Argentina - Drug Information Association

document stresses on the following points: -Every new application for clinical pharmacology research initiated from 08-Nov-
2010 must comply with the requirements established by Disposition 6677/10, as well as periodic and final reports submitted
or accepted before 08-Nov-2010. Witnesses are always required for informed consents accepted under the regime of
Disposition 5330/97. - Treatments and procedures related to a clinical pharmacology research are financed by sponsors and
free of charge for all participants. -Authenticate copies of professional title and license, as well as copies of the proofs of
training and/or experience in clinical research must be provided. -An Informed Consent is required from the participant to
clinical research or its representative when necessary. The Informed Consent specifies the age for which a written consent is
required. -A witness is required in two cases: + In case of educational, cultural, social or economic vulnerability of the
participant, during the informed consent process. +To sign a written summary of oral information bandied about severe
situations. -Sponsors must inform the ANMAT of serious and unexpected adverse drug reactions related to the
investigational product within 10 days after taking notice of it. This document also details the way to comply with this
requirement. Sponsors must inform investigators of serious and unexpected adverse drug reactions related to the
investigational product within 14 days after taking notice of it.
Comment: This document should be read together with Disposition 6677/2010: Adopts Good Practices in Clinical
Pharmacology Research, 01-Nov-2010 (115291).
Document date: Jan-2011
Type of text: Other texts
Regulatory version: None
Language: Spanish
Australia
Australia - Act: National Health Act 1953, consolidated version as of 01-Feb-
2011
This document is the current act compilation relating to the provision of pharmaceutical, sickness and hospital benefits, and
of medical and dental services. This compilation incorporates Amendments up to the Act No. 126 of 2010: National Health
Amendment (Pharmaceutical Benefits Scheme) Act 2010. This Act was amended by the National Health Regulations
(Statutory Rules 1991 No. 310) and the National Health Act 1953 (Amendment) Regulations (Statutory Rules 1993 No.
274). This Act was modified by the National Health Regulations (1954 No. 35 as amended), the National Health (Nursing
Home Respite Care) Regulations (1989 No. 173 as amended) and the National Health Regulations 1998 No. 262 (as
amended). This Act contains the following parts: - Preliminary - National health services - Approved nursing homes -
Pharmaceutical benefits - Committee of Inquiry - Miscellaneous
Comment: The last amendment (Act No. 126 of 2010) introduces, amongst others, changes in price reductions defined in
the Part VII "Pharmaceutical benefits". The changes became effective on 01-Feb-2011.
Document date: 01-Feb-2011
Type of text: Act, Law
Regulatory version: Final, Amended
Language: English
Australia - Medicines Safety Update No.1, 2011, 01-Feb-2011
In this issue of the Medicine Safety Update the Therapeutic Goods Administration (TGA) covers the following topics: -
Clozapine and severe constipation; - Drug interaction between tamoxifen and antidepressants; - Methysergide and
retroperitoneal fibrosis; - Thank you for your reports; - Suspected adverse reactions to vaccines: a reminder to report; -
What to report? (you do not need to be certain, just suspicious!).
Document date: 01-Feb-2011
Type of text: Medicines Safety Update, Safety Information
Regulatory version: None
Language: English
Australia - TGA Information: Transparency Review Public Meetings: Schedule
and Registration, 02-Feb-2011
With this document the Therapeutic Goods Administration (TGA) provides a schedule of meetings organised by the Panel
undertaking the Review to Improve Transparency of the TGA. The meetings will include the opportunity for participants to
share views with all attendees on the Review, and for discussion in small groups chaired by a member of the Panel.
Document date: 02-Feb-2011
Type of text: Publication
Regulatory version: None
Language: English
Australia - Questions & Answers Relating to the Additional Default Standards
Legislation, 31-Jan-2011
This document provides the answers to the following questions relating to the additional default standards legislation: -
What does "default standard" mean in relation to medicines? - What is the definition of 'British Pharmacopoeia'? - What is