The law today
The Central de Abastecimiento del Sistema Nacional de Servicios de Salud (“CENABAST”) updates its administrative and technical bases for bids for the acquisition of health-related products.
By Resolution No. 087, dated March 23, 2022 issued by Central de Abastecimiento del Sistema Nacional de Servicios de Salud (hereinafter “CENABAST”), which was approved by the Comptroller General of the Republic on October 5, 2022, new administrative and technical bases were approved, which will govern the bidding processes for the procurement of pharmaceuticals, cosmetics, food for medical use, pesticides, disinfectants, medical devices and supplies for the exercise of health actions, which will enter into force on November 22, 2022.
These bases are applicable to the purchases of the aforementioned products, and replace the previous bases used by CENABAST in its bidding procedures, which dated back to 2016.
Among the changes introduced, new chapters are added on the opening of the bid, objections for compliance with formal requirements and the inadmissibility of bids, entry of products by the supplier and penalties and fines.
In this regard, and among the relevant changes introduced, the following may be noted:
1. In the bid evaluation period, the economic factor acquires greater preponderance and the catalogue of score deductions is expanded.
2. Differences are established with respect to the term of the supply and standard contracts.
3. Rights of the parties during the execution of the contract are established, such as the exercise of options, contract renewal and contract term increases.
4. Regarding the entry of products by the distributor, before distribution, suppliers must enter via web or other means provided by CENABAST, the lot or series of products, quantities to be distributed and other matters. This is to improve the stock requirements of the contracting entities. It also details the documentation required for the entry of the products.
5. Regarding the distribution of products, it establishes the minimum information that the electronic tax document must have.
6. It is established that the supplier must send dispatch information through integration, according to the guidelines provided by CENABAST.
7. Regarding penalties and fines, new causes of serious non-compliance and economic sanctions are established.
As mentioned above, in view of the beginning of the validity of these bases that will take place on November 22, 2022, it is important that companies participating in public bids become aware of these new bases, since they mean substantial changes to the way in which participation in CENABAST’s public bids will be regulated and, ultimately, prepare in advance for the presentation of their future bids.
Law No. 21.504 is published, which establishes the prohibition of reporting debts contracted to finance health services and actions in Law No. 19.628.
On November 10, 2022, Law No. 21.504 was published in the Official Gazette, which establishes the prohibition of reporting debts contracted to finance health services and actions in Law No. 19.628 on the protection of privacy (hereinafter “Law No. 21.504”).
Law No. 21.504 contains a single article that amends article 17, second paragraph of Law No. 19.628, in order to incorporate a new prohibition to communicate personal data regarding debts contracted with public or private health care providers and related companies, whether financial institutions, commercial enterprises or similar, within the framework of an ambulatory, hospital or emergency health care or action, whether they are consultations, procedures, examinations, programs, surgeries or operations.
Said amendment will become effective 180 days after the publication of Law No. 21.504 in the Official Gazette. Likewise, the requirement is added for those responsible for the registries or personal data banks that store and communicate information on this type of obligations to eliminate all the data related to them, within the term indicated above.
Amendment to the Regulation that Regulates the Right to Preferential Care for caregivers is published.
On November 9, 2022, Supreme Decree No. 50 of 2022 (hereinafter the “Decree”), which amends Supreme Decree No. 2 of 2020, which approves the Regulation that Regulates the Right to Preferential Care (hereinafter the “Regulation”), both of the Ministry of Health, was published in the Official Gazette.
The amendments introduced by the Decree are in line with the provisions contained in Law No. 21.380, which establishes the right to preferential health care for caregivers.
Consequently, it establishes the right to preferential health care for caregivers, under the terms of Article 5 quater of Law No. 20.584, which regulates the rights and duties of individuals in relation to actions related to their health care, and the Regulations.
It also establishes the way to accredit the condition of caregiver, and the documents that will serve for these purposes.
Resolution of the Ministry of Health is published which establishes sanitary measures for the transfer of people to the commune of Juan Fernandez; leaves without effect resolution N°310 exempt, of 2022, of the Regional Ministerial Secretariat of Health of Valparaiso, and modifies resolution N°1.400 exempt, of 2022, of the Ministry of Health.
