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126-411: Regulatory compliance describes the goal that organizations aspire to achieve in their efforts to ensure that they are aware of and take steps to comply with relevant laws , policies, and regulations . Due to the increasing number of regulations and need for operational transparency , organizations are increasingly adopting the use of consolidated and harmonized sets of compliance controls. This approach

252-401: A constitution , written or tacit, and the rights encoded therein. The law shapes politics , economics , history and society in various ways and also serves as a mediator of relations between people. Legal systems vary between jurisdictions , with their differences analysed in comparative law . In civil law jurisdictions, a legislature or other central body codifies and consolidates

378-625: A federal system (as in Australia, Germany or the United States) or different voting configuration in a unitary system (as in France). In the UK the upper house is appointed by the government as a house of review . One criticism of bicameral systems with two elected chambers is that the upper and lower houses may simply mirror one another. The traditional justification of bicameralism is that an upper chamber acts as

504-417: A parliamentary system , as with Britain, Italy, Germany, India, and Japan, the executive is known as the cabinet, and composed of members of the legislature. The executive is led by the head of government , whose office holds power under the confidence of the legislature. Because popular elections appoint political parties to govern, the leader of a party can change in between elections. The head of state

630-652: A ruler ') is a set of ordinances and regulations made by ecclesiastical authority , for the government of a Christian organisation or church and its members. It is the internal ecclesiastical law governing the Catholic Church , the Eastern Orthodox Church , the Oriental Orthodox Churches , and the individual national churches within the Anglican Communion . The way that such church law

756-440: A "common law" developed during the reign of Henry II during the late 12th century, when Henry appointed judges who had the authority to create an institutionalised and unified system of law common to the country. The next major step in the evolution of the common law came when King John was forced by his barons to sign a document limiting his authority to pass laws. This "great charter" or Magna Carta of 1215 also required that

882-526: A Premium Listing of equity shares in the U.K. are required under the Listing Rules to report on how they have applied the Combined Code in their annual report and accounts. (The Codes are therefore most similar to the U.S.' Sarbanes–Oxley Act .) The U.K.'s regulatory framework requires that all its publicly listed companies should provide specific content in the core financial statements that must appear in

1008-580: A class of goods the sole or principal use of which is (or ordinarily is) a therapeutic use, or are otherwise determined to be a therapeutic good through a legislative instrument under the Therapeutic Goods Act 1989 . Goods that are therapeutic goods must be entered on the Australian Register of Therapeutic Goods (ARTG), or otherwise be the subject of an exemption, approval or authority by the TGA under

1134-442: A house of review. This can minimise arbitrariness and injustice in governmental action. To pass legislation, a majority of the members of a legislature must vote for a bill (proposed law) in each house. Normally there will be several readings and amendments proposed by the different political factions. If a country has an entrenched constitution, a special majority for changes to the constitution may be required, making changes to

1260-591: A process of reform, at least in terms of economic, if not social and political, rights. A new contract code in 1999 represented a move away from administrative domination. Furthermore, after negotiations lasting fifteen years, in 2001 China joined the World Trade Organization . In general, legal systems can be split between civil law and common law systems. Modern scholars argue that the significance of this distinction has progressively declined. The numerous legal transplants , typical of modern law, result in

1386-828: A product "of reactions to the changing objectives and requirements in different countries, industries, and policy contexts". Australia's major financial services regulators of deposits, insurance, and superannuation include the Reserve Bank of Australia (RBA), the Australian Prudential Regulation Authority (APRA), the Australian Securities & Investments Commission (ASIC), and the Australian Competition & Consumer Commission (ACCC). These regulators help to ensure financial institutes meet their promises, that transactional information

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1512-400: A series of resolutions calling on major changes to therapeutic goods regulation in Australia, including national legislation for drug purity standards, uniform state legislation for drug manufacture, marketing and labelling, and the establishment of a national standards laboratory for testing new drugs. It has been suggested the increased focus on national standards was prompted by concerns that

1638-701: A state of affairs to exist and continue merely through lack of appropriate action". In 1956, regulations under the 1953 act established the Therapeutic Substances Advisory Committee, the Biological Standards Committee, and the Therapeutic Substances Standards Committee to advise the Minister for Health on drug regulations. The National Biological Standards Laboratory (NBSL) was created in 1958 to test

1764-406: A yearly report, including balance sheet, comprehensive income statement, and statement of changes in equity, as well as cash flow statement as required under international accounting standards. It further demonstrates the relationship that subsists among shareholders, management, and the independent audit teams. Financial statements must be prepared using a particular set of rules and regulations hence

1890-462: Is legislated , interpreted and at times adjudicated varies widely among these three bodies of churches. In all three traditions, a canon was originally a rule adopted by a church council ; these canons formed the foundation of canon law. The Catholic Church has the oldest continuously functioning legal system in the western world , predating the evolution of modern European civil law and common law systems. The 1983 Code of Canon Law governs

2016-495: Is a code of Jewish law that summarizes some of the Talmud's interpretations. A number of countries are sharia jurisdictions. Israeli law allows litigants to use religious laws only if they choose. Canon law is only in use by members of the Catholic Church , the Eastern Orthodox Church and the Anglican Communion . Canon law ( Ancient Greek : κανών , romanized :  kanon , lit.   'a straight measuring rod;

2142-587: Is a set of rules that are created and are enforceable by social or governmental institutions to regulate behavior, with its precise definition a matter of longstanding debate. It has been variously described as a science and as the art of justice. State-enforced laws can be made by a legislature , resulting in statutes ; by the executive through decrees and regulations ; or by judges' decisions, which form precedent in common law jurisdictions. An autocrat may exercise those functions within their realm. The creation of laws themselves may be influenced by

