WTR World Trademark Review – Foreign Companies as Intellectual Property Holders in Ecuador

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DATE: 14-07-2021

PROFESSIONALS IN THE NEWS:

Andrea Miño Moncayo

On July 14, 2021, World Trademark Review (WTR), the media specialized in Intellectual Property, published an article written by Andrea Miño Moncayo.  In her article, our associate comments on a pervasive problem in Ecuador regarding the appropriation of internationally recognized brands by third parties.

The appropriation is usually done through registration applications with the relevant authority and even by marketing products under these brands without proper authorization.

The arguments of the offenders are varied, and they particularly emphasize that the foreign companies in question are not domiciled in the country. Therefore, they could not carry out activities or defend their intellectual property rights in this particular case.

Miño Moncayo emphasizes in the article that, “to try to justify this (blatantly illegal) conduct, some lawyers have resorted to wrongly allege before the courts that the doctrine of the Superintendency of Companies will be applied, according to which a company established outside the country must be domiciled in Ecuador to be able to carry out activities in the country. “

Miño Moncayo then goes through international and local regulations applicable in this case, including the hierarchy of each of them, to demonstrate that the appropriation and use of these marks are illegal and are not justified within the Ecuadorian legal system.

She concludes by highlighting that “it is essential that the preliminary decisions issued by the Court of Justice of the Andean Community in these cases are specific and clear, to avoid erroneous arguments causing damage to the rights of foreign companies not domiciled in Ecuador.”

To see the full article (under registration), click here.

Latin Lawyer – Multiple Firms Help Dutch Paint Company Expand in Latin America.

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DATE: 16-07-2021

PROFESSIONALS IN THE NEWS:

Partners: Xavier Rosales and Andrea Moya

Associates in Quito: Milton Carrera, Ana Samudio, Marta Villagómez, Rafael Serrano, Maria Isabel Torres, Jimmy Rodríguez, Darío Escobar and Sofía Rosales

Associates in Guayaquil: Ramón Paz y Miño and Edgar Bustamante 

MEDIA: Latin Lawyer

On July 16, 2021, Latin Lawyer, the international media dedicated to the legal sector, shared the transaction involving the Dutch company AkzoNobel; this company specializes in decorative and industrial paint and chemical products. CorralRosales acted as a legal advisor in Ecuador.

Through this multinational transaction closed on June 29, AkzoNobel acquired the Orbis Group, a Colombian business conglomerate with several subsidiary companies dedicated to manufacturing paint and derived chemical products. This conglomerate operates in 16 Latin American countries.

The transaction is still pending regulatory approval in several countries and is expected to be finalized by the end of this year.

In addition to having the advice of CorralRosales in Ecuador, the following firms also contributed to the transaction:

AkzoNobel advisers: Baker McKenzie in Colombia, Arias in Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, and Panama.

Grupo Orbis Advisors: Posse Herrera Ruiz in Colombia, BLP in Costa Rica, El Salvador, Guatemala, Honduras and Nicaragua, and Robalino Law in Ecuador.

If you want to see the full article (under registration), click here.

Intellectual Property regulatory corrections; border measures and penalization

Intellectual Property regulatory corrections; border measures and penalization - CorralRosales - Lawyers Ecuador

The National Assembly gave way to the partial objection issued by the Executive Branch, thus approving the “Law that Reforms Various Legal Bodies to Reinforce the Prevention and Combat of Illicit Commerce to Strengthen the National Industry and Promote Electronic Commerce.” In addition, the law foresees reforms in the matter of intellectual property.

In particular, this reform includes provisions regarding (i) intellectual property crimes, their punishment and handling, expanding the punishable acts, and (ii) the border measures process.

I. Intellectual Property Crimes

The Executive Branch veto sought to correct certain inconsistencies and drafting errors in the text approved by the Assembly. As a result, it details criminal conduct in a much better way, the conditions that must be taken into account to assess the existence of the crime and how these crimes are to be treated and judged.

The reform of the criminal law, if it refers to the COIP then it should be named. It establishes that, for these behaviors to be considered crimes, they must include several elements that would differentiate it from a “simple” infringement of intellectual property rights since its sanction is conditioned to the knowledge of the violation, a lucrative purpose, and the commercial scale.

These conditions include criminal offense and penalizing whoever manufactures, commercializes, or stores labels, stamps, or containers containing trademarks or denominations registered in the country.

