Ministry of Health can require modifications and new information when renewing health registriesMinisterio de Salud puede exigir modificaciones y nueva información al renovar registros sanitarios

“**IV.** The Trial Court indicated that, from a legal standpoint, it is not possible to establish the existence of a right to automatic renewal of the health registration (registro de salud), nor that the Administration lacks competence when questioning relevant aspects for renewing or registering the product. It considers that, in health matters, there is an evident public interest, and therefore the Ministry of Health (Ministerio de Salud, MS) is obligated to evaluate the application, assess, and propose whatever is necessary for the benefit of public health. For this reason, it adds, it finds no invalidity whatsoever in its actions, in requesting clarification of aspects and ordering changes to the product, since they are for human consumption. It points out that this matter has constitutional roots, as this Chamber has held that the MS is the public body charged with safeguarding the health of the country's inhabitants, and its powers include verifying legal requirements in any activity as well as preventing improvements. Thus, it is not feasible to place canon 15 of Decreto Ejecutivo 29317-S above the constitutional right to health, given that, in accordance with the foregoing, the relevant Ministry is obligated to corroborate that the product is suitable for its intended purpose. Therefore, it maintains, the Administration is authorized in this type of procedure to request information or order the necessary changes. To this Chamber, it is unobjectionable that the judges substantiated their position. Without yet entering into the analysis of the merits, it is undeniable that the Trial Court provides clear support for its ruling, which is its position that, because it concerns a health matter, there is an unquestionable public interest that expands the MS's powers of action. Additionally, the judges referred to in the judgment, it concerns the authorization of a product for human consumption, with a possible impact on public health, an aspect of constitutional roots that obligates the Administration to follow up and control it, in order to assess strict compliance with regulatory requirements. Consequently, given such support, the Trial Court does not incur the lack of reasoning (motivación) that the appellants point out as a procedural error, to which precept 137 of the CPCA refers, which requires that the charge under study be dismissed.

**Appeal on substantive grounds […]** **VII.** In the second censure, the appellant (casacionista) alleges disrespect for the principle of single qualification (principio de calificación única), precepts 4 and 6 of Law 8220, as well as the violation of numerals 106 and 114 of the LGS, 15 of the RICPRNICM, 11 of the LGAP, and Article 11 of the Constitution. The Trial Court indicated that there is no right to the automatic renewal of registrations; on the contrary, the Administration has the competence to question relevant aspects of the product, since the sphere in which they operate is related to the right to health. It maintains that, although norm 15 of the RICPRNICM establishes a series of requirements that must be met when submitting the renewal application, it does not follow from its text that, upon its submission, the MS is obligated to renew it “ipso facto.” It indicates that, due to the responsibilities involved and since this is a matter of public interest, the MS is obligated to evaluate the application and, where appropriate, propose whatever is necessary for the benefit of human health. For this reason, it points out, no invalidity whatsoever is found in the administrative conduct that requested clarifications and ordered changes to the product mixture for its registration, since it involves a syrup for human consumption. It cites several opinions of the Constitutional Chamber (Sala Constitucional) regarding the existence of a human right to health, which, it says, derives from precept 21 of the Magna Carta, involving physical, mental, and social well-being, and which implies the State's obligation to protect human life. It also mentions several rulings of that Chamber concerning the role of the MS as the public body charged with safeguarding the health of the country's inhabitants.

It argues that the cited Ministry has been granted various powers that include verifying the legal requirements for the operation of any activity and the prevention of improvements. It considers that canon 15 of the RICPRNICM cannot be placed above the right to health, since the latter derives from the Political Constitution itself. Now, it explains, in the specific case, on October 3, 2008, the Directorate of Registries and Controls of the MS sent the plaintiff official letter DRC-4046-08-R, by which it warned her to submit a set of artwork related to the external presentation of the product, with some corrections. It states that on November 25, 2008, the plaintiff addressed a note to the Minister of Health, indicating her disagreement with the warning, specifically, regarding the inclusion among the uses of that relating to "intermittent claudication." Later, it expresses, on July 30, 2009, by official letter DAC-1970-09-RM, the Head of the Service Platform Unit of the MS notified the plaintiff that she had not complied with the requested corrections. From the foregoing, the Court appreciates that the plaintiff did not comply with the MS's requirements, and therefore, given that she also did not demonstrate that such requirements were contrary to the unequivocal rules of science or technique (article 15 LGAP), her challenge to the administrative conduct is unfounded, as it is limited to requesting "nullity for nullity's sake." For this Chamber, the core of the argument rests on the alleged violation of the principle of single qualification (principio de calificación única) by the MS, mandates 4 and 6 of Law 8220, as well as precepts 114 of the LGS and 15 of the RICPRNICM, without in fact alluding in any way to the contested judgment. It simply refers to aspects that from its perspective would imply the nullity of a series of administrative acts, without pointing out arguments that would allow establishing the breach incurred by the judges in their judgment. Consequently, given the expression of simple general disagreements which have not been contrasted with the ruling, the charge is inadmissible, a circumstance that compels its rejection. Notwithstanding the foregoing and for greater abundance of reasons, the appellant basically argues that the MS incurred in contradictions by initially accepting the use of Panax ginseng in the mixture, which it later objected to. In that line, it also cites the issuance of a series of official letters, which, it claims, together with the change of criteria it has pointed out, prove the violation of the principle of single qualification (principio de calificación única) incurred by the Ministry. Regarding this specific point, numeral 4 of Law 8220 refers to the submission of all administrative proceedings to the principles of publicity and legality. Likewise, ordinal 6 of that normative body obliges the procedure to be resolved by verifying the information provided and warning for the presentation of requirements, on a single occasion. However, to the foregoing must be added that we are dealing with conduct related to the renewal and/or authorization of a product for human consumption, with therapeutic indications, whose impact on the sphere of public health is evident. For this reason, the competence of the MS cannot be limited to the simple receipt of the extension request and the