New pipeline for infrastructure projects under ppp law and law 5074

Recently, economist Jorge Vergara, head of the Direction of Strategic Projects (DIPE) of the Ministry of Public Works and Communications (MOPC), announced a new pipeline of infrastructure projects to be tendered under the public-private partnership modality, governed by Law No. 5102/13 (PPP Law) and under the turnkey regime, governed by Law 5074/13 and amendments. He also announced expected investments of USD 370 million in PPP projects, and tender works that represent financing of approximately USD 1,140 million in turnkey projects.

It is important to note that under both contracting modalities the private party provides the financing of the project. Nevertheless, there are important distinctions between the two regimes. In contracts under public-private partnership modality, the private party, not only designs and builds the work, but is also in charge of the operation and maintenance of the works performed. Therefore these contracts are long term, and they are generally funded with the project’s cash flow and collateral under the non-recourse Project finance scheme .

In contracts of public works with private financing (Law 5074), the contractor designs and builds the works, but payment by the State is deferred to 10 years approximately after the completion of milestones. Once the works are completed, the State operates and maintains the works. Payment obligations by the State to the contractor are implemented through “Certificates of Recognition of Payment Obligation” (“Certificado de Reconocimiento de Obligación de Pago in Spanish), unconditional and irrevocable payment certificates, that once issued, are independent to the work’s contract, and are backed by sovereign guarantee of the Paraguayan State. These certificates can be assigned by the contractor to third parties prior authorization of the State .

As announced by DIPE’s representative, the bidding package consists of 7 projects that are to be tendered in the period between 2019 and 2021.
Projects to be tendered under the PPP modality:

  • Implementation of a ferry system in the Paraguay River to transfer passengers from the capital to various cities in the metropolitan area. This is a private initiative presented by the company Somarco and is currently being analyzed by the Technical Secretariat for Planning. If the project is approved, its execution would be tendered during commencement of the following year. Estimated investment amount: USD 40 million
  • Duplication of Ruta No. 1 in the section San Lorenzo – Itá – Quiindy, and the improvement of the southern access area until the connection to Ruta No. 1 (110 km). Foreseen to be tendered next year. Estimated investment amount: USD 200 million
  • Duytu5 brplication and improvement of Ruta No. 6 from Encarnación until the cross with Pirapó (65 km). Currently in stage of project development. Estimated investment amount: USD 130 million
  • Projects to be tendered under the turnkey regime:
  • Duplication of the section Falcón – Cerrito and asphalt pavement Ruta No. 12 until General Bruguez (200 km). Foreseen to be tendered between July and August of this year. Estimated investment amount: USD 150 million
  • Second and third stages of the Bioceanic Corridor, that will consist on asphalt pavement the section Cruce Centinela – Mariscal Estigarribia – Pozo Hondo (573 km that are to be divided in two parts). This work is in design stages and the call for tender is foreseen for the year 2021. Estimated investment amount: USD 800 million
  • Asphalt pavement of the section Puerto Indio – Mbaracayú and connection to the superhighway (65 km). Foreseen to be tendered in the second semester of this year. Estimated investment amount: USD 80 million
  • Costanera Sur construction and coastal defense for the city of Pilar. Estimated to be tendered next year. Although to be tendered under the turnkey regime, the government is still analyzing the contracting modality. Estimated investment amount: USD 110 million
  • In the years 2017 and 2018 BKM|Berkemeyer has assisted the bidders that have been awarded and signed the first contracts under the PPP and turnkey modalities. To date, the firm counsels on financial closure, both in the PPP project of Ruta No. 2 and Ruta No. 7 (of USD 500 million approx.) and the bioceanic corridor (USD 445 million approx.). The contracts are in full execution, an explanation to the Paraguayan State’s decision to betting on tendering the largest infrastructure projects through these contracting regimes.

Bill of Law on Insolvency Resolution: a proposal for rescuing viable companies

The use of bankruptcy proceedings as punitive sources for insolvent debtors has been left frozen in time. When enacted, Law No. 154/69 regarding Bankruptcy was one of the most modern in Latin America. However, to this date this law is rarely applied and the idea of «punishing» a debtor for reaching insolvency is gradually abandoned. Modern insolvency systems seek to recover the debtor’s business, by reorganizing or restructuring the debts rather than liquidating the assets, as this contributes to the development of the economy and is under the belief that it is preferable to maintain a business or company that once was feasible, despite the financial problems that the business or the company may have encountered on the way.