It also sanctions whoever separates, starts, replaces, or uses labels, stamps, or containers that contain registered trademarks in the country to use them in products of different origin, fills containers identified with a foreign brand with spurious products, stores, manufactures, uses, offers for sale, sells, imports or exports products covered by an invention patent, utility model, industrial design, a plant variety (including its material for reproduction, propagation or multiplication) or a layout design.

It also includes possible infractions -which from our experience, will make up the vast majority of intellectual property criminal actions- against whoever stores, manufactures, uses, offers for sale, sells, imports or exports a product or service that uses an unregistered distinctive trademark identical or similar to one registered in the country; the competitive connection between the infringing products or services and those identified by the registered trademarks must be clear.

Additionally, the law eliminates the condition of a minimum amount to constitute a crime, clarifying that to consider the offending conduct a crime (on a commercial scale), the magnitude, economic value, quantity, and impact on the market must be considered. It also specifies that in foreign trade cases, it is regarded as a crime when the goods are valued at more than 50 unified basic salaries (SBU) – US $ 20,000 to date – stipulating that the cost of the original product must be taken into account for this valuation.

Regarding the sanctions, the law establishes an incarceration sentence of 6 months to 1 year, confiscation (of the seized products), and a fine of 8 to 300 SBU (US $ 3,200 to US $ 120,000 to date). In addition, the following are reinstated as an aggravating factor for the criminal offense: (i) having received a warning of the offense; (ii) that health-related objects cause damage to health; and (iii) that the crime is committed concerning unpublished works.

Regarding copyright, the same conditions described before apply. In addition, the following actions are sanctioned with the penalty indicated in the previous paragraph: alteration or mutilation of a piece of work; the registration, publication, distribution, communication, or reproduction of a foreign work as one’s own; unauthorized reproduction or in a number greater than the authorized number of the work, provided that the damage is greater than 50 SBU (US $ 20,000 to date); public communication of works or phonograms; introduction to the country, storage, offering for sale, sale, lease or circulation of illicit reproductions of works, by any means; unauthorized retransmission of radio broadcasting, television and in general any signal that is transmitted through the radioelectric spectrum; manufacture, import, export, sale or lease of devices, systems or software that allow deciphering an encrypted satellite signal carrying programs or telecommunications in general.

The reform makes an essential clarification about certain conditions on the crime, such as the precise meaning of the term “commercial scale” and how to assess the value of the products.

The law also includes provisions on the destination of the seized products, which may be considered free of charge to cover social needs by the State or destroyed. They must have the report of an expert duly accredited by the Judicial Council. He has to clarify whether the products must be destroyed or render useless “the aspects of the same that violate or transgress the intellectual property, as long as this action does not harm the nature or the functionality of the merchandise.”

Finally, the law includes conciliation is as a dispute resolution mechanism.

In conclusion, the reform is positive because it seeks greater agility in processing and prosecuting intellectual property crimes.

II. Border Measures

After almost five years of a legal vacuum in this matter, the Executive Branch veto, accepted by the Assembly, also corrected the inadequate text approved by the Legislature returning the “mixed” system to the country for the execution of measures on the border. It allows the National Customs Service of Ecuador (SENAE) to be the first filter of infringing products entering or exiting the country, suspending the customs process provisionally, which has to be confirmed by the local intellectual property office.

The reform empowers SENAE to: (i) suspend the customs procedure for products that, in any way, violate intellectual property rights, (ii) alert the holders of these rights, and (iii) provide adequate information to act in these cases.

The suspension of the customs process will initially be five days. During these five days, this suspension must be communicated to the importer, the right holder, and the local intellectual property office. After that, it will have three days to decide on a resolution.

The law maintains the obligation to provide sufficient information to the intellectual property authority about the infringing products and the conditions of the infringement, and the possibility of inspecting the products involved.

The authority may sanction the offender with a cash penalty ranging between 1.5 and 142 SBU (US $ 600 to 56,800 to date).

Per the regulations of the Andean Community, the reform provides that the right holder initiates at their discretion an administrative, civil, or criminal action when the adoption of the border measure has been confirmed. Although there is a contradiction with the supranational norm regarding the term to present it (10 days), it prevails. The holders of intellectual property rights will have a predominant performance in these cases since they must participate actively, both in the criminal proceedings and in the cases of border measures, accompanying the authorities through all the steps.

The law maintains the possibility of requiring the person requesting the adoption of a border measure to provide a guarantee or surety that will be proportional to the possible economic and commercial impact generated by the suspension, to protect the importer or exporter from a possible case of abuse of rights.