verification of compliance with regulatory requirements. On the contrary, the MS is obliged to verify the uses of the components and, eventually, to formulate those requirements that, from its technical point of view, it deems valid, for the purpose of authorizing the corresponding registrations (canon 2 LGS). This is part of the function constitutionally and legally attributed to the State, in order to safeguard the health of the population, in adherence to the principle that champions health as a fundamental human right. In that sense, according to numeral 1 of the LGS, there is no doubt that health is a public interest asset protected by the State. Additionally, one must start from the irrefutable fact that both the Law and the Regulation widely cited grant the MS a prior and higher-ranking power than the simple review of compliance with requirements for the purpose of extending registrations, which is the power to authorize the registration application. According to precept 8 of the RICPRNICM, applications for registration of industrialized products based on natural elements must comply with a wide range of requirements and informational aspects, which obviously allow for interaction between the technical commission appointed for that purpose and the applicant. It is noteworthy that for this purpose and in accordance with the referenced regulatory mandate, the responsibility for providing scientific documentation attesting to the validity of the application falls on the applicant. Likewise, continuous advances in scientific knowledge also impose on the MS the obligation to stay up to date regarding the consequences that the products whose registration is requested may cause, which implies reviewing the formulations, whether for original applications or renewals. From that perspective, in no way could it be considered that the formulations or mixtures may remain unchanged by the sole act of granting the original registration, since it is undeniable that they may eventually be objected to or modified in light of the generation of new knowledge about their field of action. Hence, it is not observed that the administrative conduct of the MS is contrary to law by changing its criteria regarding the use of certain components in the formula of the product whose registration renewal was requested, unless the contrary is proven through technical evidence. Indeed, note that numeral 112 of the LGS establishes the obligation of the applicant to satisfy technical requirements by indicating that: "*Any natural or legal person may only import, manufacture, handle, trade, or use medications registered with the Ministry and whose registration has satisfied the regulatory requirements, especially those relating to: the nature and quantity of the information required about the medication or product submitted for registration; the delivery of samples necessary to carry out the required analyses; those pertaining to the name under which the product will be identified; the content of the labeling; the type of containers or packaging to be used; and the payment of the fees indicated in the relevant tariff*". Equally, according to canon 119 of the LGS: "*The importation, sale, dispensing, handling, and storage of all medications is subject to general legal and regulatory requirements and to the restrictions that the Ministry decrees for each medication in particular*…" In the specific case, the Court considered it proven that on October 3, 2008, the Directorate of Registries and Controls of the Ministry of Health sent the plaintiff official letter DRC-4046-08-R, by which it warned her to send two sets of artwork with the following corrections: "*1. Accepted indication: 'Adjunct in the symptomatic treatment of mild or moderate cerebrovascular insufficiency; symptomatic relief of intermittent claudication. A prior medical evaluation must exist.' 2. Eliminate the phrase appearing above the name PROMITON, which mentions CEREBRAL AND VASCULAR CIRCULATION. 3. Correct the storage form: 'KEEP IN A COOL, DRY PLACE, AWAY FROM SUNLIGHT, CLOSE THE BOTTLE WELL AFTER USE, ONCE OPENED IT MUST BE REFRIGERATED, AND DISCARD AFTER 10 DAYS OF BEING OPENED.' 4. Correct the legend: 'Shake the bottle before using.' 5. Correct the legend: 'The Ministry of Health does not endorse uses other than those accepted on this label.' 6. Place the legend 'Keep out of reach of children' in Warnings. I do not omit to inform you that in accordance with Law 8220 the procedure will remain pending a response to this official letter and that you have a maximum of 10 days for that effect.*" (fact deemed proven no. 11). Although the plaintiff, by note of November 25, 2008, opposed the warning, she did not comply with what was required, a situation that was notified to her on July 30, 2009, by official letter DAC-1970-09-RM (fact deemed proven 17). This resolution, as has been shown, consisted of a series of informational corrections in the artwork of the product to be marketed. In this way, it is not observed that official letter DRC-4046-08-R (requirement that was not fulfilled) exceeded the powers conferred by law to the Ministry in question. Likewise, precept 114 of the LGS was not violated, since said numeral only establishes the validity period of the registration, a topic on which the MS did not issue any opinion, a circumstance which, moreover, has not been the subject of examination in this proceeding. Additionally, the cited mandate mentions: "*The registration of any medication shall last five years, unless infractions in its manufacture, trade, or use incurred by its holder, or experiences demonstrating that the product is unsafe or ineffective under the terms in which it was authorized and registered, make its cancellation or corresponding modification appropriate*". As can be observed, the rule limits the validity period to five years, which could be even shorter should the exception scenarios provided therein arise. In the species, it is clear that the MS has not issued any act limiting the validity period of the product's registration; on the contrary, it was facing an extension request upon expiration, hence no breach of the rule in question is observed. For its part, mandate 15 of the RICPRNICM mentions the requirements that must accompany the requested renewal, among them, the respective application, an affidavit from the legal representative stating that the registration conditions have not changed, the product label as it is being marketed, proof of payment for the registration concept, and the current operating permit. The appellant considers that by requesting modifications to the mixture, the MS violated said rule, since it formulated demands beyond the powers conferred upon it by law. Such a position is not shared by this deciding body, as it is reiterated that the right to health of the population has its origin in the Fundamental Charter. Likewise, the LGS itself confers powers on the governing body of the health sector so that, among other things, it may request extensive information from the applicant, all for the purpose of safeguarding the right to health. Thus, it is not possible to interpret that in the specific case, the MS was limited to the simple receipt of the documents provided for in precept 15 of the RICPRNICM. On the contrary, in the face of novel information regarding the uses of the product, and even in case of doubt about the qualities of the proposed mixture, it could perfectly well request new information or the modifications it deemed pertinent in that line, all in application of superior principles constitutionally provided and powers legally granted, in order to guarantee the fundamental right to health. For the reasons stated, the charge must be rejected.

