International Pharmacy Regulations
Drug prices in the United States are higher than in any other country in the world. Many Americans can no longer afford to fill their prescriptions in U.S. pharmacies, and are looking beyond their borders for more affordable options. Purchasing low-cost Canadian and internationally available prescription drugs online or through mail-order is now affordable and convenient through ibenefitRx.com.
At ibenefitRx.com we source medications from around the world that are dispensed and approved for sale in Canada, the United States, the United Kingdom, South Africa, Israel, Australia and New Zealand. ibenefitRx.com is concerned about the safety, quality and efficacy of the medications, which are dispensed from our pharmacies. Each country has a government regulatory body, which is responsible for approving and monitoring each medication that is released in that country. Additionally, these regulatory bodies may be responsible that each manufacturer has facilities that meet the standards set out for good manufacturing practices (GMP). The regulatory bodies of each country also share information in order to help make determinations regarding drug approvals. The standard for safe dispensing and quality control in our facilities has been regulated by professional regulatory agencies. ibenefitRx.com operates in accordance with the rules and guidelines these regulatory bodies have established.
In the United States the guidelines are set out by the Food and Drug Administration (FDA). Before a new drug is introduced in the United States, it must meet certain approval guidelines. These guidelines include Clinical Research. The Clinical Research consists of Clinical Studies and Clinical Trials. Once the Clinical Research is completed, the Drug Application Process begins. The FDA reviews the application and if all criteria are met, the drug is approved for human consumption. In Canada, medications are regulated by Health Canada and the Health Products and Food Branch (HPFB). All drugs filled through Canadian pharmacies are approved by the Therapeutic Products Directorate of Health Canada (the regulatory equivalent of the Food and Drug Administration (FDA) in the U.S.)
Prescriptions medications supplied through our international network are all filled by pharmacies licensed and regulated according to the standards of the country in which they are located. The standards for Pharmacy Practice as well as the standards for the manufacture and distribution of pharmaceuticals in these other countries are at least as stringent as those in Canada and the U.S.
For more information on each of the countries in our international network, please click on the country name below.
The Pharmaceutical Society of Australia (PSA) is the national professional organization for pharmacists in Australia. PSA was established by the state professional pharmaceutical societies in 1977, some of which had been in existence for over 100 years, and is a federation. The establishment of PSA provided the profession not only with a national identity, but an opportunity to more effectively regulate its affairs, to achieve better coordination in consultation and liaison with the Commonwealth Government, other professions and industry.
The Society is the leading advocacy organization for pharmacists, influencing attitudes, opinions and policies through representation, networking, consultation and a range of publications and health promoting programs and resources.
The Pharmacy Guild of Australia was established in 1928, bringing together several small retail pharmacy organizations then operating in the various States. The Guild is registered under the federal Workplace Relations Act 1996 as an employers' organization. Its members are owners of some 4,500 pharmacies throughout Australia.
The Guild is a national employers' organization which functions as a single legal entity rather than a federation. The development of policy is the responsibility of the Guild's supreme governing body, the National Council, on which all State and Territory Branches are represented. Implementation of policy is overseen by the National Executive and effected through the National Secretariat.
The National Secretariat in Canberra works with the National President and the National Executive in performing its functions of servicing the Council, the Executive, the President and the National Committees. The Secretariat administers Guild policy and plays a significant role in policy development.
Currently the National Secretariat is involved in eight broad areas: Communications, Finance, Quality Care Pharmacy Program, Health Economics, Industrial Relations and Training, Economic Analysis and Information Technology, Strategic Policy and Professional Services and Research. Branch activities centre on the day-to-day servicing of members in such fields as industrial relations, marketing, staff training, and product and economic information. A major Guild activity at all levels is close liaison and negotiation with governments, manufacturers, wholesalers and other organizations in or around the health care delivery system.
