zilongwang/ReadingBank huggingface dataset:
an Australian business that tracks individuals in the EU on the internet and uses data processing techniques to profile individuals to analyse and predict personal preferences, behaviours and attitudes. What information does the GDPR apply to? The GDPR applies to ‘personal data’. This means ‘any information relating to an identified or identifiable natural person’ (Article 4). Additional protections apply to the processing of ‘special categories’ of personal data, which includes personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, and the processing of genetic data, biometric data for the purpose of uniquely identifying a natural person, data concerning health or data concerning a natural person's sex life or sexual orientation (Article 9). Example: The GDPR makes clear that a wide range of identifiers can be ‘personal data’ including a name, an identification number, location data, an online identifier or one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person. What are some of the new requirements in the GDPR? Accountability and governance The GDPR sets out expanded accountability and governance requirements. These include that data controllers must: demonstrate that they comply with the ‘Principles relating to the processing of personal data’ – this is referred to as the ‘accountability principle’ (Article 5). ensure and demonstrate through the implementation of appropriate technical and organisational measures, including data protection policies, that processing activities comply with the GDPR (Article 24). implement technical and organisational measures to show that they have considered and integrated data protection into their processing activities – this is referred to as ‘data protection by design and by default’ (Article 25).
37 4.85 Tetrafluoromethane emission factor updated for IPCC AR4 GWPs. 38 4.89 Hexafluoroethane emission factor updated for IPCC AR4 GWPs. Chapter 5: Waste Part 5.2 Solid waste disposal in land Part 5.2 updates GWPs and adjusts non-CO2 emission factors provided as part of methodologies. Item NGER (Measurement) Determination Reference Commentary 39, 40, 41, 42, 43, 44, 45, 46 5.4(1) 5.4(3) 5.4B(3) 5.4D 5.13(2)(c) 5.15(1) 5.15(4) 5.15A(3) GWP for methane provided for equation updated from 21 to 25 for IPCC AR4 GWP. 47 5.15A (3) note (c) Collection efficiency calculation reference updated. 50 5.22(2) Methane and nitrous oxide emission factors for biological treatment updated for IPCC AR4 GWPs. 48, 49, 51 5.17AA (note 3) 5.17L (note) 5.22A – 5.22L Provisions supporting the estimation of legacy waste for supporting emissions estimation under the Clean Energy Act 2011 repealed.
Item NGER (Measurement) Determination Reference Commentary 59 – 64 Part 1, 2, 3, and 4 Updates emissions factors for the combustion of fuel. Updates incorporate updated IPCC AR4 GWPs, and updates based on most recent emissions estimates contained in the National Greenhouse Accounts. Schedule 3 Carbon conent factors Schedule 3 provides the carbon content factors of fuels. Item NGER (Measurement) Determination Reference Commentary 65 - 68 Part 2 and 3 Updates are based on most recent emissions estimates contained in the National Greenhouse Accounts. 2— COMMENCING 1 JULY 2015
Details of the proposed amendments to the Determination are set out in Attachment A. In making these draft amendments publicly available the Department seeks views on their practical operation and application. This consultation will inform the finalisation of a draft National Greenhouse and Energy Reporting Measurement Amendment Determination 2014 (No.1) which will be a legislative instrument for the purposes of the Legislative Instruments Act 2003 (Cwlth). This Amendment Determination will commence on registration and apply to the financial year. The amendments would affect NGER reports to be submitted by corporations in October 2015. - NGER A) 16 May 2014 Consultation draft available on the Department of the Environment’s website. 5 June 2014 Submissions on the consultation draft close (Attachment A) 30 June 2014 NGER Measurement Amendment Determination 2014 (No.1) scheduled for lodgement. Information is also included in relation to the estimation of emissions from carbon capture and storage. The National Greenhouse and Energy Reporting Regulations 2008 require reporters to report data associated with carbon capture and storage operations, including the provision of estimates of fugitive emissions: that occur during the transportation of the CO2 to the storage site; that occur when the CO2 was been injected into the storage site; and
[13] 3.40 A Expands the definition of natural gas which applies for Part 3.3 (Oil and natural gas – fugitive emissions) of the Determination to include coal seam methane, tight gas and shale gas. [14] 3.46A(2)(b)(i) Changes reference from coal seam gas to natural gas. This extends the availability of the existing voluntary method 4 for vented fugitive emissions from well completions and workovers from coal seam gas to all sources of natural gas. Chapter 4: Industrial Processes Emissions Part 4.3 Ammonia production Clarification of guidance for the measurement of emissions released from ammonia production in situations involving the use of multiple fuels. Item NGER Measurement Determination Reference Commentary [15] [16] 4.42 4.43 Provides additional guidance on the allocation of CO2 emissions to fuel use, when ammonia is produced using multiple fuels and the CO2 is captured for re-use. Part 4.5 Industrial processes – emissions of hydroflurocarbons and sulphur hexafluoride Item NGER Measurement Commentary