**VIII.** In the third objection, it claims that official letters DRC-2640-08-R, DRC-4046-08-R, DAC-0068-09-RM, and DAC-1301-09-RM are absolutely null, since they lack essential elements of validity. The plaintiff highlights in turn that said documents lack reasoning. It refers that act DRC-2640-08-R indicates that Ginseng played no role in the mixture, without justifying the reason for this. For its part, it argues that official letter DRC-4046-08-R invokes canons 157 of the LGAP and 114 of the LGS as its grounds, without a material error having occurred nor being in the presence of a cancellation and/or modification of a registration. It affirms that official letter DAC-0068-09-RM evaluates the extension request as if it were a new registration, without stating the reason for this. Document DAC-1301-09-RM, it argues, refers to 25 bibliographic citations from Lexi Drugs, which are not in the bibliography recommended by the MS nor were they presented to the case file. In this regard, this Chamber observes that although the appellant considers that the referenced acts lack elements of validity, pointing out some of the possible flaws that lead her to that conclusion, it is unquestionable that the charge fails to attack the grounds of the ruling being appealed. Although it refers to aspects that from that perspective justify its thesis regarding the limitations and nullity of a series of administrative acts, the reasons that would allow establishing the breach incurred by the judges in their resolution are not actually pointed out. Indeed, no reference is made to the judgment or to the errors the judges may have incurred. Consequently, although it expresses a series of general and merely argumentative disagreements, the contrast of what was decided with the infractions that, in its view, took place is omitted, which is why the charge is inadmissible, a circumstance that compels its rejection.

**IX.** In the fourth ground, the appellant alleges violation of the constitutional principles of legal certainty and legality. However, in the opinion of this Chamber, as indicated in recital VII of this resolution, the thesis put forward by the Court regarding the existence of a fundamental right to health is incontestable. It is not, as the appellant states, a simple argument to justify asking the party for "*whatever it may think of*", but rather the exercise of a power/duty, provided for among others by rules 1, 2, 112, and 119 of the LGS, which, in compliance with that basic principle of the social rule of law, as well as those of legality, public safety, reasonableness, and good faith, oblige the request for modifications and the request for all information deemed convenient for that purpose. There is, of course, no violation of the principle of legitimate expectation, nor of the so-called principle of intangibility of one's own acts, as it is evident that this is a review which, beyond being discretionary, is also mandatory, without disregarding that the authorization of the registration for the first time cannot be considered as the consolidation of a subjective right that would prevent subsequent reviews of the therapeutic conditions of the mixture to be marketed. Although the appellant blames the Court for basing its ruling on the alleged non-compliance with what was required in official letter CRC-4046-08-R, without noting that said act was challenged, in the terms set forth in recital VII, no violation of the constitutional principles of legal certainty and legality is observed, since what was requested in act CRC-4046-08-R was nothing more than a warning so that some modifications to the artwork could be made, a requirement that, according to the reasoning provided in recital VII of this ruling, is far from an arbitrary act.

Thus, the claim must be dismissed.” **Appeal on substantive grounds […]** **VII.** In the second challenge, the appellant alleges disrespect for the principle of single review (principio de calificación única), precepts 4 and 6 of Law 8220, as well as the violation of numerals 106 and 114 of the LGS, 15 of the RICPRNICM, 11 of the LGAP, and 11 of the Constitution. The Court indicated that there is no right to the automatic renewal of registrations; on the contrary, the Administration possesses the competence to question relevant aspects of the product, because the scope in which they operate is related to the right to health. It maintains that while norm 15 of the RICPRNICM establishes a series of requirements that must be met when submitting the renewal application, it does not follow from its text that upon submission, the MS is obligated to renew it “ipso facto.” It indicates that, due to the responsibilities it entails and as it is a matter of public interest, the MS is obligated to assess the application and, where appropriate, propose whatever is necessary for the benefit of human health. For this reason, it notes, no invalidity is found in the administrative conduct that requested clarifications and ordered changes in the product mixture for its registration, as it is a syrup for human consumption. It cites several theses of the Constitutional Chamber regarding the existence of a human right to health, which, it says, derives from precept 21 of the Magna Carta, involving physical, mental, and social well-being, and implying the State's obligation to protect human life. It also mentions several rulings of that Chamber referring to the role of the MS as the public body responsible for safeguarding the health of the country's inhabitants. It argues that the cited Ministry has been endowed with various powers that include the verification of legal requirements for the operation of any activity and the prevention of improvements. It considers that canon 15 of the RICPRNICM cannot be placed above the right to health, since this right derives from the Political Constitution itself. Now then, it explains, in the specific case, on October 3, 2008, the Directorate of Registries and Controls of the MS sent the plaintiff official letter DRC-4046-08-R, by which it formally required her to submit a set of artwork pertaining to the external presentation of the product, with some corrections. It states that on November 25, 2008, the plaintiff addressed a note to the Minister of Health, indicating her disagreement with the requirement, specifically regarding the inclusion among the uses of that relating to “intermittent claudication.” Subsequently, it expresses, on July 30, 2009, by means of official letter DAC-1970-09-RM, the Head of the Service Platform Unit of the MS notified the plaintiff that she had not complied with the requested corrections. From the foregoing, the Court appreciates that the plaintiff did not comply with the MS's requirements, and for this reason, given that she also did not demonstrate that such requirements were contrary to the unequivocal rules of science or technique (article 15 LGAP), her challenge of the administrative conduct is improper, as it is limited to requesting “nullity for nullity’s sake.” For this Chamber, the allegation is essentially based on the violation of the principle of single review by the MS, mandates 4 and 6 of Law 8220, as well as precepts 114 of the LGS and 15 of the RICPRNICM, without in fact referring in any way to the contested judgment. It simply mentions aspects that, from her perspective, would imply the nullity of a series of administrative acts, without providing arguments that allow establishing the violation incurred by the judges in their judgment. Consequently, given the expression of simple general disagreements which have not been contrasted with the ruling, the claim is not admissible, a circumstance that mandates its rejection. Notwithstanding the foregoing and for further abundance of reasons, the appellant basically argues that the MS