New regulations for travelers entering Ecuador

boletin-aeronautico-nuevas-disposiciones-para-ingreso-de-viajeros-a-ecuador-abogados
In accordance with the ruling issued by the Constitutional Court declaring the unconstitutionality of the executive decree that established the state of emergency throughout the national territory, the Tax and Customs Authorities have lifted the suspension of terms and conditions, as established below:
1. The Internal Revenue Service, through Regulation NAC-DGERCGC21-00000001 issued on January 3, 2021, repealed the Regulation NAC-DGERCGC20-00000081 issued on December 23, 2020, by which the terms and deadlines of all administrative processes and the statute of limitations for collecting debts were suspended until January 17, 2021.
2. The National Customs Service of Ecuador, through Regulation SENAE-SENAE-2021-0001-RE, issued on January 3, 2021, canceled the suspension of terms and deadlines of all tax administrative processes and the statute of limitations for collecting debts until January 20, 2021, ordered by Regulation SENAE-SENAE-2020-0062-RE, issued on December 22, 2020.
3. Although when this bulletin was prepared, these regulations have not been published in the Official Gazette, the authorities of the Tax and Customs Authorities have established that the terms counted in calendar days will run as of January 3 and the terms counted in working days will run as of January 4, 2021.

Do you want to receive our newsletters with information like the one you just read?
Click here and subscribe.

DISCLAIMER: The preceding text has been prepared for general information purposes only. CorralRosales is not responsible for any loss or damage caused as a result of having acted or stopped acting based on the information contained in this document. Any given situation requires the specific opinion and view of the firm in Quito / Guayaquil, Ecuador.

CORRALROSALES

Special consumptions tax (ICE) – Tariffs applicable in 2021

special-consumptions-tax-ice-tariffs-applicable-in-2021-lawyers-ecuador
The General Director of the Internal Revenue Service issued three regulations on December 23, 2020, which were published in the Second Supplement of the Official Registry 359 on December 29, 2020, which are:

1. Regulation NAC-DGERCGC19-00000078 establishes the Special Consumption Tax (ICE) specific tariffs applicable in 2021:

Compared to the tariffs applicable in 2020, the tariffs for cigarettes and soft drinks remain the same, the tariff for plastic bags increases -established by law- and the remaining tariffs are slightly reduced compared to 2020.
2. Regulation NAC-DGERCGC19-00000079 adjusted the manufacturer’s and ex-customs’ sales price value by US$4.29 per liter for applying the Ad Valorem tariff on alcoholic drinks, including beer, applicable for fiscal year 2021.
In 2020 the value was US$4.33 per liter.
3. Regulation NAC-DGERCGC19-00000080 established the percentages of increase to be applied over the ex-customs price or the total production costs to determine the referential prices of perfumes and toilet waters marketed through direct sale (the manufacturer or importer sells to final consumers directly and not through commercial establishments), for fiscal year 2021, according to the percentages detailed in the following table:

The values detailed in the table are the same as those established for the year 2020.
For calculating the tax, the total production costs of the nationally manufactured goods must include raw materials, direct labor, and indirect manufacturing expenses.
Any royalty payments calculated on the basis of volume, value or amount of sales will be considered part of the total production costs for calculating the tax. However, if the royalties do not exceed 5% of the sales, they should not be considered as part of the taxable base.

Do you want to receive our newsletters with information like the one you just read?
Click here and subscribe.

DISCLAIMER: The preceding text has been prepared for general information purposes only. CorralRosales is not responsible for any loss or damage caused as a result of having acted or stopped acting based on the information contained in this document. Any given situation requires the specific opinion and view of the firm in Quito / Guayaquil, Ecuador.

CORRALROSALES

Tariffs applicable in 2021 for calculating income tax

corral-rosales-abogados-ecuador-tablas-para-el-calculo-de-impuesto-a-la-renta-aplicables-en-2021
Regulation NAC-DGERCGC19-00000077 issued on December 23, 2020, by the General Director of the Internal Revenue Service establishes the tariffs applicable in the fiscal year 2021 for calculating income tax.

1. Tariffs for calculating and paying income tax applicable to income received by Individuals and Undivided Inheritances in the fiscal year 2021:

2. Tariffs for calculating and paying income tax applicable to patrimonial increase derived from inheritances, legacies, donations, discoveries and any type of act or contract by which the ownership is acquired free of charge of goods and rights in the fiscal year 2021:

Do you want to receive our newsletters with information like the one you just read?
Click here and subscribe.