On November 8, 2022, exempt resolution No. 1.530 of the Ministry of Health was published in the Official Gazette, which establishes sanitary measures for the transfer of persons to the commune of Juan Fernández; leaves without effect exempt resolution No. 310, of 2022, of the Regional Ministerial Secretariat of Health of Valparaíso, and modifies exempt resolution No. 1,400, of 2022, of the Ministry of Health (hereinafter “Rex No. 1.530”).
The main content of Rex No. 1.530 is as follows.
1. It contains the applicable regulation for the transfer of persons to the commune of Juan Fernández, in relation to the sanitary measures that must be complied with, for the control and management of the COVID-19 pandemic.
2. In addition, at the national level, the definition of “suspected case of re-infection” is modified, redefining the time period in which a case of COVID-19 will be considered as a suspected case of re-infection.
Public consultation for the modification of the regulations for hospitals and clinics, procedure rooms and minor surgery wards, regarding sanitary authorizations is concluded.
On October 31, 2022, the public consultation called by the Ministry of Health regarding modifications to DS 161/1982, which approves the Regulation on Hospitals and Clinics, and DS 283/1997, which approves the Regulation on Procedure Rooms and Minor Surgery Wards, concluded.
The modifications proposed by the Ministry go hand in hand with the modifications to Decree 58, which approved the technical standards for the sanitary authorization of health care establishments, and seek to harmonize the aforementioned regulations with the technical standards.
In this sense, the proposed amendments to the Regulation on Hospitals and Clinics seek to clarify and expand the powers of the SEREMIs of Health in the authorization of projects for the construction, modification or expansion of hospitals or clinics, in addition to granting them powers for the authorization of their installation and operation.
The amendments to the Regulation on Procedure Rooms and Minor Surgery Wards are along the same lines mentioned above, expanding the powers of the SEREMIs of Health in the authorization of projects for the construction, modification and expansion of procedure rooms and wards, in addition to granting them powers for the authorization of their installation and operation.
Having concluded the public consultation process, it is important to be aware of when these modifications become effective since, according to the proposed modifications, any hospital, clinic, procedure room or pavilion, even if they have an approved design, building permit or are in bidding or execution of works, must request the approval of the project by the SEREMI.
The Public Consultation for the Modification of the Food Sanitary Regulation regarding Food Additives and the issuance of its Technical Standard will be extended until November 30, 2022.
The public consultation called by the Ministry of Health on August 22, 2022, and which refers to the modification of Title III of the Food Additives of the Food Sanitary Regulation (hereinafter “RSA”) and the issuance of a Technical Standard on Food Additives (hereinafter the “Technical Standard”) will be extended until November 30, 2022.
The ministerial proposal implies different modifications to the RSA to adapt the food classification system to the international standards on food additives set by the Codex Alimentarius, adapting these criteria to the national reality.
In addition, the amendment seeks to validate the application of additives added to foods, harmonize the use of food additives by food category and establish limitations on their use and application according to the different regulated categories.
Later, the Technical Standard will specify the permitted food additives and their maximum limits of use, for each of the different food categories contemplated, standards that must be used for the products that will be marketed in our territory, whether manufactured in Chile or imported into our country.
The different observations to the proposed modifications to the TTF or to the text of the Technical Standard itself, may be sent to the authority until November 30, 2022, through the observations form published on the website of the Ministry of Health.
Supreme Decree of the Ministry of Health is published approving regulations on general clinical conditions and circumstances for certifying emergency or urgent conditions in adult, newborn and pediatric patients.
On October 25, 2022, Supreme Decree No. 34, dated 2021, of the Ministry of Health was published, which approves regulations on general clinical conditions and circumstances for certifying emergency or urgency status in adult, newborn and pediatric patients (hereinafter the “Regulations”). This decree replaces the current regulations on the matter, contained in Supreme Decree No. 369, of 1985, of the Ministry of Health, which approves the regulations of the health benefits system, in what is incompatible with what is regulated by the new Regulations.
