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Medicines Chain Of Drugs - Regulation - Full Text Of The Norm

Original Language Title: MEDICAMENTOS CADENA DE FRIO DE LOS MEDICAMENTOS - REGULACION - Texto completo de la norma

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image inicio sitio infoleg MInisterio de Justicia y Derechos Humanos
MEDICAMENTS Law 26.492 Regulation of the cold chain of drugs. Sanctioned: March 11 of 2009 Enacted: March 26, 2009

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


ARTICLE 1 Within two (2) years of the validity of this law, all medicines of human or veterinary use, containing thermal active principles, must have incorporated a temperature witness in the individual packaging, of an indelible, inalterable and irreversible character, that allows to verify that this product has not lost the cold chain at the time of reaching the consumer.

ARTICLE 2 The witness will be incorporated by the factory and must remain in the medication until the individual consumption unit.

Article 3 For multidose presentations, the witness must remain in the container, so that the consumer can verify that the cold chain was not interrupted in the product in its power, denaturalizing or inactivating the original properties of the medication.

ARTICLE 4 The implementation authority will promote directly and/or through the actors in the cold chain, the greater knowledge of the population about the system implemented, its characteristics, and the recommendations for proper and effective implementation.

ARTICLE 5o The Executive Power shall designate the authority for the implementation of this Act and shall issue its regulation, for the purpose, inter alia, of:

(a) Determine for their properties that products should be classified as thermolabils and establish a priority order for them to apply the temperature witness;

(b) Establish the maximum and minimum temperatures to which each product may be subjected without losing its essence, and the estimated useful life time from the cold chain cut;

(c) Define rules with the characteristics to be possessed by the witness, in accordance with Article 1 of the present, and establish the procedures for monitoring them;

(d) Establish the program to comply with each medication to implement the incorporation of the witness;

(e) Determine the responsibility of actors at each stage of the cold chain and how such compliance should be recorded;

(f) Establish the procedure for the destruction of unity;

(g) Establish penalties for violations of each liability.

ARTICLE 6 In exceptional cases, and with the express and due substantiation, the enforcement authority may extend the period of two (2) years provided for in article 1 of this Act by twelve (12) months maximum.

ARTICLE 7 Contact the national executive branch.



JULY C. C. COBOS. EDUARDO A. FELLNER. . Enrique Hidalgo. . Juan H. Estrada.

MEASURES Decree 248/2009 Observe and Promute Act No. 26.492.

Bs. As., 26/3/2009

VISTO the Bill registered under No. 26,492, sanctioned by the HONORABLE CONGRESS OF NATION on 11 March 2009 and


That the aforementioned Bill regulates the cold chain of medicines, establishing that within a period of DOS (2) years all human or veterinary medications, containing thermal active principles, must have incorporated a temperature witness in the individual packaging, of an indelible, inalterable and irreversible nature, that allows to verify that this product has not lost the cold chain at the time of reaching the consumer.

Article 5 of the Draft Law empowers the NATIONAL EXECUTIVE PODER to designate the authority of application and to issue its regulation with the aim, inter alia, to establish penalties for the infringement of each responsibility of the actors at each stage of the cold chain of drugs.

In this regard, Marienhoff, with respect to the delegated regulations, points out that "They are the ones that issue the Executive Power by virtue of an attribution or empowerment that expressly confers upon it by the Legislative Power." He also points out that "... to the issuance of delegated regulations it must be restricted or limited, for the benefit of public liberties; and that "they must be limited to developing basic principles contained in the law that the delegation does. Such regulations have a double limit: one immediate, which is the law of reference, another mediate, which is the Constitution, whose principles, in the interest of delegated matter and the extension of the delegation, must be respected by the delegate." (Treaty of Administrative Law Volume I p. 267).

Which, moreover, points out that "the SUPREMA COURT OF JUSTICE DE LA NATION accepts that the delegated regulation may be issued in our country, without this injuring any text or principle of constitutional order. But the validity of these regulations is subject to certain conditions: the normative powers granted to the executive branch must be within a certain and expressly determined sphere. Ultimately, with reference to punitive matter (police law), he further circumscribed the scope of delegated decrees" (Treaty of Administrative Law Volume I p. 269).

