It is effective as of its publication in the Official Gazette.
(Sinalevi Note: By means of article 4 of Decreto Ejecutivo N° 40387 of February 27, 2017, chapter IX of these regulations and articles 63 through 66 are ordered to be amended. However, the amendment does not indicate anything regarding the repeal of this article, so it remains with its full text and may be consulted in its current version in article 66) Given at the Presidency of the Republic.—San José, on the 22nd day of February, two thousand twelve.
Transitional Provision I.—The digital prior-control system to implement articles 12, 12 bis, 13, and 13 bis of these Regulations shall begin operating as of May 9, 2016.
(As amended by article 1 of Decreto Ejecutivo N° 39617 of March 17, 2016) (As amended by article 1 of Decreto Ejecutivo N° 40387 of February 27, 2017)
Affidavit on the fulfillment of the requirements for formalities (trámites) for the Application of Positive Silence (Silencio Positivo) I ____________________________________________, in my capacity as petitioner for the procedure (trámite) of ____________________________________, declare under oath the following:
FIRST: That on the ______ day of _____ 20___ I submitted the application for the: (permit, license or authorization) called:_______________________________________, before the (Office/Unit/Region): _____________________________________ of the Institution____________________________________________________; as recorded in the receipt document for my application.
SECOND: That the application indicated in the previous article fully complies with all the requirements demanded by the (decree/ regulation or law) No. _______, published in La Gaceta No. ___________; since, in accordance with article 4 of the Law for the Protection of Citizens from the Excess of Administrative Requirements and Formalities, Law No. 8220, these are the only requirements I must fulfill; the same being as follows:
1- ____________________________________________________________________ 2- ____________________________________________________________________ 3- ____________________________________________________________________ 4- ____________________________________________________________________ THIRD: That on the past _____ of ____ 20_____ the legal deadline for the institution to resolve the aforementioned application elapsed. In this regard, and in compliance with the provisions of articles 7 of Law 8220 and 42 of the regulations to said Law, I request that the appropriate action be taken so that Positive Silence (Silencio Positivo) is applied.
FOURTH: That I am aware of the legal consequences with which the crimes of false testimony and perjury are punished, in cases of not telling the truth, the foregoing in accordance with the provisions of the current Penal Code.
FIFTH: I designate the following email address for receiving notifications: ________________________________________________________________________ Signature ID No.
Authenticated
Complaint for non-compliance with the Law for the Protection of Citizens from the Excess of Administrative Requirements and Formalities, No. 8220 I, _(first name and both surnames)__, identity card number ____________________, hereby file a formal complaint against the official _(first name and surnames of the official)____________________________________________________, who works at (Office/Unit/Region) __________________________ of the institution (Name of the institution)______________________________________________________.
The complaint is due to the fact that the indicated official, as the person responsible for the formality (trámite) of: (permit, license or authorization): (Name of the Formality)___, which I submitted, breached article 10 of the Law for the Protection of Citizens from the Excess of Administrative Requirements and Formalities, Law No. 8220, in the following manner:
□ Not accepting the single submission of documents or demanding more requirements than those established in the law, executive decrees, or regulations as established by law.
□ Not respecting competencies.
□ Not publicizing formalities (trámites) or adhering to the law.
□ Not informing interested persons clearly and completely about the formality (trámite).
□ Not resolving or evaluating those requests, procedures (gestiones), applications, and other documents within the established deadline for each of those formalities (trámites) in the General Law of Public Administration or in a special law.
□ Failing to comply with the positive silence procedure.
□ Failing to comply with the institutional and inter-institutional coordination procedure.
□ Disrespecting the procedure before a single administrative instance.
□ Rejecting documents validly issued by other organs, entities, or institutions of the State in the exercise of their own competence.
□ Not carrying out the cost-benefit evaluation of the regulation, when applicable.
□ Not abiding by the binding criteria issued by the Ministry of Economy, Industry and Commerce, through the Directorate of Regulatory Improvement, in compliance with the obligations established in this law and the principles of regulatory improvement.