The manufacture, packaging and control of finished pharmaceuticals (pharmaceutical products) and Active Pharmaceutical Ingredients (APIs) for human, biological and veterinary drugs, is regulated by the Pharmaceutical Division of the Israeli Ministry of Health. The organizational unit with the authority and responsibility for compliance and enforcement of current Good Manufacturing Practice (GMP) regulations is The Institute for Standardization and Control of Pharmaceuticals (The Institute).
Based on the Pharmaceutical Laws of the State of Israel, the Ministry of Health is entrusted with the mission of enforcing Good Manufacturing Practice so as to protect consumer health. The Ministry is responsible for conducting comprehensive regulatory monitoring of all aspects of production and control of pharmaceutical products and APIs. Monitoring of such activities is intended to ensure that such products meet USA or European GMP requirements so as to ensure their safety and efficacy at all times through their life-cycle.
In order to ensure GMP enforcement the Ministry of Health has set a target to inspect every company at least once in two years. The inspectional guidance is designed to maximize efficient use of resources. It is the Ministry’s intention to continually improve the level of nationwide compliance with current interpretation of the USA or European GMP regulations, guidelines and guidance.
Useful Links: http://www.health.gov.il/english/Pages_E/default.asp?maincat=10
Medsafe is the New Zealand Medicines and Medical Devices Safety Authority. It is a business unit of the Ministry of Health and is the authority responsible for the regulation of therapeutic products in New Zealand.
Medsafe regulates products used for a therapeutic purpose including medicines, herbal remedies, medical devices and controlled drugs used as medicines.
New Zealand Medicines Act
The Medicines Act 1981 defines the term "medicine" and contains controls relating to medicines, medical devices, related products and cosmetics. The purpose of all these controls is the protection of public safety.
The Act controls which products may legally be distributed, the places where medicines may be manufactured, through a licensing system, the importation and distribution of medicines, as well as quality standards for medicines and for packaging. The three elements of safety, quality and efficacy must all be assured if the public is to be adequately protected from products which have the potential to harm if they do not meet the standards claimed for them, or if they are used unwisely or inappropriately
The Medicines Act 1981 places control on the distribution and use of medicines through a classification system, which dictates the manner in which that product can be made available to the public.
There are four levels of classification:
Products in the most severely restricted classification level are called Prescription Medicines and can only be made available to the public by medical practitioners or other classes of professional occupation, such as mid-wives or optometrists, specified in the legislation.
Products in the next level down of classification are called Restricted Medicines. A Restricted Medicine can only be sold or prescribed by pharmacists within a pharmacy and that a sale must be recorded in a register.
The next level of classification is described as the Pharmacy-Only Medicine category and all products in this class must be sold through a registered pharmacy or from a retail outlet, which is more than ten kilometers from a pharmacy that has been licensed under the Medicines Act to sell specified pharmacy only medicines. Pharmacy only medicines, unlike restricted medicines, may be sold by any staff member working within a pharmacy.
The lowest level of medicines classification is the so-called unclassified group. These products are often referred to as General Sale Medicines and can be sold from any retail outlet.
Medicines are classified on the basis of a recommendation for either or two Ministerial advisory committees, the Medicines Assessment Advisory Committee, MAAC of the Medicines Classification Committee MCC.
The objective of the medicines legislation is to manage the risk of avoidable harm associated with the use of medicines. The legislation is designed to ensure that:
Medicines meet acceptable standards of safety, quality and efficacy;
Personnel, premises and practices used to manufacture, store and distribute medicines comply with requirements designed to ensure that products meet acceptable standards right up until they are delivered to the end-user; and
Information about the selection and safe use of medicines is provided to health professionals and consumers.
Medsafe is responsible for applying a framework of controls designed to ensure that the therapeutic products available in New Zealand are those that can be expected to have greater benefits than risks if used appropriately. This is achieved through:
Pre-marketing approval of products;
Post-marketing surveillance and monitoring of the chain of distribution of products.
