Therapeutic Goods Information (Stakeholder Consultation on Database of Adverse Event Notifications) Specification 2012

Link to law: https://www.comlaw.gov.au/Details/F2012L00972

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Therapeutic Goods Information (Stakeholder Consultation on Database of Adverse Event Notifications) Specification 2012
Therapeutic Goods Act 1989
I, BRIAN RICHARDS, a delegate of the Minister for Health, make this Specification under subsection 61(5AB) of the Therapeutic Goods Act 1989.
Dated   24   April 2012
 
(signed by)
BRIAN RICHARDS
Delegate of the Minister for Health
1              Name of Specification
                This Specification is the Therapeutic Goods Information (Stakeholder Consultation on Database of Adverse Event Notifications) Specification 2012.
2              Commencement
                This Specification commences on the day after it is registered.
3              Definitions
                In this Specification:
Act means the Therapeutic Goods Act 1989.
Adverse event means any untoward medical occurrence in a patient administered medicine and which does not necessarily have to have a causal relationship with this treatment.  An adverse event can therefore be any unfavourable and unintended sign (for example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicine, whether or not considered related to this medicine.
Register means the Australian Register of Therapeutic Goods.
TGA means the Therapeutic Goods Administration.
4              Therapeutic goods information, persons and purposes
                The kinds of therapeutic goods information and persons, and the bodies and purposes, mentioned in Schedule 1 are specified for the purposes of subsection 61(5AB) of the Act.
Schedule 1        Specified kinds of therapeutic goods information and persons, and specified bodies and purposes
(section 4)
 
 
The following kinds of therapeutic goods information, bodies, persons and purposes:
 
Note:      The following specified kinds of therapeutic goods information may be released by the Secretary under subsection 61(5AA) of the Act to the following specified bodies and kinds of persons for the following specified purposes.
 
1              List of Reports in relation to a medicine
 
(a)     the information provided to the TGA by users, medical practitioners or other persons, when reporting an adverse event in relation to a medicine in relation to a person, and recorded by the TGA under or in relation to the headings set out in the below table, being information kept by the TGA in the prototype of the database of adverse event information (the Database of Adverse Event Notifications, or DAEN) and able to be extracted from that database as part of a document titled a List of Reports, for any particular period of time:
 
Medicine
Other medicine taken at time of the adverse event (if any)
Age[1]
 
(aa)    the information listed below that is derived by the TGA from, or allocated by the TGA in relation to, the information provided by the person reporting an adverse event in relation to the medicine, being also part of the information that is kept by the TGA in the prototype of the database of adverse event information (the DAEN) and able to be extracted from that database as part of a document titled List of Reports:
 
(i)       the report entry date, being the date that the reported adverse event is recorded by the TGA[2];
(ii)     the adverse event description term that relates to the reported adverse event as described in the Medical Dictionary for Regulatory Activities (MedDRA)[3]; and
(iii)   the unique case number allocated by the TGA to the adverse event report;
 
 
(b)     the following bodies and kinds of persons:
 
(i)            the Australian Consumers Association;
(ii)          the Consumers’ Health Forum of Australia;
(iii)        the Australian Medical Association;
(iv)        AusBiotech;
(v)          the Australian Self-Medication Industry Incorporated;
(vi)        the Complementary Healthcare Council of Australia;
(vii)      Generic Medicines Industry Association of Australia;
(viii)    IVD Australia;
(ix)        Medicines Australia;
(x)          the Medicines and Medical Devices Safety Authority, of New Zealand (Medsafe);
(xi)        the New Zealand Ministry of Health;
(xii)      the New Zealand Pharmacovigilance Centre, University of Otago, New Zealand;
(xiii)    Medicines New Zealand;
(xiv)    the New Zealand Self Medication Industry Association Incorporated; and
(xv)      employees, members or agents of the bodies mentioned in (i) – (xiv) above;
 
(c)     for the purposes of obtaining feedback from the bodies and persons mentioned in paragraph (b) about the functionality, suitability (in terms of informing the public about adverse events involving medicines) and presentation of the TGA’s prototype of the database of adverse event information (the DAEN) as part of the development and improvement of that database.
 
2               Medicine Summary in relation to a medicine
 
(a)     the information listed below, collated by the TGA in relation to a medicine based on information provided to the TGA by users, medical practitioners or others, when reporting an adverse event in relation to the medicine in relation to a person, being part of the information kept by the TGA in the prototype of the database of adverse event information (the Database of Adverse Event Notifications) and able to be extracted from that database in the form of a document titled a Medicine Summary, for any particular period of time:
(i)                 the number of cases of reported adverse events in Australia for the medicine;
(ii)               the number of such cases reported to have resulted in death;
(iii)             the number of such cases in which the medicine was reported to be the sole suspected medicine (that is, the only medicine suspected of being related to the reported adverse event);
(iv)             the system organ class terminology, as described in the MedDRA, for the part of the body which each adverse event was reported as affecting (e.g. the cardiovascular system); and
(v)               the MedDRA adverse event description term that relates to each reported adverse event (e.g. an injection site reaction);
 
(b)     the following bodies and kinds of persons:
 
(i)                 the Australian Consumers Association;
(ii)               the Consumers’ Health Forum of Australia;
(iii)             the Australian Medical Association;
(iv)             AusBiotech;
(v)               the Australian Self-Medication Industry Incorporated;
(vi)             the Complementary Healthcare Council of Australia;
(vii)           Generic Medicines Industry Association of Australia;
(viii)         IVD Australia;
(ix)             Medicines Australia;
(x)               the Medicines and Medical Devices Safety Authority, of New Zealand (Medsafe);
(xi)             the New Zealand Ministry of Health;
(xii)           the New Zealand Pharmacovigilance Centre, University of Otago, New Zealand;
(xiii)         Medicines New Zealand;
(xiv)         the New Zealand Self Medication Industry Association Incorporated; and
(xv)           employees, members or agents of the bodies mentioned in (i) – (xiv) above;
 
(c)     for the purposes of obtaining feedback from the bodies and persons mentioned in paragraph (b) about the functionality, suitability (in terms of informing the public about adverse events involving medicines) and presentation of the TGA’s prototype of the database of adverse event information (the DAEN) as part of the development and improvement of that database.
 
Note
1.       All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See http://www.frli.gov.au
 

[1]           Meaning the age of the person reported to have suffered the adverse event.
[2]           This date will in most cases be the same date or very close in time to the date that the adverse event was reported.
[3]           MedDRA is an internationally recognised set of terms relating to medical conditions, medicines and medical devices, maintained and distributed by the MedDRA Maintenance and Support Services Organisation (MSSO).  The MedDRA is available for viewing by subscribers to the MSSO’s services from www.meddramsso.com.