2268-458: Is a system of rules, divided into primary (rules of conduct) and secondary ones (rules addressed to officials to administer primary rules). Secondary rules are further divided into rules of adjudication (to resolve legal disputes), rules of change (allowing laws to be varied) and the rule of recognition (allowing laws to be identified as valid). Two of Hart's students continued the debate: In his book Law's Empire , Ronald Dworkin attacked Hart and

2394-472: Is an "authority" to mediate people's interests. Oliver Wendell Holmes defined law as "the prophecies of what the courts will do in fact, and nothing more pretentious." In his Treatise on Law , Thomas Aquinas argues that law is a rational ordering of things, which concern the common good, that is promulgated by whoever is charged with the care of the community. This definition has both positivist and naturalist elements. Definitions of law often raise

2520-706: Is apart from the executive, and symbolically enacts laws and acts as representative of the nation. Examples include the President of Germany (appointed by members of federal and state legislatures ), the Queen of the United Kingdom (an hereditary office ), and the President of Austria (elected by popular vote). The other important model is the presidential system , found in the United States and in Brazil . In presidential systems,

2646-513: Is authority, identifiable purely through social sources and without reference to moral reasoning. In his view, any categorisation of rules beyond their role as authoritative instruments in mediation is best left to sociology , rather than jurisprudence. The history of law links closely to the development of civilization . Ancient Egyptian law, dating as far back as 3000 BC, was based on the concept of Ma'at and characterised by tradition, rhetorical speech, social equality and impartiality. By

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2772-511: Is becoming very difficult. Laws like the CAN-SPAM Act and Fair Credit Reporting Act in the U.S. require that businesses give people the right to be forgotten . In other words, they must remove individuals from marketing lists if it is requested, tell them when and why they might share personal information with a third party, or at least ask permission before sharing that data. Now, with new laws coming out that demand longer data retention despite

2898-405: Is controlled and managed, and investigate illegal action such as money laundering and terrorist financing. On a provincial level, each province maintain individuals laws and agencies. Unlike any other major federation, Canada does not have a securities regulatory authority at the federal government level. The provincial and territorial regulators work together to coordinate and harmonize regulation of

3024-467: Is law?" There have been several attempts to produce "a universally acceptable definition of law". In 1972, Baron Hampstead suggested that no such definition could be produced. McCoubrey and White said that the question "what is law?" has no simple answer. Glanville Williams said that the meaning of the word "law" depends on the context in which that word is used. He said that, for example, " early customary law " and " municipal law " were contexts where

3150-506: Is one of the primary international standards for how businesses handle regulatory compliance, providing a reminder of how compliance and risk should operate together, as "colleagues" sharing a common framework with some nuances to account for their differences. The ISO also produces international standards such as ISO/IEC 27002 to help organizations meet regulatory compliance with their security management and assurance best practices. Some local or international specialized organizations such as

3276-537: Is stronger in civil law countries, particularly those with a separate system of administrative courts ; by contrast, the public-private law divide is less pronounced in common law jurisdictions. Law provides a source of scholarly inquiry into legal history , philosophy , economic analysis and sociology . Law also raises important and complex issues concerning equality, fairness, and justice . The word law , attested in Old English as lagu , comes from

3402-441: Is that law is a system of rules and guidelines which are enforced through social institutions to govern behaviour. In The Concept of Law , H. L. A. Hart argued that law is a "system of rules"; John Austin said law was "the command of a sovereign, backed by the threat of a sanction"; Ronald Dworkin describes law as an "interpretive concept" to achieve justice in his text titled Law's Empire ; and Joseph Raz argues law

3528-994: Is the Supreme Court ; in Australia, the High Court ; in India, the Supreme Court of India ; in the UK, the Supreme Court ; in Germany, the Bundesverfassungsgericht ; and in France, the Cour de Cassation . For most European countries the European Court of Justice in Luxembourg can overrule national law, when EU law is relevant. The European Court of Human Rights in Strasbourg allows citizens of

3654-486: Is the legal systems in communist states such as the former Soviet Union and the People's Republic of China . Academic opinion is divided on whether it is a separate system from civil law, given major deviations based on Marxist–Leninist ideology, such as subordinating the judiciary to the executive ruling party. There are distinguished methods of legal reasoning (applying the law) and methods of interpreting (construing)

3780-541: Is the medicine and therapeutic regulatory agency of the Australian Government . As part of the Department of Health and Aged Care , the TGA regulates the safety, quality, efficacy and advertising in Australia of therapeutic goods (which comprise medicines, medical devices, biologicals and certain other therapeutic goods). Therapeutic goods include goods that are represented to have a therapeutic effect, are included in

3906-563: Is to make laws, since they are acts of the general will ; nor whether the prince is above the law, since he is a member of the State; nor whether the law can be unjust, since no one is unjust to himself; nor how we can be both free and subject to the laws, since they are but registers of our wills. Jean-Jacques Rousseau, The Social Contract , II, 6. The philosophy of law is commonly known as jurisprudence. Normative jurisprudence asks "what should law be?", while analytic jurisprudence asks "what

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4032-681: Is used to ensure that all necessary governance requirements can be met without the unnecessary duplication of effort and activity from resources. Regulations and accrediting organizations vary among fields, with examples such as PCI-DSS and GLBA in the financial industry, FISMA for U.S. federal agencies, HACCP for the food and beverage industry , and the Joint Commission and HIPAA in healthcare. In some cases other compliance frameworks (such as COBIT ) or even standards ( NIST ) inform on how to comply with regulations. Some organizations keep compliance data—all data belonging or pertaining to

4158-501: Is well documented, and that competition is fair while protecting consumers. The APRA in particular deals with superannuation and its regulation, including new regulations requiring trustees of superannuation funds to demonstrate to APRA that they have adequate resources (human, technology and financial), risk management systems, and appropriate skills and expertise to manage the superannuation fund, with individuals running them being "fit and proper". Other key regulators in Australia include