The South African Medical and Pharmacy Environment
Recent Prescription Drug pricing and distribution regulations in South Africa (similar to those in Canada) have provided an opportunity for us to consistently supply multinational brands and generics directly to US based patients at competitive prices. In South Africa, the supply process adheres to pharmaceutical supply chain regulations as detailed in the Medicines Control Act, while offshore shipping is to international standards through multi-national and reputable shipping companies
Healthcare in South Africa
South African Healthcare Professionals are sought after throughout the world. The countries strong technological and economic infrastructure facilitates world-class medical and pharmaceutical research and development environments.
The Health Professions Council of South Africa
The Health Professions Council of South Africa (HPCSA) is a statutory body, established in terms of the Health Professions Act, 1974 (Act 56 of 1974).
The Council, in conjunction with its 12 Professional Boards, is committed to promoting the health of the population, determining standards of professional education and training and setting and maintaining excellent standards of ethical and professional practice. In order to safeguard the public and indirectly the professions, registration in terms of the Act is a prerequisite for practicing any of the health professions with which Council is concerned. Registration confers professional status upon a practitioner and therefore the right to practice his or her chosen profession. Practitioners thus enjoy the security of being registered in terms of an Act in the knowledge that no unqualified person may practice their profession. The register is furthermore to the advantage of practitioners whose names appear in it, since this confers public recognition on the competent practitioner who will thus be able to command a reward for his or her services. The HPCSA is a co-coordinating body for all the professions registered with it. Matters relating to a specific profession are dealt with by a professional board established for that profession. These boards consist of elected members, certain members appointed by the Minister of Health as well as by education institutions
Medicines Control Council of South-Africa
Over the last thirty years, South Africa has developed a medicines regulatory authority with internationally recognized standing. Over the past five years, it has been transformed in order to improve its performance and regulatory processes. The Medicines Control Council (MCC) is a statutory body that was established in terms of the Medicines and Related Substances Control Act, 101 of 1965, to oversee the regulation of medicines in South Africa. It is appointed by the Minister of Health and its main purpose is to safeguard and protect the public through ensuring that all medicines that are sold and used in South Africa are safe, therapeutically effective and consistently meet acceptable standards of quality.
The control of medicines in the UK is primarily through the system of licensing and conditional exemptions from licensing laid down in EC legislation, the Medicines Act 1968 and in relevant subordinate legislation. This legislation covers the systems by which licenses to manufacture, market, distribute, sell and supply medicinal products are granted by Ministers ("the Licensing Authority") (or, in the new centralized system, by the relevant Community institutions), once they are satisfied about the safety, efficacy and quality of the product. http://www.mhra.gov.uk/index.htm
There are controls also on clinical trials, on the claims, which may be made in advertising and other promotion, on quality control, manufacture of unlicensed products and supply of imports. The Authority is also required to monitor the safety of licensed medicinal products and to take action when adverse effects are recognized.
The MHRA (medicines) (MHRA) is accountable to Health and Agriculture Ministers in the UK for the discharge of the functions they exercise collectively or singly as the "Licensing Authority" (LA). Department of Health Ministers are accountable to Parliament on matters concerning human medicines regulation on a UK basis.
The Medicines Act 1968 also set up a statutory advisory body called the Medicines Commission to give advice on matters specified in the Act relating to medicinal products, under Section 4 of the Act Ministers have also established special advisory committees. The (LA) may not refuse to grant a marketing authorization, revoke, vary or suspend it (in the latter case except in an emergency) on grounds relating to safety, quality or efficacy without first consulting the appropriate independent advisory body. The MHRA provides the professional assessors and administrative support for these bodies.
The legislation provides a regulatory framework in respect of the safety, quality and efficacy of medicinal products to be sold or supplied or administered to patients. The MHRA accordingly discharges, on behalf of Ministers, functions which have been put in place by or as a consequence of EC legislation as well as functions covered purely by domestic law.