SUPPLEMENT
Year I - No. 34
Quito, Wednesday July 12, 2017
Value: US $ 1.25 + VAT
SUMMARY:
EXECUTIVE FUNCTION AGREEMENT:
MINISTRY OF PUBLIC HEALTH:
P.
0088-2017 Delegate yourself to the National Regulatory Agency,
ING. HUGO DEL POZO BARREZUETA DIRECTOR
Quito: Avenida 12 de Octubre N23-99 and Wilson
Health Control and Surveillance - ARCSA, “Doctor Leopoldo Izquieta Pé ez, authorize processes of
import and export of samples
Biological ................................................. ................         two
RESOLUTIONS:
Second floor
MINIST
RIVER OF AGRICULTURE, LIVESTOCK,
Headquarters and sales: Tel. 3941-800
Exts .: 2301 - 230
Guayaquil Branch:
Av. 9 de Octubre Nº 1616 and Av. Del Army corner, Building of the Bar Association of Guayas, first floor. Tel.
252-7107
Annual Subscription:
US $ 400 + VAT for the city of Quito US $ 450 + VAT for the rest of the country
Printed in National Editor 40 pages www.registroficial.gob.ec
At the service of the country since July 1, 1895
AC ACULTURE AND FISHING:
AGRO ECUADORIAN AGENCY ASSURANCE AGENCY - AGROCALITY:
0069 Issue the Supplementary Standard to facilitate the application of the Pesticide Regulation and
related products for agricultural use ............................ 3
MINISTRY OF INDUSTRIES AND PRODUCTIVITY:
SUBSECRETARIAT OF THE QUALITY SYSTEM:
Approve and formalize as voluntary the following technical standards
Ecuadorians:
17 327 NTE INEN-ISO 17997-1 | IDF 29-1 (Milk - Deter-
mining of caseic nitrogen content - Part 1: Indirect method (Reference method)
(ISO 17997-1: 2004ǀǀDF 29-1: 2004, IDT)) 33
17 328 NTE INEN-EN 1041 + A1 (Information provided by the manufacturer of medical devices
(EN 1041: 2008 + A1: 2013, IDT)) 34
2 - Wednesday, July 12, 2017 Supplement - Official Registry
No. 34
INTERNAL RENTS SERVICE:
NAC-DGERCGC17-00000350 Establish the rules and requirements for the return of Value Added Tax
(VAT) to direct exporter suppliers
P.
That, the aforementioned Statute, in article 86, second paragraph, determines: “The administrative bodies shall be competent
to resolve all matters and adopt all measures and decisions that they consider reasonably necessary
to meet its specific objectives determined in the law, despite said matters, measures
and decisions have not been expressly and in detail attributed to them ”;
of goods 35
No. 0088 - 2017
THE MINISTER OF PUBLIC HEALTH
Considering:
That, the Constitution of the Republic of Ecuador, in
That, with Executive Decree No. 1290, published in the Supplement of Official Registry No. 788 of September 13
In 2012, the National Agency for Regulation, Control and Health Surveillance was created - ARCSA, Doctor Leopoldo
Izquieta Pérez as a legal person under public law, with administrative, economic and financial independence,
attached to the Ministry of Public Health, technical agency responsible for regulation, technical control and
health surveillance of products related to human use and consumption;
That, by Executive Decree No. 1293 published in the Supplement to the Official Registry No. 934 of January 31,
2017, the Constitutional President of the Republic appointed
Article 361, provides the State to exercise the rectory of the National Health System through
the National Health Authority, being responsible for formulating the
Dr. Verónica Espinosa Serran Public Health; Y,
as Minister of
national health policy, and to regulate, regulate and control all health-related activities, as well as
the operation of the entities of the sector;
That, the aforementioned Constitution of the Republic of Ecuador, in article 387, numeral 2, establishes responsibility
That, with memorandum No. MSP-CGDES-2017-0244-M of
May 3, 2017, the General Coordinator of Strategic Health Development, requests the preparation of
Present Agreement Minister ia.
In the exercise of the legal powers conferred by the
of the State promote
the generation and production of
Articles 151 and 154, numeral 1 of the Constitution of the
knowledge, promote scientific research and Republic of Ecuador and by article
17 of the Statute of
technological, and enhance ancestral knowledge, in order to contribute to the realization of good living, to sumak
kawsay
That, the Organic Health Law, in article 4, provides that
Regime
Juridical
and Administrative of the Executive Function
Agree:
The National Health Authority is the Ministry of Public Health, the entity responsible for the exercise of
the rectory functions in health; as well as the responsibility of the application, control and monitoring of compliance
of said Law, the norms that it dictates for its full validity being obligatory;
That, the Organic Law of Donation and Transplantation of Organs, Tissues and Cells, in Article 9,
excludes from the scope of this Standard to human blood, its differentiated components, sperm and
ovules;
That, article 35 of the Law of Modernization of the State, Privatization and Provision of Public Services by
of the Private Initiative foresees that, when the institutional convenience requires it, the maximum representatives of
State institutions will issue agreements, resolutions and offices that are necessary to delegate their
attributions;
That, the Statute of the Legal and Administrative Regime of the Executive Function, in the first paragraph of the
Article 55, establishes that the powers of the various entities and authorities of the
Central and Institutional Public Administration will be delegable in the authorities or organs of lower hierarchy,
except those that are prohibited by law or by decree;
Art. 1.- Delegate to the National Agency for Regulation, Control and Health Surveillance - ARCSA, “Doctor Leopoldo
Izquieta Pérez ”, to authorize processes of import and export of biological samples, to be used by
Health researchers in the development of their studies. Except for this provision those samples
Biological regulated by the Organic Law of Donation and Transplantation of Organs, Tissues and Cells.