incurred contradictions by initially accepting the use of Panax ginseng in the mixture, which it later objected to. She also cites along those lines, the issuance of a series of official letters, which she says, together with the change of criteria she has pointed out, prove the violation of the principle of single review incurred by the Ministry. Regarding this specific point, numeral 4 of Law 8220 refers to the submission of all administrative procedures to the principles of publicity and legality. Likewise, ordinal 6 of that regulatory body obligates the resolution of the procedure, verifying the information provided and formally requiring the presentation of requirements only once. However, to the foregoing, it must be added that we are dealing with conduct related to the renewal and/or authorization of a product for human consumption, with therapeutic indications, whose incidence in the sphere of public health is evident. For this reason, the competence of the MS cannot be limited to the simple receipt of the renewal application and the verification of compliance with regulatory requirements. On the contrary, the MS is obligated to verify the uses of the components and, eventually, to formulate those requirements that from its technical point of view it deems valid, with the purpose of authorizing the corresponding registrations (canon 2 LGS). This is part of the function constitutionally and legally attributed to the State, in order to safeguard the health of the population, in accordance with the principle that champions health as a fundamental human right. In that sense, according to numeral 1 of the LGS, there is no doubt that health is a public interest good protected by the State. Additionally, one must start from the irrefutable fact that both the Law and the widely cited Regulation grant the MS a power prior to and of a higher degree than the simple review of compliance with requirements for the purpose of extending registrations, which is that of authorizing the registration application. In accordance with precept 8 of the RICPRNICM, applications for the registration of industrialized products based on natural elements must comply with a wide range of requirements and informational aspects, which obviously allow an interaction between the technical commission appointed for that purpose and the applicant. It is noteworthy that for this purpose and according to the referenced regulatory mandate, the responsibility for providing scientific documentation that proves the validity of the application falls on the applicant. Likewise, continuous advances in scientific knowledge also impose on the MS the obligation to stay up-to-date regarding the consequences that the products whose registration is requested may cause, which implies reviewing the formulations, whether they are original applications or renewals. From this perspective, it could in no way be considered that by the mere act granting the original registration, the formulations or mixtures can remain unchanged, as it is unquestionable that these can eventually be objected to or modified in light of the generation of new knowledge about their field of action. Hence, it is not observed that the administrative conduct of the MS is contrary to law when changing criteria regarding the use of certain components in the formula of the product for which registration renewal was requested, unless proven otherwise through technical evidence. Indeed, note that numeral 112 of the LGS establishes the applicant's obligation to satisfy the technical requirements by stating: “Every natural or legal person may only import, manufacture, handle, trade, or use medications registered with the Ministry and whose registration has satisfied the regulatory requirements, especially those relating to: the nature and quantity of the information required about the medication or product submitted for registration; the delivery of samples necessary to carry out the analyses that may be needed; those pertinent to the name with which the product will be identified; the content of the labeling; the type of containers or wrappers to be used; and the payment of the fees indicated by the relevant tariff.” Equally, according to canon 119 of the LGS: “The importation, sale, dispensing, handling, and storage of any medication is subject to the general legal and regulatory requirements and to the restrictions that the Ministry decrees for each medication in particular…” In the specific case, the Court deemed it proven that on October 3, 2008, the Directorate of Registries and Controls of the Ministry of Health sent the plaintiff official letter DRC-4046-08-R, by which it formally required her to send two sets of artwork with the following corrections: “1. Accepted indication: ‘Adjunctive in the symptomatic treatment of mild to moderate cerebrovascular insufficiency; symptomatic relief of intermittent claudication. A prior medical evaluation must exist.’ 2. Eliminate the phrase that appears above the name PROMITON, which mentions CEREBRAL AND VASCULAR CIRCULATION. 3. Correct the storage form ‘KEEP IN A COOL, DRY PLACE, AWAY FROM DIRECT SUNLIGHT, CLOSE THE BOTTLE TIGHTLY AFTER USE, ONCE OPENED IT MUST BE REFRIGERATED, AND DISCARD AFTER 10 DAYS OF BEING OPENED.’ 4. Correct the legend: ‘Shake the bottle before using.’ 5. Correct the legend: ‘The Ministry of Health does not endorse uses other than those accepted on this label.’ 6. Place the legend ‘Keep out of the reach of children’ under Warnings. I must not omit to inform you that according to Law 8220, the procedure will remain pending a response to this official letter and that you have a maximum of 10 days for this purpose.” (fact deemed proven no. 11). Although the plaintiff, by note of November 25, 2008, opposed the requirement, she did not comply with what was requested, a situation that was notified to her on July 30, 2009, by official letter DAC-1970-09-RM (fact deemed proven 17). Said resolution, as has been noted, consisted of a series of informational corrections to the artwork of the product to be marketed. Thus, it is not observed that official letter DRC-4046-08-R (a requirement that was not fulfilled) exceeded the powers conferred by law on the Ministry in question. Nor was precept 114 of the LGS violated, since said numeral only establishes the term of validity of the registration, a topic on which the MS did not issue any opinion, a circumstance which, moreover, has not been the subject of examination in this proceeding. Additionally, the cited mandate mentions: “The registration of any medication shall last five years, unless the infractions in its manufacture, commerce, or use incurred by its holder, or demonstrative experiences that the product is unsafe or ineffective under the terms in which it was authorized and registered, make its cancellation or the corresponding modification appropriate.” As can be observed, the norm limits the validity period to five years, which could be even shorter if the exception scenarios provided therein were to occur. In the case at hand, it is clear the MS has not issued any act that limits the validity period of the product's registration; on the contrary, it was facing a renewal application upon expiration, hence no violation of the norm in question is observed. For its part, mandate 15 of the RICPRNICM mentions the requirements that must accompany the requested renewal, among them, the respective application, a sworn declaration from the legal representative that the registration conditions have not changed, the product label as it is being marketed, proof of payment for the registration fee, and a valid operating permit. The appellant considers that by requesting modifications to the mixture, the MS violated said norm, given that it formulated demands beyond the powers conferred upon it by law.