academic year 2020/2021. New starters and existing children on roll at Frenchay CE Primary School would attend the new site from 1 September 2020. Would there be an impact on the operation of the existing school during the building works? The operation of the existing school would not be affected by the project to build a new school on the former Frenchay Hospital site. The school’s ethos, Christian and British beliefs and values would not change as a result of the proposed expansion. The Council and the school are confident that the expansion would achieve its aims and be properly managed, with the school growing across the age range. What are the key dates for the decision making process? The proposed transfer and enlargement of Frenchay CE Primary School is a major step. Following the drop-in session, the Council will need to undertake the legal process for enlarging Frenchay CE Primary School. Government regulations set down a statutory process for enlarging a school – see table below. It is proposed that the Council will take a final decision by the end of the current academic year 2017/2018. Statutory Process for Enlarging a School Stage Action Timescale Informal consultation The council will consult with parents/carers, local schools and stakeholders on the proposal to enlarge Frenchay CE Primary School and hold a drop-in event for parents/carers to discuss the proposal Consultation during May 2018 Drop-in event 24 May 2018 Decision to proceed The Council will consider all the responses received in the consultation and will decide whether to proceed to publish a statutory notice about the proposal. 4 June 2018 Statutory Notice The publication of a statutory notice with full details of the proposal 5 June 2018 Representation Period An opportunity for interested parties to make any comments on the proposal. 4 week period starting 5 June 2018 Final Decision The Council makes a final decision on whether to go ahead with the proposal bearing in mind all the details and all the comments which have been received. July 2018 Implementation It is planned that Frenchay CE Primary School will operate with an increased admission number from the new site 1 September 2020 How to make your views known Drop-in - Parents and other people in the local community, together with the staff and governors of the school, are invited to respond to this consultation. A drop-in event will be held on Thursday 24 may 2018 at 4.15pm – 6pm at
APRA’s power to disqualify an accountable person 37J APRA’s power to vary or revoke the disqualification of an accountable person 37JA APRA’s examination powers Sch. 2 Penalties and other enforcement powers APRA may seek penalties where an ADI breaches BEAR in a way which causes systemic or prudential concerns. APRA may disqualify an ‘accountable person’ for breaching the requirements of BEAR. Consequences and penalties applicable to an ADI 37G Consequences and penalties applicable to an accountable person 37J Consequences applicable to a person prohibited from being an accountable person 37JB Insurance An ADI or accountable person is prevented from obtaining insurance to cover the penalties which may apply for breaching BEAR. Prohibition on indemnification of ADIs and accountable persons 37KB Commencement date and transitional provisions Part 3 1 July 2018, with transitional provisions for the remuneration requirements.
Stop supporting institutions Streamline and simplify the RDSP process More signage for tran (sic) For all businesses and non-profit agencies, provide information/education on reasonable accommodations, universal design Website that has all resources available by location, age, diagnosis, regularly updated, dedicated gov’t funding Build capacity in all health professionals ie. increase # of graduates from all disciplines, allied, nursing and doctors Larger grants to fund education for PWD – it takes longer to complete a program when you have med. issues Guide Dog Act – no act in BC for guide dogs or service animals Provide loop systems in public buildings, meeting grooms, churches, etc. – universal symbol posted! Make evidence based decisions/policy for spending on healthcare – shift from acute to community based Caregiver assigned when child is born or diagnosed with a disability – marriages continue – life resumes – couples back at work Accessible education for college, university, including post graduate, incl. funds for assistance and access to technology (software and equipment) Extra assistance on buses and other transit for security and safety Primary health in each community – interprofessional teams to service everyone – GP,RN, OT, PT, SW We need to change consciousness – start in our schools by creating inclusive high schools No institutions Covering medical devices Legislate that employers must have 3% of work force be PWDs Law that requires employers to hire 3% - 5% PWDs (UK, Brazil) Full transparency of all funds top to bottom Everybody must have the opportunity and support to meaningfully participate in their own life Criteria to measure meaningful – choice, safety, acceptance, accessibility, accommodations made, adapted from Dr. Roberta Woodgate, Winnipeg Manitoba Post secondary education resources targeted/protected for people with DD Review how we are spending money on health – is it effective, efficient? Accessible voting – independent voting for PWD Stop making PWD fight bureaucracy for basic needs, housing Take action Needs to be a provincial disability act - accountability Better coordination between MCFD and MSD – need seamless system – no more hitting a wall at 19! Accessible bus stops/busses - transit Funding for vision rehab Tax breaks for equipment and supplies for employment Access/transparency/linking information re: available resources