Details: (Detail of the reported acts or omissions, indicating the persons and bodies involved in the complaint - additional sheets may be added/enabled) ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ A receipt or reference for the service provided before the cited Department is attached.
A place is designated for receiving notifications at:___________________________________________________________________________ ____________________________________________________________________________________________________ _________ Signature of the complainant _________________________________ Signature of the official receiving the complaint
| SECTION 1: PRIOR CONTROL OF REGULATORY IMPROVEMENT | |
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| Institution: Click here to enter text | Regulation Title: Click here to enter text |
| Contact Point: Name: Click here to enter text Phone: Click here to enter text Email: Click here to enter text | Date of receipt: Click here to enter a date |
| 1.- DESCRIPTION OF THE REGULATION |
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| 1. Briefly explain what the proposed regulation consists of. Click here to enter text |
| SECTION 2: REGULATORY IMPACT STATEMENT | |
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| I.- DEFINITION OF THE PROBLEM AND GENERAL OBJECTIVES OF THE REGULATION | |
| Identify and describe the problem or situation that the regulation proposal aims to resolve. Click here to enter text |
| Describe the general objectives of the regulation. Click here to enter text |
| Cite the legal basis that grants you the authority to issue the proposed regulation. Indicate if there are other regulations in force on the matter that are insufficient to address the identified problem, or that generate duplications or contradictions. (In this latter case, you must make an express amendment that repeals the non-applicable legislation.) Click here to enter text |
| II. ALTERNATIVES CONSIDERED TO THE REGULATION | |
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| Identify and compare all the regulatory and non-regulatory alternatives that were evaluated which could resolve the problem, including the option of not issuing the regulation. For each of the alternatives considered, describe their costs and benefits qualitatively. | |
| Selection | Clear description of the alternatives, as well as their costs and benefits |
| Do not issue regulation Regulatory: Government Regulation Performance-Based Regulation Co-Regulation Non-Regulatory: Market Instruments Quasi-regulation Self-Regulation Information Campaigns. | Click here to enter text |
| Justify the reasons why the proposed regulation is considered the best option to address the identified problem over the alternatives mentioned in the previous question. Click here to enter text | |
| III. IMPACT OF THE REGULATION Does the proposed regulation create or modify formalities (trámites) that involve new requirements for the regulated parties? | | |
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| Select | Name of the formality (trámite) Click here to enter text | Resolution deadline (working or calendar days) Click here to enter text |
| CREATES MODIFIES N/A | Validity of the formality (trámite) Click here to enter text | Positive Silence Applies Yes No |
| Requirements it Creates or modifies Click here to enter text | Legal basis (Art. of law, decree, or regulation) Click here to enter text | Justification of why it is ESSENTIAL to resolve the administrative act and to fulfill the objectives of the regulation (technical-scientific basis, if applicable) Click here to enter text |
¿ Does the proposed regulation request requirements that are obtained in another office within the same institution or in another institution?
(*) (*)(Thus added by means of Errata published in La Gaceta No. 114 of June 14, 2016, page No. 52)
| Select | Requirement | Justification of why COORDINATION does not apply |
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| Establishes deadline Increases deadline N/A | Click here to enter text | Click here to enter text |
10. Does the proposed regulation reduce the validity period of a formality (trámite)? (Example: permit, license, or authorization)
| Select | Name of the Formality (Trámite) Click here to enter text | Change in validity Click here to enter text | Justification (legal and/or technical) Click here to enter text |
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| Yes NO | | | |
11. Does the regulation proposal establish or increase fees, tariffs, or charges for services?
| Select | Amount Click here to enter text | Justification and setting parameters (attach calculations for setting) Click here to enter text | Legal basis Click here to enter text | Adjustment mechanism Click here to enter text |
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| Fee Tariff Charge for Services N/A | | | | |
12. Does the regulation proposal regulate or restrict any activity that was not previously regulated? Explain the additional conditions established and justify why.
Click here to enter text 13. Provide the quantitative estimate of the costs and benefits that the regulation entails for each individual or group of individuals.