The truth is that, when facing financial problems in these days, insolvency and bankruptcy provided by Law No. 154/69 are not considered attractive for both debtors and creditors, so we express our total approval to the insolvency reform initiative in Paraguay. In fact, the Bill of Law on Insolvency Resolution was submitted to the Congress, intended to keep those effective provisions of the current law but, at the same time, adding some modern touches to our bankruptcy system through the incorporation of new institutions.

Extrajudicial reorganization agreement, preservation of business through a sale under way, cross-border insolvency and mixed model of receivership are some of the new additions.

Extrajudicial reorganization agreement is a preliminary step before filing for insolvency and allows the debtor in a state of insolvency or with financial problems to agree with an absolute majority of the creditors, namely representing two thirds of the accountable capital, a debt restructuring. The Bill provides for the approval of this agreement before a judge and such approval has the same effects as an approved composition of creditors in insolvency proceedings.

Furthermore, as a novelty, the bankruptcy process incorporates the sale of assets as a unit or the company in working order, which allows a more efficient settlement. In some cases, selling the unit or the company is more practical than liquidating the assets separately. This inclusion demonstrates the trend towards reorganization and recovery of a feasible business even in bankruptcy cases.

In addition, Model Law on Cross-Border Insolvency by the United Nations Commission on International Trade Law is adopted. This section of the project basically seeks to regulate cooperation between the Paraguayan authorities and those of foreign countries, create a mechanism that provides greater legal security to trade and investment, guarantee the protection of the debtor’s assets, optimize their value and protect the interests of creditors and other interested parties. 

Perhaps one of the most expected inclusions is the mixed system of receivers established by the bill. Currently, there are only six receivers in charge of all bankruptcy proceedings in the country. This deficiency also contributes to make the bankruptcy proceedings an unattractive solution for both debtors and creditors. This project is focused in appointing independent professionals with degrees in Laws or Economics, Accounting or Business Administration, as receivers; to that end, a registry or list under responsibility of the Judicial Council and the General Bankruptcy Receivership should be set. This list would be valid for five years. 

The interesting part of this is the procedure established for the selection and appointment of receivers in bankruptcy proceedings. The same will be drawn by lot and the appointed receiver shall not participate in future draws until the list is closed, which ensures a good and balanced distribution of the work for receivers.

Undoubtedly these inclusions will strengthen the system in regard to insolvency cases in the country. Promulgation thereof will contribute for developing the economy and attracting new businesses in the country.

Bill of Law on movable guarantees: the possibility of establishing pledges on movable assets

A «Bill of Law on Movable Guarantees» was recently filed before the Congress for consideration, based on the Model Law on Secured Transactions of the United Nations Commission on International Trade Law. The purpose of this Bill is to incorporate into national legislation the possibility of establishing pledges on movable assets to secure the obligations to be entered.

The purpose of the mentioned Bill is the possibility that movable assets can be used as a guarantee on contractual obligations, following in a certain way the real property rights model, regulated and provided under our current laws. If the Bill is approved, movable assets may be given as a guarantee of compliance with any obligation, own or belonging to others, regardless of the form of legal figure used, and would comprise, by way of example, conventional pledges, registered pledges, operations with warrants, sales with retention of title, trust in guarantee on movable assets, financial or commercial leasing, factoring operations and other similar operations.

Regarding the constitution of guarantees on movable assets, they would be implemented through a written guarantee agreement, provided that the secured debtor has rights over the asset to be encumbered or powers to encumber it, and must indicate (a) secured creditor and secured debtor; (b) the guaranteed obligation; (c) the encumbered asset and (d) the maximum amount for which the guarantee on a movable assets could be executed. Likewise, also the constitution of guarantees on future movable assets, which will be conditioned on the fact that the secured debtor actually acquires rights over such asset or is empowered to encumber it. It is an extensive Bill, it provides detailed information on the obligations to be guaranteed, movable assets subject to guarantee, amount of guaranteed obligation, enforceability against third-parties, among others.

The virtue of the Bill lays on the fact that, if approved, it would expand the range of available alternatives for assets that could be used to guarantee obligations. Several economic sectors will benefit from the possibility of using movable assets as a credit guarantee, for instance, to generate new capital, thus increasing their productivity, competitiveness and growth. We see that this bill, if passed and enacted, will specially contribute with MIPYMES, which usually do not have real estate assets to guarantee their obligations, therefore they would be able to offer movable assets that make up their capital as guarantee, namely machinery, vehicles, receivables, among others. Considering the benefits that would be brought into the legal system of guarantees in Paraguay if aforementioned Bill is approved, we can assure that its economic impact will be beneficial not only for MIPYMES, in all economic sectors, but for the population in general.