4284-683: The Manusmriti (c. 100–300 AD) were foundational treatises in India, and comprise texts considered authoritative legal guidance. Manu's central philosophy was tolerance and pluralism , and was cited across Southeast Asia. During the Muslim conquests in the Indian subcontinent , sharia was established by the Muslim sultanates and empires, most notably Mughal Empire 's Fatawa-e-Alamgiri , compiled by emperor Aurangzeb and various scholars of Islam. In India,

4410-454: The "is" and what "ought to be" problem. Bentham and Austin argued for law's positivism ; that real law is entirely separate from "morality". Kant was also criticised by Friedrich Nietzsche , who rejected the principle of equality, and believed that law emanates from the will to power , and cannot be labeled as "moral" or "immoral". In 1934, the Austrian philosopher Hans Kelsen continued

4536-582: The American Society of Mechanical Engineers (ASME) also develop standards and regulation codes. They thereby provide a wide range of rules and directives to ensure compliance of the products to safety, security or design standards. Regulatory compliance varies not only by industry but often by location. The financial, research, and pharmaceutical regulatory structures in one country, for example, may be similar but with particularly different nuances in another country. These similarities and differences are often

4662-749: The Australian Communications & Media Authority (ACMA) for broadcasting, the internet, and communications; the Clean Energy Regulator for "monitoring, facilitating and enforcing compliance with" energy and carbon emission schemes; and the Therapeutic Goods Administration for drugs, devices, and biologics; Australian organisations seeking to remain compliant with various regulations may turn to AS ISO 19600:2015 (which supersedes AS 3806-2006). This standard helps organisations with compliance management, placing "emphasis on

4788-497: The Codex Hammurabi . The most intact copy of these stelae was discovered in the 19th century by British Assyriologists , and has since been fully transliterated and translated into various languages, including English, Italian, German, and French. The Old Testament dates back to 1280 BC and takes the form of moral imperatives as recommendations for a good society. The small Greek city-state, ancient Athens , from about

4914-591: The Council of Europe member states to bring cases relating to human rights issues before it. Some countries allow their highest judicial authority to overrule legislation they determine to be unconstitutional . For example, in Brown v. Board of Education , the United States Supreme Court nullified many state statutes that had established racially segregated schools, finding such statutes to be incompatible with

5040-478: The Early Middle Ages , Roman law was rediscovered around the 11th century when medieval legal scholars began to research Roman codes and adapt their concepts to the canon law , giving birth to the jus commune . Latin legal maxims (called brocards ) were compiled for guidance. In medieval England, royal courts developed a body of precedent which later became the common law . A Europe-wide Law Merchant

5166-559: The English Court of Common Pleas had five. This powerful and tight-knit judiciary gave rise to a systematised process of developing common law. As time went on, many felt that the common law was overly systematised and inflexible, and increasing numbers of citizens petitioned the King to override the common law. On the King's behalf, the Lord Chancellor started giving judgments to do what

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5292-1218: The Enlightenment . Then, in the 19th century, both France, with the Code Civil , and Germany, with the Bürgerliches Gesetzbuch , modernised their legal codes. Both these codes heavily influenced not only the law systems of the countries in continental Europe but also the Japanese and Korean legal traditions. Today, countries that have civil law systems range from Russia and Turkey to most of Central and Latin America . In common law legal systems, decisions by courts are explicitly acknowledged as "law" on equal footing with legislative statutes and executive regulations . The "doctrine of precedent", or stare decisis (Latin for "to stand by decisions") means that decisions by higher courts bind lower courts to assure that similar cases reach similar results. In contrast , in civil law systems, legislative statutes are typically more detailed, and judicial decisions are shorter and less detailed because

5418-551: The Fourteenth Amendment to the United States Constitution . A judiciary is theoretically bound by the constitution, just as all other government bodies are. In most countries judges may only interpret the constitution and all other laws. But in common law countries, where matters are not constitutional, the judiciary may also create law under the doctrine of precedent . The UK, Finland and New Zealand assert

5544-645: The French , but mostly the German Civil Code. This partly reflected Germany's status as a rising power in the late 19th century. Similarly, traditional Chinese law gave way to westernisation towards the final years of the Qing Dynasty in the form of six private law codes based mainly on the Japanese model of German law. Today Taiwanese law retains the closest affinity to the codifications from that period, because of

5670-527: The Hindu legal tradition, along with Islamic law, were both supplanted by common law when India became part of the British Empire . Malaysia, Brunei, Singapore and Hong Kong also adopted the common law system. The Eastern Asia legal tradition reflects a unique blend of secular and religious influences. Japan was the first country to begin modernising its legal system along Western lines, by importing parts of

5796-654: The Latin Church sui juris . The Eastern Catholic Churches, which developed different disciplines and practices, are governed by the Code of Canons of the Eastern Churches . The canon law of the Catholic Church influenced the common law during the medieval period through its preservation of Roman law doctrine such as the presumption of innocence . Roman Catholic canon law is a fully developed legal system, with all

5922-474: The Old Norse word lǫg . The singular form lag meant ' something laid or fixed ' while its plural meant ' law ' . But what, after all, is a law? [...] When I say that the object of laws is always general, I mean that law considers subjects en masse and actions in the abstract, and never a particular person or action. [...] On this view, we at once see that it can no longer be asked whose business it

6048-568: The Pharmaceutical Benefits Scheme (PBS) was allowing for government subsidy of sub-standard medicines. The Menzies government 's Therapeutic Substances Act 1953 , passed in the wake of the National Health Act 1953 , was the first effective federal therapeutic goods legislation and allowed for federal control over drug imports, drug sold to the federal government, drugs subject to interstate trade, and drugs supplied under

6174-608: The Quran has some law, and it acts as a source of further law through interpretation, Qiyas (reasoning by analogy), Ijma (consensus) and precedent . This is mainly contained in a body of law and jurisprudence known as Sharia and Fiqh respectively. Another example is the Torah or Old Testament , in the Pentateuch or Five Books of Moses. This contains the basic code of Jewish law, which some Israeli communities choose to use. The Halakha

