing industry to discuss some of the modelling and assumptions used to develop the discussion paper on the proposed fees and charges.

Child resistant packaging

The Joint Therapeutic Goods Subcommittee on Child Resistant Packaging met at the end of July and considered the summary of submissions on the child resistant packaging requirements for therapeutic goods. Submissions closed on 4 April 2006 and 33 submissions were received. It has been agreed that once the draft Order has been amended to reflect changes agreed following the first round of consultation, there will be a further opportunity to comment on the proposals.

Interim Joint Expert Advisory Committee on Complementary Medicines

The Advisory Committee met last month and considered a number of new substances that have been evaluated as part of the Permitted Ingredients List project. Work on this project is ongoing and involves the evaluation, free of charge, of complementary medicine substances which are unique to New Zealand or are not currently permitted in listable medicines in Australia. This work will go towards the creation of a joint Permitted Ingredients List under the proposed joint Authority. Further information about this project, including details about the substances recommended for approval is expected to be made available in the coming weeks.

Upcoming events

The second consultation phase on the proposed joint regulatory scheme is due to begin around mid-September 2006. This phase will include the release of the advertising and the blood and blood component draft Rules and further components of the draft Administration Rule.

The third consultation phase on the proposed joint regulatory scheme is scheduled to take place in March 2007.