DISCLAIMER: The preceding text has been prepared for general information purposes only. CorralRosales is not responsible for any loss or damage caused as a result of having acted or stopped acting based on the information contained in this document. Any given situation requires the specific opinion and view of the firm in Quito / Guayaquil, Ecuador.

CORRALROSALES

Annual declaration of hazardous waste

corral-rosales-lawyers-ecuador-annual-declaration-of-hazardous-waste
Within the first ten (10) days of the next year, generators of hazardous waste must submit the annual declaration of hazardous waste to prevent and reduce the generation of such waste.
1. About the Hazardous Waste Generator
Article 237 of the Organic Code of the Environment establishes that any hazardous waste generator must obtain an administrative authorization.
The waste generator will be responsible for the environmental management of the waste from its generation to its elimination and final disposal.
The generator will be jointly responsible in case of incidents that produce pollution and environmental damage.
2. About the Annual Hazardous Waste Declaration
Part of the generator of hazardous waste’s obligations is the presentation of the Annual Declaration to prevent, reduce, or minimize the generation of hazardous waste.
The Annual Declaration must be filed within the first ten days of January.
The declaration submitted will be subject to verification by the authority, which may request additional information in this matter.
3. Non-compliance
Non-compliance with the Annual Declaration may result in the cancellation of the registration as a generator of hazardous waste.
Additionally, it may be considered a minor Non-Conformity according to article 500 j) “failure to comply with the obligations established in the administrative authorizations.”
CorralRosales will be happy to assist you in the presentation of the Annual Declaration of Hazardous Waste as well as any questions you may have regarding waste management.

Do you want to receive our newsletters with information like the one you just read?
Click here and subscribe.

DISCLAIMER: The preceding text has been prepared for general information purposes only. CorralRosales is not responsible for any loss or damage caused as a result of having acted or stopped acting based on the information contained in this document. Any given situation requires the specific opinion and view of the firm in Quito / Guayaquil, Ecuador.

CORRALROSALES

Amendments to the law of companies

corral-rosales-lawyers-ecuador-amendments-to-the-of-companies
On December 10, 2020, the Law of Modernization to the Law of Companies was published in the third supplement of Official Gazette 347, of which the most relevant aspects are the following:

a) Permitted activities outside the corporate purpose: Companies are allowed to occasionally or in an isolated manner enter into acts or contracts for investment, research or experimentation purposes, or as reasonable contributions of a civic or social nature.

b) Elimination of the opposition process: The process of opposition by third parties to the reduction of capital, change of name, early dissolution and change of domicile is hereby eliminated.

c) Single shareholder: The stock company and the limited liability company may subsist with a single shareholder. For its incorporation, at least two contracting parties must participate. Consequently, the cause for dissolution is hereby eliminated if a second shareholder is not incorporated within six months.

d) Corporate acts that do not require approval:  The voluntary and anticipated dissolution does not require previous authorization of the Superintendence of Companies, Securities and Insurance. Therefore, the direct inscription of the corporate act in the Mercantile Registry is allowed for the beginning of the liquidation, which will be supervised by the control entity.

Neither does the change of name, change of domicile and modification of the corporate term require prior authorization.

e) Indefinite term: Stock and limited liability companies can be set up for an indefinite term.

f) President of the board of directors and legal representative: In the companies in which the bylaws provide for the existence of a board of directors, the legal representative of the company may not be the president or representative of that body.

g) Share premium: When non-shareholders participate in a capital increase, it may be decided the new shares to be issued with a value greater than the nominal value (share premium) to be paid by the new shareholders. The issue premium will be part of the voluntary reserves and will be freely agreed upon by the investor and the company.

h) Voluntary control: Stock companies may or may not have commissaries as a control body.

i) Loss absorbency: When a company registers operational losses and has reserves, these will be automatically called to be wiped out.

j) Cause of dissolution for losses: A company will incur in a cause of dissolution for losses when these represent 60% or more of the assets and this situation is maintained for more than 5 continuous years.

k) Transfer of the registered office abroad: The transfer of the registered office of an Ecuadorian company abroad is allowed if the receiving country allows the maintenance of the legal status of the company.

l) Global assignment of assets and liabilities to liquidate a company: A company may transfer in block all its assets to third parties, shareholders or other parties in exchange for a consideration. The global transfer of assets and liabilities must be approved unanimously by the general meeting of shareholders, granted by public deed and will not require the approval of the Superintendence of Companies, Securities and Insurance.  The global assignment of assets and liabilities will have the effects of the transfer of companies as economic units as provided in the Code of Commerce.  The assigning company will cancel its registration in the Commercial Registry without any additional procedure once the total value received from the global assignment of assets and liabilities has been distributed among its shareholders.  The joint and several obligations that under the Commercial Code are attributable to the person transferring the company will be assumed by the shareholders of the extinct company in proportion to their participation in the share capital.

m) Association or Joint Purse Agreements: The regulations regarding this figure, with some modifications, are excluded from the Law of Companies and are incorporated as reforms to the Code of Commerce.