Bill of Law to create the Simplified Shares Company (EAS)

The purpose of the new Bill is to create a new type of company that, as indicated by its name, establishes a smaller number of formalities for its incorporation and operation than the companies already existing according to our laws. A novel characteristic shown by the EAS would be that they may be incorporated by a single natural or legal person, with the only limitation that single EAS cannot constitute or participate in other single EAS.
If the law is enacted, the Ministry of Finance should create an exclusive unit that will record, control and monitor the EAS. The EAS will acquire legal status upon being registered at the Ministry of Finance, so registration before the Public Registries will not be required. In addition, it must be registered in the Unified System for Opening and Closing Companies (SUACE), with a website where a registration form and a model for articles of incorporation will be published.

Share capital of the EAS will be represented by nominative shares, whether endorsable or not, ordinary or preferred, and the capital may be paid up in cash or with other assets. When the contribution is in money, payment is authorized to be made by delivering 50% of the payable amount at the incorporation act and the remaining 50% within the 2 (two) years upon the incorporation, and on the other hand, contributions in assets should be made at the moment of incorporation.

It should be noted that no minimum or maximum amount is set as share capital for this new type of company. The EAS will meet their obligations only with their equity assets, meaning that all members of the EAS should respond up to the amount of their respective contributions.
Regarding the EAS organization, the organizational structure of the company can be freely determined. Anyhow, it is established that the governing body of the company will include the EAS members and that a legal representative must be appointed. Nevertheless, the creation of an administrative body, as well as an audit body, will be optional.

EAS are required to keep the following corporate books:

  • Minutes book of the governing body;
  • Stock registration book;
  • Minutes book of the administrative body (in case it is created);
  • Journal book; and
  • Inventory book.

Should you want to know more about this Bill, do not hesitate to contact us.

Simplified Joint Stock Companies (EAS)

This new year arrived with it a new type of company, through the promulgation of Law No. 6480/2020: the Simplified Joint Stock Companies or “EAS” (according to its initials in Spanish). The novelty of EAS lay on the fact that they can be incorporated by one or more natural or legal persons. That is, ownership of the company by a single person is admitted. The only proviso in the law in this regard is that a single-person EAS cannot be a shareholder of another single-person EAS.

EAS are created through a unilateral contract or act stated in a public or private instrument with certification of signatures. The interesting facility presented for the incorporation process is the non-mandatory recordal of the company in the Public Registry Office, as documents must be entered only and exclusively through the SUACE, which will then refer the procedure to the Ministry of Finance.

Once the documents are registered before the corresponding division of the Ministry of Finance appointed for such purpose, the EAS acquires a legal personality different from that of its members. Until acquiring legal personality, each member of the EAS is jointly and unlimitedly responsible for the obligations taken on behalf of the company. After the personality is acquired, the partners are liable up to the limit of their contributions.

The Law does not require a minimum capital for the incorporation of EAS, divided in shares. Subscription and payment of the capital can be done in such conditions, proportions and terms as agreed by the members, although the payment period must not exceed 2 years after subscribing the capital. To this date, corporations (“SA”) do not have this obligation.

The EAS’ articles of incorporation are important since they define their organization. The governing body is the meeting of the members, to take decisions, regardless of whether it is formed by a single member.

Another peculiarity of the EAS is that the figure of a corporate trustee is not mandatory, meetings of members can be held without calls published in newspapers and it is not necessary to do it in advance. However, EAS must have corporate books similar to those used by SA.

It is important to mention that, although the Law whereby this type of company is created is currently in force; the Ministry of Finance must designate the agency in which the EAS will be registered, so such procedure is still pending in order to make their incorporation effective. Furthermore, these companies bring other innovations and particularities which will be described in more detail in the next newsletters.

Finally, with regard to the tax regime of the EAS, they will be under the same regime as any other person who is engaged in the same activity, without any distinction. However, the single-person EAS owned by a natural person could have a competitive advantage compared to other companies, losing fiscal neutrality, since they could pay the IRE by the SIMPLE Regime, as long as they invoice up to G. 2,000,000,000 per year. In that way, the single-person EAS owned by a natural person will enjoy tax benefits agreed to single-person companies but obtaining the additional benefit of limiting the liability to the value of the contributed capital.