Businesses respond to incentives – phase in/phase out Most progressive = everything together (gov’t, community, etc.) No crisis grants for moving, replacing worn-out furniture Volunteering as a step towards employment Took way $100 volunteer money Interacting in community – feeling better – earning No stigma, no hiding because of disability Volunteer supplement was leading to employment Costs: clothes, transportation, child care WorkBC – good experience – work – do have what you need? GT hiring post support – 3 months ends CLBC support continues CLBC not available for acquired brain injury Being different is ok Employment supports – individualize, flexible, coaching focussed, not policy focussed System needs to recognize difference between ABI and CLBC – new way of being us …how you were born Job coaches need to know the jobs before the client gets the placement and knowledge of the job Concept of social capital should be embedded into programs Social capital – more ppl you know, more support you have, better you feel, more you can do Loneliness, isolation, poverty, are HUGE issues How do you be a good friend? Everyone is different, this is good Interdependence vs. safety and independence – holistic interdependence is reality Labels damage people How do we involve the medical community? TAPS works w/SDSI, medical professionals People vs. patients Transition to adulthood – supports drop off, waitlists Do services help people? – depends on person It’s the focus of the services, social connection, foster care services drop off, no $ for housing Eligible for IA at 19, PWD at 18 Have to be denied IA to get PWD Should not have to go thru this – needs to be changed Why welfare first? Should be higher rates depending on where you live
Significant increases in declared forecast conditions relative to current arrangements Region Forecasting horizon (hrs) Increased number of TIs with declared condition (per NSW 24 LOR2 increase by ~ 6 TIs NSW 48 LOR2 increase by ~ 15 TIs NSW 72 LOR2 increase by ~ 16 TIs SA 12 LOR2 increase by ~ 5 TIs SA 48 LOR2 increase by ~ 43 TIs SA 72 LOR2 increase by ~ 51 TIs Vic 72 LOR2 increase by ~ 5 TIs It should be noted that a declaration of a forecast LOR2 condition does not necessarily mean immediate intervention by AEMO, particularly for longer forecasting horizons. Once such a declaration is made, where time allows AEMO will first seek a market response before considering intervention. The adjustment of the chosen confidence levels to ensure monotonic variation was included to reduce risk of fluctuations of LOR levels as forecasting horizon reduces. The adjustment to achieve consistent confidence levels for all regions, subject to substantially meeting the other criteria, was included on the basis that the tolerance for risk should be consistent across the entire NEM. For forecasting horizons than those specifically analysed, the appropriate confidence level was chosen by extrapolating between the confidence levels chosen for the specific forecasting horizon studied in this analysis. The selection for each forecasting horizon up to 72 hours ahead is recorded in the Guidelines. Expected impact of new approach The following table provides indications of the likely FUM values for a range of scenarios. Indicative values of FUM for specific scenarios Region Scenario Approximate FUM value (MW) South Australia Hot temperatures (>35 degrees C), high wind (>1000MW) 6 900 24 496 Hot temperatures (>35 degrees C), low wind (<300MW) 6 434 24 383 Victoria Hot temperatures (>31 degrees C), high wind (>800MW) 6 1,750 24 1,192 Hot temperatures (>31 degrees), low wind (<200MW) 6 1,750 24 953
Linezolid Meropenem Metronidazole (IV) Piperacillin/tazobactam Posaconazole Rifabutin Rifampicin Teicoplanin Sodium thiosulphate injection Emergency and Critical Care Adrenaline Alteplase Amiodarone Benztropine injection Calcium chloride 1 g/10 mL* Calcium gluconate gel Oxytocin Quinine injection Rasburicase * Specific concentrations are included for these products as they are they are used in specific emergency situations. National immunisation program vaccines Any vaccine on the NIP that includes the following: Hepatitis A Hepatitis B Diphtheria Tetanus Acellular pertussis Haemophilus influenzae type b (Hib) Inactivated poliomyelitis (IPV) Rotavirus Meningococcal C Measles Mumps Rubella Varicella (chickenpox) Human papillomavirus (HPV) Seasonal influenza Pneumococcal polysaccharide (23vPPV) Pneumococcal conjugate (13vPCV) Herpes zoster (shingles) Meningococcal B Meningococcal A Meningococcal W Meningococcal Y Specific Immunoglobulins CMV immunoglobulin Rh(D) immunoglobulin Tetanus immunoglobulin Zoster immunoglobulin Rabies immunoglobulin Rabies vaccine Hepatitis B immunoglobulin Anticonvulsants Phenytoin IV Diazepam IV Obstetrics Ergometrine Antivenoms Brown snake antivenom Death adder antivenom Sea snake antivenom Taipan antivenom Polyvalent snake antivenom Black snake antivenom Funnel web spider antivenom S3 medicines Adrenaline injection Chloramphenicol Glyceryl trinitrate Macrogols Naloxone injection Salbutamol inhaler Ulipristal
Version history Version Description of change Author Effective date V1.0 Original publication Technical and Safety Improvement Section, Pharmacovigilance and Special Access Branch March 2018 Therapeutic Administration PO Box 100 Woden ACT 2606 Australia Email: Phone: 1800 020 653 Fax: 02 6203 1605 Reference/Publication #