Do you want to receive our newsletters with information like the one you just read?
Click here and subscribe.

DISCLAIMER: The preceding text has been prepared for general information purposes only. CorralRosales is not responsible for any loss or damage caused as a result of having acted or stopped acting based on the information contained in this document. Any given situation requires the specific opinion and view of the firm in Quito / Guayaquil, Ecuador.

CORRALROSALES

New employment agreement modalities

nuevas-modalidades-para-la-contratacion-laboral-noviembre-2020-redes-abogados-ecuador
The Ministry of Labor (“MdT”) has regulated the following employment agreement modalities:
1. PRODUCTION AGREEMENT
(MDT-2020-220) 
– Sector: Productive sectors.
– Term: For the duration of the work, service, or activity to be performed; continuously or discontinuously, for up to 1 year, renewable for an additional year. If this period is exceeded, the employment relationship becomes an open-term agreement. A 90 day trial period may be agreed.
– Work day: The working days will be carried out as part-time or ordinary with a maximum of 40 hours per week that may be distributed in no more than 6 days a week. If the activities require uninterrupted services, the parties may agree on consecutive days of up to 20 successive working days.
– Termination of the agreement: It will end upon the conclusion of the term or the contracted activity. If the unilateral decision of the employer terminates the employment relationship before the agreed term, the worker will be entitle to severance.
– SUT registration: Within a period of 15 days upon its execution.
2. SPECIAL AGREEMENT FORTOURISM AND / OR CULTURAL AND CREATIVE SECTORS
(MDT-2020-221)
– Sector: Tourism, cultural and creative.
– Term: For the duration of the work, service, or activity to be performed; continuously or discontinuously, for up to 1 year, renewable for an additional year. If this period is exceeded, the employment relationship becomes an open-term agreement. A 90 day trial period may be agreed.
– Work day: The working days will be carried out as part-time or regular with a maximum of 40 hours per week that may be distributed in no more than 6 days a week. If the activities require uninterrupted services, the parties may agree on 20 to 70 consecutive days. Shifts that exceed 20 continuous days must be registered in the Ministry of Labor.
– Termination of the agreement: It will end upon the conclusion of the term or the contracted activity. If the unilateral decision of the employer terminates the employment relationship before the agreed term, the worker will be entitle to severance.
– SUT registration: Within a period of 15 days upon its execution.
3. ENTREPRENEURSHIP AGREEMENT
(MDT-2020-222)
– Sector: Employers registered in the National Registry of Entrepreneurship (RNE).
– Term: Up to 1 year, renewable up to the term of registration in the RNE. If this period is exceeded, the employment relationship becomes an open-term agreement. A 90 day trial period may be agreed.
– Work day: The working days will be carried out as part-time or regular with a maximum of 40 hours per week that may be distributed in no more than 6 days a week. If the activities require the provision of uninterrupted services, the parties may agree on consecutive days of up to 20 successive working days.
– Termination of the agreement: It will end upon the conclusion of the term. If the unilateral decision of the employer terminates the employment relationship before the agreed term, the worker will be entitle to severance.
– SUT registration: Within 15 days upon its execution along with the certificate issued by the RNE.
4. AGREEMENT FOR YOUNG PEOPLE
(MDT-2020-223) 
– Sector: All sectors.
– Agreement for young people: Work agreement aimed to  promote the employment of young people up to 26 years of age.
– Agreement for young people: under academic education: The purpose of this agreement is to promote the employment of young people up to 26 years old who are studying at any educational level. Their remuneration may not be less than US$333.32.
– Work day: The working days will be carried out as part-time or regular with a maximum of 40 hours per week. If the activities require the provision of uninterrupted services, the parties may agree on consecutive days of up to 20 successive working days.
– Term: For the duration of the work, service or activity to be carried out; continuously or discontinuously, for up to 1 year, renewable for an additional year, or until the worker reaches 26 years of age. If they exceed this period, the employment relationship becomes an open-term agreement. A 90 day trial may be agreed.
– Termination of the agreement: It will end upon the conclusion of the term or the contracted activity. If the unilateral decision of the employer terminates the employment relationship before the agreed term, the worker will be entitle to severance.
– SUT registration: Within a period of 15 days upon its execution.