Art. 2.- The National Agency for Regulation, Control and Health Surveillance - ARCSA, “Doctor Leopoldo Izquieta
Pérez ”, to authorize import and export processes of biological samples, to be used by
Health researchers in the development of their studies, will observe the technical standards that guarantee the
product safety, as well as the investigations for which the samples will be used, are
are authorized in accordance with the current regulatory framework.
FINAL DISPOSITION
This Ministerial Agreement will enter into force upon its subscription, notwithstanding its publication
in the Official Registry and of its execution, the National Agency for Regulation, Control and
Health Surveillance - ARCSA, Doctor Leopoldo Izquieta Pérez.
Official Registry No. 34 - Supplement
Given in the city of Quito, Metropolitan District, on June 19, 2017.
f.) Dr. Verónica Espinosa Serrano, Minister of Public Health.
It is a faithful copy of the document that appears in the Archive of the National Directorate of the General Secretariat to which I refer in
necessary case.- I certify it in Quito, as of June 19, 2017.- f.) Illegible, General Secretariat, Ministry of Health
Public
No. 0069
MINISTRY OF AGRICULTURE, LIVESTOCK, AQUACULTURE AND FISHERIES
THE EXECUTIVE DIRECTOR OF THE AGENCY
Wednesday, July 12, 2017 - 3
That, by Executive Decree No. 1449 dated November 22, 2008, published in the Registry
Official 479, on December 2, 2008, “is reorganized to the Ecuadorian Health Service
Agropecuaria - SESA, transforming it into Ecuadorian Agency for Quality Assurance of Agro -
AGROCALITY, as a technical entity under public law, with legal status, assets and
own funds, decentralized, with administrative, economic, financial and operational independence; with
headquarters in Quito and national competition, attached to the Ministry of Agriculture, Livestock, Aquaculture and
Fishing";
That, through Personnel Action No. 0290 of June 19, 2012, the Minister of Agriculture,
Livestock, Aquaculture and Fisheries, Mr. Javier Ponce, designates Mr. Diego Vizcaíno Cabezas as Director
Executive of the Ecuadorian Agency for Quality Assurance of Agro - AGROCALIDAD;
That, by Memorandum No. MAGAP-DE / AGROCALIDAD-2017-000074-M, of March 1,
2017, the Executive Director of AGROCALIDAD informs Minister Javier Ponce Cevallos that the Directorate of
ECUADORIAN INSURANCE OF THE
Agricultural Input Registry has
culminated with the
AGRO QUALITY - AGROCALITY
Considering:
That, article 13 of the Constitution of the Republic of
technical update of the complementary standard to facilitate the application of D creto 3609. Text
Unified Secondary Legislation to the Ministry of Agriculture and Livestock. (May 20, 2003),
Title XXVIII of the regulation of pesticides and related products for agricultural use refers to the registration and control of
role of control agents
Ecuador states that “people and communities have
biological extracts
go etales, mineral preparations,
right to safe and permanent access to healthy food,
semi here
icos and related products for agricultural use, and;
sufficient and nutritious; preferential nt produced at niv l
local and in correspondence with its diverse identities and cultural traditions. The Ecuadorian State will promote the
food sovereignty ”;
That, article 73 of the Constitution of the Republic of
In use of the legal powers granted by Executive Decree No. 1449 and the Organic Statute of
Organizational Management by processes of the Ecuadorian Agency for Quality Assurance of Agro-AGROCALITY.
Ecuador states that “the State will apply
measures of
RESOLVES:
caution and restriction for activities that require
lead to the extinction of
species, the destruction of
ISSUE THE COMPLEMENTARY STANDARD FOR
ecosystems or the permanent alteration of the cycles FACILITATE THE APPLICATION OF
REGULATION
natural. It's prohibited
the troduction of organisms and
OF PESTICIDES AND RELATED PRODUCTS
organic and inorganic material that can permanently alter the national genetic heritage ”;
That, article 281 numeral 13 of the Constitution of the Republic of Ecuador states that “the
Food sovereignty constitutes a strategic objective and an obligation of the State to guarantee
that people, communities, peoples and nationalities achieve food self-sufficiency
healthy and culturally appropriate permanently. For this, it will be the responsibility of the
Status: Prevent and protect the population from the consumption of contaminated or put food
at risk your health or that science has uncertainty about its effects ”;
That, article 397 numeral 3 of the Constitution of the Republic of Ecuador establishes that the
“[…] The State will regulate the production, importation, distribution, use and final disposal of toxic materials and
dangerous to people or the environment […] ”;
FOR AGRICULTURAL USE, FOR REGISTRATION AND CONTROL OF BIOLOGICAL CONTROL AGENTS, VEGETABLE EXTRACTS,
MINERAL PREPARATIONS, SEMIOCHEMICALS AND RELATED PRODUCTS FOR AGRICULTURAL USE
CHAPTER I
PURPOSE AND SCOPE
Article 1.- Objective.- Establish the requirements and procedures for registration and control
of biological control agents, plant extracts, mineral preparations, semi-chemicals and products
related agricultural use; in order to ensure its effectiveness and regulate its trade nationwide.
Article 2.- Scope of application.- The scope of the provisions established herein
Supplementary resolution applies to all control agents