6300-628: The Sarbanes–Oxley Act developed by two U.S. congressmen, Senator Paul Sarbanes and Representative Michael Oxley in 2002 which defined significantly tighter personal responsibility of corporate top management for the accuracy of reported financial statements; and the Dodd-Frank Wall Street Reform and Consumer Protection Act . The Office of Foreign Assets Control (OFAC) is an agency of the United States Department of

6426-507: The Therapeutic Goods Act 1989 , Therapeutic Goods Regulations 1990 or Therapeutic Goods (Medical Devices) Regulations 2002 before they can be imported, supplied, exported or manufactured in Australia. Regulation of therapeutic goods in Australia was initially undertaken at a state level, with regular conferences held between state and federal governments aimed at achieving uniform standards for drugs. Although federal legislation

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6552-676: The absolutist theory of Thomas Hobbes ' Leviathan . Sun Yat-sen 's Five Power Constitution for the Republic of China took the separation of powers further by having two additional branches of government—a Control Yuan for auditing oversight and an Examination Yuan to manage the employment of public officials. Max Weber and others reshaped thinking on the extension of state. Modern military, policing and bureaucratic power over ordinary citizens' daily lives pose special problems for accountability that earlier writers such as Locke or Montesquieu could not have foreseen. The custom and practice of

6678-597: The "basic pattern of legal reasoning is reasoning by example"—that is, reasoning by comparing outcomes in cases resolving similar legal questions. In a U.S. Supreme Court case regarding procedural efforts taken by a debt collection company to avoid errors, Justice Sotomayor cautioned that "legal reasoning is not a mechanical or strictly linear process". Jurimetrics is the formal application of quantitative methods, especially probability and statistics , to legal questions. The use of statistical methods in court cases and law review articles has grown massively in importance in

6804-424: The 22nd century BC, the ancient Sumerian ruler Ur-Nammu had formulated the first law code , which consisted of casuistic statements ("if … then ..."). Around 1760 BC, King Hammurabi further developed Babylonian law , by codifying and inscribing it in stone. Hammurabi placed several copies of his law code throughout the kingdom of Babylon as stelae , for the entire public to see; this became known as

6930-467: The 6th century, which were rediscovered by 11th century Italy. Roman law in the days of the Roman Republic and Empire was heavily procedural, and lacked a professional legal class. Instead a lay magistrate , iudex , was chosen to adjudicate. Decisions were not published in any systematic way, so any case law that developed was disguised and almost unrecognised. Each case was to be decided afresh from

7056-431: The 8th century BC was the first society to be based on broad inclusion of its citizenry, excluding women and enslaved people . However, Athens had no legal science or single word for "law", relying instead on the three-way distinction between divine law ( thémis ), human decree ( nomos ) and custom ( díkē ). Yet Ancient Greek law contained major constitutional innovations in the development of democracy . Roman law

7182-1114: The Canadian capital markets through the Canadian Securities Administrators (CSA). Other key regulators in Canada include the Canadian Food Inspection Agency (CFIA) for food safety, animal health, and plant health; Health Canada for public health; and Environment and Climate Change Canada for environment and sustainable energy. Canadian organizations seeking to remain compliant with various regulations may turn to ISO 19600:2014 , an international compliance standard that "provides guidance for establishing, developing, implementing, evaluating, maintaining and improving an effective and responsive compliance management system within an organization". For more industry specific guidance, e.g., financial institutions, Canada's E-13 Regulatory Compliance Management provides specific compliance risk management tactics. The financial sector in

7308-928: The Department of Health was reorganised and replaced by the Therapeutic Goods Administration (TGA). Some functions of the NHMRC were transferred to the TGA later in the 1990s. In Australia, medical products are regulated by the TGA and, for controlled drugs such as cannabis, by the Office of Drug Control (ODC). Together, the TGA and ODC form the Health Products Regulation Group within the Department of Health and Aged Care. The Health Products Regulation Group comprises 14 regulatory branches and one legal branch, organised into four divisions. The TGA also includes seven specialised statutory committees, which

7434-519: The Federal government released vaccine allocation projections and forecast that the Oxford-AstraZeneca vaccine would be in "little need" past October 2021 when all Australians over 60 years were expected to be fully vaccinated. On 9 February 2022 within Australia the Oxford-AstraZeneca vaccine was approved by the TGA (still pending ATAGI approval) as booster vaccines for individuals – joining Pfizer and Moderna booster vaccines for individuals approved months ago. On 25 June 2021, provisional approval

7560-438: The King's entourage of judges hold their courts and judgments at "a certain place" rather than dispensing autocratic justice in unpredictable places about the country. A concentrated and elite group of judges acquired a dominant role in law-making under this system, and compared to its European counterparts the English judiciary became highly centralised. In 1297, for instance, while the highest court in France had fifty-one judges,

7686-425: The Netherlands is heavily regulated. The Dutch Central Bank (De Nederlandsche Bank N.V.) is the prudential regulator while the Netherlands Authority for Financial Markets (AFM) is the regulator for behavioral supervision of financial institutions and markets. A common definition of compliance is:'Observance of external (international and national) laws and regulations, as well as internal norms and procedures, to protect

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7812-436: The PBS. The new act allowed for the replacement of the British Pharmacopoeia (BP) as the primary source of quality standards for drugs in Australia, following concerns that the BP had not kept up to date with new medications. In introducing the legislation, federal health minister Earle Page – a former surgeon – referred to the existing poor standard of drug quality in Australia and stated it "would be criminal to allow such

7938-441: The Pfizer–BioNTech vaccine at Castle Hill in Sydney. An 84-year-old  aged care resident was the first Australian to receive the vaccine. To show confidence in the national immunisation vaccine rollout, Prime Minister Morrison and Chief Medical Officer Professor Paul Kelly also received vaccinations. On 23 February 2021, Australia's second shipment of the Pfizer vaccine arrived at Sydney airport. Health Minister Hunt confirmed