This reform corrects elements that have caused a notable increase in intellectual property infringements in Ecuador and led to actions against retailers or small merchants. Unfortunately, these elements have left importers or wholesalers who are the primary beneficiaries of the illicit trade unpunished.

The reforms will come into force after its publication in the Official Registry.

Eduardo Ríos
Asocciate at CorralRosales
eduardo@corralrosales.com

Industria Legal – The Cannabis and Hemp Industry Generates Expectations in Ecuador

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DATE: 02-07-2021

CORRALROSALES IN THE NEWS:

Felipe Samaniego

December 2019 was a month of legal changes in Ecuador. First, the Organic Law Reforming the Comprehensive Organic Criminal Code was published. Still, it was not until June 2020 that it came into force, reforming the Organic Law for the Comprehensive Prevention of the Socioeconomic Phenomenon of Drugs and the Regulation and Control of the Use of Listed Substances Subject to Control. The magazine Industria Legal dedicates a page to the information offered about this matter by our expert partner in Regulatory Law, Felipe Samaniego since this reform gave way to Ecuador’s new cannabis and hemp industry.

The exclusion of substances subject to control to cannabis and hemp with less than 1% THC in dry weight and a term of 120 days for the Ministry of Agriculture and Livestock to issue the corresponding regulation are among the new reforms.

Not only that, but also, through this agreement, new guidelines are established applicable to the regime of seven licenses, different for each activity allowed in the non-psychoactive cannabis industry, hemp and hemp for industrial use, “from the import and production of seeds to the production and export of derivatives, biomass and/or flowers,” according to Samaniego.

Our expert ends his article stating that “the rapid development of the regulatory framework that regulates the activities of agroindustrial activities, by the Ministry of Agriculture and Livestock, caused that both the Ministry of Health and the National Agency for Regulation, Control, and Sanitary Surveillance (ARCSA) as well as the Agency for the Regulation and Control of Phytosanitary and Zoosanitary (AGROCALIDAD) issue the normative bodies that regulate finished products destined for human and veterinary use and consumption that have derivatives of non-psychoactive cannabis or hemp in their composition ”.

If you want to see the article, click here

PharmaBoardroom – Emerging cannabis and hemp industry in Ecuador

PharmaBoardroom - Emerging cannabis and hemp industry in Ecuador - CorralRosales - Lawyers Ecuador

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DATE: 28-06-2021

CORRALROSALES IN THE NEWS:

Felipe Samaniego

With the Criminal Law Reform enacted a year ago, the cannabis and industrial hemp industry has become an emerging industry in Ecuador. Our partner Felipe Samaniego writes about it for Pharma Boardroom.

Samaniego begins the article by writing about what’s new since the reforms now include decriminalizing the possession of drugs that contain cannabis or derivatives as an active ingredient for therapeutic, palliative, medicinal use, or alternative medicine.

The Law for Drug Use, Prevention, and Control is also modified with the change, which now excludes the control of non-psychoactive cannabis or hemp.

On October 19, 2020, the Ministry of Agriculture issued Ministerial Agreement No. 109-2020, which regulates the Import, Sowing, Cultivation, Harvest, Post-harvest, Storage, Transportation, Processing, Marketing, and Export of non-psychoactive cannabis or hemp and hemp for industrial use.

Samaniego adds that “this regulation establishes the requirements that must be met to obtain the seven types of licenses, which authorize the following activities only concerning cannabis or hemp with a THC concentration of less than 1%:

  1. License for Import and Marketing of Non-Psychoactive Cannabis or Hemp Seeds or Cuttings, or Hemp Seeds for Industrial Use.
  2. License for the Import and Commercialization of Non-Psychoactive Cannabis or Hemp Seeds, or Non-Psychoactive Cannabis or Hemp Cuttings or Hemp Seeds for Industrial Use.
  3. License for the cultivation of cannabis or non-psychoactive hemp.
  4. License to grow hemp for industrial use.
  5. License for the processing of non-psychoactive cannabis or hemp and production of non-psychoactive cannabis or hemp derivatives.
  6. License for Banks and Research of Plant Improvement and/or Germplasm.
  7. License for the Acquisition of Non-Psychoactive Cannabis or Hemp Derivatives and/or Biomass or Flowers, or Hemp Biomass for Industrial Use for Export.