This position is not shared by this decision-making body (órgano decisor), for, it is reiterated, the right to health of the population has its origin in the Fundamental Charter (Carta Fundamental). Likewise, the General Health Law (Ley General de Salud, LGS) itself confers powers upon the governing body of the health sector so that, among other things, it may request extensive information from the applicant (gestionante), all with the aim of protecting the right to health. Thus, it is not possible to interpret that in the specific case, the Ministry of Health (Ministerio de Salud, MS) was limited to the simple receipt of the documents required by precept 15 of the RICPRNICM. On the contrary, in the face of new information about the uses of the product; and even in case of doubt about the qualities of the proposed mixture, it could perfectly well request new information or the modifications that it deemed pertinent along those lines, all in application of higher principles constitutionally established and powers legally granted, in order to guarantee the fundamental right to health. For the reasons stated, the objection must be rejected.

**VIII.** In the third objection, it claims that official letters (oficios) DRC-2640-08-R, DRC-4046-08-R, DAC-0068-09-RM, and DAC-1301-09-RM are absolutely null, since they lack essential elements of validity. The plaintiff (actora) highlights, in turn, that those documents lack motivation. It states that the act (acto) DRC-2640-08-R indicates that Ginseng (Ginseng) played no role in the mixture, without justifying the reason for it. For its part, it argues, official letter (oficio) DRC-4046-08-R invokes as grounds canons 157 of the General Law of Public Administration (Ley General de la Administración Pública, LGAP) and 114 of the General Health Law (LGS), even though no material error had been presented nor was it a situation involving a cancellation and/or modification of a registration. It asserts that official letter (oficio) DAC-0068-09-RM evaluates the request for an extension as if it were an initial registration, without stating the reason for it. The document DAC-1301-09-RM, it argues, makes reference to 25 bibliographic citations from Lexi Drugs (Lexi Drugs), which are not in the bibliography recommended by the Ministry of Health (MS) nor were they presented to the case file. In this regard, this Chamber (Sala) observes that, although the appellant (casacionista) considers that the referenced acts lack elements of validity, pointing out some of the possible flaws that lead her to that conclusion, it is unquestionable that the objection omits to attack the grounds of the ruling under appeal. Although it mentions aspects that from that viewpoint justify its thesis regarding the limitations and nullity of a series of administrative acts, the reasons that would make it possible to establish the violation incurred by the judges in their resolution are not actually indicated. Indeed, no reference is made to the judgment or to the errors into which the adjudicators might have fallen. Consequently, although it expresses a series of general and merely argumentative disagreements, the contrast between what was decided and the infractions that, in its opinion, took place is omitted, which is why the objection is not admissible, a circumstance that requires its rejection.

**IX.** In the fourth ground, the appellant (recurrente) alleges an infringement of the constitutional principles of legal certainty and legality. However, in the opinion of this Chamber (Cámara), as indicated in recital (considerando) VII of this resolution, the thesis argued by the Trial Court (Tribunal) regarding the existence of a fundamental right to health is incontestable. It is not, as the appellant (casacionista) presents it, a simple argumentation in order to justify that the party be asked for "whatever occurs to them," but rather the exercise of a power/duty, established among others by norms 1, 2, 112, and 119 of the General Health Law (LGS), which, in compliance with that basic principle of the social state of law, as well as those of legality, public safety, reasonableness (razonabilidad), and good faith, obligate the requiring of modifications and the requesting of all information that is deemed convenient for that purpose. There is, of course, no violation of the principle of legitimate expectations, nor of the so-called principle of the intangibility of one's own acts, since it is evident that we are dealing with a review, which, beyond being discretionary (potestativa), is also mandatory, without setting aside the fact that the authorization of the registration for the first time cannot be considered the consolidation of a subjective right that prevents subsequent reviews of the therapeutic conditions of the mixture to be marketed. Although the appellant (casacionista) attributes that the Trial Court bases its ruling on the alleged non-compliance with what was required in official letter (oficio) CRC-4046-08-R, without noticing that said act was challenged; in the terms set forth in recital (considerando) VII, no violation of the constitutional principles of legal certainty and legality is observed, since what was requested in act (acto) CRC-4046-08-R was nothing more than a warning (prevención) so that some modifications be made to the labels (artes), a requirement that, according to the basis provided in recital (considerando) VII of this judgment, is far from an arbitrary act. Thus, the objection must be dismissed.