1-iii Legalising a signature or seal £30 YER 11,400 PART II NOTARIAL AND RELATED MATTERS 2-i Preparing any single certificate or declaration(in English) £45 YER 17,100 3 Signing a declaration of existence £15 YER 5,700 4 Administering an oath or attesting the signature on a declaration or affirmation £55 YER 20,900 5 Witnessing a signature(we do not witness a signature on wills or power of Attorney Documents) £20 YER 7,600 6 Making or verifying a copy of a document £30 YER 11,400 7 Uniting a document £20 YER 7,600 MARRIAGES, CIVIL PARTNERSHIPS 10 Receiving a notice of intended marriage £65 YER 24.700 11-i Issuing a certificate of no impediment £65 YER 24,700 PART III EMERGENCY ASSISTANCE 21 Exceptionally, administering an application for, and if successful, providing an emergency passport, on occasions when it is not possible to provide an emergency Travel Document £75 YER 28, 500
Consultation on Academy Admissions Arrangements (to apply to admissions from September 2020 onwards) You may be that Trafford MBC are currently consulting on a change to the admissions criteria. In summary, they are proposing to amend their admissions criteria to include children who were previously in state care outside of England in their oversubscription criterion. At Old Trafford Community Academy we have always aligned our own oversubscription criteria to those of local Trafford community schools. The Governing Body (LGB) have therefore agreed to consult on making a parallel change to OTCA’s oversubscription criteria as shown in the attached paper. The consultation period opens on 26th November 2018, and closes on 14th January 2019. Please send any comments or objections to: Judith Stott (Principal) Old Trafford Community Academy Malvern Street Old Trafford Manchester M15 4FL Alternatively, comments can be sent by email to Judith Stott, Principal 26/11/18 Old Trafford Community Academy Proposed 2020 Admission Arrangements Any admission authority that wishes to amend its arrangements for admission in 2020 must carry out the required consultation. Consultation must be for a
Transparent. The results from LRCS largely supported the original assumptions on ‘low risk’ product and the following are the product by risk ratings outcomes from the LRCS: Extremely Low Product type Examination gowns Very Low Product type Oral homoeopathic products Mattresses Hard surface disinfectants (Hospital grade without claims) Light sources (examination, surgical, head mounted) Hard surface disinfectants (Household grade) Antiperspirants Examination tables Chairs and stools Exercise equipment (treadmills, weights, etc) Pillows and cushions Aromatherapy products Ear Candles Magnetic items (static, apparel and bedding) Enzymatic detergents Breast pumps Spectacle frames Marker pens Low Product type Registered desensitising toothpastes Rubefacient preparations for minor aches and pains of muscles (e.g. methyl salicylate, menthol, capsicum, etc.) Antacids – containing carbonates, hydroxides, silicates, and/or alginates Personal lubricants Acne treatments containing benzoyl peroxide Menstrual cups Oral soluble vitamin products Rehydration or formulated sports products Antidandruff antifungal shampoos Nappy rash cream
Version history Version Description of change Author Effective date V1.0 Original publication Prescription Medicine Authorisation Branch 14 October 2016 V1.1 Minor editorial changes and correction of designation to registration and registration to designation on page 15 Prescription Medicine Authorisation Branch 24 October 2016
State of Victoria as author. The licence does not apply to any images, photographs or branding, including the Victorian Coat of Arms, the Victorian Government logo and the Department of Environment, Land, Water and Planning (DELWP) logo. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ Disclaimer This publication may be of assistance to you but the State of Victoria and its employees do not guarantee that the publication is without flaw of any kind or is wholly appropriate for your particular purposes and therefore disclaims all liability for any error, loss or other consequence which may arise from you relying on any information in this publication. If you would like to receive this publication in an alternative format, please telephone the DELWP Customer Service Centre on 136186, email , or via the National Relay Service on 133 677 . This document is also available on the internet at .
500 - 5000 Cardboard/paper (virgin) 0 – 50 50 – 500 500 - 5000 Local Imported Cardboard/paper (recycled) 0 – 50 50 – 500 500 - 5000 Local Imported Plastic mono-layers 0 – 50 50 – 500 500 - 5000 Local Imported Plastic multi-layers 0 – 50 50 – 500 500 - 5000 Imported Plastic laminate 0 – 50 50 – 500 500 - 5000 Imported Plastic rigid 0 – 50 50 – 500 500 - 5000 Local Imported Plastic co-extruded 0 – 50 50 – 500 500 - 5000 Local Imported Plastic (recycled) 0 – 50 50 – 500 500 - 5000 ☐Local ☐Imported 0 – 50 50 – 500 500 - 5000 ☐Local ☐Imported Composites (eg. Paper/foil/plastic) 0 – 50 50 – 500 500 - 5000 ☐Local ☐Imported Glass 0 – 50 50 – 500 500 - 5000 ☐Local ☐Imported Ceramic 0 – 50 50 – 500 500 - 5000 ☐Local ☐Imported Other 0 – 50 50 – 500 500 - 5000 ☐Local ☐Imported *Kilo tonnes per annum Question 4 (refer to p. 12)
5: Sunset date changes under section 51A (thematic review) Item (instruments) Date of declaration Earliest sunset date Latest sunset date New sunset date Outcome of review More information 1 Agricultural export (control) instruments made under various Acts 40 13 Nov 2014 1 Apr 2015 1 Apr 2022 1 Apr 2020 Pending 2 Instruments made under the Hearing Services Administration Act 1997 5 10 Sep 2015 1 Apr 2016 1 Oct 2022 1 Oct 2019 Pending 3 Instruments made under the Fuel Quality Standards Act 2000 8 11 Feb 2016 1 Oct 2016 1 Oct 2022 1 Oct 2019 Pending 4 Medical indemnity instruments made under various Acts 15 11 Feb 2016 1 Apr 2016 1 Apr 2020 1 Oct 2019 Pending 5 Instruments made under the Hearing Services Act 1991 2 7 Nov 2016 1 Apr 2017 1 Oct 2018 1 Oct 2019 Pending 6 Agricultural levies instruments made various Acts 25 7 Nov 2016 1 Apr 2017 1 Oct 2022 1 