8064-405: The Quran as its constitution , and is governed on the basis of Islamic law. Iran has also witnessed a reiteration of Islamic law into its legal system after 1979. During the last few decades, one of the fundamental features of the movement of Islamic resurgence has been the call to restore the Sharia, which has generated a vast amount of literature and affected world politics . Socialist law

8190-437: The Sharia: the Supreme Constitutional Court of Egypt may invalidate such laws, and in Iran the Guardian Council ensures the compatibility of the legislation with the "criteria of Islam". Prominent examples of legislatures are the Houses of Parliament in London, the Congress in Washington, D.C., the Bundestag in Berlin, the Duma in Moscow, the Parlamento Italiano in Rome and the Assemblée nationale in Paris. By

8316-444: The Therapeutic Substances Section. The NBSL was merged into the Therapeutics Division in 1985. In 1981, the Fraser government 's Health Acts Amendment Bill 1981 significantly broadened the scope of the Therapeutic Goods Act 1966 to include a wide range of medical devices, update standards and monitoring of manufacturing and testing, established a new National Register of Therapeutic Goods, and increase penalties for contraventions of

8442-559: The Treasury under the auspices of the Under Secretary of the Treasury for Terrorism and Financial Intelligence. OFAC administers and enforces economic and trade sanctions based on U.S. foreign policy and national security goals against targeted foreign states, organizations, and individuals. Compliance in the U.S. generally means compliance with laws and regulations. These laws and regulations can have criminal or civil penalties. The definition of what constitutes an effective compliance plan has been elusive. Most authors, however, continue to cite

8568-430: The U.S. , the two systems were merged . In developing the common law, academic writings have always played an important part, both to collect overarching principles from dispersed case law and to argue for change. William Blackstone , from around 1760, was the first scholar to collect, describe, and teach the common law. But merely in describing, scholars who sought explanations and underlying structures slowly changed

8694-482: The United Kingdom . Important compliance issues for all organizations large and small include the Data Protection Act 2018 and, for the public sector, Freedom of Information Act 2000 . The U.K. Corporate Governance Code (formerly the Combined Code) is issued by the Financial Reporting Council (FRC) and "sets standards of good practice in relation to board leadership and effectiveness, remuneration, accountability, and relations with shareholders". All companies with

8820-416: The act. Following a series of government and parliamentary inquiries in the 1980s, the Hawke government 's Therapeutic Goods Act 1989 came into effect in 1991, repealing the preceding 1966 act. The effect of the new legislation was to establish a comprehensive national framework for therapeutic goods, including a mandatory Australian Register of Therapeutic Goods. The existing Therapeutics Division within

8946-468: The adjudicator is only writing to decide the single case, rather than to set out reasoning that will guide future courts. Common law originated from England and has been inherited by almost every country once tied to the British Empire (except Malta, Scotland , the U.S. state of Louisiana , and the Canadian province of Quebec ). In medieval England during the Norman conquest , the law varied shire-to-shire based on disparate tribal customs. The concept of

9072-574: The agency can call upon for assistance on technical or scientific issues. Four other committees also exist to give guidance on annual influenza vaccines, industry consultation matters, and the Therapeutic Goods Advertising Code. In September 2003, the Australian and New Zealand Government signed a treaty to establish a common therapeutic regulatory agency for the two countries. Australia New Zealand Therapeutic Products Agency, as it

9198-488: The approach of identifying and assessing potential risks of money laundering and terrorist financing and implementing regulatory measures proportional to those risks. However, the shared enforcement powers between EU and national authorities in the implementation and enforcement of AML/CFT regulations can create legal implications and challenges. The potential for inconsistent application of AML regulations across different jurisdictions can create regulatory arbitrage and undermine

9324-602: The arrival of 166,000 doses, and 120,000 more doses expected to arrive in the following week. On 9 April 2021, Prime Minister Morrison announced that Australia had secured another 20 million doses of Pfizer vaccine on top of 20 million already on order, meaning 40 million doses should be available to Australians in 2021. This was amid concerns about the AstraZeneca vaccine, in rare cases, causing blood clots; see section Oxford–AstraZeneca vaccine below. The additional doses of Pfizer were expected to arrive in Australia in

9450-476: The continuing lack of adequate statutory control over the importation of new therapeutic substances". The committee's lobbying resulted in the Therapeutic Goods Act 1966 , which significantly expanded the Minister for Health's powers in that area. However, regulations under the 1966 act were not proclaimed until 1970, amid significant criticism that the act gave the minister too much power and reduced parliamentary oversight. The new legislation also failed to resolve

9576-561: The costs and benefits to each country". The joint statement announcing the cessation outlines that both the TGA and Medsafe would continue to cooperate on medicine regulation and that the New Zealand Government would still participate in the now defunct, Council of Australian Governments Health Council. On 25 January 2021, the TGA provisionally approved the two-dose Pfizer–BioNTech COVID-19 vaccine , named COMIRNATY , for use within Australia. The provisional approval only recommends

9702-575: The defining features of any legal system. Civil law is the legal system used in most countries around the world today. In civil law the sources recognised as authoritative are, primarily, legislation —especially codifications in constitutions or statutes passed by government—and custom . Codifications date back millennia, with one early example being the Babylonian Codex Hammurabi . Modern civil law systems essentially derive from legal codes issued by Byzantine Emperor Justinian I in

9828-620: The effectiveness of AML efforts. Additionally, a lack of clear and consistent legal frameworks defining the roles and responsibilities of EU and national authorities in AML enforcement can lead to situations where accountability is difficult to establish. Corporate scandals and breakdowns such as the Enron case of reputational risk in 2001 have increased calls for stronger compliance and regulations, particularly for publicly listed companies. The most significant recent statutory changes in this context have been