 

Do you want to receive our newsletters with information like the one you just read?
Click here and subscribe.

DISCLAIMER: The preceding text has been prepared for general information purposes only. CorralRosales is not responsible for any loss or damage caused as a result of having acted or stopped acting based on the information contained in this document. Any given situation requires the specific opinion and view of the firm in Quito / Guayaquil, Ecuador.

CORRALROSALES

Conditions for filing customs import declarations

presentacion-de-declaraciones-aduaneras-noviembre-2020-redes-abogados-ecuador

On November 4, 2020 the National Court of Justice issued a ruling within the judicial process 17751-2020-00001 by which it declared that the Regulation SENAE-SENAE-2019-0049-RE (Regulation) issued on June 26, 2019 by the General Director of the Customs Authority was void.

The Regulation established that importers were not able to file customs import declarations if they had any unpaid obligations with the Tax or Customs Authorities. The National Court of Justice resolved that this condition could not be established by a regulation, since it exceeds the legal power of the general director of the Customs Authority.

Once the Regulation has been declared void, importers may file customs import declarations even if they have outstanding obligations with the Tax or Customs Authorities.

 

Do you want to receive our newsletters with information like the one you just read?
Click here and subscribe.

DISCLAIMER: The preceding text has been prepared for general information purposes only. CorralRosales is not responsible for any loss or damage caused as a result of having acted or stopped acting based on the information contained in this document. Any given situation requires the specific opinion and view of the firm in Quito / Guayaquil, Ecuador.

CORRALROSALES

Reform of the codification of regulations issued by SERCOP

reformas-codificación-de-resoluciones-del-sercop-octubre-2020-redes-abogados-ecuador

By Regulation No. RE-SERCOP-2020-0111 of September 23, 2020, the Regulation No. RE- SERCOP-2016-0000072 was amended (hereinafter, the “Regulation”), replacing Chapter II of Title VIII, relative to the “ACQUISITION OF DRUGS OR STRATEGIC GOODS IN HEALTH THROUGH A SPECIAL REGIME”. The main aspects of this reform are the following:

1. The Corporate Reverse Auction procedure is regulated for the selection of suppliers of drugs or strategic health goods (hereinafter and collectively, the “Products”) for the acquisition of the Products.

2. The Corporate Tender procedure is regulated for the selection of service providers for the storage, distribution and delivery or dispensing of drugs or strategic health goods (hereinafter, the “Services”) for contracting the Services.

3. It is established that the suppliers that participate in corporate purchase procedures must declare that they have no connection with other participants.

4. The attributions of the Inter-Institutional Committee are regulated, mainly  in the preparatory and contractual execution stage of the procedures for the acquisition of the Products and the contracting of the Services. This Committee is different from the Technical Commission, which will act in the pre-contractual stage.

5. As a result of the Corporate Reverse Auction and Corporate Tender procedures, the respective corporate framework agreements will be signed and the Products and Services will be included in the virtual directory of SERCOP´s Portal of PUBLIC PROCUREMENT  (hereinafter, the “Directory”), for their acquisition or contracting, respectively, through purchase orders.

6. It is established that the termination of a corporate framework agreement will not necessarily generate the sanction of a non-compliant contractor.

7. The obligations of the suppliers of the Products or Services are regulated, without prejudice to those established in the specifications of the selection procedure, the corporate framework agreement and the purchase orders. In the case of Service providers, the following obligations stand out:

7.1. The provision of a “continuity of service guarantee” that ensures the Services’ provision, even in the event of early and unilateral termination of the respective corporate framework agreement.

7.2. The implementation of a technological solution to monitor the Products’ route in real-time.

7.3. The implementation of a technological solution for the registration, administration, and control of stock and inventories in collection centers, warehouses, pharmacies, medicine cabinets, and other units or areas necessary to comply with the Services.

7.4. The creation of tickets for Products not delivered in health establishments for causes attributable to the supplier. Through the tickets, the patient will be able to withdraw the Products in the private pharmacies network associated with the supplier  at a national level or with those subject to a previously signed agreement.

8. It is mandatory for the contracting entities that make up the Integrated Public Health Network (“IPHN”) to acquire the Products and contract the Services through the Directory. Only when the Product does not appear in the Directory, these entities may avail themselves of other contracting procedures.