Successful placement of Paraguayan sovereign bonds

Paraguay renews the confidence of international investors by successfully issuing and placing USD 450 million in 30-year sovereign bonds. The rate was 4.45% and there was an oversubscription of 8 times, demonstrating a higher performance than other countries in the region. In the issuance of the year 2018, the interest rate was 5.6%, which demonstrates an improvement in the positioning of Paraguay on its way to the degree of investment. Part of these funds will be used for infrastructure projects of the central government. On the other hand, in 2019 there were 2 international project bond issues (first in the history of Paraguay) totaling more than USD 1 billion and whose performance also demonstrated the high degree of interest in international markets for investing in Paraguay (bonds 144A / Reg S at 15 years, with three times oversubscription and rates of approximately 100 bps above the sovereign’s curve). BKM was the advisor under the exclusive local law of the sponsors in both international issues (Bioceanic and Routes 2 and 7). For more information on the issuance of sovereign bonds see below 2 recent news related to the subject:

The keys of Paraguay for the successful placement of sovereign bonds
Our country placed sovereign bonds abroad for the eighth time in its history, this time, for 450 million dollars at 30 years. The slowdown and recession of 2019 were not impediment, but there were five keys to making the operation a success.

https://bit.ly/2uYBo3W

High demand for investors allowed Paraguay to obtain its best interest rate for bonds
The publication notes that Paraguay took advantage of the low bond issuance of Latin American countries and took advantage of the demand of investors, added to the country’s upward trajectory in the region.

https://bit.ly/2NBxZyj

New Regulatory Decree of the Public Procurement Law

On December 9, our President signed Decree No. 2992/2019, regulating Law No. 2051/03 on Public Procurement, which aims to establish a unified system for public procurement procedures.

Although it does not introduce substantial modifications to the current current regime, it harmonizes 10 regulations that were dispersed in order to unify the existing regulations making it more practical and easy to apply, in addition to incorporating new regulations that improve the transparency of the system.

Three contracting modalities are incorporated i) Framework Agreement, ii) National Agreement and iii) Joint Purchases.

The first one is aimed at the selection of suppliers of goods, works, services and consultancies that, once selected, the products are included in an electronic catalog that will be published in the Public Information and Contracting System so that the Organizations, Entities and Municipalities can acquire them directly.

The National Agreement modality consists of an open call addressed to national suppliers of the goods or services to be acquired. Its purpose is that entities and organizations have several suppliers for the same benefit since the demand requires to be served by a large number of suppliers.

 The third modality of Joint Purchases is aimed at accumulating the purchase of two or more agencies, entities or municipalities when they require the contracting of the same good, work or service in order to obtain the benefits that common purchases represent.

Regarding the bidding procedures, the obligation to recognize the preference margins for local companies in international procedures is incorporated since, if not indicated in the bidding documents, it is understood that the minimum percentage of 1% is applied.

The obligation for the Convocant to proceed within 5 calendar days of having resolved the award to publish a copy of the evaluation report and the administrative awarding act is established. Likewise, the power of the bidder to request an informative hearing is established so that the Convocant explains to him the grounds that motivate his decision. These are new additions that make the improvement of transparency in the processes.

Among the exceptions to the tender, the assumption of “Termination Contract” is included in the case of breaches by the Contractor, providing for the possibility of awarding the balance pending execution to the next adjudicable offer.

In the event of default in payment by the Contracting Party within a period greater than 60 days, the Contractor has the right to request the suspension of the execution of the contract for reasons attributable to the Contracting Party.

For the filing of the protests against the specifications, two new requirements are added, in which the challenger must prove (i) that the commercial activity of his company corresponds to the item called and (ii) that he has previously consulted with the Convocante, the provision of the contesting document. Likewise, a more detailed procedure is regulated for the substantiation of protests.

Regarding the regime of the remedies for reconsideration, its interposition is extended against the decisions that resolve the agreements, maintaining its non-suspensive effect as a general principle.

Finally, it incorporates the regimes of the “System of Information of Suppliers of the State (SIPE)”, the “System of registration of payment to suppliers”, the “Procedure for the application of the Sanctions”, “Procedure for the Application of Sanctions” and “ Mechanisms for Dispute and Dispute Settlement ”. These regimes already existed in other regulations, and from now on they are incorporated into the same legal body, incorporating minimal modifications or aggregates.