9954-492: The enterprise or included in the law, which can be used for the purpose of implementing or validating compliance—in a separate store for meeting reporting requirements. Compliance software is increasingly being implemented to help companies manage their compliance data more efficiently. This store may include calculations, data transfers, and audit trails. The International Organization for Standardization (ISO) and its ISO 37301:2021 (which deprecates ISO 19600:2014 ) standard

10080-406: The executive acts as both head of state and head of government, and has power to appoint an unelected cabinet. Under a presidential system, the executive branch is separate from the legislature to which it is not accountable. Although the role of the executive varies from country to country, usually it will propose the majority of legislation, and propose government agenda. In presidential systems,

10206-505: The executive often has the power to veto legislation. Most executives in both systems are responsible for foreign relations , the military and police, and the bureaucracy. Ministers or other officials head a country's public offices, such as a foreign ministry or defence ministry . The election of a different executive is therefore capable of revolutionising an entire country's approach to government. Therapeutic Goods Administration The Therapeutic Goods Administration ( TGA )

10332-496: The first shipment of the vaccine, around 300,000 doses, arrived at Sydney for rollout from 8 March. On 5 March 2021, Italy stopped the export of AstraZeneca vaccine to Australia due to their slower rollout of that vaccine in the EU. On 23 March, TGA approved the first batch of locally manufactured AstraZeneca vaccine by CSL-Seqirus in Melbourne, and 832,200 doses were ready for rollout in

10458-564: The following weeks. On 17 June 2021, Federal Health minister Greg Hunt announced a rise in the age limit for administration of the AstraZeneca vaccine. After new advice from the Australian Technical Advisory Group on Immunisation (ATAGI), the vaccine was no longer recommended for people aged under 60 years. This advice came after new cases of blood clotting, thrombosis with thrombocytopenia syndrome (TTS), in those under 60 after AstraZeneca vaccinations. On 23 June 2021,

10584-870: The golden age of Roman law and aimed to restore it to the peak it had reached three centuries before." The Justinian Code remained in force in the East until the fall of the Byzantine Empire . Western Europe, meanwhile, relied on a mix of the Theodosian Code and Germanic customary law until the Justinian Code was rediscovered in the 11th century, which scholars at the University of Bologna used to interpret their own laws. Civil law codifications based closely on Roman law, alongside some influences from religious laws such as canon law , continued to spread throughout Europe until

10710-673: The guidance provided by the United States Sentencing Commission in Chapter 8 of the Federal Sentencing Guidelines. On October 12, 2006, the U.S. Small Business Administration re-launched Business.gov (later Business.USA.gov and finally SBA.Gov) which provides a single point of access to government services and information that help businesses comply with government regulations. The U.S. Department of Labor, Occupational Health and Safety Administration (OSHA)

10836-524: The idea of the rule of law because he did not accept the primacy of abstract normative principles over concrete political positions and decisions. Therefore, Schmitt advocated a jurisprudence of the exception ( state of emergency ), which denied that legal norms could encompass all of the political experience. Later in the 20th century, H. L. A. Hart attacked Austin for his simplifications and Kelsen for his fiction in The Concept of Law . Hart argued law

10962-428: The ideal of parliamentary sovereignty , whereby the unelected judiciary may not overturn law passed by a democratic legislature. In communist states , such as China, the courts are often regarded as parts of the executive, or subservient to the legislature; governmental institutions and actors exert thus various forms of influence on the judiciary. In Muslim countries, courts often examine whether state laws adhere to

11088-525: The individual’s desires, it can create some real difficulties. Money laundering and terrorist financing pose significant threats to the integrity of the financial system and national security. To combat these threats, the EU has adopted a risk-based approach to Anti-Money Laundering and Combating the Financing of Terrorism (AML/CFT) that relies on cooperation and coordination between EU and national authorities. In this context, risk-based regulation refers to

11214-460: The industry segment in addition to the geographical mix. Most regulation comes in the following broad categories: economic regulation, regulation in the public interest, and environmental regulation. India has also been characterized by poor compliance - reports suggest that only around 65% of companies are fully compliant to norms. The Monetary Authority of Singapore is Singapore 's central bank and financial regulatory authority. It administers

11340-430: The integrity of the organization, its management and employees with the aim of preventing and controlling risks and the possible damage resulting from these compliance and integrity risks'. In India, compliance regulation takes place across three strata: Central, State, and Local regulation. India veers towards central regulation, especially of financial organizations and foreign funds. Compliance regulations vary based on

11466-523: The issue of uniform state regulations. A separate Therapeutic Substances Section was created in the Department of Health in 1963, under the Division of National Health, with regulations having previously been overseen by the director of the NBSL. The National Therapeutic Goods Committee was established in 1971 and in 1974 the Department of Health was restructured to create a separate Therapeutics Division in place of

11592-564: The last few decades. It is a real unity of them all in one and the same person, made by covenant of every man with every man, in such manner as if every man should say to every man: I authorise and give up my right of governing myself to this man, or to this assembly of men, on this condition; that thou givest up, thy right to him, and authorise all his actions in like manner. Thomas Hobbes, Leviathan , XVII The main institutions of law in industrialised countries are independent courts , representative parliaments, an accountable executive,

11718-625: The last quarter of 2021. On 23 July 2021, the TGA approved the Pfizer COVID-19 vaccine for teenagers between 12 and 15 years old. On 5 December 2021, the TGA provisionally approved the Pfizer COVID-19 vaccine access for five to 11-year-olds. On 16 February 2021, the Oxford–AstraZeneca vaccine was approved by the TGA for use in Australia. The administration of this vaccine was scheduled to start in March. Two weeks later, on 28 February,

11844-502: The law more difficult. A government usually leads the process, which can be formed from Members of Parliament (e.g. the UK or Germany). However, in a presidential system, the government is usually formed by an executive and his or her appointed cabinet officials (e.g. the United States or Brazil). The executive in a legal system serves as the centre of political authority of the State . In