Remember to include in the costs box: the estimated number of formalities (trámites) expected to be granted in a year; as well as the costs incurred by users, and in the benefits box: the number of agents who benefit and the economic amount of that benefit; a time range must be specified within which the benefits of the regulatory or non-regulatory measure are
| COSTS | Groups or industries impacted by the regulation Click here to enter text |
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| Describe and estimate the costs Click here to enter text | |
| BENEFITS | Groups or industries benefitted by the regulation Click here to enter text |
| Describe and estimate the benefits Click here to enter text | |
14. Justify that the benefits of the regulation outweigh its costs.
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IV. COMPLIANCE AND APPLICATION OF THE PROPOSAL
15. Describe the form and/or mechanisms through which the regulation will be implemented (include public monetary and in-kind resources).
Click here to enter text 16. Describe the monitoring and verification schemes that will ensure compliance with the regulation.
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V. EVALUATION OF THE PROPOSAL
17. Describe the form and means through which the achievement of the regulation's objectives will be evaluated. Also mention the indicators and goals that will be used to evaluate the success of the regulation.
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VI. CITIZEN PARTICIPATION
18. Were the interested parties and/or groups consulted for the drafting of the regulation?
| Select | Group consulted Click here to enter text | Comments received during public consultation Click here to enter text | Comments included in the regulation Click here to enter text |
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| Inter-institutional consultation. Formation of a working group/technical committee for the joint drafting of the preliminary draft. Circulation of the draft to interested groups or persons and receipt of comments. Presentation of the proposal at a conference (by invitation and closed). Presentation of the proposal at a conference open to the public. Consultation with international bodies or authorities. Others. | | | |
VII.- ANNEXES 19. Attach the regulation proposal and the documents consulted or prepared for designing the regulation.
Click here to enter text VII.- RESULT OF THE COST-BENEFIT EVALUATION I, Click here to enter text, in my capacity as Click here to enter text, certify that based on the cost-benefit evaluation and the analysis of the information detailed therein, the regulation proposal should be issued because the benefits it generates are greater than the costs of applying it.
Signature of the Formality Simplification Officer ______________________________ Seal: Date:
(As amended by article 1 of Decreto Ejecutivo N° 39726 of May 24, 2016)
| SECTION 1: PRIOR CONTROL OF TECHNICAL REGULATIONS | |
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| Institution: | Title of the regulation: |
| Proposing Institutional Department: Name of the responsible technician: Phone: Email: | Date: |
| 2. Indicate | Regulatory Actions of Prior Control | Select |
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| which of the following | (yes/no) |
| regulatory actions | a. | Contains or modifies the technical specifications of a product or the related processes and production methods, including the applicable administrative provisions, the observance of which is mandatory. | YES |
| of Prior Control | | | |
| apply(ies) to the | | | |
| proposed | | | |
| regulation. | b. | Includes or modifies prescriptions concerning terminology, symbols, packaging, marking, or labeling applicable to the same, or deals exclusively with them. | YES |
| c. | Establishes or modifies definitions, classifications, formulas, criteria, characterizations, or any other term of a technical nature that, by itself or jointly with another regulation, affects the rights, obligations, services, or procedures of the regulated parties. | YES |
| d. | Creates or modifies conformity assessment procedures? | YES |
| e. | Creates or modifies formalities (trámites) that the regulated parties must fulfill. | YES |
| f. | Creates or modifies requirements or obligations for the regulated parties, or makes existing requirements or obligations stricter. | YES |
| g. | Establishes or increases the resolution deadline for a formality (trámite). | YES |
| h. | Regulates an activity that was not previously regulated or makes the regulation more restrictive. | YES |
| i. | Makes the fulfillment of a formality (trámite) or requirement more complex. | YES |
A. Legality Analysis.
8. Briefly describe the conclusions of the legality analysis carried out for the issuance of the Technical Regulation.
Click here to enter text 8.1 Please indicate whether the draft Technical Regulation derives from or is based on one or more international standard(s) or a current national technical standard. If yes, indicate the name of the standard, the issuing body, date of issuance, and the articles or sections considered in the Regulation, in whole or in part.