Apr 2023 Pending 7 Recovery plans made under the Environment Protection and Biodiversity Conservation Act 1999 39 20 Mar 2017 1 Apr 2017 1 Apr 2021 1 Apr 2022 Pending TOTAL INSTRUMENTS AFFECTED (EACH INSTRUMENT COUNTED ONCE ONLY): 126 6. Exemptions from sunsetting All legislative instruments are subject to sunsetting unless they are exempt from sunsetting. Exemptions are set out in section 54 of the , the LEOMR and in other Acts. Most exemptions are set out in the LEOMR. Agencies are asked to nominate whether an instrument is subject to sunsetting at time of lodgement, and provide details of the authority for this. Agencies may also lodge written requests to update this information e.g. because a new exemption has been created for a class of instrument. There are currently nine generic exemptions and more than 80 specific exemptions as detailed in tables 6B and 6C respectively. Many cover only a few instruments but others are very large. The largest categories of instrument on the FRL that are exempt from sunsetting are as follows: Table 6A: Extent of exemptions from sunsetting Categories of legislative instrument Instruments registered Instruments repealed Instruments not repealed (likely to be in force) Double exemption (sunsetting and disallowance) Legislative instruments exempt from sunsetting: - Airworthiness Directives 15,223 6,116 9,107 YES
Cost recovery mechanism Administrative simplicity Flexibility in amounts recovered Transparency Minimising of monitoring & compliance Legislative obligation on distribution businesses (DBs) There are only 5 DBs with a fixed number of customers. This will result in administrative ease where scheme costs are spread based on the relative loads of each business DBs can adjust network tariffs on a 6-monthly or annual basis in line with changing scheme costs (requires AER approval) DBs are regulated by the AER and are required to submit a breakdown of costs which must be approved by the AER before they can be passed on to customers A framework for monitoring compliance with regulatory requirement cost pass throughs is already in place Legislative obligation on electricity retailers The customer bases of different retailers are constantly changing due to switching, making it very hard to calculate each retailers liability under the scheme based on the load of their customers. New retailers are also continuously entering the market, with others leaving. Victorian retailers are not subject to price regulation and therefore will be able to pass on scheme costs as they change over time. Retailers currently operate in a market free from regulation. There would be no requirement on them to disclose how scheme costs were passed on to customers. Monitoring of cost recovery practices would require a new compliance framework to be established to undertake this role. With more than 15 active retailers currently in the market the costs of doing so are likely to be significant. Legislative obligation on the State’s one transmission business As there is only one transmission business in Victoria, also with a fixed customer base. This would make calculating scheme liabilities based on relative customer loads very simple. AusNet Services can adjust its network tariffs on a or annual basis in line with changing scheme costs (requires AER approval) AusNet Services as the transmission network operator is regulated by the AER and required to submit a breakdown of costs which must be approved by the AER before they can be passed on to customers A framework for monitoring compliance with regulatory requirement cost pass throughs is already in place
ALCLOMETASONE 2 ALIMEMAZINE 1d - sedating 2 AMINOPHYLLINE 1c 1d - safer alternatives 2 AZATADINE 1d - sedating 2 BROMPHENIRAMINE 1d - sedating 2 BUCLIZINE 2 CHLORBUTANOL 1a 2 CHLORPHENAMINE (CHLORPHENIRAMINE) 1d - sedating 2 CIMETIDINE 1b 1d - sedating 2 CLEMASTINE 1d - sedating 2 CYCLIZINE 1a 1b 2 CYPROHEPTADINE 1d - sedating DEXCHLORPHENAMINE (DEXCHLORPHENIRAMINE) 1d - sedating DIHYDROCODEINE 1a DIIODOHYDROXYQUINOLINE (iodoquinol) 2
Do you agree that we need to understand the extent of hidden homelessness? Fully Partially Not at all If you have answered ‘partially’ or ‘not at all’, please tell us why: Do you agree that we need to ensure that appropriate services exist for young people? Fully Partially Not at all If you have answered ‘partially’ or ‘not at all’, please tell us why: Do you agree that we need to improve access to health and social care services? Fully Partially Not at all If you have answered ‘partially’ or ‘not at all’, please tell us why:
What entity should administer a DVDS? If it is an existing entity, entity is it? If it is a multi-agency entity, please outline which agencies should be included and how it might operate. Who should be eligible to apply for information under a DVDS? Should the eligible applicants under a DVDS be limited to people in an intimate personal relationship, or also include people in a family or informal care relationship? Should a DVDS also be available to people who were in, but who are no longer in, an intimate personal relationship (or other relevant relationship for the scheme)? Should a DVDS permit a party to make an application on behalf of a person who may be at risk? In what circumstances should this occur? Entry into a DVDS What should be the process for applying for information under a DVDS (that is, for a ‘right to ask’ pathway)? Should the process differ between an application made by a person who may be at risk and a third party applicant? Should a DVDS provide for information to be disclosed, without an application, to a person who may be at risk (that is, a ‘right to know’ or ‘power to tell’ pathway)? In what circumstances should this occur?