As soon as this came into effect, the Ministry of Health and the Agency for Health Regulation, Control, and Surveillance had to develop regulations applicable to finished products. This happened because the Criminal Law “also opened the door to producing and importing finished products,” according to our partner.

Samaniego also adds that at the end of February of this year 2020, “the Health Regulation, Control, and Surveillance Agency issued a resolution with the ‘Sanitary Technical Regulations for the regulation and control of products for human use and consumption that contain cannabis non-psychoactive or hemp, or its derivatives.” This resolution makes it possible to legally produce, import, and commercialize the following finished products with the THC concentration specified in each category:

  • Less than 1% THC: general, natural pharmaceutical products processed for medicinal use and homeopathic. Also cosmetic products and medical devices; hygienic products for industrial use; pesticides for domestic use, for public health or for industrial use; household hygiene products and absorbents for personal hygiene.
  • Less than 0.3% THC: processed foods and food supplements.

On February 26, Ministerial Agreement No. 148-2021 was also issued after a meeting of experts developed regulations for the prescription, provision, and therapeutic use of medicinal cannabis and pharmaceutical products containing cannabinoids.

Samaniego concludes by pointing out that “the regulatory framework for cannabis / hemp has moved relatively quickly in Ecuador and has opened the eyes of many local and international investors. The authorities are aware of what this industry can generate for the country regarding research and investment. Ecuador is the only country in the region that has shown such openness; the players will be able to develop a myriad of producs as long as they abide by all the rules. As a result, this area is expected to become a research and development group for cannabis and hemp products to be sold worldwide.”

If you want to see the article, click here

Implementation of boards of directors of the port authorities of Guayaquil, Manta, Puerto Bolívar and Esmeraldas

Implementation of boards of directors of the port authorities of Guayaquil, Manta, Puerto Bolívar and Esmeraldas - CorralRosales - Lawyers Ecuador
By Executive Decree 78 of June 15, 2021, the President of the Republic implemented the boards of directors of the Port Authorities of Guayaquil, Manta, Puerto Bolivar and Esmeraldas.

The boards will be constituted as follows:

1. Members of the board of directors:

  1. A member appointed by the President of the Republic, who shall preside over the board of directors
  2. A member appointed by the General Commander of the Navy of Ecuador, who will replace the president of the board of directors in case of absence.
  3. A member appointed by the Ministry of Production, Foreign Trade, Investment and Fisheries.
  4. A member appointed by the Ministry of Transportation and Public Works; and
  5. A member appointed by the Customs Administration.

The Subsecretary of Ports and Maritime and River Transportation of the Ministry of Transportation and Public Works will act as secretary of the boards of directors. The members of the board of directors are freely appointed and removable officials.

The President of the Republic is responsible for appointing the managers of the Port Authorities of Guayaquil, Manta, Puerto Bolivar and Esmeraldas.

2. Functions of the board of directors (Article 8 of the National Port Administrative Regime Law):

  1. Submit an annual report to the Direction of the Merchant Marine and Littoral -currently Subsecretary of Ports and Maritime and Fluvial Transportation of the Ministry of Transportation and Public Works- on the activities carried out during the previous fiscal year.
  2. To appoint the Departmental Chiefs from among the candidates suggested by the Manager.
  3. To know and approve the Financial Statements, balance sheets, and other reports of the Entity.
  4. Approve the Port Services Regulations, organization manuals, personnel organization manuals and other pertinent regulations, based on the preliminary drafts submitted by the Manager; and formulate the regulations of uniform application to all the Port Entities, to be submitted for consideration of the Direction of the Merchant Marine and Littoral -currently the Subsecretary of Ports and Maritime and Fluvial Transportation of the Ministry of Transportation and Public Works.
  5. To authorize the Manager to sign contracts, investments, acquisitions, studies and other acts necessary for the fulfillment of the purposes of the Entity, the amount of which requires the Bidding Contest, subject to the Bidding Law -current public contracting regulations- and the approved Budget.
  6. To resolve in second instance the claims of the users, in all matters related to port services.
  7. The others determined in the General Ports Law and in the respective statutes.

3. Liability of the members of the board of directors (Article 11 of the National Port Administrative Regime Law):

They are civilly and criminally responsible, personally and jointly and severally, for all acts or resolutions that are detrimental to the interests of the Entity and that have been taken with their vote. They are especially liable for decisions that contravene Port policy and resolutions issued by higher authorities. The manager and officers of the Entity shall also be liable for their participation in such acts.

