Therapeutic Goods Information (Joint Recalls Portal) Specification 2013

Link to law: https://www.comlaw.gov.au/Details/F2013L00640

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Therapeutic Goods Information (Joint Recalls Portal) Specification 2013
Therapeutic Goods Act 1989
I, ANDREW STUART, acting National Manager of the Therapeutic Goods Administration and delegate of the Minister for Health, make this Specification under subsection 61(5D) of the Therapeutic Goods Act 1989.
Dated 8 April 2013
 
(Signed by)
 
ANDREW STUART
Acting National Manager
Therapeutic Goods Administration
Delegate of the Minister for Health
1              Name of Specification
                This Specification is the Therapeutic Goods Information (Joint Recalls Portal) Specification 2013.
2              Commencement
                This Specification commences on the day after it is registered.
3              Definitions
                In this Specification:
Act means the Therapeutic Goods Act 1989.
ARTG means the Australian Register of Therapeutic Goods.
Australian Responsible Entity means, in the case of therapeutic goods supplied in Australia, the person in relation to whom the goods are included in the ARTG or, in the case of therapeutic goods not on the ARTG, the supplier of those therapeutic goods or any other person who undertakes the recall action in Australia.
Medsafe means the New Zealand Medicines and Medical Devices Safety Authority, within the New Zealand Ministry of Health.
New Zealand Responsible Entity means the person who imports, manufactures or distributes the therapeutic goods, or any other person who undertakes the recall action, in New Zealand.
Recall action means action taken by:
·         the Australian Responsible Entity in relation to resolving a problem with therapeutic goods supplied in Australia; or
·         the New Zealand Responsible Entity in relation to resolving a problem with therapeutic goods supplied in New Zealand,
where the therapeutic goods have, or may potentially have, deficiencies relating to safety, quality, efficacy or presentation.  Recall actions may include: the permanent removal of therapeutic goods from supply in the market; the taking of corrective action in relation to therapeutic goods, such as repair, modification, adjustment or relabelling; and, in the case of medical devices that have been implanted into patients, the issuing of a hazard alert containing information for health practitioners on how to manage such patients.
TGA means the Therapeutic Goods Administration, being a division of the Department of Health and Ageing.
4              Therapeutic goods information
                The kinds of therapeutic goods information mentioned in Schedule 1 are specified under subsection 61(5D) of the Act for the purposes of subsection 61(5C) of the Act.
Schedule 1        Specified kinds of therapeutic goods information
(section 4)
 
 
The following kinds of therapeutic goods information:
Note:      The following specified kinds of therapeutic goods information may be released by the Secretary to the public under subsection 61(5C) of the Act.
 
Recall actions in Australia
 
(a)           information in relation to recall actions in Australia, being information kept by the TGA in its Joint Recalls Portal, of a kind set out below:
(i)                 the country of the recall action;
(ii)               the recall commencement date, being the date on which the recall action commenced;
(iii)             a description of the therapeutic goods being recalled, including the brand name(s) of the goods, any active ingredients in the goods (where relevant) and any other information that is necessary to identify the goods;
(iv)             the product type, e.g., whether it is a medicine or a medical device;
(v)               the recall action taken, e.g., whether the therapeutic goods have been or are being permanently removed from the market, whether other corrective action has been, or is being, taken or if a hazard alert has been issued;
(vi)             the class of recall, being Class I, Class II or Class III, with Class I representing the greatest risk and Class III the lowest risk, to safety;
(vii)           the level of recall action that has been or is being taken, e.g., whether it is a recall of therapeutic goods from hospitals, wholesalers, retailers and/or consumers;
(viii)         the ARTG number of the recalled goods (where applicable), being the identifier number for the therapeutic goods that are registered, listed or included in the ARTG;
(ix)             the TGA recall reference, being the unique identifier number the TGA gives to the recall action;
(x)               the Australian Responsible Entity;
(xi)             recall instructions, being instructions given by the TGA or the Australian Responsible Entity to health practitioners or consumers in relation to the recalled therapeutic goods; and
(xii)           contact information, being information about the person that the customer or consumer should contact for additional information about the therapeutic goods the subject of the recall action (e.g., a representative of the Australian Responsible Entity).
 
 
 
Recall actions in New Zealand
 
(b)          information in relation to recall actions in New Zealand, being information provided by Medsafe to the TGA and kept by the TGA in its Joint Recalls Portal, of a kind set out below:
(i)                 the country of the recall action;
(ii)               the recall commencement date, being the date on which the recall action is commenced;
(iii)             a description of the therapeutic goods being recalled, including the brand name(s) of the goods, any active ingredients in the goods (where relevant) and any other information that is necessary to identify the goods;
(iv)             the product type, e.g., whether it is a medicine or a medical device;
(v)               the recall action taken, e.g., whether the therapeutic goods have been or are being permanently removed from the market, whether other corrective action has been, or is being, taken or if a hazard alert has been issued;
(vi)             the class of recall, being Class I, Class II or Class III, with Class I representing the greatest risk and Class III the lowest risk, to safety;
(vii)           the level of recall action that has been or is being taken, e.g., whether it is a recall of therapeutic goods from hospitals, wholesalers, retailers and/or consumers;
(viii)         the Medsafe recall reference, being the unique identifier number Medsafe gives to the recall action;
(ix)             the New Zealand Responsible Entity;
(x)               recall instructions, being instructions given by Medsafe or the New Zealand Responsible Entity to health practitioners or consumers in relation to the recalled therapeutic goods;
(xi)             the manufacturer of the therapeutic goods; and
(xii)           contact information, being information about the person that the customer or consumer should contact for additional information about the therapeutic goods the subject of the recall action (e.g., a representative of the New Zealand Responsible Entity).
 
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