Generic drugs have the same active ingredients, pharmaceutical form, dosage and way of administration as their brand-name counterparts. They are approved by the regulatory authority and their effectiveness and safety are duly proven. Upon expiration of a brand -name patent after at least 20 years of exclusive use, generic medicines can be marketed.
To receive a license to manufacture and sell drugs in Argentina, both brand name and generic drug companies must receive the approval of the National Administration of Drugs, Food and Medical Devices (ANMAT), an agency decentralized from the National Public Administration, subject to the scientific and technical standards and directions set forth by the Secretary of Policies, Regulations and Institutes of the Health Department.
Generic medicines must meet the same quality, safety and efficacy strict standards as brand – name drugs to receive the approval of the regulatory authorities before they are available for prescription. In addition, the regulatory authorities carry out the same audit, inspection and quality control procedures in all the laboratories in Argentina (including generic medicine producing facilities).
Yes, generic medicines are subject to the same procedures and controls than any other drugs. Moreover, the therapeutic efficacy and reliability of generic medicines is evidenced by their long-lasting permanency in the market, their acceptance by health professionals, their proven performance and their approval by the competent authority..
Generic medicines allow a significantly lower retail price, notably less expensive than their original brand equivalents, since there is no need to amortize the investments in research and development of new medicines. In addition, because generics are locally produced, a continued supply resulting in consisting treatments can be ensured. Generic medicines contribute to savings in pharmaceutical public expenditure without compromising the quality, the safety or the effectiveness of the drug, thus releasing public resources which can be allocated to other health areas resulting in taxpayer benefit..
Law 25.649 on Drug Prescriptions, better known as “Law on Generics” passed in 2002, was drafted and conducted by the then Minister of Health Gines Gonzalez Garcia. This law represents a change of paradigm in the region in connection with the local pharmaceutical industry participants. The spirit of this is aimed at broadening patients’ right to choose medicines and to foster laboratories to produce in the country those medicines over which a patent is sought.Read document