The main content of the Regulation is as follows:
1. Standardizes the regulation applicable to emergency or urgent care, so that they may enjoy the benefit of direct payment and loans in accordance with the provisions of the legislation in force.
2. For these purposes, the Regulation regulates the requirements and procedures to certify the state of emergency or stabilization of the patient, by a surgeon, according to the clinical conditions established therein. The above with respect to adult patients or newborn and pediatric patients.
3. In addition, the functions of the establishments that have an emergency unit are regulated, as well as those of the surgeon who works in them. The functions of the Isapre are also regulated, if applicable.
Finally, it is established that the regulations contained in the decree in question will enter into force the day after its publication in the Official Gazette, that is to say on October 26, 2022.
Ministry of Health Decree modifying technical standards related to therapeutic equivalence and reference pharmaceutical products is published.
On September 30, 2022, Exempt Decree No. 60.2022, of the Ministry of Health was published, which amends Decree No. 500, of 2012, which approved technical standard No. 136, “Standard that determines the active ingredients contained in pharmaceutical products that must demonstrate their therapeutic equivalence and list of pharmaceutical products that serve as reference thereof”, and Decree No. 27, of 2012, which approved technical standard No. 131, which “Defines the criteria intended to establish therapeutic equivalence in pharmaceutical products in Chile”, both of the Ministry of Health.
The modifications made by the Exempt Decree are as follows:
1. Regarding Technical Standard N°136, the following products were added to the “List of Reference Products for Therapeutic Equivalence Studies”:
2. A time period was granted until March 31, 2024, to comply with the requirement to submit therapeutic equivalence studies to the ISP for the following pharmaceutical products containing Active Ingredients or Association, under the form of release indicated in the Exempt Decree.
3. A “List of Products that without losing their Bioequivalent status in Chile, may be used as reference products for Therapeutic Equivalence studies” was added:
Regarding technical standard N°131, a series of “active ingredients or associations” with their solid pharmaceutical form, oral administration type of release, were added to the “List of non-new (mature) active ingredients with long experience of use”.
The new Instructions for Verification of the Manual of the General Standard of Accreditation of Clinical Laboratories, prepared by the Institute of Public Health, is published in the Official Gazette.
On August 11, 2022, was published in the Official Gazette the Exempt Resolution No. 1.297, of 2022, of the Institute of Public Health, which approves the “Instructions of verification of the Manual of the General Standard of Accreditation of Clinical Laboratories”.
Bearing in mind the antiquity of the instruction of verification of the Manual of the General Accreditation Standard for Clinical Laboratories of the year 2020, which aims to support and guide the accreditation bodies to use the format of the Accreditation Report of such laboratories, in cases where it is necessary to evaluate the compliance with the indicated manual, Resolution No. 1.297 was issued, which approves a new version of this document, where its normative references are updated, new instructions are incorporated and a new structure is given to the document to facilitate its use.
The contents of the instructions include those data for the accreditation or reaccreditation process that must be submitted, the procedures established for the evaluation, the considerations for filling out the accreditation report format, how the verification of indicators and the periodic evaluation will be carried out, how the description of the evaluated characteristics containing several attributes must be made, among others.
On August 17, 2022, Decree No. 60, of the Undersecretariat of Public Health, was published in the Official Gazette, which in turn amends Supreme Decree No. 43 of 2015, of the Ministry of Health, which approves the Regulation of Storage of Hazardous Substances (or “Storage Regulation”.
In consideration of the entry into force of the regulation of chemical substances established in Supreme Decree N°57, of 2019, of the Ministry of Health, which approves the Regulation of Classification, Labeling and Notification of Hazardous Chemical Substances and Mixtures (or the “Classification, Labeling and Notification Regulation”), the need to amend the Storage Regulation was born, due to the existence of a duality in the requirements of the safety data sheets of hazardous substances and mixtures.