Click here to enter text 8.2 Cite the legal basis that grants you the authority to issue the proposed regulation.
Click here to enter text 8.3 Indicate if there are other regulations in force on the matter that are insufficient to address the identified problem, or that generate duplications or contradictions. In this latter case, indicate whether, derived from the issuance of the RT, any legislation related to the matter must be repealed or abolished.
Click here to enter text B. Technical-Scientific Analysis.
9. Determine the technical and scientific basis of the matter to be regulated to justify the technical regulation; for this purpose, cite the scientific or technical documents that support the proposed Technical Regulation and, if possible, attach the cited studies.
Click here to enter text 10. Does the proposed regulation create or modify formalities (trámites) or procedures for the regulated parties?
Yes / No 11. If affirmative, identify all the formalities (trámites) or procedures that are created or modified in the Technical Regulation proposal. For each formality (trámite) or procedure, indicate the following:
| Select | Name of the formality (trámite) Click here to enter text | Resolution deadline (working or calendar days) Click here to enter text |
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| Creates | Validity of the formality (trámite) | Positive Silence Applies No |
| Requirements it creates or modifies | Legal basis (Art. of law, decree, or regulation) | Justification of why it is ESSENTIAL to resolve the administrative act and to fulfill the objectives of the regulation (technical-scientific basis, if applicable) |
| Click here to enter text | Click here to enter text | Click here to enter text |
| Click here to enter text | Click here to enter text | Click here to enter text |
| Click here to enter text | Click here to enter text | Click here to enter text |
12. Does the proposed regulation request requirements that are obtained in another office within the same institution or in another institution?
| Select | Requirement | Justification of why INSTITUTIONAL OR INTERINSTITUTIONAL COORDINATION does not apply |
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| Creates | | |
13. Does the proposed regulation create new requirements or obligations for the regulated parties, or make existing ones stricter? (Example: establishes inspections that did not previously exist)
| Select | Applicable Article | Justification |
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| Creates Requirement | | |
| Select | Applicable Article | Justification |
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| Creates Requirement | | |
14. Does the proposed regulation establish or increase the resolution deadline for a formality (trámite)?
| Select | Name of the Formality (Trámite) | Deadline or change in deadline (in working or calendar days) | Justification of the resolution deadline (legal and/or technical) |
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| N/A | | | |
15. Does the proposed regulation reduce the validity of a formality (trámite)? (Example: permit, license, or authorization)
| Select | Name of the Formality (Trámite) | Change in Validity | Justification (legal and/or technical) |
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| No | | | |
17. Indicate if the Technical Regulation proposal carries out one or more of the following situations. Bearing in mind that all Technical Regulations limit free competition in markets. If affirmative, justify your answer and indicate in which provision of the Technical Regulation it is determined.
17.1 Does it establish procedures for obtaining licenses, permits, or authorizations as a requirement to commence operations, or to initiate any additional activity? Yes () No ( ) 17.2 Does it establish technical, administrative, or economic-type requirements for agents to participate in the market(s)? Yes ( ) No ( ) 17.3 Does it establish conditions or delineate geographic areas or zones for offering goods? Yes ( ) No ( ) 17.4 Does it establish rules or regulations on quality for products? Yes ( ) No ( ) 17.5 Does it determine the mandatory use of any particular standard, model, platform, or technology, or of any product protected by intellectual property rights? Yes ( ) No ( ) 17.6 Does it establish or substantially influence the determination of maximum or minimum prices, tariffs, or in general, any other price control mechanism and/or quantities of goods? Yes ( ) No ( ) 17.7 Does it modify or diminish the information so that consumers can make an informed consumption decision? Yes ( ) No ( ) 17.8 Does it create preferential schemes in Government procurement to promote or benefit certain agents? Yes ( ) No ( ) If affirmative, indicate whether the implementation of the Technical Regulation affects the Micro, Small, and Medium-Sized Enterprise (MIPYMES) sector. Justify your answer, quantifying the impact on the sector (Indicate the number of affected MIPYMES).