The new regulatory decree will enter into force as of January 1, 2020 and the calls that are being processed, as well as the execution and execution of awarded contracts in progress will be governed by the legislation in force at the time of publication of the call to contract .

For more information contact Martín Carlevaro – martin.carlevaro@berke.com.py or Sofía Suárez sofia.suarez@berke.com.py.

The Executive Branch set the effective date of the tax reform

Through Decree No. 2787/19, published in the Official Gazette on 04/11/19 and in the national newspapers today, the Executive Branch established the dates of entry into force of the provisions contained in Law No. 6380/19, «Modernization and simplification of the national tax system».

Regulated ConceptsEffective date
Change of name of balances in favor of the taxpayer (without any tax incidence from the practical point of view)Possibility of incorporating technological tools for SETSpecific modifications on incentives to investments contained in Law No. 60/90 and Law No. 5542/1505/11/2019
Corporate Income Tax (IRE) *Dividends and Utilities Tax (IDU)Personal Income Tax (IRP)Non-Resident Income Tax (INR)Value Added Tax (VAT)01/01/2020
Special rules for the valuation of operations (transfer prices)01/01/2021
All other provisions*01/01/2020

The decree also provides that those taxpayers whose fiscal year end is April 30, 2020 and June 30, 2020, the provisions of the IRE will be applicable from May 1, 2020 and July 1, 2020, respectively.

Since the transfer pricing rules will be applied only from January 1, 2021, the decree provides that the rules of “Export Price Adjustments” (APE) established in art. 4 of Law No. 5061/13 will continue to apply until 12/31/2020.

Finally, it is also provided that the new and beneficial form of the calculation of the advances of the IRE (which will take the average of the tax paid in the last three years, instead of the current system that uses the tax paid in the previous year) will only enter vigor in fiscal year 2023.

It is important to remember that Law No. 6380/19 established what in principle looks like a simpler tax system than the current one and certainly more modern, which includes rules and recommendations of several international organizations.

The aforementioned law unifies the Iragro and Iracis in a single tax, the Corporate Income Tax (“IRE”), replaces the additional rates of the Iracis with a Tax on Dividends and Utilities (“IDU”) and with the Income Tax Non-Resident Income (“INR”), with different rates depending on the quality of the person receiving the rent.

It also legally incorporates certain modifications that were made through decrees to the IRP. This tax is basically divided into a tax on labor income with progressive rates of 8% to 10% and up to 8% (effective rate) on capital gains obtained by natural persons.

Although this decree grants security as to the validity of the new provisions, it is still necessary to have the regulations of the new taxes and, above all, the transition rules that will be in force during the year 2020.

In case you have questions or queries, you can contact us at mauro.mascareno@berke.com.py, carlos.vargas@berke.com.py and federico.valinotti@berke.com.py

Law whereby bearer shares are eliminated in Paraguay is modified

After two years from regulating the elimination of bearer shares in the country, shareholders and companies obtained a new grace period to fulfill the provisions required by Law and avoid falling into breaches or incurring in fines. Although companies are facing possible more strict and forceful limitations, a precise regulation that contemplates a wide range of assumptions grants the benefit of an objective guide instead of one subject to diverse interpretations.

In fact, legal frame for corporations in Paraguay underwent an strategic change in October 2017 with the promulgation of Law No. 5895 (the «Law»), through which transparency rules were established for joint stock companies, being one of the most specific issues, the elimination of bearer shares and the obligation to exchange them for registered shares, modifying corporate bylaws thereby.

Just recently, on October 9, 2019, the Executive Branch enacted Law No. 6399/29, which modifies Articles 3 and 4 of Law No. 5895/2017, the “New Law”.

The New Law kept the purpose and spirit of the Law and was limited to modifying matters in established manner and regulating others that were not included at the beginning. However, such modifications cannot go unnoticed as they affect processes, prohibitions and restrictions relevant to the operation of corporations, as described below.

The Law established a term, 24 months after coming into effect, for shareholders to exchange their bearer shares for registered shares. Considering that said law was published on October 9, 2017, the deadline expired on the same day in which the New Law is published and provides as follows:

a) The deadline is extended until December 10, 2019 to initiate the procedures for requesting a resolution regarding the modification of Bylaws by the Department of Registries and Supervision of Companies, a division of the Legal Section of the Treasury Dept.

b) A period of 180 days is established as of 10/12/2019, for the effective fulfillment of the exchange of bearer shares for registered shares.

c) Instead of requiring the exchange of 90% of bearer shares, it is provided that, within the established term, all shares must be converted to registered shares.
In case the above is not fulfilled, serious penalties are established for shareholders that fail to exchange their shares as well as for the companies themselves.
Besides the suspension of financial rights for those holders of shares that were not exchanged, the New Law creates situations and penalties not previously established.