9. It is established that the contracting entities of the IPHN will centralize the acquisition of the Products. Each IPHN health subsystem must define the entity or administrative body (contracting entity) that will be responsible for the centralized generation of purchase orders, in accordance with its planning.

10. It is the obligation of the contracting entities of the IPHN to contract the Services before the acquisition of the Products, except in cases of  contracts related to small amount and emergencies, or when the Products are received by donation.

11. Contracting entities that do not belong to the IPHN will not be obliged to verify and acquire the Product or contract the Services through the Directory. These entities may directly use other procedures provided by law.

12. The public contracting entities that are not part of the IPHN will preferably use the Institutional Reverse Auction procedure for the selection of suppliers and acquisition of the Products. The contracting entities that are part of the IPHN may use this procedure as long as the amount exceeds the one established  for a small amount procedure, and the Products are not available in the Directory for direct purchases.

 

Do you want to receive our newsletters with information like the one you just read?
Click here and subscribe.

DISCLAIMER: The preceding text has been prepared for general information purposes only. CorralRosales is not responsible for any loss or damage caused as a result of having acted or stopped acting based on the information contained in this document. Any given situation requires the specific opinion and view of the firm in Quito / Guayaquil, Ecuador.

CORRALROSALES

Regulation of simplified stocks corportations (S.A.S.)

reglamento-sociedades-por-acciones-simplificadas-octubre-2020-redes-abogados-ecuador

By Resolution No. SCVS-INC-DNCDN-2020-0015 issued on September 14, 2020, and published in the Special Edition Number 1071 of the Official Registry of September 25, 2020, the Superintendency of Companies, Securities and Insurance issued the Regulation of the Simplified Stock Corporations (S.A.S.)

The main aspects of the Regulations include

1. The determination of the legal existence of a S.A.S. starts with its registration in the Registry of Companies of the Superintendency of Companies, Securities and Insurance.

2. The shareholders of a S. A. S. will only be responsible for the amount of their respective shares, unless they expressly waive it in writing.

3. The impossibility of negotiating it´s own shares in the stock market. Notwithstanding being able to negotiate shares issued by other mercantile societies or other negotiable securities, according to the law of the matter.

4. The incorporation of the Simplified Stock Corporations will be done through private documents unless the assets contributed require a public deed. In this case, the public deed must be registered in the corresponding Registry Office.

5. The process of electronic incorporation of the S.A.S. is hereby established, and the SCVS is required to keep its online system open so that all users can access consultations, certifications, and access all the relevant corporate information of the S.A.S.

6. Foreign companies that are founders and shareholders of a S. A. S. must present a certificate of incorporation and legal existence issued by the authority of the corresponding country. The capital of the foreign company must be represented in shares, participations or nominative papers.

7. The document of incorporation of the S.A.S. will have a presumption of stability, enforceability, and execution. Consequently, it may not be revoked, cancelled or annulled, unless expressly provided by competent Judge.

8. It shall establish the rules of the capital and shares of the S.A.S., their organization, statutory reforms, reorganization, dissolution, liquidation, reinstatement and cancellation.

The Regulations of the Simplified Stock Corporations also govern, among other things, the procedure for the resolution of corporate conflicts, causes of voluntary removal of shareholders, payment of dividends, presentation of corporate/financial documentation, management reports, and balance sheets, removal of shareholders, digital corporate books, and the liability of the shareholder before the company for the abuse of his voting rights, when seeking his own benefit or that of a third party.

 

Do you want to receive our newsletters with information like the one you just read?
Click here and subscribe.

DISCLAIMER: The preceding text has been prepared for general information purposes only. CorralRosales is not responsible for any loss or damage caused as a result of having acted or stopped acting based on the information contained in this document. Any given situation requires the specific opinion and view of the firm in Quito / Guayaquil, Ecuador.

CORRALROSALES

Protection of Test Data for Medicines and Agricultural Chemicals

prueba-protection-of-test-data-for-medicines-and-agricultural-chemicals

Test data is the necessary information required by the health Authority to approve the marketing of a medicine or agricultural chemical product in order to guarantee its safety and efficacy. This information is protected by intellectual property regulations to avoid possible unfair commercial use. Ecuador has signed several international instruments that impose the obligation to guarantee the protection of this data. Internal regulations have developed this protection.