On the other hand, it expresses that "... the act that the Executive issues as a result of this legislative delegation, since it is a member of the respective law, participates in the characters of the law; consequently, such an act could be prosecuted by the same means by which it could be the law that integrates it (verbly, it could be tagged as unconstitutional, if such a vice exists). If the law of the delegation refers to an indelible faculty de, for example, creating taxes or setting up crimes, etc. y, and the Executive issues an act creating taxes or setting up crimes, both the law that contains that delegation, and the act of the Executive that gave it course, can be objected to unconstitutional." (Treaty of Administrative Law Volume I, p. 274).

That, "in issuing a regulation, the executive body must respect the so-called "reservation of the law", in whose merit it must refrain from staging on matters reserved for the competence of the legislator. In that order of ideas, it could not establish taxes, set up crimes and establish penalties..." (Treaty of Administrative Law Volume I p. 282 ).

That, moreover, states that "the administrative, national or provincial authorities, whatever their hierarchy or rank, lack the empire to set up or create contraventional figures or faults. Such a configuration or creation must be, indefectably, the work of the legislator: the executive branch ). and for more reason its subordinates ). will only be able to regulate that law, for the purposes of its execution or compliance, but always taking care not to alter its spirit" (Treaty of Administrative Law Volume IV p. 560).

That, the Supreme Court of Justice of the Nation, in the case of "Mouviel, Raúl Oscar and others" (Fallos CSJN 237:626) has expressed: "In the republican representative system of government adopted by the Constitution and that is fundamentally supported in the principle of the division of powers, the legislator cannot simply delegate in the executive branch or in administrative divisions the total free choice of the crimes. Nor is it lawful for the executive branch, under the pretext of the regulatory powers ... to replace the legislator and by supposed regulatory means to dictate, in rigor, the previous law that requires the constitutional guarantee of art. 18 of the National Constitution".

That, in the same sense, the PROCURATION OF THE THIRD OF NATION has been pronounced in Views 244: 833: "This Treasury Procuration has already pointed out before now the improcedence of translating criminally punishable behaviours through administrative rules, in merit to the flagrant violation of Article 18 of the National Constitution (v. Dictámenes 188:85).

That, on the other hand, Bidart Campos in his Manual of the Reformed Constitution states: "As a general principle it is appropriate to formulate the following criterion: the law that confers on administrative bodies in contraventional matters requires one of these frames: a) or to be an assimilable law to the "white" penal laws, in which case the contours must be drawn to the complementary administrative norm which, as regulation, will be subsequently ruled; bctorate If the location is not reached in one of the two hypotheses, it must be concluded by saying that the law that empowers administrative bodies in contravention is unconstitutional. c) in either case, the law cannot leave the penalty undetermined, so that it delegates the administration to establish it to its arbit" (Manual of the Reformed Constitution, Volume II p. 248).

In addition, Sagües, in the case of invasion of legislative areas, states that: "A typical case of invasion occurs if the regulatory decree establishes sanctions not programmed by law" (Elements of Constitutional Law, p. 464).

Accordingly, it is appropriate to observe article 5 (g) of the Bill registered under No. 26.492.

That the proposed measure does not alter the spirit or unity of the Draft Law sanctioned by the HONORABLE CONGRESS OF NATION.

That the present is dictated in the use of the powers conferred on the NATIONAL EXECUTIVE POWER by Article 80 of the NATIONAL CONSTITUTION.




Article 1 el Note article 5 (g) of the Bill registered under No. 26.492. Art. 2o With the exception set out in the preceding article, please amend, and refer to the draft law registered under No. 26.492.

Art. 3o Note the Permanent Bicameral Commission of the HONORABLE CONGRESS OF NATION.

Art. 4o Communicate, publish, give to the NATIONAL DIRECTION OF THE OFFICIAL REGISTRATION and archvese. . KIRCHNER FERNANDEZ. . Sergio T. Massa. Aníbal F. Randazzo. . Jorge E. Taiana. . Nilda C. Garré. . Carlos R. Fernández. . Julio M. De Vido. Aníbal D. Fernández. . Carlos A. Tomada. . Alicia M. Kirchner. . María G. Ocaña. . Juan C. Tedesco. . José L. S. Baranao.