Refer to, or imply, the treatment, prevention, alleviation or cure of any form of a disease, ailment, defect or injury Treatment, prevention, alleviation and cure have a more definitive meaning which are not suitable for permitted indications as they may lead to a delay in seeking medical treatment and adverse consequences for the patient. Prevents indigestion Treats dehydration Treats cold sores Alleviates Irritable Bowel Syndrome Contain a prohibited representation Any reference regarding the treatment, cure or prevention of the following diseases: Neoplastic Sexually Transmitted Diseases HIV AIDS and/or HCV Mental illness Any reference to: depression / anxiety / low mood cancer genital / prevention of the transmission of herpes virus Contain a restricted representation Any reference (even by implication) to a serious disease, condition, ailment or defect specified in Table 1 of Part 2 of Appendix 6 of the Therapeutic Goods Advertising Code Serious, in this context means those diseases, conditions, ailments or defects that are: Generally accepted not to be appropriate to be diagnosed and/or treated without consulting a suitably qualified healthcare professional, and/or Generally accepted to be beyond the ability of the average consumer to evaluate accurately and to treat safely without regular supervision by a qualified healthcare professional Reduces risk of atherosclerosis Reduces elevated blood glucose (referring to diabetes and or unhealthy biomarkers) Helps naturally decrease high blood pressure Alleviates arthritis symptoms, such as inflammation and pain Reduces symptoms of reflux Beneficial for anaphylaxis
Your views are sought The TGA description takes into account the response of stakeholders to the previous consultation. Does the description of the problems adequately reflect the actual or potential problems associated with the existing regulation of autologous cells and tissue? Are you able to provide specific evidence particularly in the Australian context, in relation to the practices outlined above, that demonstrates risk to patient health? Part C – Objectives of any government action The objectives of any government action in relation to autologous human cells and tissues would be as follows: to minimise public health and safety risks; to maintain consumer confidence in the regulation of therapeutic goods, specifically the national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods; to duplication of regulatory effort, particularly where the regulation of therapeutic goods intersects with the regulation of medical practice (by AHPRA and State/Territory regulators) and the regulation of consumer goods more generally (via the ACCC); to align, as far as possible, with international best practice; and to minimise unnecessary regulatory burden. Part D – Options Revised options Four options are proposed for the future regulation of autologous human cell and tissue products. Each of the options represents progressively increased regulation based on the two key risks: the risk that direct-to-consumer advertising may result in patients failing to get more suitable or efficacious treatment in a timely way and/or expose them to unnecessary risk; and the risk associated with increased manipulation of the cells or tissue. Each option describes the regulatory exclusions and inclusions that would apply: Option 1 – Human cell and tissue products: for autologous use, under the supervision of a medical/dental practitioner, as part of a single course of treatment, would be excluded from TGA regulation;
Response of the Equality and Human Rights Commission to the Consultation Consultation details Title: Review of the adult gender identity service specification for England Source of consultation: NHS England Date: 16 October 2017 For more information please contact Name of EHRC contact providing response and their office address: Max Edelstyn Equality and Human Rights Commission Arndale House The Arndale Centre Manchester M4 3AQ address: Max.edelstyn@equalityhumanrights.com About the Equality and Human Rights Commission The Equality and Human Rights Commission is a statutory body established under the Equality Act 2006. It operates independently to encourage equality and diversity, eliminate unlawful discrimination, and protect and promote human rights. It contributes to making and keeping Britain a fair society in which everyone, regardless of background, has an equal opportunity to fulfil their potential. The Commission enforces equality legislation on age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex and sexual orientation. It encourages compliance with the Human Rights Act 1998 and is accredited by the UN as an ‘A status’ National Human Rights Institution. Find out more about the Commission’s work at:
About the Equality and Human Rights Commission The Equality and Rights Commission is a statutory body established under the Equality Act 2006. It operates independently to encourage equality and diversity, eliminate unlawful discrimination, and protect and promote human rights. It contributes to making and keeping Britain a fair society in which everyone, regardless of background, has an equal opportunity to fulfil their potential. The Commission enforces equality legislation on age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex and sexual orientation. It encourages compliance with the Human Rights Act 1998 and is accredited by the UN as an ‘A status’ National Human Rights Institution. Find out more about the Commission’s work at: Summary The Commission welcomes the opportunity to respond to this consultation on changes to arrangements for fees in the Employment Tribunal system (ET fees) and to comment on the outcome of the review. We recognise the potential benefits of the proposed changes on claimants’ ability to access their employment rights (through Employment Tribunals). However, we remain concerned that the introduction of substantial fees has had a significant adverse impact on access to justice, with disproportionate impacts on people sharing certain protected characteristics. The Commission considers that the introduction of ET fees of up to £1,200 (e.g. for a discrimination case to be heard) is compromising claimants’ rights under common law, Article 6 ECHR, and EU law. It is impairing the essence of the right to access the courts, and the Government has failed to show that the introduction of fees is a proportionate means of achieving a legitimate aim.