As a consequence of this duality, the present Decree was issued, which amends Supreme Decree N°43 of 2015, in its Articles 14, 15 and 190, to make it congruent with the Classification, Labeling and Notification Regulation regarding the format and content that the safety data sheets must have, all these aspects having to be in accordance with what is indicated in NCh 2245:2015.
The guide for modifications to the sanitary registration of pharmaceutical products prepared by the Institute of Public Health is published in the Official Gazette.
On August 11, 2022, Exempt Resolution No. 1.263, of 2022, of the Institute of Public Health, which approves the guide of modifications to the sanitary registration of pharmaceutical products, was published in the Official Gazette.
This guide was issued due to the need to standardize different services associated to the sanitary registration and to present to the user, in a clear and precise manner, the requirements of each one of them, in order to correctly modify their sanitary registrations.
The guide provides a glossary of terms associated with the matters included in the document, a classification of the modifications according to the aspect that needs to be updated, clarifications on the background information that must be submitted to request a modification of legal aspects of the registration, technical aspects of the registration, analytical aspects of the registration and therapeutic aspects of the registration, as the case may be, and explains the procedure for minor changes in notifications.
Exempt Decree No. 51 of 2022, which incorporates condoms to the Sanitary Control Regime established in Article 111 of the Sanitary Code and Supreme Decree No. 825 of 1998, of the Ministry of Health, is published.
On August 9, 2022, Exempt Decree N°51 of 2022, which amends Decree N°93 of 2018, of the Ministry of Health, was published in the Official Gazette, incorporating condoms into the Sanitary Control Regime established in Article 111 of the Sanitary Code and Supreme Decree N°825 of 1998, of the Ministry of Health.
The decision means that condoms, as devices incorporated into the conformity verification system, will now be subject to a lot-by-lot verification.
This decision was taken in response to the alerts communicated by the Institute of Public Health regarding the quality problems of these devices, as well as the imperative need to guarantee their optimal performance.
Exempt Resolution No. 3292 of 2022, which amends Exempt Resolution No. 395 of 2022, both issued by the Institute of Public Health, incorporating a deadline to make the update of the labeling required for the renewal of the Health Registration of pharmaceutical products.
On July 26, 2022, Exempt Resolution No. 3292 of 2022 was issued, which amends Exempt Resolution No. 395 of 2022, both issued by the Institute of Public Health, incorporating a term to make the update of the labeling required for the renewal of the sanitary registration of pharmaceutical products.
Thus, taking into account the impossibility, as stated by the Asociación Industrial de Laboratorios Farmacéuticos A.G. (ASILFA), that the update of the labels to be made at the time of renewing the sanitary registrations in accordance with the Exempt Resolution 395/2022, since it is impossible in practice for this modification to be reflected immediately on the containers or cases of the products to be distributed, this resolution was modified, in the sense that the term of enforceability of this measure will be one year from the date on which the respective renewal is granted.
Exempt Decree No. 48 of the Undersecretariat of Public Health of the year 2022, which approves the Nuclear Medicine Technical Standard No. 223 for health facilities, is published.
On July 19, 2022, Exempt Decree Nº48 of the year 2022, issued by the Undersecretariat of Public Health, was published in the Official Gazette, approving the Nuclear Medicine Technical Standard N°223, which provides the technical criteria to plan the operation of a Nuclear Medicine facility, and design these facilities according to space, equipment, and personnel who handle it.
The dictation of the Technical Standard is made in the context of the National Cancer Plan 2010-2028, and the need to regulate Nuclear Medicine establishments and to comply with the State’s function of guaranteeing the protection of health and its correct access.
The Decree together with the full text of the Technical Standard will be published on the website www.minsal.cl. The deadline for compliance with the Technical Standard will be 12 months from the date of its full processing.
Decree No. 63, of 2022, of the Undersecretariat of Public Health, which amends Supreme Decree No. 13, of 2015, of the Ministry of Health, which amends the Sanitary Regulation of Food, regarding food labeling, is published.
On July 14, 2022, Decree N°63 dated June 15, 2022, of the Undersecretariat of Public Health, (hereinafter the “Decree”) was published in the Official Gazette, which amends Supreme Decree N°13, of 2015, of the Ministry of Health, which in turn amends the Sanitary Regulation of Food.