“IV. El Tribunal indicó, desde un punto de vista jurídico no es posible establecer la existencia de un derecho a la renovación automática del registro de salud, ni que la Administración carezca de competencia al cuestionar aspectos relevantes para renovar o inscribir el producto. Considera, en materia de salud hay un evidente interés público, por ello el MS está en la obligación de calificar la gestión, valorar y proponer lo que sea necesario en beneficio de la salud pública. Por esta razón, agrega, no encuentra invalidez alguna en sus actuaciones, al solicitar aclarar aspectos y ordenar cambios en el producto, pues son para el consumo humano. Apunta, dicha materia posee raigambre constitucional, pues esa Sala ha sostenido que el MS es el órgano público encargado de velar por la salud de los habitantes del país, y entre sus facultades se incluyen la verificación de los requisitos de ley en cualquier actividad así como prevenir mejoras. De esa forma, no es factible situar el canon 15 del Decreto Ejecutivo 29317-S, por encima del derecho constitucional a la salud, ya que de conformidad con lo expuesto, el Ministerio del ramo, se encuentra en la obligación de corroborar que el producto sea apto para el fin propuesto. De tal manera, sostiene, la Administración está autorizada en este tipo de trámites, para requerir información u ordenar los cambios necesarios. A esta Cámara le resulta inobjetable, los juzgadores fundamentaron su posición. Sin entrar aún al análisis de fondo, es indudable que el Tribunal brinda un claro sustento a su fallo, cual es, su posición en cuanto a que, por tratarse de un un tema de salud, existe interés público incuestionable, que amplía las potestades de actuación del MS. Adicionalmente, los jueces refirieron en la sentencia, se trata de la autorización de un producto de consumo humano, con posible impacto sobre la salud pública, aspecto de raigambre constitucional, que obliga a la Administración a darle seguimiento y control, a fin de valorar el cumplimiento estricto de los requerimientos normativos. Por consiguiente, ante tal sustento, el Tribunal no incurre en la falta de motivación que como yerro procesal apuntan las recurrentes, a la cual hace referencia el precepto 137 del CPCA, lo que obliga al rechazo del cargo de estudio.

Recurso por motivos sustanciales […]

VII.En la segunda censura, la casacionista endilga irrespeto al principio de calificación única, preceptos 4 y 6 de la ley 8220, así como el quebranto de los numerales, 106 y 114 de la LGS, 15 del RICPRNICM, 11 de la LGAP y 11 Constitucional. El Tribunal indicó, no existe un derecho a la renovación automática de los registros, por el contrario, la Administración posee competencia para cuestionar aspectos relevantes del producto, pues el ámbito donde operan, está relacionado con el derecho a la salud. Sostiene, si bien la norma 15 del RICPRNICM establece una serie de requisitos que deben cumplirse al momento de presentar la solicitud de renovación, de su texto no se desprende que con su presentación, el MS esté obligado a renovarla “ipso facto”. Indica, por las responsabilidades que conlleva y tratándose de un asunto de interés público, el MS se encuentra obligado a calificar la gestión y en su caso, proponer lo que sea necesario en beneficio de la salud humana. Por esta razón, apunta, no se encuentra invalidez alguna en la conducta administrativa que solicitó aclaraciones y ordenó cambios en la mezcla del producto para su inscripción, pues se trata de un jarabe para el consumo humano. Cita varias tesis de la Sala Constitucional en cuanto a la existencia de un derecho humano a la salud, el cual, dice, deriva del precepto 21 de la Carta Magna, involucrando el bienestar físico, mental y social, y, que implica la obligación del Estado de proteger la vida humana. Menciona también varios fallos de esa Sala referentes al rol del MS como órgano público encargado de velar por la salud de los habitantes del país. Aduce, al Ministerio de cita se le ha dotado de diversas facultades que incluyen la verificación de los requisitos de ley para la operación de cualquier actividad y la prevención de mejoras. Considera, no puede situarse al canon 15 del RICPRNICM por encima del derecho a la salud, puesto que éste deriva de la propia Constitución Política. Ahora bien, explica, en el caso concreto, el 3 de octubre del 2008, la Dirección de Registros y Controles del MS, le remitió a la actora el oficio DRC-4046-08-R, mediante el cual le previno presentar un juego de artes atinentes a la presentación externa del producto, con algunas correcciones. Manifiesta, el 25 de noviembre del 2008, la accionante dirigió una nota a la Ministra de Salud, indicando su inconformidad con lo prevenido, específicamente, en cuanto a incluir dentro de los usos, el relativo a la “claudicación intermitente”. Luego, expresa, el 30 de julio del 2009, mediante oficio DAC-1970-09-RM, la Jefa de Unidad Plataforma de Servicios, del MS, le comunicó a la demandante que no había cumplido con las correcciones solicitadas. De lo anterior, aprecia el Tribunal, la accionante no cumplió con los requerimientos del MS, razón por la cual, en vista de que tampoco demostró que tales requisitos resultaran contrarios a las reglas unívocas de la ciencia o técnica (artículo 15 LGAP), su cuestionamiento de las conductas administrativas resulta improcedente, pues se limita a pedir la “nulidad por la nulidad misma”. Para esta Sala, en lo medular el alegato se sustenta en la violación del principio de calificación única por parte del MS, mandatos 4 y 6 de la Ley 8220, así como de los preceptos 114 de la LGS y 15 del RICPRNICM, sin que en efecto se aluda en forma alguna a la sentencia combatida. Simplemente refiere aspectos que desde su perspectiva implicarían la nulidad de una serie de actos administrativos, sin que se señalen argumentos que permitan establecer el quebranto en que incurren los juzgadores en su sentencia. Por consiguiente, ante la expresión de simples disconformidades generales las cuales no han sido contrastadas con el fallo, el cargo no es admisible, circunstancia que obliga a su rechazo. Sin perjuicio de lo anterior y a mayor abundamiento de razones, la casacionista básicamente aduce, que el MS incurrió en contradicciones al aceptar en principio la utilización del Panax ginseng en la mezcla, lo que luego