18. Given that risk mitigation represents the benefits (Cost-Benefit Matrix for Technical Regulations), mention the manner in which the regulatory actions included in the Technical Regulation mitigate the risks, evidencing the degree of reduction or elimination of the same (amount, units, or percentage), and include the conclusions of said analysis.
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19. Once the risk analysis is completed, estimate the quantification of the benefits generated by the application of the Technical Regulation (mention the assumptions and other elements considered to monetarily determine the benefits included in the Cost-Benefit Matrix for Technical Regulations).
Click here to enter text 20. From the information included in the Cost-Benefit Matrix for Technical Regulations, indicate the assumptions and calculations made to determine each of the direct financial costs (such as fees, tariffs, or charges for formalities (trámites)) generated by the RT, and justify their inclusion.
Click here to enter text 21. From the information included in the Cost-Benefit Matrix for Technical Regulations, indicate the assumptions and calculations made to determine each of the regulatory costs generated by the Technical Regulation.
21.1. Indirect costs (compliance costs for the regulated parties) 21.2. Indirect costs (costs of technical specifications for the regulated parties) 21.3. Indirect costs (costs of the Conformity Assessment Procedure) 21.4. Indirect costs (administrative burdens for carrying out formalities (trámites)) 21.5. Opportunity costs.
22. Identify and quantify the costs that the Administration will incur for the implementation of the Technical Regulation (include public monetary and in-kind resources).
Click here to enter text 23. Indicate the proportion of direct and indirect financial costs with respect to the total costs of the regulation.
Click here to enter text 24. Considering the information included in the "Cost-Benefit Matrix for Technical Regulations," indicate and demonstrate whether the gross benefits are greater than the costs generated by the Technical Regulation to determine its viability.
Click here to enter text 25. In accordance with Decreto Ejecutivo Nº37662-MEIC-H-MICIT, Procedure for the demonstration of the conformity assessment of Technical Regulations, indicate which of the following methods is established in the Draft Technical Regulation to assess conformity with the same:
- a)Model 1: Type examination.
- b)Model 2: Type examination followed by verification through testing of samples withdrawn from the market.
- c)Model 3: Type examination followed by verification through testing of samples withdrawn at the manufacturer's facilities d) Model 4: Type test followed by verification through testing of samples withdrawn from the market and at the manufacturer's facilities.
- e)Model 5: Type test, assessment and approval, through audits of the manufacturer's quality management system and testing on samples withdrawn from the market and at the manufacturer's facilities.
- f)Model 6: Assessment and approval of the manufacturer's quality management system g) Model 7: Batch test.
- h)Model 8: 100% test.
- i)Model 9: Specific systems or schemes established in the respective technical regulation (reglamento técnico).
26. If model 9 was chosen, please duly justify and remember that this must be stated in the Costa Rican Technical Regulation (Reglamento Técnico Costarricense):
Click here to enter text 27.2 What will be the procedure to follow to assess conformity (conformidad) with the Technical Regulation? Will it be ex officio or by request of a party?
Click here to enter text 27.3 How long after its publication in the Official Gazette (Diario Oficial) will the Technical Regulation enter into force?
Click here to enter text 28. Indicate the indicators with which the administration will monitor compliance with the provisions contained in the technical regulation; for each indicator you design, indicate whether the institution already has prior records, or whether new administrative records must be generated to obtain the indicators. If prior records already exist, indicate the precise data held for the indicator at the time the regulatory proposal is analyzed.
Click here to enter text | Compliance Indicators | | | | | | --- | --- | --- | --- | --- | | Indicator Name | Description | Mathematical formula | Does it have administrative records? Y/N, indicate the area that maintains them | Initial status (if applicable) | 29. Describe the form and means through which the achievement of the regulation's objectives will be evaluated. Indicate whether the RT has a regulatory review clause and/or a regulatory validity clause, and describe what they consist of. If the Technical Regulation does not have these clauses, justify why it is not considered appropriate to include them.
