Bs. As., 26/11/97.
I refer to file No. 1-47 10.365/97-0 of the Register of the National Administrative Assistance of MEDICAL, FOLLOW-UP AND MEDICAL TECHNOLOGY (ANMAT), Laws 16.463 and 17.565, Decree No. 9763/64, 7123/68 and 150/92 and their modulatory and complementary standards, and
That the aforementioned rules regulate, inter alia, commercialization and deposit of medicinal specialties in national jurisdiction or for inter-provincial trade.
Article 2 of Act No. 16.463 provides that the above-mentioned activities may be carried out only upon authorization by the Health Authority, all in the conditions and within the rules established by the regulation in accordance with the particular characteristics of each activity and reasonable technical guarantees safeguarding public health.
That article 7 (g) of Decree No. 150/92 and its amendments prescribes that establishments dedicated to the production or fractionation of drugs and/or drugs intended for use in the preparation of medicines shall give them only to natural persons or ideals authorized for use, possession or sale to the public taking in all cases the necessary precautions that justify their insured destiny.
That article 1, paragraph 10, of the FEDERAL COVENANT FOR EMPLEMENT, PRODUCTION AND GROWING, which was signed on 12 August 1,993 between the President of the Nation and the Governors, encourages the adherence of the Provinces to the federal drug policy established by Decree No. 150/92 and its amendments, recognizing also federal and provincial drug control and registrations.
That, in the face of the detection of illegitimate medicinal specialties by the MINISTERY OF HEALTH and SOCIAL ACTION, it is indispensable for the achievement of comprehensive and effective control to regulate some of the critical stages that make up the drug marketing chain.
That NATIONAL ADMINISTRATION OF MEDICAMENTS, FOLLOW-UP AND MEDICAL TECHNOLOGY (ANMAT) and the GENERAL DIRECTION OF JURIDIC MATTERS OF THE MINISTERY OF HEALTH SOCIAL has taken the intervention of its competence.
It is acted in accordance with the powers conferred by article 99, paragraph (2) of the NATIONAL CONSTITUTION.
THE PRESIDENT OF THE ARGENTINA NATION
RIGHT:Article 1 Las The provisions of this Decree shall govern the trade in the medicinal specialties authorized by the MINISTERY OF HEALTH and SOCIAL ACTION that takes place in national jurisdiction or for inter-provincial traffic. Art. 2° . Labs authorized by competent health authority should market the medicinal specialties that they produce and/or import, either by themselves or through the distribution companies that act on their own and order, exclusively with drugstores, pharmacies and care facilities and/or health, public or private, enabled by the MINISTERIO DE SALUD and ACCION SOCIAL or by the respective provincial jurisdictions. Art. 3rd . The laboratories, the distribution companies of medicinal specialties referred to in the preceding article, the drugstores and pharmacies authorized by provincial health authorities must be registered with the National Health Authority to carry out commercial transactions of medicinal specialties between Provinces and/or between Provinces and the Autonomous City of Buenos Aires, as suppliers. Art. 4° . Pharmacies can only acquire medicinal specialties to drugstores, laboratories and/or to the distribution companies of medicinal specialties mentioned above, legally authorized by the MINISTERY OF HEALTH and SOCIAL ACTION or by the respective provincial health authorities.
Pharmacies may sell medicinal specialties only to the public and/or to care and/or health care facilities, public or private.
The only operations admitted as an exception to the preceding paragraph are the usual returns or exchanges that pharmacies carry out with their respective suppliers, provided that they are actually documented.
In case of cessation of the commercial activity of the pharmacy, the sale operation of the stock of medicines will require the prior operation of the health authority.Art. 5° . The public or private care and/or health facilities can buy medicinal specialties, regardless of the modality of the acquisition, only to laboratories, drugstores, pharmacies and/or to the distribution companies of medicinal specialties mentioned above, legally authorized by the MINISTERIO DE SALUD and ACCION SOCIAL or by the respective provincial health authorities. Art. 6° . The legally-enabled laboratories are required to record in the primary and secondary packaging of the medicinal specialties, as well as in any instrument documenting their marketing, the identification of the lot or manufacturing series corresponding to the produced and/or imported item. Instruments that document the commercialization of medicinal specialties in commercial transactions between drugstores should have the corresponding batch or manufacturing series. The MINISTERY OF HEALTH AND SOCIAL ACTION will dictate the additional measures that will allow better and effective identification of medicinal specialties in the following stages of the marketing chain. Art. 7° . Companies involved in the marketing chain of medicinal specialties are obliged to notify the authority of application of the removal, loss and/or destruction of those, indicating the data in their possession of the products in question. Art. 8° . The laboratories that make their sales through the distribution companies of medicinal specialties mentioned above must communicate such a circumstance in a fervent way to the application authority, indicating the identification data of the company in question. Art. 9° . The laboratories, drugstores and/or the distribution companies referred to in Article 2 of the present will be the only ones who will be able to market the medicinal specialties listed as free sale by the National Health Authority with the commercial establishments authorized for sale to the public, as stipulated in Article 14 of Decree No. 2284/91, ratified by Law 24.307. Art. 10. . For the purpose of concentrating the information, believe in the area of the NATIONAL ADMINISTRATION OF MEDICAMENTS, FOLLOW-UP AND TECHNOLOGY MEDICA (ANMAT), dependent on the MINISTERY OF HEALTH and SOCIAL ACTION, the Unique Base of Establishment Data, which will gather the data of the National Register of Establishments and/or Importers of medicinal products, as well as of the special distributions of the The information obtained shall be published within the time limit and manner established by the implementing authority. Art. 11. . Invite the Governments of the Provinces and the Autonomous City of Buenos Aires to adhere to the regime of this Decree, to join the Database created by the preceding article and to proceed to the official publication of the payroll of companies authorized by the jurisdictional authorities as laboratories, drugstores, pharmacies and distribution companies of medicinal specialities. Art. 12. . Being the present regulatory decree on the provisions contained in Act No. 16,463, infractions shall be liable to the penalties provided for therein. Art. 13. El The MINISTERY OF HEALTH and SOCIAL ACTION will be the Authority of Application of this regime, being empowered to dictate the complementary norms of this Decree. Art. 14. . The MINISTERY OF HEALTH and SOCIAL ACTION shall regulate the functioning of the companies of distribution of medicinal specialties referred to in Article 2 within the period of SESENTA (60) days from the entry into force of this Decree. Art. 15. . Communicate, publish, give to the National Directorate of the Official Register and archvese. . MENEM. . Jorge A. Rodriguez. . Alberto J. Mazza.