objetó. Cita también en esa línea, la emisión de una serie de oficios, los cuales dice, junto con el cambio de criterio que ha señalado, acreditan la vulneración al principio de calificación única en que incurre el Ministerio. En cuanto a este punto específico, el numeral 4 de la Ley 8220, refiere el sometimiento de toda gestión administrativa, a los principios de publicidad y legalidad. De igual forma, el ordinal 6 de ese cuerpo normativo, obliga a resolver el trámite, verificando la información aportada y previniendo la presentación de los requisitos, por una única vez. No obstante, a lo anterior, debe aunarse, que se está frente a conductas relacionadas con la renovación y/o autorización de un producto para consumo humano, con indicaciones terapéuticas, cuya incidencia en el ámbito de la salud pública es evidente. Por esta razón, la competencia del MS no se puede limitar a la simple recepción de la solicitud de prórroga y a la comprobación del cumplimiento de los requisitos reglamentarios. Al contrario, el MS está obligado a verificar los usos de los componentes y de manera eventual, a formular aquellos requerimientos que desde su punto de vista técnico estime válidos, con la finalidad de autorizar los registros correspondientes (canon 2 LGS). Ello como parte de la función que le ha sido atribuida constitucional y legalmente al Estado, a fin de velar por la salud de la población, con apego al principio que enarbola a la salud, como un derecho humano fundamental. En ese sentido, de acuerdo al numeral 1° de la LGS, no existe duda en cuanto a que la salud es un bien de interés público tutelado por el Estado. Adicionalmente, debe partirse del hecho irrefutable, de que tanto la Ley como el Reglamento de amplia cita, conceden al MS una facultad anterior y de mayor grado, que la simple revisión del cumplimiento de requisitos a efecto de prorrogar los registros, cual es, la de autorizar la solicitud de inscripción. Acorde al precepto 8 del RICPRNICM, las solicitudes de inscripción de productos industrializados con base en elementos naturales, deben cumplir con una amplia gama de requisitos y aspectos informativos, que obviamente, permiten una interacción entre la comisión técnica nombrada al efecto y el solicitante. Llama la atención, que con esa finalidad y de acuerdo al mandato reglamentario de referencia, la responsabilidad de aportar documentación científica que acredite la validez de la solicitud, recae en el solicitante. Asimismo, los continuos avances en el conocimiento científico, imponen además al MS, la obligación de mantenerse al día en cuanto a las consecuencias que puedan provocar los productos cuyo registro se solicita, lo cual implica revisar las formulaciones, sea que se trate de solicitudes originales, o renovaciones. Desde esa arista, en modo alguno podría estimarse, que por el solo acto que conceda el registro original, las formulaciones o mezclas puedan mantenerse inalteradas, pues es indudable, éstas pueden ser eventualmente objetadas o modificadas de cara a la generación de conocimientos novedosos sobre su campo de acción. De ahí que no se observe que la conducta administrativa del MS sea contraria a derecho al cambiar de criterio en cuando a la utilización de ciertos componentes en la fórmula del producto cuya renovación del registro se solicitó, salvo que se pruebe mediante probanzas técnicas lo contrario. En efecto, nótese que el numeral 112 de la LGS, establece la obligación del solicitante en cuanto a satisfacer los requerimientos técnicos al indicar que: “Toda persona física o jurídica sólo podrá importar, fabricar, manipular, comerciar o usar medicamentos registrados en el Ministerio y cuyo registro haya satisfecha las exigencias reglamentarias, en especial las relativas a: la naturaleza y cantidad de la información requerida sobre el medicamento o producto sometido a registro; la entrega de muestras necesarias para practicar los análisis que haya menester, a las pertinentes al nombre con que se identificará el producto; al contenido de la rotulación; al tipo de envases o envolturas que se usarán y al pago de las tasas que indique el arancel pertinente”. Igualmente, acorde al canon 119 de la LGS: “La importación, venta, expendio, manipulación y almacenamiento de todo medicamento queda sujeto a las exigencias generales legales y reglamentarias y a las restricciones que el Ministerio decrete para cada medicamento en particular…” En el caso concreto, el Tribunal tuvo por demostrado, que el 3 de octubre de 2008, la Dirección de Registros y Controles del Ministerio de Salud, le remitió a la demandante el oficio DRC-4046-08-R, mediante el cual le previno enviar dos juegos de artes con las siguientes correcciones:"1. Indicación aceptada: "Coadyuvante en el tratamiento sintomático de la insuficiencia cerebro vascular leve o moderada; alivio sintomático de la claudicación intermitente. Debe existir una valoración médica previa. 2. Eliminar la frase que aparece encima del nombre PROMITON, que menciona CIRCULACIÓN CEREBRAL Y VASCULAR. 3. Corregir la forma de almacenamiento "MANTÉNGASE EN UN LUGAR FRESCO, SECO, ALEJADO DE LA LUZ SOLAR, CIERRE BIEN EL FRASCO LUEGO DE SU USO, UNA VEZ ABIERTO ÉSTE DEBE REFRIGERARSE, Y DESECHARSE DESPUÉS DE 10 DÍAS DE ABIERTO 4. Corregir la leyenda: "Agitar el frasco antes de usar". 5. Corregir la leyenda: "El Ministerio de Salud no avala otros usos que los aceptados en esta etiqueta". 