Answers : 77 Paper Online Combined Option Votes Percentage Votes Percentage Percentage The riverside should just be used for housing. 0 0 0 0 0 The buildings along the riverside should be preserved. 16 43.2% 19 47.5% 45.4% The riverside is an under used resource and needs to be developed to create an attractive, vibrant place for people to live work and play. 33 89.1% 33 82.5% 85.7% I love to see the riverside being used for watersports. 21 56.7% 13 32.5% 44.1% Some restaurants, bars and eateries on the riverside be great. 32 86.4% 31 77.5% 81.8% The riverside should only be used for businesses. 0 0 0 0 0 I like to be able to walk all the way along the riverside from the Trent Bridge through to Morton. 31 83.7% 29 72.5% 77.9% The riverside should be used to provide boat trips. 27 72.9% 19 47.5% 59.7% Whittons Gardens should be retained as a place to sit and relax on the riverside 27 72.9% 26 65.0% 68.8% Whittons Gardens should be made available for development. 2 5.4% 3 7.5% 6.49% A Marina will help revitalise the riverside 27 72.9% 26 65.0% 68.8% I like the way Whittons Mill was developed. 12 32.4% 19 47.5% 40.25% Riverside Summary As 85.7% of people agree that the Riverside is an underused resource and needs to be developed to create an attractive, vibrant place for people to live work and play, it is clear that development towards such an area would be supported. Within such a development provision of food outlets and bars would be welcomed by the public, with 81.8% keen for this to happen. During consultation a number of people
-Respond to different areas of need and adapt -Provide approaches that suit different communities -Some communities may not want to access services that are mainly prescribing -Staff could be single point of contact at community events -Need to retain City-based focus Education-providing information to people about the effects of NPS 24% -Provide info to users and other professionals -People need the -Increase knowledge and understanding -Educate on dangers -Develop factsheets -Educate through media -Provide training Promote-promote services to different groups 28% -Get the word out to different communities -Make services more visible -Have a presence in communities -Have open days on drug issues -Advertise in community centres, libraries, places of worship -Check communities know what is available Research-gaining information about local use and substance 24% -Gain understanding from -Research user experience and harm reduction -Use groups -Research and testing in Prison -Keep up to date-it’s ever changing Research-need to find out more about what different communities need 21% -Services need to understand community needs and expectations -Involve service users in design -Find out about needs and preferences
implications of increased foreign investment and the impact of product shortages, while positioning us to offer and access reliable products in a growing international market. International considerations Enhance international collaboration and work-sharing The (MMDR) recommended that we better utilise opportunities to work-share with CORs. To facilitate this work we must align our dossier formats. Globally, CORs are transitioning to dossiers. Therefore, to continue and to increase our collaboration, we must also transition. Health Canada, EMA and FDA are well underway with this transition. As an observer on the ICH M8 IWG responsible for the development and implementation of eCTD, we are currently collaborating with other regulators on the development and revision of eCTD specifications, including fixes for the current version 3.2.2 and development of the version 4.0 specifications. To continue to collaborate and comment on this important work our focus needs to be on the eCTD format. Proposed change on the information highlighted above, the TGA proposes to mandate the use of the eCTD format for all prescription medicine dossiers. Applications included in a future eCTD requirement Prescription medicine application types: Category 1 applications via the standard pathway New Chemical Entity New Biological Entity Biosimilar New Combination Extension of Indications Major Variation New Generic Product Variation Changes to PI involving the evaluation of data Extension of Indications – Generic Product Additional Trade Name Category 3 – Variation involving only chemistry, quality control and manufacturing information Minor Variations MEC – Changes to PI where no evaluation is required
Summary of evidence, reporting and advertising requirements for the regulatory options for autologous cells Issue Option 1 Option 2 Option 3 Option 4 Option 5 Evidence to support the safety and efficacy of the product No requirement for review the Act. No requirement for review under the Act but only excluded if homologous use and not subject to more than minimal manipulation thus represent less risk. No requirement for product to be safe or efficacious. Applicant for Class 1 must certify that the product is safe for the purpose for which it is to be used (grounds for /suspension cancellation if that statement false or misleading). Evidence of safety and efficacy required before inclusion in the ARTG. Advertising of the product No requirements under the Act but subject to ACCC and AHPRA regulation. No advertising to the public, advertising permitted to health practitioners and subject to AHPRA regulation. No advertising to the public. No advertising to the public. No advertising to the public. Reporting of adverse effects of the product No requirements under the Act. No requirements under the Act. Yes, there would be a requirement for reporting adverse effects related to the product if the conditional exemption under Schedule 5A was adopted. Yes, there would be a requirement for reporting adverse effects related to the product. Yes, there would be a requirement for reporting adverse effects related to the product.