Considering the deadlines established by transitory article 3° of Decree N°13 indicated above, which requires the labeling of products containing high levels of calories, fats, sugars, sodium or other determined ingredients, within 72 and 36 months in micro and small companies respectively.
And, by virtue of the technical report called “Food Labeling Law – Implementation costs for small and micro enterprises”, which indicates that the “ALTOS EN (HIGH IN)” seals required by Decree N°13, represent a cost higher than 1% of the sales of micro enterprises, a matter that is also affected by inflation, the Decree is issued, which amends Decree N°13 replacing in its 3rd transitory article the terms 72 and 36 months, by 120 and 36 months respectively.
Exempt Decree No. 41 of 2022 of the Undersecretariat of Public Health is published, which incorporates the indicated HIV detection devices to the sanitary control regime established in Article 111 of the Sanitary Code.
On June 16, 2022, it was published in the Official Gazette the Exempt Decree N°41 dated June 8, 2022, issued by the Undersecretary of Public Health, which incorporates the devices for HIV detection indicated, to the sanitary control regime established in article 111 of the Sanitary Code.
Whereas Article 1 of Law No. 19. 779 establishes as a duty of the State the elaboration of policies that tend to the prevention, diagnosis and control of the infection caused by HIV, and that, in accordance with article 111 of the Sanitary Code, within the measures established therein to ensure the quality of medical devices, it is that these shall be subject to the quality control regime established in article 111 of the Sanitary Code, is that they shall be subject to quality controls and standards subject to the technical specifications established by the official Chilean standards of the National Institute of Standardization and approved by the Ministry of Health by a founded decree, this decree is issued to incorporate, at the request of the ISP, the following medical devices to the aforementioned control system:
A. Instrumental assays for determination of anti-HIV antibodies.
Sensitivity 100% / Specificity ≥ 95%.
B. Visual / rapid assays for anti-HIV antibody determination.
Sensitivity 100% / Specificity ≥ 95%.
C. Visual / rapid assays for HIV self-testing.
Sensitivity 99% / Specificity ≥ 98%.
All of which will come into effect after 6 months of this publication, i.e. December 17, 2022.
Decree No. 48 of 2022 is published, which amends Supreme Decree No. 977 of 1996, of the Ministry of Health, on Food Sanitary Regulations, regarding the fortification of milk and flour with Vitamin D.
On July 5, 2022, Resolution No. 48 dated May 11, 2022, issued by the Undersecretariat of Public Health of the Ministry of Health, was published in the Official Gazette, amending Supreme Decree No. 977 of 1996 of the Ministry of Health, or Food Sanitary Regulation (hereinafter the “Regulation”).
In view of the Vitamin D deficiency in women of childbearing age and elderly people evidenced by the National Health Survey of 2017, the aforementioned Regulation is amended, establishing a new regulation of the process of elaboration of liquid milk, powdered milk, and flour, which must be fortified with Vitamin D3, in the terms, components and doses indicated.
In this sense, new paragraphs are added to article 211 of the Regulation, referring to liquid milk, and related to its fortification with Vitamin D3.
New paragraphs are added to article 216 of the Regulation, referring to powdered milk and its fortification with Vitamin D3.
Finally, new paragraphs are added to article 350 of the Regulation, referring to flour, a product that must be fortified with Vitamin D3, preferably of vegetable origin.
This decree will become effective 24 months after its publication in the Official Gazette, that is, on July 6, 2024.
Exempt Resolution Nº1297 of 2022, issued by the Institute of Public Health, which approves “Instructions for the verification of the manual of the general standard of accreditation of clinical laboratories”.
On June 13, 2022, the Institute of Public Health issued Exempt Resolution No. 1297 of 2022, which approves the “Instructions for the verification of the manual of the general standard of accreditation of clinical laboratories”.
