Legislation 16463 - Updated Standard

Original Language Title: MEDICAMENTOS REGLAMENTASE LEY 16463 - Texto actualizado de la norma

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image inicio sitio infoleg MInisterio de Justicia y Derechos Humanos
Ministerio de Asistencia Social y Salud Pública MEDICAMENTS Rule Law 16.463. DECRECT No. 9.763. Bs. As., 2/12/64

See Background

VISTO the Regime established by Law 16.463 concerning products of use and application in human medicine and persons involved in their import, export, production, processing, fractionation, marketing or deposit in national jurisdiction or for inter-provincial trade, and

CONSIDERING:

That it is necessary to dictate the regulations of the aforementioned legal body for the purpose of their proper application by the health agencies, which is primarily the duty of the State to ensure the purity of drugs and the effectiveness of medicines; that, in addition, the abuse of drugs must be avoided and to ensure that the evolution of this industry is realized within the legal framework provided by the law;

The President of the Argentine Nation, Decreta:

Article 1 El The exercise of the power of the health police regarding the activities referred to in Article 1 of Law No. 16,463 and persons of visible or ideal existence who are involved in them shall be effective by the Ministry of Social Welfare and Public Health, by means indicated by this regulation:

(a) In the Federal Capital, national territories and places subject to the jurisdiction of the National Government.

(b) in relation to traffic or trade between one province with another or with any of the places mentioned in subparagraph (a);

(c) With regard to import and export operations with the foreigner;

(d) in all cases where provincial governments request their action within the limits of their respective jurisdictions.

Art. 2o provincia Provincial governors, as natural agents of the national government, must cooperate within the limits of their respective territories for the purposes of Law No. 16,463.

Without prejudice to this, the Ministry of Social Welfare and Public Health may:

(a) to avail themselves of their own agencies and staff, with all necessary authority for the realization of their purposes, where circumstances require:

(b) To promote and/or adopt, where appropriate, appropriate coordination with provincial governments for the achievement of the purposes of law and the application of their standards;

(c) To promote, with the collaboration of the scientific and professional associations of the art of healing, the dissemination of standards to prevent drug abuse.

Art. 3o o (Article repealed by art. 19 of Decree No. 150/92 B.O. 23/01/1992)

Art. 4o . The production, fractionation, possession and delivery of the products referred to in article 1 of Act No. 16,463 are prohibited outside the establishments authorized for such purposes by the Ministry of Social Welfare and Public Health or the local health authority.

Article 5 Las The activities covered by Article 1 of Law No. 16,463 must be carried out, where appropriate, under the technical direction of a university professional, in accordance with the provisions of this decree and the regulations of the Ministry of Social Welfare and Public Health.

The holders of the activity and the respective professionals must communicate the modifications and interruptions in the technical direction concerned, for the purposes of the respective administrative authorization.

Article 6 La The authorization referred to in Article 3 shall be granted in relation to the nature of the operations carried out in the establishment, number of the products and volume of the production as established by the Ministry of Social Welfare and Public Health, having in reasonable view guarantees that impose the defense of the health of the persons.

Once the authorization has been obtained, the permissionary cannot, without a new administrative act:

(a) to make any changes to the establishment.

(b) To incorporate new development, production or fractionation activities.

The technical director is also responsible for the duty imposed in the preceding paragraph.

Article 7 todo The authorisation holder must promptly notify the Ministry of Social Welfare and Public Health of any act involving the transfer of the establishment or modification of the social contract. The same obligation rests with its successors in a universal or particular capacity.

Art. 8 personas The persons covered by this decree are obliged to exhibit all the documentation related to the property, the commercial turn of the establishment and the technical processes of elaboration, production and control required by the Ministry of Social Welfare and Public Health in the fulfilment of the powers accorded to it by Law No. 16,463 and this regulation.

Art. 9o o (Article repealed by art. 19 of Decree No. 150/92 B.O. 23/01/1992)

Art. 10. (Article repealed by art. 19 of Decree No. 150/92 B.O. 23/01/1992)

Art. 11. (Article repealed by art. 19 of Decree No. 150/92 B.O. 23/01/1992)

Art. 12. (Article repealed by art. 19 of Decree No. 150/92 B.O. 23/01/1992)

Art. 13. (Article repealed by art. 19 of Decree No. 150/92 B.O. 23/01/1992)

Art. 14. (Article repealed by art. 19 of Decree No. 150/92 B.O. 23/01/1992)

Art. 15. (Article repealed by art. 19 of Decree No. 150/92 B.O. 23/01/1992)

Art. 16. (Article repealed by art. 19 of Decree No. 150/92 B.O. 23/01/1992)

Art. 17. (Article repealed by art. 19 of Decree No. 150/92 B.O. 23/01/1992)

Art. 18. (Article repealed by art. 19 of Decree No. 150/92 B.O. 23/01/1992)

Art. 19. (Article repealed by art. 19 of Decree No. 150/92 B.O. 23/01/1992)

Art. 20. (Article repealed by art. 19 of Decree No. 150/92 B.O. 23/01/1992)