Click here to enter text 30. Indicate the indicators with which the institution will evaluate the performance of the provisions contained in the technical regulation; for each indicator you design, indicate whether the institution already has prior records, or whether new administrative records must be generated to obtain the indicators. If prior records already exist, indicate the precise data held for the indicator at the time the regulatory proposal is analyzed. In this case, indicate the goals that will be used to assess the success of the regulation. (Ex-post Evaluation) | RT Performance Evaluation Indicators | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | Indicator Name | Description | Mathematical formula | Does it have administrative records? Y/N, indicate the area that maintains them | Initial status (if applicable) | Goal | RT Objective with which it is related (see question 7) |
31. Indicate whether a Technical Committee (Comité Técnico) was formed:
31.1 If your answer is no, justify:
Click here to enter text 31.2 Was consensus reached on the Project?
Click here to enter text 31.3 What were the Technical Committee's main contributions to the development of the Costa Rican Technical Regulation?
Click here to enter text 31.4 Was any other type of prior consultation carried out? If so, indicate which one, who participated, and what elements were modified or added to the Costa Rican Technical Regulation?
Click here to enter text 32. Indicate the final result of the Cost-Benefit evaluation (To obtain the final result, it must be taken into account that the costs considered are associated with the risks to be mitigated by the regulatory actions and the technical specifications included in the Technical Regulation; for example, the mitigation of a risk may generate a financial cost, a compliance cost, and a technical specification cost, therefore these three costs must be reflected and the risk recorded with its value for each cost).
Excel Worksheet Cost-Benefit Matrix for Technical Regulations Sheet No. 1. Risk Analysis | Identification and behavior of Risks prior to the implementation of the Technical Regulation (RT) | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | No. | Identify and describe the risk(s) to be mitigated | Identify the geographical area of the risk | Identify the population, group or industry potentially affected | Identify the number of events per unit of time that have occurred 1 | Probability of occurrence | Magnitude of the damage and possibilities of recovery (either for objects or subjects) 2 | Risk impact | Level of Risk without regulation | 1 Must include in the Form the statistical data, scientific studies, global alerts, news that allowed you to select the suggested parameters.
2 The selected option must be justified in the Form, indicating the population and area affected, for example: Fluoride in toothpastes, in children under 5 years old or iodized salt and water in the Agua Caliente area of Cartago.
| Risk Management with the implementation of the RT | | | | | | --- | --- | --- | --- | --- | | Indicate the Legitimate Objective sought to be guaranteed | Indicate the regulatory action within the Technical Regulation with which the risk will be mitigated | Indicate the article number containing the provision | Indicate the expected level of reduction or elimination of the risk with the application of the RT | Justify how the regulatory action mitigates the risk and indicate the amount, units or percentage reduction thereof | Sheet No. 2. Benefits | Quantification of the benefits generated by the Technical Regulation upon mitigating the risks | | | | | | --- | --- | --- | --- | --- | | Indicate the benefits generated by the proposed regulation (potential incidents sought to be reduced or eliminated) | Indicate the number of potential incidents expected to be reduced with the issuance of the Technical Regulation (number of incidents without regulation - number of incidents with regulation) | Indicate the current unit cost of addressing the potential incident | Total benefit generated by risk mitigation with the RT | Net Present Value (NPV)1 | | 1 If the regulator wishes to evaluate the Technical Regulation over a determined period of time | Total regulatory benefits | | | | | (for example 5 years) they may use the net present value (NPV) technique as an analysis method for both benefits and costs. | | | | | | Sheet No. 3. Regulatory Costs | Analysis of costs with the implementation of the Technical Regulation | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | Regulatory action within the Technical Regulation that generates the cost | Type of cost | Description of cost | Identify the number of regulated subjects that must comply with the provision | Indicate the unit cost of complying with the provision | Total costs (Column D * Column E) | Net Present Value (NPV) | | | Total regulatory costs | | | | | | Sheet No. 4. Cost-Benefit Analysis (Thus added by Article 1 of Executive Decree (Decreto Ejecutivo) No. 40923 of November 13, 2017) Go to beginning of document