Patient access Direct public access to products in the absence of any on advertising directly to consumers. Patient access unlikely to be affected. Access via referral from health professional in absence of advertising to the public (?) Whether patient access is affected will depend on extent to which currently available treatments involve homologous and minimally manipulated products. Like other biologicals, access normally via referral from health professional. Whether patient access is affected will depend on extent to which currently available treatments involve homologous and minimally manipulated products and comply with any applicable standards. Like biological, access normally via referral from health professional. Whether patient access is affected will depend on extent to which currently available treatments involve homologous and minimally manipulated products and comply with any applicable standards. Like other biological, access normally via referral from health professional. In the absence of good clinical evidence, products likely not to be included, at least in the short term, so patient access likely to be affected.
a ‘Certificate of medicine listing’ is generated for downloading by the sponsor; and a ‘Conditions of listing’ letter is generated and sent to the sponsor by the TGA. The product details will usually be viewable on the eBS website the day after the information has been written to the ARTG. Diagram 1 the process for listing a medicine on the ARTG via the ELF. Diagram 1: The process for listing a medicine on the ARTG via ELF Product variation Following the inclusion of a product as a listed medicine on the ARTG, sponsors may need to update certain product details. Changes in manufacturer, changes in product ingredients or developing marketing strategies may require amendment of the product details of a medicine included listed on the ARTG. Where the intended change does not create another product altogether i.e. a ‘separate and distinct’ therapeutic good (see below), there are provisions in the legislation for certain details to be amended in a medicines’ ARTG entry. However, if the intended change would create a ‘separate and distinct’ good sponsors are required to submit a new application to list the goods and a new AUST L number will be issued (unless the two medicines are eligible for ‘grouping’ under the Therapeutic Goods (Groups) Order- see ‘The Therapeutic Goods (Groups) Order’ below). Changes that result in ‘separate and distinct’ goods Section 16 (1A) of the Act outlines those criteria which make listed medicines (other than ‘export only’ medicines) ‘separate and distinct’ from other therapeutic goods. (1A) Medicines that are listable goods (other than export only medicines) are taken to be separate and distinct from other therapeutic goods if the medicines have: (a) different active ingredients; or (b) different quantities of active ingredients; or (c) a different dosage form; or (d) such other different characteristics as the regulations prescribe; In relation to 16 (1A) (d) of the Act, ‘different characteristics’ for listed medicines (other than ‘export only’ medicines) are provided in Regulation 11: (a) a different name; or (b) different indications; or (c) a different excipient; or (d) for medicines that contain any restricted ingredients: (i) a different quantity of a restricted ingredient that is an excipient; or (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine — a different concentration of the restricted ingredient; or
Travel costs depend on approximate location away from Labrador: To reserve your consultation date please make the payment (including relevant travel costs) in the two following ways: Beenleigh to Burleigh $0 1.Direct Debit Payment Bank: Commonwealth Bank Account Name: Calm Companions BSB: 06 4794 Account: 1004 0096 Labrador to Mt Nathan $0 South Brisbane $30 Brisbane City Area $50 North Brisbane $100 East and West Brisbane $70
KBL Container material – if the container is a blister pack, the goods are a solid dosage form (e.g. tablet) and the change is of a type listed in assurance 15 N 2, 7, 10 & 15 9D(3) KOT Container material – other than in changes KBT, KGL or KBL [This might result in a making the goods separate and distinct under S16(1)(g)] A - 9D(3) KCL Closure N 2, 10 9D(3) KSL Tamper-resistant seal – addition (including label notice to alert consumers to presence of seal) O - KSX Tamper-resistant seal – removal (including removal of label notice re seal) O - KWA Inert wadding material – addition, substitution or removal where stability is not affected by the action O - KDA Desiccant – inclusion in container A - 9D(3) KDX Desiccant – removal from container A - 9D(3) KPP Specifications of primary pack (other than labelling) O - KSP Introduction of a measuring device (e.g. spoon, cylinder) or applicator (e.g. finger cot); this change can include graphical representation of the device on the label (copy of current and proposed label must be supplied if label is changed) N 2, L 9D(3) KMD Changes to existing measuring device (e.g. cylinder) or applicator supplied with the goods, or removal of a measuring device or applicator, where other means of accurately measuring or applying the dose are readily available N 2, L 9D(3) KPA Introduction of a primary pack (no new text or graphics) N 2, 11 9D(3)
SNOMED CT as the standard system of clinical terminology for all point of care applications. The capture all sources of hospital information, including ED & Theatres, nursing observations and eReferrals triage. Single access by clinicians to all sources of information. Provide data to the National Electronic Health Record (EHR) for delivery of each capability. National EHR Integration with the national EHR During the design phase of the national EHR, regions will engage with the national programme to establish sector requirements. During the implementation phase the regions will continue to support the national programme and integrate their systems with the EHR. All Regions Participation on advisory groups Please be aware that as work on this progresses, additional work may be required regionally.