When we talk about intellectual property, we usually think exclusively about patents, trademarks and copyrights, however, there are some other modalities that are also part of intellectual property, such as, for example, test data. The importance of its protection lies in avoiding the use, by unauthorized third parties, of valuable information about the research and development process of a novel product, activities that demand a considerable economic and human effort on the part of its creators.

Test data is often associated with patents; however, these are figures that, although both are closely related to the development of drugs and agrochemicals, the test data has independent protection.

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) established a minimum standard of protection to prevent unfair commercial use of test data[1]. Similarly, Decision 486 of the Andean Community provides for this special protection “against any disclosure, except when necessary to protect the public, or unless measures are adopted to guarantee data protection, against any unfair commercial use.[2]

In the Trade Agreement between the European Union and its Members on one hand and Colombia, Peru and Ecuador on the other, the protection of undisclosed information is included within the intellectual property rights.[3]

In the aforementioned international instruments, although the protection of test data is established as an obligation for the Members, a specific period of time is not foreseen for its material protection, which is therefore regulated by each State. However, in the case of Ecuador, the Organic Code of the Social Economy of Knowledge, Creativity and Innovation establishes:

 “Article 508.- Test Data.- Test data or other undisclosed data on safety and efficacy of pharmaceutical products and agricultural chemical products, in accordance with the provisions of Article 27 number 7 of the Organic Law of Market Power Control, when the information contained in the data meets the following conditions:

  1. a) It is secret in the sense that it is not, as a body or in the precise configuration and assembly of its components, generally known or easily accessible to people introduced in the circles in which the type of information in question is normally used;
  2. b) It has a commercial value because it is secret; and
  3. c) Has been subject to reasonable measures, in the circumstances, to keep it secret, taken by the person who legitimately controls it.

 Article 509.- Exclusivity of test data.- When the competent authority requires as a condition to approve the commercialization of pharmaceutical or agricultural chemical products that contain new chemical entities, the presentation of test data or other undisclosed information on safety and efficacy, whose elaboration demands a considerable effort, will be granted an exclusivity period of five years from the date of marketing approval for pharmaceutical products, and ten years for agricultural chemical products. “

Thus, Ecuador has provided a period of five and ten years of exclusivity for the protection of test data on drugs and agricultural chemicals, respectively.

The National Service for Intellectual Rights -SENADI- has reiterated that, although the Agency for Regulation and Control of Phytosanitary and Zoosanitary and the Agency for Regulation, Control and Sanitary Surveillance are the entities in charge of defining the requirement to submit test data prior to granting a marketing authorization and to define its deposit and safeguard procedures, the test data protection system remains in force and that said protection is without a doubt a modality of Intellectual Property.[4]

On August 21, 2020, the State Attorney General’s Office issued a statement regarding agrochemical products expressly stating that, since the Agency for the Regulation and Control of Phytosanitary and Animal Health – AGROCALIDAD- is the competent Authority to approve the commercialization of agricultural chemical products, it is also responsible for granting the period of exclusivity when it has required the submission of test data on their safety and efficacy.[5]

This protection system and the corresponding establishment of a period of time for the exclusivity of the test data guarantees that, at least during that period, any interested party who intends to market a medicine or agrochemical product with a new chemical entity, must carry out their own studies and trials that prove its effectiveness and efficacy. Thus, avoiding the use of test data that have already been developed by a third party. Hence, it is vitally important that the public entities called upon to intervene in this protection system work in an integrated manner to ensure compliance with these international and national provisions.

[1]Article 39 (…) 3. Members, when they require, as a condition for approving the marketing of pharmaceutical products or agricultural chemical products that use new chemical entities, the submission of undisclosed tests or other data, the preparation of which requires considerable effort , will protect that data against any unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure the protection of data against unfair commercial use. ”

[2] “Article 266.- The Member Countries, when they require, as a condition to approve the commercialization of pharmaceutical products or agricultural chemical products that use new chemical entities, the presentation of undisclosed test data or other, whose elaboration involves a considerable effort, will protect those data against any unfair commercial use. In addition, Member Countries will protect this data against any disclosure, except when necessary to protect the public, or unless measures are adopted to guarantee the protection of the data, against any unfair commercial use. The Member Countries may take the measures to guarantee the protection enshrined in this article. ”

[3] “5. For the purposes of this Agreement, intellectual property rights include: (…)

  1. j) protection of undisclosed information. “

[4] Official Letter No. SENADI-DG-2019-0402-OFLetter

[5] Official Letter No. OF-PGE-09818

Katherine González H.
Associate at CorralRosales
katherine@corralrosales.com

1 2 3 7