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DISCLAIMER: The previous text has been prepared for informational purposes. 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 additional determined situation requires the specific opinion and concept of the firm.

CORRALROSALES

New methodology for the calculation of fines for infractions to the Organic Law for the Regulation and Control of Market Power

New methodology for the calculation of fines for infractions to the Organic Law for the Regulation and Control of Market Power - CorralRosales - Lawyers Ecuador
The Resolution No. SCPM-DS-2021-19 issued by the Superintendency of Market Power Control (“SCPM”) containing the new methodology for the calculation of fines for committing infractions to the Organic Law for the Regulation and Control of Market Power (the “LORCPM” and the “Fines Calculation Resolution”, as appropriate) was published in the Fourth Supplement to the Official Gazette No. 465, on June 3, 2021.

Along with other modifications introduced in the Regulation for the Application of the Organic Law for the Regulation and Control of Market Power (“RALORCPM”) last December, the power to determine fines was brought back to the SCPM. Up until this reform, the determination of fines was regulated by Resolution No. 012, issued by the Market Power Regulation and Control Board (“Resolution 012”).

Although this new calculation model is based on the same principles as Resolution 012, it provides greater clarity in the application and, therefore, greater predictability – and the possibility of verification – of the fines that may be imposed in the event of an infringement of the LORCPM. The calculation formulas incorporated in the Fines Calculation Resolution continue to have a certain level of complexity, but each term is clearly defined, which will allow the fined operator to verify it.

The Fines Calculation Resolution seeks to transmit a dissuasive effect on economic operators through the application of exponential fines, so that those imposed for the most serious anti-competitive acts are proportional and markedly higher to those applicable to the less serious infractions.

The aforementioned resolution establishes the following criteria for the calculation:

  1. Turnover in the relevant market
  2. Degree of participation in the relevant market
  3. Temporality
  4. Size of the relevant market
  5. Market concentration and state of competition
  6. Geographical determination segmented by province or at the national level.
  7. Effect of the infringement on the rights and legitimate interests of consumers and users or on other operators
  8. Benefits obtained as a result of the infringement.
  9. Proportion
  10. Weighing
  11. Damage to the competition
  12. Subsidiarity
  13. Aggravating and mitigating circumstances that concur in relation to each of the investigated/responsible parties.

And establishes as calibration parameters the severity rating as set forth by the LORPCM (mild, serious, or very serious) as well as specific rules for agreements and restrictive practices by object and for collusion (in bids, auctions, contests, and the like).

Among the novel parameters of the methodology, we highlight the inclusion of a differentiated weighting criterion for each of the provinces affected by the illegal conduct.

Additionally, the Fines Calculation Resolution introduces the regulation of fines applicable to the following circumstances/behaviors, which are determined in article 79 of the LORCPM:

  • Sanctions to legal representatives or members of the governing bodies of the infringing economic operator.
  • Cases of noncompliance with information requests by the Authority, delivery of incomplete information and delivery of incorrect information.
  • Calculation of coercive fines, depending on the delay – in days – to comply with the Authority´s decision.
  • Calculation of fines for obstruction of inspections.
  • Fines for failure to comply with a resolution.

The Fines Calculation Resolution is applicable in sanctioning procedures that begin after its publication in the Official Gazette (June 3, 2021). The determination of fines regarding sanctioning procedures that are in the investigation or sanction stage will be governed by the norm in force at the time of their initiation.

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DISCLAIMER: The previous text has been prepared for informational purposes. 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 additional determined situation requires the specific opinion and concept of the firm.

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LexLatin – Change of Government in Ecuador: investment opportunities

LexLatin - Change of Government in Ecuador: investment opportunities - CorralRosales - Lawyers Ecuador

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DATE: 23-06-2021

CORRALROSALES IN THE NEWS:

Andrea Moya

MEDIA: LexLatin

Ecuador has gone through the first month of Guillermo Lasso’s presidency and, as our partner specialist in Tax Law, Andrea Moya, says for LexLatin, “the basis of his administration have been established”. If we consider the benefits that were created during the last two governments with the proposals of the new president, and the return to ICSID, the outlook is very interesting for foreign investors.

CorralRosales is going through a moment in which a large number of foreign companies are requesting advice on investments in Ecuador and on Mergers and Acquisitions. It is important to know the incentives available if you want to invest in Ecuador and the different mechanisms to protect such investment.

