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Cross border drug sales from Canada to the USA

The cross border sale of drugs to the United States has become an important business in Canada because many Americans are taking advantage of lower Canadian patented drug prices and are purchasing their drugs from Canada. Neither Canada's international trade obligations nor our domestic laws prohibit these exports.

-- The Government of Canada ensures that Canadians have access to high quality, safe and reasonably priced drugs. Canada's regulatory requirements for the approval of drugs are governed by the Food and Drugs Act and Regulations monitored by Health Canada. Canada has one of the most rigorous drug approval systems in the world and one of the best safety records.

-- Canada's Food and Drugs Regulations stipulates that only a licensed practitioner (a doctor or a dentist) can legally write a prescription. Only a registered pharmacist may dispense a drug to the holder of a prescription. Without a signed prescription, drugs cannot be provided to individual consumers.

-- All pharmacies in Canada must comply with Canadian laws. The provinces and territories are responsible for regulating the practice of medicine and pharmacy, often through their Colleges or Registrars of Physicians and/or Pharmacists. They also have a responsibility for providing health care services to Canadians.

-- The U.S. Food and Drug Administration is responsible for ensuring that drugs entering the U.S. meet the requirements of the Food, Drug and Cosmetics Act.

-- Price differentials in pharmaceutical products between different countries exist due to a combination of factors, including regulatory and legislative systems, currency, patent status, prescription requirements, and approaches to reimbursement.

-- While prices for patented drug products in Canada are, on average, lower than those in the U.S., they are in line with the six other industrialized countries in Europe, that are used for price comparison purposes. These countries all have publicly-funded health care systems and use a variety of measures to control the prices of drugs or profits of manufacturers and overall expenditures on drugs. Other market-place dynamics also influence prices.

-- Canada's Patented Medicine Prices Review Board (PMPRB) was created in 1987 under the Patent Act to protect consumer interests and contribute to Canadian health care by ensuring that prices charged by manufacturers of patented medicines are not excessive. The PMPRB's jurisdiction extends to manufacturer prices of patented medicines approved for sale in Canada. More specifically, the PMPRB regulates the first price at which the drug product is sold by the manufacturer - regardless of the purchaser, whether it be the wholesaler, pharmacy, hospital, or other.

-- Canada's drug price regime is based on factors established in the Patent Act. For new drugs, prices are limited to prices of other drugs used to treat the same disease; and to prices at which the drug is sold in seven comparator countries (France, Germany, Italy, Sweden, Switzerland, U.K., U.S.) As for existing drugs, the price increases are limited to changes in the Consumer Price Index.

This article comes from HEALTH CANADA





Transfrontaliere de vânzare de droguri din Canada pentru a SUA - Cross border drug sales from Canada to the USA - articole medicale engleza - startsanatate