11970-622: The law. In common law systems, judges may make binding case law through precedent, although on occasion this may be overturned by a higher court or the legislature. Religious law is in use in some religious communities and states, and has historically influenced secular law. The scope of law can be divided into two domains: public law concerns government and society, including constitutional law , administrative law , and criminal law ; while private law deals with legal disputes between parties in areas such as contracts , property , torts , delicts and commercial law . This distinction

12096-731: The law. The former are legal syllogism , which holds sway in civil law legal systems, analogy , which is present in common law legal systems, especially in the US, and argumentative theories that occur in both systems. The latter are different rules (directives) of legal interpretation such as directives of linguistic interpretation, teleological interpretation or systemic interpretation as well as more specific rules, for instance, golden rule or mischief rule . There are also many other arguments and cannons of interpretation which altogether make statutory interpretation possible. Law professor and former United States Attorney General Edward H. Levi noted that

12222-577: The laws of the State, which mirrors the (theoretical) unimportance of judges' decisions for future cases in civil law systems today. From 529 to 534 AD the Byzantine Emperor Justinian I codified and consolidated Roman law up until that point, so that what remained was one-twentieth of the mass of legal texts from before. This became known as the Corpus Juris Civilis . As one legal historian wrote, "Justinian consciously looked back to

12348-426: The legal profession is an important part of people's access to justice , whilst civil society is a term used to refer to the social institutions, communities and partnerships that form law's political basis. A judiciary is a number of judges mediating disputes to determine outcome. Most countries have systems of appeal courts, with an apex court as the ultimate judicial authority. In the United States, this authority

12474-472: The mid-1940s, efforts have been made, in country after country, to bring Sharia law more into line with modern conditions and conceptions. In modern times, the legal systems of many Muslim countries draw upon both civil and common law traditions as well as Islamic law and custom. The constitutions of certain Muslim states, such as Egypt and Afghanistan, recognise Islam as the religion of the state, obliging legislature to adhere to Sharia. Saudi Arabia recognises

12600-510: The military and police, bureaucratic organisation, the legal profession and civil society itself. John Locke, in his Two Treatises of Government , and Baron de Montesquieu in The Spirit of the Laws , advocated for a separation of powers between the political, legislature and executive bodies. Their principle was that no person should be able to usurp all powers of the state , in contrast to

12726-669: The most influential. In contrast to English common law, which consists of enormous tomes of case law, codes in small books are easy to export and easy for judges to apply. However, today there are signs that civil and common law are converging. EU law is codified in treaties, but develops through de facto precedent laid down by the European Court of Justice . Ancient India and China represent distinct traditions of law, and have historically had independent schools of legal theory and practice. The Arthashastra , probably compiled around 100 AD (although it contains older material), and

12852-505: The necessary elements: courts , lawyers , judges, a fully articulated legal code, principles of legal interpretation, and coercive penalties, though it lacks civilly-binding force in most secular jurisdictions. Until the 18th century, Sharia law was practiced throughout the Muslim world in a non-codified form, with the Ottoman Empire 's Mecelle code in the 19th century being a first attempt at codifying elements of Sharia law. Since

12978-538: The notion of justice, and re-entered the mainstream of Western culture through the writings of Thomas Aquinas , notably his Treatise on Law . Hugo Grotius , the founder of a purely rationalistic system of natural law, argued that law arises from both a social impulse—as Aristotle had indicated—and reason. Immanuel Kant believed a moral imperative requires laws "be chosen as though they should hold as universal laws of nature". Jeremy Bentham and his student Austin, following David Hume , believed that this conflated

13104-445: The onset of World War II. The National Health and Medical Research Council (NHMRC) took a more active role in co-ordinating regulation during war time, including uniformity of labelling, medical nomenclature, and dangerous drugs legislation. In 1952, following lobbying from the NHMRC, the federal government organised a Therapeutic Substances Conference attended by representatives of federal and state governments. The conference passed

13230-592: The organisational elements that are required to support compliance" while also recognizing the need for continual improvement . In Canada , federal regulation of deposits, insurance, and superannuation is governed by two independent bodies: the OSFI through the Bank Act , and FINTRAC , mandated by the Proceeds of Crime (Money Laundering) and Terrorist Financing Act, 2001 (PCMLTFA). These groups protect consumers, regulate how risk

13356-564: The positivist tradition in his book the Pure Theory of Law . Kelsen believed that although law is separate from morality, it is endowed with "normativity", meaning we ought to obey it. While laws are positive "is" statements (e.g. the fine for reversing on a highway is €500); law tells us what we "should" do. Thus, each legal system can be hypothesised to have a ' basic norm ' ( German : Grundnorm ) instructing us to obey. Kelsen's major opponent, Carl Schmitt , rejected both positivism and

13482-483: The positivists for their refusal to treat law as a moral issue. Dworkin argues that law is an " interpretive concept" that requires judges to find the best fitting and most just solution to a legal dispute, given their Anglo-American constitutional traditions. Joseph Raz , on the other hand, defended the positivist outlook and criticised Hart's "soft social thesis" approach in The Authority of Law . Raz argues that law

13608-416: The principle of representative government people vote for politicians to carry out their wishes. Although countries like Israel, Greece, Sweden and China are unicameral , most countries are bicameral , meaning they have two separately appointed legislative houses. In the 'lower house' politicians are elected to represent smaller constituencies . The 'upper house' is usually elected to represent states in

13734-575: The quality of imported drugs and drugs to be supplied under the PBS. One notable absence from the 1953 legislation was the lack of any penalty for possessing or dealing with a sub-standard therapeutic substance. The Thalidomide scandal of the early 1960s prompted a reconsideration of federal regulation of drugs. In 1963, the Australian Drug Evaluation Committee was formed to consider legislative reforms and expressed its "grave concern at