6. La leyenda "Manténgase fuera del alcance de los niños", colocarla en Advertencias. No omito manifestarles que de acuerdo a la ley 8220 el trámite quedará pendiente de respuesta a este oficio y que cuenta con un máximo de 10 días para tal efecto." (hecho tenido por probado no. 11). Aunque la actora, mediante nota del 25 de noviembre de 2008 se opuso a la prevención, no cumplió con lo requerido, situación que le fue notificada el 30 de julio del 2009, mediante oficio DAC-1970-09-RM (hecho tenido por probado 17). Dicha resolución, según se ha hecho ver, consistía en una serie de correcciones informativas en los artes del producto a comercializar. De tal manera, no se observa que el oficio DRC-4046-08-R (requerimiento que no fue cumplido), haya excedido las potestades conferidas por ley al Ministerio en cuestión. Tampoco, se quebrantó el precepto 114 de la LGS, puesto que dicho numeral solo establece el plazo de vigencia del registro, tema respecto del cual el MS no emitió opinión alguna, circunstancia que por demás, no ha sido objeto de examen en este proceso. Adicionalmente, el mandato de cita menciona: “El registro de todo medicamento durará cinco años, salvo que las infracciones en la elaboración, comercio o uso en que haya incurrido su titular, o experiencias demostrativas de que el producto es inseguro o ineficaz en los términos en que fue autorizado y registrado, hagan procedente su cancelación o la modificación que corresponda”. Como se observa, la norma limita el plazo de vigencia a cinco años, el cual podría ser aún menor de llegar a presentarse los supuestos de excepción ahí dispuestos. En la especie, es claro, el MS no ha emitido acto alguno que limite el plazo de vigencia del registro del producto, por el contrario, se encontraba frente a una solicitud de prórroga ante el vencimiento, de ahí que no se observe quebranto de la norma en cuestión. Por su parte, el mandato 15 del RICPRNICM menciona los requisitos que deben acompañarse a la renovación solicitada, entre ellos, la solicitud respectiva, declaración jurada del representante legal en cuanto a que las condiciones de inscripción no han variado, etiqueta del producto tal y como se está comercializando, recibo de pago por concepto del registro y permiso de funcionamiento vigente. La casacionista considera que al solicitarse modificaciones en la mezcla, el MS violentó dicha norma, toda vez que formuló exigencias mas allá de las potestades que le han sido conferidas por ley. Tal posición no es compartida por este órgano decisor, pues, se reitera, el derecho a la salud de la población, tiene su origen en la Carta Fundamental. Asimismo, la propia LGS confiere facultades al órgano rector del sector salud, a fin de que, entre otras cosas, solicite amplia información al gestionante, todo ello con el fin de tutelar el derecho a la salud. Así las cosas, no es dable interpretar que en el caso concreto, el MS estuviese limitado a la simple recepción de los documentos dispuestos por el precepto 15 del RICPRNICM. Por el contrario, ante información novedosa sobre los usos del producto; y aún en caso de duda sobre las cualidades de la mezcla propuesta, podía perfectamente solicitar nueva información o las modificaciones que en esa línea estimara pertinentes, todo ello en aplicación de principios superiores dispuestos constitucionalmente y facultades concedidas legalmente, a fin de garantizar el derecho fundamental a la salud. Por las razones expuestas el cargo debe ser rechazado.

VIII.En el tercer reparo, reclama, los oficios DRC-2640-08-R, DRC-4046-08-R, DAC-0068-09-RM y DAC-1301-09-RM, son absolutamente nulos, toda vez que carecen de elementos esenciales de validez. La actora destaca a su vez, que dichos documentos carecen de motivación. Refiere, el acto DRC-2640-08-R indica que el Ginseng no cumplía ningún papel en la mezcla, sin justificar la razón para ello. Por su parte, arguye, el oficio DRC-4046-08-R, invoca como motivo los cánones 157 de la LGAP y 114 de la LGS, sin que se hubiese presentado un error material ni se estuviera ante una cancelación y/o modificación de un registro. Afirma, el oficio DAC-0068-09-RM, evalúa la solicitud de prórroga como si se tratara de una inscripción, sin hacer constar la razón para ello. El documento DAC-1301-09-RM, argumenta, hace referencia a 25 citas bibliográficas del Lexi Drugs, que no están en la bibliografía recomendada por el MS ni fueron presentadas al expediente. Al respecto, observa esta Sala, si bien la casacionista considera, que los actos de referencia carecen de elementos de validez, señalando algunas de las posibles falencias que la llevan a esa conclusión, es incuestionable, el cargo omite atacar los fundamentos del fallo que se recurre. Aunque refiere aspectos que desde esa óptica justifican su tesis en cuanto a las limitaciones y nulidad de una serie de actos administrativos, no se señalan en realidad las razones que permitan establecer el quebranto en que incurren los jueces en su resolución. En efecto, no se hace referencia alguna a la sentencia o a los yerros en que los juzgadores pudieran haber incurrido. Por consiguiente, aunque el contraste de lo decidido con las infracciones que, en su criterio, tuvieron lugar, razón por la cual, el cargo no es admisible, circunstancia que obliga a su rechazo.

IX.En el cuarto motivo, la recurrente alega infracción de los principios constitucionales de seguridad jurídica y legalidad. No obstante, en criterio de esta Cámara, conforme se indicara en el considerando VII de esta resolución, la tesis que esgrime el Tribunal en cuanto a la existencia de un derecho fundamental a la salud, resulta incontestable. No se trata, como lo expone la casacionista, de una simple argumentación a fin de justificar que a la parte se le pida “lo que se le ocurra”, sino del ejercicio de un poder/deber, dispuesto entre otras por las normas 1, 2, 112 y 119, de la LGS, que en acatamiento de ese principio básico del Estado social de derecho, así como de los de legalidad, seguridad pública, razonabilidad y buena fe, obligan a requerir modificaciones y a solicitar toda aquella información que a ese fin se estime conveniente. No existe por supuesto violación al principio de confianza legítima, tampoco al denominado de intangibilidad de los actos propios, pues es evidente, se está ante una revisión, que más allá de resultar potestativa, es también obligatoria, sin dejar de lado, que la autorización del registro por primera vez, no puede ser considerada con la consolidación de un derecho subjetivo, que impida las posteriores revisiones de las condiciones terapéuticas de la mezcla a comercializar. Aunque la casacionista endilga, que el Tribunal funda su fallo en el supuesto incumplimiento de lo requerido en el oficio CRC-4046-08-R, sin reparar en que dicho acto fue impugnado; en los términos dispuestos en el considerando VII, no se observa la violación a los principios constitucionales de seguridad jurídica y legalidad, puesto que lo solicitado en el acto CRC-4046-08-R, no era mas que una prevención a fin de que fueran realizadas algunas modificaciones en los artes, requerimiento que acorde al fundamento brindado en el considerando VII de este fallo, dista mucho de un acto arbitrario. De esa suerte, el cargo debe ser desestimado.”