Subscribe to a Global-Regulation Premium Membership Today!

MEDICINAL SPECIALITIES Law 25.649 Promotion of the use of drugs by their generic name. Sanctioned: August 28, 2002. Partially promulgated: September 18, 2002.

The Senate and Chamber of Deputies of the Argentine Nation assembled in Congress, etc. sanction with force of Law:

ARTICLE 1 The purpose of this law is to defend the consumer of pharmaceutical drugs and drugs and to use them as a means of diagnosis in biomedical technology and all other products of use and application in human medicine. ARTICLE 2 Any prescription or medical prescription must be made in a mandatory manner by expressing the generic name of the medication or international common denomination indicated, followed in a pharmaceutical form and dose/unit, in detail of the degree of concentration.

The recipe may also indicate the generic name the name or trademark, but in this case the pharmaceutical professional, at the request of the consumer, will have the obligation to replace it with a lower price medicinal specialty that contains the same active principles, concentration, pharmaceutical form and similar quantity of units.

The pharmacist, duly authorized by the competent authority, is the sole responsible and qualified for the proper dispensation of pharmaceutical specialties, as well as for their replacement. In the latter case, you must subscribe to the prescription replacement authorization.

Freedom of limitation and dispensation is guaranteed by the choice of the active principle and not on specialties of reference or brand. Article 3 Any prescription or medical prescription that does not comply with the provisions of the first paragraph of Article 2 of this Law shall be unregistered, without any value to authorize the release of the drug concerned. ARTICLE 4 For the purposes of this Act, the following is: (a) Medication: any preparation or pharmaceutical product used for the prevention, diagnosis or treatment of a disease or pathological condition, or to modify physiological systems for the benefit of the person to whom it is administered; (b) Effective or monodrug principle: any chemical or mixture of related substances, of natural, biogenetic, synthetic or semi-synthetic origin, which, having a specific pharmacological effect, is used in human medicine; c) Generic name: denomination of an active, monodrogative principle, or of an association of active principles at fixed doses, adopted by the health authority, or in its absence the international common denomination of an active principle or combination of When a product that collects these characteristics is not commercialized in the country, it may be used as a reference medicinal specialty in order to compare the generic medicinal speciality, that endorsed by the World Health Organization for having proven its therapeutic action through its leadership in the international pharmaceutical market. ARTICLE 5o The use of the generic name will be mandatory: (a) In any primary, secondary, label, prospect or any document used by the pharmaceutical industry for medical information or promotion of medicinal specialties; (b) In all policy texts, including records and authorizations relating to the development, fractionation, marketing, export and import of medicines; (c) In any advertising or propaganda directed to the general public. ARTICLE 6 In the signs and prospects of the drugs registered with the health authority, generic names should be incorporated in the same size and enhancement as the commercial name. When drugs are made up of two or more generic names, the size of the typography for each of them can be reduced proportionally.

ARTICLE 7 In the sale of medicines, authorized establishments must inform the public of all medicinal specialties that contain the same active principle or combination of them as prescribed in the medical prescription that is displayed and the different prices of these products. In case of non-compliance, the penalties provided for by law 24,240, for the defence of the consumer, shall apply.

ARTICLE 8 The national executive branch, through the Ministry of Health, will be the body responsible for monitoring compliance with this law, without prejudice to the provisions of the previous article. In this framework, it should especially design mass dissemination campaigns on the benefits of the use of generic denominations in medical prescriptions Article 9 The national health authority shall develop, within 60 days of the promulgation of this law, a vademécum, which shall be updated on a regular basis, which shall order the generic medicinal specialties or commercial forms authorized on the basis of its contents of active principle, monodroga or generic name and a list of combinations of monodromes identified by its generic name that have been recommended by the World Health Organization or authorized by the national public authorities. ARTICLE 10. The national executive branch will jointly promote, with medical, pharmaceutical and dental organizations and all those recognized in the art of healing, mechanisms that ensure broad communication, information and education on generic drugs. They should also carry out actions that are relevant to the effect that in all universities in the country and in areas related to the formation of knowledge in the health sciences the study of the research and transfer of knowledge on the subject covered by this law is incorporated into the curriculum. ARTICLE 11. The Executive Power will propose, in the field of medicines, a policy of progressive import substitution.

ARTICLE 12. Invite the provinces to accede to this law. The national executive branch is also empowered to conclude agreements with the provinces and the Government of the City of Buenos Aires in order to delegate control powers. ARTICLE 13. Contact the national executive branch.

AT THE SESSION OF THE ARGENTINE CONGRESS, IN GOOD AIRES, TO 28 AGO 2002

_

EDUARDO O. CHANGE. . MARCELO E. LOPEZ ARIAS. . Eduardo D. Rollano. . Juan C. Oyarzún.

NOTE: The bold texts were observed.