Medicines Law N? 16.463 - Regulation - Full Text Of The Norm

Original Language Title: MEDICAMENTOS LEY N? 16.463 - REGLAMENTACION - Texto completo de la norma

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Please refer to the activities set out in article 1 of Act No. 16,643, regarding disposable equipment and consumption, use and application in human medicine.


No. 2.505

Bs. As., 30/12/85

VISTO the provisions of Act No. 16,463 and its Decree No. 9,763 of 2 December 1964; and


It is appropriate to rule on the activities referred to in Article 1 of the above-mentioned Act, with regard to disposable equipment and consumption, use and application in human medicine.

That the rapid development of modern technology, with the consequent incorporation of new materials and instruments, makes it imperative to ensure, among other aspects, sterility, absence of toxicity, operation and mechanical properties, etc. of them.

Acts under the powers granted by Article 86, Decision 2 of the National Constitution.




Article 1 . Without prejudice to the compliance of the rules set out in Articles 1; 2nd, Subparagraphs (a) and (b); 3rd; 4th; 5th; 6th; 7th and 8th of Decree No. 9.763/64, are subject to the provisions of this decree, the activities referred to in Article 1 of Law No. 16.463, concerning the materials, instrumentals and equipment contained in the Decree I. Art. 2o El . MINISTERY OF HEALTH AND SOCIAL ACTION, through the HEALTH SECRETARY, will be the authority to apply these rules and dictate those that are necessary for their best compliance, and will also be empowered to keep Annex I updated, by including elements in the same. Art. 3o Las Persons who intend to carry out activities of import, export, production, processing, fractionation, marketing and/or deposit of the elements mentioned in Annex I shall certify dea the effects of the empowerment of their establishments: the following requirements:

(a) The performance in the direction of the establishment, of a technical director with a university degree that determines the authority of application, in addition to the auxiliary staff that is deemed necessary.

(b) The establishment has adequate premises and elements for the storage, maintenance, processing and sterilization of the products, as well as the environments that allow the necessary controls and analysis to be carried out to ensure the quality and characteristics of the raw material and the finished products; all in accordance with the standards provided by the implementing authority.

Art. 4o . Persons referred to in the previous article and its technical directors shall be obliged to comply with the sterilization standards established by the enforcement authority. Art. 5o La The application authority may authorize partial or total, the development of the products in a place other than the authorized, for specified periods, when it means fortuitous, force majeure, or when a phase of specialized or high-cost technology is sought. Art. 6th La The application authority will establish the books and records that the establishments must carry, as well as the forms and conditions that they must meet. Art. 7o s The establishments must archive:

(a) Protocols to control and analyse raw materials, as well as final manufacturing protocols.

(b) The manufacturing control protocols and final controls of the imported elements with the copy of the office to square and the import license, as well as the control and analysis protocols made in the Argentine Republic, to ensure the quality of the imported goods. In all cases, they must be archived for a period not less than ten (10) years after the date of carrying out the related analytical records.

Art. 8o El The technical director will be responsible:

(a) Of the products produced in the country must carry out the controls and analyses that ensure the technical quality of the product.

(b) Of the quality of the imported products, it must demand in all cases the certification of the country of origin, duly legalized, in which it is aware that it meets the sanitary requirements in that country.

Art. 9th . The conditions for the production, packaging and identification of the products will be established by the application authority, in order to guarantee the quality and sterility of the products. Art. 10. La The application authority may establish variants of an inscription when a product is identical to the original, with the same function and purpose, giving rise to different types or sizes that will be identified by a reference number or code. Art. 11. La The authorization for the processing, import and sale of the products will have a validity of five (5) years, having the interested party initiate in advance of one (1) year of the expiration date, the procedures for renewal of the authorization for a new period. Art. 12. La The application authority may at any time request the updating of the documentation that is taken into account to extend the corresponding authorization. In duly substantiated cases, the validity period of the certificate may be reduced by half. Art. 13. . For the control of the conditions of production and suitability of the products in their different stages, the implementing authority may require the collaboration of any official entity or specialized agency, who will be obliged to provide it on a preferential basis. Art. 14. . The distribution and sale of the products may be carried out through drugstores or pharmacies or specially authorized establishments, which must comply with the rules and requirements established by the implementing authority. Art. 15. . For the export of the products contained in Annex I, apart from the strict controls, the enforcement authority shall issue the rules to be complied with, specifying those relating to containers and languages in which appropriate legends should be drafted, taking into account the country of destination of the same.

Measures aimed at the protection and preservation of the goods should also be extreme in order to safeguard the prestige that the products of the country should enjoy abroad.

Art. 16. La The qualification granted for import, export, production, processing, fractionation, marketing and/or deposit of the elements mentioned in Annex I shall be annulled:

(a) At the request of the holder.

(b) For any modification, alteration or non-compliance with the conditions of the authorization.

(c) Due to the expiry of the period established in Article 11.

Art. 17. . The establishments that are in operation must request the relevant authorization and registration of their products, within the period of one hundred and eighty (180) days of the validity of this decree. Art. 18. . the infractions to the present decree and the rules that are set forth therein shall be punished in accordance with the provisions of Act No. 16.463. Art. 19. La The application authority is empowered to set tariffs for services requested to be provided in its unit and will have the creation of the Register of Producers and Products. Art. 20. . Communicate, publish, give to the National Directorate of the Official Register and archvese.

Annex I

1. . Material that will be in contact with the blood.

2. . Transfusion equipment and/or devices and blood containers.

3. . Equipment and/or devices for lung and/or heart.

4. . Equipment and/or devices for hemodialysis.

5. . Cat├ęteres.

6. . Injecting Needles and Intravenous Nuns.

7. . Material used for fluid management.

8. . Equipment and/or devices for parenteral solutions.

9. . Equipment and/or devices for peritoneal dialysis.

10. . Equipment and/or devices for irrigation.

11. . Equipment and/or devices for parenteral nutrition.

12. Jeringas.

13. . Devices used for anesthesia and/or breathing.

14. . Needles for lumbar puncture.

15. . Endotracheal tubes and tracheotomy.

16. . Equipment and systems for epidural anesthesia.

17. . Devices used in drainage and/or suction.

18. Sondas.

19. . Surgical drains and equipment.

20. . Suture materials.

21. . Gynaecological implants (DIU, etc.).

22. . Clinical implants, deposits and healing material.

23. . Any other device or instrumental used in the medical-surgical practice, which in accordance with the criteria set out in the definition, has not been specifically considered in the above sections.