Summary for ARTG Entry:
Musculoskeletal Tissue - DBX Putty - Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes - Paste -
ARTG entry for
Biological Included Class 3
Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
PO Box 134,NORTH RYDE, NSW, 2113
ARTG Start Date
Included Class 3
Conditions applicable to all included biologicals as specified in section 32EA of the Act.
1. DBX Putty
DBX is indicated for treatment of surgically created osseous defects or osseous defects created from
traumatic injury. DBX can be used as an extender in orthopaedic spine and trauma use with autograft,
allograft and bone marrow aspirate.
6) The sponsor must comply with any reporting requirements that are prescribed. For the purpose of this condition the reporting requirements set out in
section 32 DQ of the Act must be complied with, specifically the Sponsor must inform the Secretary in writing, within the periods specified in the
regulations, of: a) information that contradicts information already given by the person under this Act in relation to the biological (including information
given about the quality, safety or efficacy of the biological): b) information that indicates that the use of the biological in accordance with the
recommendations for its use may have an unintended harmful effect and: c) information that indicates that the biological, when used in accordance with
the recommendations for its use, may not be as effective as the application for inclusion of the biological in the Register or information already given by
the person under this Act suggests. Note: Section 32DQ of the Act also provides for penalties where the Sponsor of the goods fails to inform the
Secretary in writing of the matters set out in section 32DQ.
5) The DBX Putty Risk Management Plan (RMP), version AE, dated 06 June 2013, included with submission BIO-2011-BA-00004-3, and any
subsequent revisions, as agreed with the TGA must be implemented in Australia. An obligatory component of the Risk Management Plan applicable to
this therapeutic good is Routine Pharmacovigilance. Routine Pharmacovigilance includes the submission of Periodic Safety Update Reports (PSURs).
The reports must meet the requirements for Periodic Safety Update Reports as described in the European Medicines Agency's Guideline on Good
Pharmacovigilance Practices (GVP) Module VII-Periodic Safety Update Report. Each report must have been prepared within seventy calendar days of
the data lock point for that report, as required by the European Medicines Agency's Guideline for PSUR's covering intervals up to 12 months (including
intervals of exactly 12 months). Unless agreed separately between the supplier who is the recipient of the approval and the TGA, the first report must be
submitted to TGA no later than 15 calendar months after the date of this letter. The subsequent reports must be submitted no less frequently than
annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of this approval
letter. No fewer than three annual reports are required. The annual submission may be made up of two Periodic Safety Update Reports each covering
six months. If the sponsor wishes, the six monthly reports may be submitted separately as they become available. Another obligatory component of the
Risk Management Plan applicable to the therapeutic good is traceability of the biological material from the point of collection of donor tissue through to
4) The actual date of commencement of supply of the therapeutic good must be notified to the Director, Biological Sciences Section of the TGA. Should it
be decided not to proceed to supply the therapeutic good in Australia, notification to this effect must be provided to the Director, Biological Sciences
Section of the TGA. A copy of the notification form has been provided as Attachment 5
3) Promotional material relating to the therapeutic good must comply with the requirements outlined in the Code of Conduct of Medicines Australia,
Edition 17 effective 11 January 2013 (http://medicinesaustralia.com.au/code-of-conduct/)
2) Changes or variations in respect of any information concerning the therapeutic good that would have been relevant to a decision to include the goods
in the ARTG, shall be notified to the Secretary, or the Secretary's delegate appointed for the purposes of section 32ED of the Act. This includes
information on the formulation of the goods or other aspects of their manufacture and the labelling of the goods. The change or variation shall not be
implemented until approved by the Secretary
1) The therapeutic good must be supplied with the Product Insert at Attachment 4. Any proposed changes to the approved text of the PI must be
submitted to, and be approved by, the TGA prior to distribution
© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.
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Produced at 22.11.2017 at 11:49:42 AEDT
This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information