This instruction has as background the provisions of Supreme Decree No. 15 of 2007, Regulation of the accreditation system for institutional health providers and the Exempt Resolution No. 1538 dated June 10, 2020, which approved the instruction of verification of the Manual of the General Accreditation Standard for Clinical Laboratories, which needed to be updated in terms of its normative references and incorporate new instructions.
The objective of this new version is to guide Accreditation Bodies (AE) in the verification and use of the accreditation report format, in cases where it is necessary to evaluate compliance with the Manual of the General Accreditation Standard for Clinical Laboratories.
In general, the new instructions include specifications regarding:
I. Data of the accreditation or reaccreditation process.
II. Procedures established for the evaluation, referring to the measures adopted by the entities to be accredited, its objectives and essential aspects.
III. Considerations for filling out the accreditation report format, both in terms of laboratories and sampling of the provider, characteristics that do not apply to laboratories, clinical laboratories without sampling and description of the documents required by the standard.
IV. Verification of indicators and periodic evaluation of the same, in addition to the record of the results delivered by the provider for the periodic evaluation.
V. Description of the evaluated attributes that have a large number of documents associated with them.
VI. Other characteristics of the measured standard.
This resolution leaves without effect the Exempt Resolution No. 1538 dated June 10, 2020.
It is hereby noted that this resolution and its effects will become effective upon its publication in the Official Gazette, which is still pending.
Exempt Resolution No. 1881, of 2022, issued by the Institute of Public Health, which establishes the obligation to implement a test method for the determination of the Burkholderia Cepacia complex in raw materials and finished products, is published.
On June 6, 2022, it was published in the Official Gazette the Exempt Resolution No. 1.881 dated April 29, 2022, issued by the Institute of Public Health, which establishes the obligation to implement a test method for the determination of the Burkholderia Cepacia complex, objectionable microorganisms, in raw materials and finished products that it indicates.
In consideration of the seriousness of the presence of Burkholderia Cepacia complex (BCC) in non-sterile drugs containing water in their composition, because it causes a series of risks, especially to immunocompromised persons, and is characterized by its high degree of resistance to antibiotics, and considering the existence of a series of studies that determine control measures to verify the absence of this in water, raw materials and finished pharmaceutical products, and considering the need to establish a reinforced surveillance in the production and quality assurance activities of the manufacturers of pharmaceutical products to prevent risks of microbiological contamination, this resolution is issued, which establishes:
1. The obligation for quality control laboratories belonging to pharmaceutical production laboratories or external quality control laboratories to implement an appropriate microbiological test method for the determination of Burkholderia Cepacia complex, in order to ensure that the components of a pharmaceutical product and the batch of the finished product prior to distribution are free of this contaminant.
2. The mandatory incorporation of the absence of Burkholderia Cepacia complex as a microbiological parameter in the finished product specifications of non-sterile water-based drugs.
3. Implement the analytical method for the detection of Burkholderia Cepacia complex the chapter <60> Microbiological Examination of Nonsterile Products: Tests for Burkholderia Cepacia Complex in the United States Pharmacopoeia (USP), or another validated detection method.
4. Timelines for implementation and inspection.
Exempt Decree No. 32 of 2022 of the Ministry of Health is published, which approves “General Technical and Administrative Standard No. 221 of Law No. 21.371 for the integral accompaniment of people in gestational and perinatal bereavement”.
On May 24, 2022, Exempt Decree Nº32 dated April 27, 2022, of the Ministry of Health was published in the Official Gazette, which approves the “General Technical and Administrative Norm N°221 of Law N°21.371 for the integral accompaniment of people in gestational and perinatal bereavement”.
The aforementioned guide is issued and approved in the context of the enactment of Law No. 21.371, also known as “Dominga Law”, which mandates the Ministry of Health to issue a technical standard that will establish the mechanisms or concrete actions to be carried out by health facilities to safeguard the right to containment, empathy and respect for the grief of parents and families who experience a gestational or perinatal death.
Institute of Public Health approves technical guide for the dispensing of medicines by electronic media
On May 25, 2022, Exempt Resolution No. 2271 of the same date was published on the website of the Institute of Public Health, which approves the technical guide for the dispensing of medicines by electronic means.