Art. 21. (Article repealed by art. 19 of Decree No. 150/92 B.O. 23/01/1992)

Art. 22. (Article repealed by art. 19 of Decree No. 150/92 B.O. 23/01/1992)

Art. 23. (Article repealed by art. 19 of Decree No. 150/92 B.O. 23/01/1992)

Art. 24. (Article repealed by art. 19 of Decree No. 150/92 B.O. 23/01/1992)

Art. 25. (Article repealed by art. 19 of Decree No. 150/92 B.O. 23/01/1992)

Art. 26. (Article repealed by art. 19 of Decree No. 150/92 B.O. 23/01/1992)

Art. 27. (Article repealed by art. 19 of Decree No. 150/92 B.O. 23/01/1992)

Art. 28. (Article repealed by art. 19 of Decree No. 150/92 B.O. 23/01/1992)

Art. 29. (Article repealed by art. 19 of Decree No. 150/92 B.O. 23/01/1992)

Art. 30. (Article repealed by art. 19 of Decree No. 150/92 B.O. 23/01/1992)

Art. 31. (Article repealed by art. 19 of Decree No. 150/92 B.O. 23/01/1992)

Art. 32. (Article repealed by art. 19 of Decree No. 150/92 B.O. 23/01/1992)

Art. 33. (Article repealed by art. 19 of Decree No. 150/92 B.O. 23/01/1992)

Art. 34. (Article repealed by art. 19 of Decree No. 150/92 B.O. 23/01/1992)

Art. 35. . In the authorisations for the preparation and sale of medicinal specialties and industrial medicines and in the certificates that consequently are extended, the conditions in which they must be dispatched in the pharmacies will be recorded. These conditions shall be:

(a) Sale under recipe and decree.

(b) Sale under an archived recipe.

(c) Sale under recipe.

(d) Free sale.

The condition of "Venta under recipe and decree" corresponds to all those medicinal specialties and industrial medicines that by the nature of the active principles that integrate them are included within the regime of decrees number 126,351, of 19 February 1938, and 130,827, of 17 September 1942, and of the Ministerial Resolutions that in their consequence and by the application of the International Conventions that the country is a party, circulation and

It corresponds to the condition of "Venta Under Recipe Filed" to all those medicinal specialties and industrial medicines constituted by active principles that by their action should only be used under rigorous prescription and medical surveillance, by the dangers and harmful effects that uncontrolled use can generate.

It corresponds to the condition of "Venta Under Recipe" to all those medicinal specialties and industrial medicines that are susceptible to being dispatched with medical prescription more than once.

It corresponds to the condition of "free sale" to those medicines intended to relieve ailments that do not in practice require a medical intervention and that, in addition, its use, in the form, conditions and doses foreseen does not entail, by its wide margin of safety, dangers to the consumer.

Art. 36. (Article repealed by art. 19 of Decree No. 150/92 B.O. 23/01/1992)

Art. 37. . All forms of advertisements are prohibited to the public for products that have been authorized in the pre-prescription condition.

For free-sale products, their holders must strictly limit public propaganda to pharmacological action, expressed in such a way that it does not induce self-medication or commit excesses, and does not violate the interests of public health or professional morals.

The Ministry of Social Welfare and Public Health shall determine the conditions under which any form of public propaganda shall be subject.

Art. 38. . For the purposes of the fulfillment of the forecasts established by Article 13 of Law No. 16.463, the Ministry of Social Welfare and Public Health shall proceed to the removal, by triplicate, of samples of the products covered by it, of the pharmacies, drugstores, laboratories and authorized deposits, to dispose of all the tests or analytical determinations that it deem necessary for the control and verification of the quality, purity and composition.

The sample-taking procedure will produce records that will be signed by the technical director of the establishment or its legal substitute and the acting officials, and will clearly identify the products or products subject to the procedure, with details of its labelling, composition, contents of the sales unit, heading and manufacturing series, and, if any, pharmaceutical form, doses, expiration date and conditions in which it is preserved. One of the samples and copy of the record will be held by the owner of the establishment.

Art. 39. . In the event of the cancellation of processing and sale authorizations pursuant to Article 8 of Law No. 16,463, the holder shall proceed to withdraw from square all units of the cancelled product, within the time and conditions determined by the Ministry of Social Welfare and Public Health.

Art. 40. (Article repealed by art. 19 of Decree No. 150/92 B.O. 23/01/1992)

Art. 41. . Offences to the present decree and to the rules set forth therein shall be punished in accordance with Act No. 16.463.

Art. 42. . Derogate, as soon as they object to this decree, all the existing legal norms.

Art. 43. El This decree will be endorsed by the Minister Secretary in the Department of Social Welfare and Public Health.

Art. 44. . Communicate, publish, give to the National Directorate of the Official Register and archvese.

ILLIA.. Arturo Oñativia.

Background - Article 36 replaced by art. 2nd Decree No. 908/91 B.O. 10/05/1991; - Article 32 repealed by art. 2nd Decree No. 908/91 B.O. 10/05/1991.