Indeed, it provides that, if after six months of the expiration date for the effective exchange of shares, still there are bearer shares, these would lose their validity as a share title. In this case, shareholders who can prove the legitimate ownership of the shares would have the right to be reimbursed only for their nominal value, unless they request their readjustment to real values, but with the proportional reduction of the liability assumed by the company.

Specifically, the collection action for reimbursement that the holder of the shares may exercise against the company will expire after five years.

In line with the loss of validity of the shares and the reimbursement of their nominal value, the New Law establishes that within six months after the deadline for the loss of validity mentioned in the previous paragraph expired, the companies must call for an extraordinary meeting to reduce capital, decreasing it in the value of the shares not exchanged.

Subsequently, the New Law includes three additional provisions as previously provided by the Law:

a) For companies that had not initiated any procedure after six months of the expiration of the term, it is established the obligation to begin its process of termination and liquidation, as well as the authorization to the Legal Section of the Treasury Dept. to judicially require the dissolution, liquidation and extinction of company.

b) It provides monetary fines for breaching the exchange of shares (established in the Law and which were not modified), would enjoy special privileges over any other credit that the bearer may have against the company and those derived from the relation between shareholders.

c) It orders that, in the event that bearers claim reimbursement of their shares, the company should require the shareholder to provide proof of the payment of the fines due for failing to exchange the same (ranging between G. 8,600,000 (USD 1400) and G. 42,000,000 (USD 6800) approximately).

Finally, the New Law establishes transitory provisions and formalities related to the extraordinary meeting of shareholders that must be held to approach the reduction of issued capital in regard to the value of the not exchanged shares.

Medicinal Cannabis in Paraguay: regulatory framework for licensing.

In December 2017, the National Congress enacted Law No. 6007 that creates the “National Program for the Medical and Scientific Study and Research of the Medicinal Use of Cannabis and its Derivatives (PROINCUMEC)”, (the “Program”), being regulated by Decree No. 9303/18.

The purpose of this law is to establish a regulatory framework to promote the study as well as the medical and scientific research of the medicinal, therapeutic and/or palliative use of the Cannabis plant and its derivatives for the treatment of diseases and conditions in humans, in addition to regulating its controlled production.

An interdisciplinary framework is set forth because different public entities take part in the process depending on the prerrogatives of each one.
The National Sanitary Vigilance Directorate (the “DINAVISA”), under the authority of the Ministry of Public Health and Social Welfare, is appointed as the enforcement authority, who will act as the national coordinator of said Program.

Likewise, the National Service for Quality and Health of Plants and Seeds (the “SENAVE”) will be responsible for defining the conditions, requirements and monitoring to grant the authorization to import the seeds to the interested parties.

Finally, the National Anti-Drug Secretariat (the “SENAD”) must implement the security conditions that will be applied to obtain and maintain the license and will carry out the control during the validity period of the license.

Through the regulation of said Law, the requirements for the production, controlled industrialization, import, export, commercialization, prescription, dispensation and rational use of medicinal cannabis under the Program, are incorporated.

In order to access the production, industrialization and commercialization activities, it is mandatory to obtain a license granted by DINAVISA, in coordination with SENAVE and SENAD, within the scope of each one.

The granting of said license necessarily implies the prior fulfillment of a series of requirements provided for in the regulations and must be requested by an authorized national laboratory that has a certificate of good manufacturing practices (GMP) in force.

It is worth mentioning that the license shall be granted for a period of 5 years, and may be renewed for equal periods and may not be transferred or assigned under any title, nor obtained only for the exclusive performance of certain processes, since the licensee must perform all the activities of the process, except for transportation and final disposal, which may be outsourced.

Currently, the government is working on a complementary regulation in order to establish the procedure for obtaining a license for a controlled production and industrialization, given that there is a limited number of licenses to be granted, that the applications must be evaluated, and that the eventual rejection must be properly grounded.

For more information please contact Sofía Suárez – sofia.suarez@berke.com.py – and Ignacio Serratti –Ignacio.Serratti@berke.com.py –