Andrea points out that the most important tax benefits are the exemption from income tax (25%), which can be for 8 years or even 12 years, depending on the location of the investment, and the exemption from outflow tax on the import of commodities and capital goods necessary for the project.

It is also essential to know the scope of the investment contracts that may be entered into with the Ecuadorian government. These instruments allow to protect the investment, agree arbitration, and maintain immovable the applicable benefits, despite any subsequent legal reform.

In order to sign this contract, there is a fundamental requirement: the investment must be at least US$1 million and US$250,000 of this amount must be executed in the first year.

However, the most important thing to attract investments to Ecuador is to undertake a comprehensive reform to the tax and labor regimes.

If you want to see the article, click here

Revista Gestión – Legal mayhem

revista-gestion-legal-mayhem - Lawyers Ecuador - CorralRosales

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DATE: 22-06-2021

CORRALROSALES IN THE NEWS:

Francisco Rosales

“A great number of laws does not make a nation better. On the contrary, the proliferation of laws is a symptom of disorder and underdevelopment. There is a good need for a legislative moratorium so that the National Assembly can fix the legal chaos by codifying the fundamental laws for social coexistence, among which, without a doubt, are the tax laws”.

That’s how our partner Francisco Rosales begins his article for Gestión Magazine. He offers his opinion on the lack of a legal framework in Ecuador to provide confidence to the investor. From his point of view, “A fundamental element for the development of a country is its legal framework; it must be clear, orderly, stable and consistent. And, along with it, an enlightened, timely, autonomous and trustworthy administration of justice”. Unfortunately, Ecuador does not have it.

Tax laws become essential within the legal framework. Rosales adds that “in the last 14 years, between 2007 and 2021, 28 tax reforms have been enacted in Ecuador containing a plethora of laws and changes that have created monumental chaos complicating the already serious economic situation we are experiencing.”

Ecuador is currently in need of sustained economic growth of at least 5% per year for the next 20 years, but this projection does not seem to be happening today.

The Legislative Chaos

In the words of Rosales, on top of the norm that applies to dividends paid by companies domiciled in the country, “we have to add the regulations of the Internal Tax Regime Law and the hundreds of general resolutions issued by the Internal Revenues Service.

Legislative Failure

The Legislature Assembly of the country has failed to fulfill one of its fundamental functions, that is: “Mandatorily Issue, codify, reform and interpret laws.” “In turn, Article 31 of the Organic Law of the Legislative Function carries out its obligation to codify the laws by ruling that the Plenary of the Assembly may request that the Legislative Technical Unit carries out the obligation to codify the laws by ruling that the Plenary of the Assembly may request that the Legislative Technical Unit prepares the codification of certain laws, send it to the respective permanent commission, and that, with its report, the plenary, in a single debate, approve the codification and that the president of the plenary orders its publication in the Official Registry”, concludes Rosales.

If you want to see the article, click here

Amendments to regulations for traceability of medicines and medical devices

Amendments to regulations for traceability of medicines and medical devices - CorralRosales - Lawyers Ecuador
Regulation ARCSA-DE-010-2021-LDSS issued on May 19, 2021, amended Regulation ARCSA-DE-030-2020-MAFG, published in the Official Gazette of November 26, 2020, through which the “Substitute Technical Sanitary Regulation establishes the guidelines for the Control of Traceability of Medicines, Biological Products and Medical Devices” was issued. The main aspects of this reform, which entered into force on the date of its subscription, are the following:

1.It is clarified that the inclusion of the unique traceability code in the packaging of medicines, biological products, and medical devices does not require a modification to their marketing authorization unless changes must be made to the packaging to include said code.

2. The maximum term to implement the traceability of medicines, biological products, and medical devices (hereinafter, the “Products”) is modified, depending on the phase to which they correspond. The national health authority shall determine the Products list for each phase.

3. The members of the National Traceability System (hereinafter, “SNT”) must submit to the National Agency for Sanitary Regulation, Control and Surveillance (hereinafter, “ARCSA”) a gradual plan for the implementation of the traceability of their Products (hereinafter, “Gradual Plan”), according to the regulations issued[1] by ARCSA for this purpose.

4. Until ARCSA has a computer system to control the traceability of the Products, the members of the SNT must record the logistical movements of their Products in the system they have for that purpose.

5. The ARCSA computer system will have a database where all the records generated by the systems of each SNT member will be stored. The characteristics of the ARCSA system shall be indicated in the regulations issued by the said authority for this purpose.

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CORRALROSALES