13860-469: The question of the extent to which law incorporates morality. John Austin 's utilitarian answer was that law is "commands, backed by threat of sanctions, from a sovereign, to whom people have a habit of obedience". Natural lawyers , on the other hand, such as Jean-Jacques Rousseau , argue that law reflects essentially moral and unchangeable laws of nature. The concept of "natural law" emerged in ancient Greek philosophy concurrently and in connection with

13986-504: The rationale behind allowing the companies to apply the provisions of company law, international financial reporting standards (IFRS), as well as the U.K. stock exchange rules as directed by the FCA. It is also possible that shareholders may not understand the figures as presented in the various financial statements, hence it is critical that the board should provide notes on accounting policies as well as other explanatory notes to help them understand

14112-526: The report better. Data retention is a part of regulatory compliance that is proving to be a challenge in many instances. The security that comes from compliance with industry regulations can seem contrary to maintaining user privacy. Data retention laws and regulations ask data owners and other service providers to retain extensive records of user activity beyond the time necessary for normal business operations. These requirements have been called into question by privacy rights advocates. Compliance in this area

14238-525: The risk of exposure. Border, quarantine, and front-line health and aged care workers were vaccinated first, followed by over 70 year-olds, other health care workers, and essential emergency service members. Following the provisional approval of COMIRNATY, Prime Minister Scott Morrison said that it was planned for the first group to begin vaccinations by February 2021, six weeks earlier than originally planned. The first public COVID-19 vaccination in Australia actually took place on 21 February 2021 with

14364-402: The sharing of many features traditionally considered typical of either common law or civil law. The third type of legal system is religious law, based on scriptures . The specific system that a country is ruled by is often determined by its history, connections with other countries, or its adherence to international standards. The sources that jurisdictions adopt as authoritatively binding are

14490-454: The split between Chiang Kai-shek 's nationalists, who fled there, and Mao Zedong 's communists who won control of the mainland in 1949. The current legal infrastructure in the People's Republic of China was heavily influenced by Soviet Socialist law , which essentially prioritises administrative law at the expense of private law rights. Due to rapid industrialisation, today China is undergoing

14616-435: The vaccine for patients over the age of 16, pending ongoing submission of clinical data from the vaccine sponsors (the manufacturers, Pfizer and BioNTech). Additionally, every batch of vaccines have their composition and documentation verified by TGA laboratories before being distributed to medical providers. The Department of Health and Aged Care planned the administration of COVID-19 vaccinations in five phases, organised by

14742-649: The various statutes pertaining to money, banking, insurance, securities and the financial sector in general, as well as currency issuance . There is considerable regulation in the United Kingdom , some of which is derived from European Union legislation. Various areas are policed by different bodies, such as the Financial Conduct Authority (FCA), Environment Agency , Scottish Environment Protection Agency , Information Commissioner's Office , Care Quality Commission , and others: see List of regulators in

14868-614: The way the law actually worked. Religious law is explicitly based on religious precepts. Examples include the Jewish Halakha and Islamic Sharia —both of which translate as the "path to follow". Christian canon law also survives in some church communities. Often the implication of religion for law is unalterability because the word of God cannot be amended or legislated against by judges or governments. Nonetheless, most religious jurisdictions rely on further human elaboration to provide for thorough and detailed legal systems. For instance,

14994-418: The word "law" had two different and irreconcilable meanings. Thurman Arnold said that it is obvious that it is impossible to define the word "law" and that it is also equally obvious that the struggle to define that word should not ever be abandoned. It is possible to take the view that there is no need to define the word "law" (e.g. "let's forget about generalities and get down to cases "). One definition

15120-644: Was created by Congress to assure safe and healthful working conditions for working men and women by setting and enforcing standards and by providing training, outreach, education, and assistance. OSHA implements laws and regulations regularly in the following areas, construction, maritime, agriculture, and recordkeeping. The United States Department of Transportation also has various laws and regulations requiring that prime contractors when bidding on federally funded projects engage in good faith effort compliance, meaning they must document their outreach to certified disadvantaged business enterprises. Law Law

15246-467: Was equitable in a case. From the time of Sir Thomas More , the first lawyer to be appointed as Lord Chancellor, a systematic body of equity grew up alongside the rigid common law, and developed its own Court of Chancery . At first, equity was often criticised as erratic. Over time, courts of equity developed solid principles , especially under Lord Eldon . In the 19th century in England, and in 1937 in

15372-490: Was formed so that merchants could trade with common standards of practice rather than with the many splintered facets of local laws. The Law Merchant, a precursor to modern commercial law, emphasised the freedom to contract and alienability of property. As nationalism grew in the 18th and 19th centuries, the Law Merchant was incorporated into countries' local law under new civil codes. The Napoleonic and German Codes became

15498-461: Was heavily influenced by Greek philosophy, but its detailed rules were developed by professional jurists and were highly sophisticated. Over the centuries between the rise and decline of the Roman Empire , law was adapted to cope with the changing social situations and underwent major codification under Theodosius II and Justinian I . Although codes were replaced by custom and case law during

15624-448: Was sought from an early period, there was considerable uncertainty as to the extent of the federal parliament's ability to legislate in that area . Commonwealth Serum Laboratories was created by the federal government in 1916 and in 1932 was nominated as the local repository for biological standards set by the League of Nations . The first federal legislation relating to therapeutic goods

15750-475: Was the Lyons government 's Therapeutic Substances Act 1937 , which gave the federal Minister for Health to regulate the import and export of therapeutic goods and bring Australian standards into line with League of Nations standards. The act was amended in 1938 to better define which substances were therapeutic. Ultimately the provisions of the legislation was never brought into effect due to changes of government and

15876-520: Was to be called, would replace the TGA and Medsafe , the national regulator in New Zealand. In June 2011, eight years after the original treaty, Australian Prime Minister Julia Gillard and New Zealand Prime Minister John Key signed a letter of intent, reaffirming plans to create such an agency. In November 2014, both Australia and New Zealand agreed to cease plans to create a shared regulator, citing "a comprehensive review of progress and assessment of

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