This resolution deepens the characteristics with which electronic sites that dispense medicines must comply, clarifies the processes involved in the dispensing of medicines and explains the scope of the dispensing and control of medicines.
Exempt Resolution No. 93 dated January 19, 2022, issued by the Institute of Public Health, which instructs the National Medicines Agency in relation to the Technical Guidelines for the validation of pharmaceutical production processes using the retrospective approach, was published in the Official Gazette.
On April 26, 2022, was published in the Official Gazette the Exempt Resolution N°93 dated January 19, 2022, issued by the Institute of Public Health, which instructs the National Agency of Medicines in relation to the Technical Guidelines for the validation of pharmaceutical production processes through the retrospective approach.
Retrospective validation is understood as that evaluation carried out based on past experiences, through the presentation of production documentation, with the obligation that the conditions of composition, procedure and equipment remain unchanged, thus applying to manufacturing processes already consolidated or stable.
In this sense, the guidelines have a scope for those non-sterile pharmaceutical products, with active ingredients referred to as mature, and in cases of demonstration of therapeutic equivalence when the alternative method applies.
Thus, the technical guide establishes the characteristics, criteria and requirements for retrospective validation, as well as the steps for its performance.
Exempt Resolution No. 357 dated March 1, 2022, of the Institute of Public Health, which approves the Recommendations for ABO Blood Classification, for the National Biomedical Reference Laboratory Department, is published.
On April 26, 2022, was published in the Official Gazette the Exempt Resolution N°357 dated March 1, 2022, issued by the Institute of Public Health, which approves the Recommendations for ABO Blood Classification, for the National Biomedical Reference Laboratory Department.
This document updates the recommendations for the ABO blood classification procedure, being directed to Blood Centers, Transfusion Medicine Units, Blood Banks and Clinical Laboratories.
These recommendations are intended to achieve a correct standardization of the ABO blood classification system, which aims to determine the presence of antigens and antibodies of this system in human blood.
Thus, the document provides definitions, indications for the development of blood classification studies, in terms of sample collection, reagents and techniques, as well as the procedure and results.
Additionally, a procedure for the resolution of discrepancies in ABO classification is indicated, to determine the causes of the differences and actions for their solution, as well as mechanisms for the solution of other discrepancies (globular-weak reactions with anti-A or anti-B, serum-weak reactions with RBC A1 or B, among others).
Exempt Resolution No. 273, dated February 11, 2022, of the Institute of Public Health, which approves the Technical Guidelines and Orientation Guide for the conduct of clinical studies with biological products, is published.
On April 26, 2022, was published in the Official Gazette the Exempt Resolution N°273 issued by the Institute of Public Health on February 11, 2022, which approves the technical guide containing the guidelines and orientation for the conduct of clinical studies with biological products.
This technical guide addresses the structure and requirements for the conduct of a local clinical study with investigational biological drugs, providing a general overview on this matter. To this end, the guide delves into the quality information required, non-clinical and clinical development, Good Manufacturing Practices (GMP) considerations for this type of production and the authorization of manufacturing establishments.
In order to carry out a clinical study with biological products, including advanced therapies, it is necessary to have a sanitary authorization from the laboratory in charge of the production of the drug to be investigated, and to have all the documents with the quality information and the pre-clinical information of the product under investigation. With this information, the evaluation of the clinical study can be requested at the Institute of Public Health (ISP).
Once the procedure has been submitted to the ISP, and within the framework of the evaluation carried out by its professionals, the compliance with GMP by the producing laboratory will be verified, considering the possibility of carrying out an inspection visit, according to the risk assessment, the type of product and the development phase, among other aspects.
Exempt Resolution No. 473 dated April 1, 2022, issued by the Undersecretariat of Public Health, which creates the National Commission for Pandemic Response COVID-19 and leaves without effect the COVID-19 Advisory Council, was published in the Official Gazette.
On April 2, 2022, was published in the Official Gazette the Exempt Resolution N°473 dated April 1, 2022, issued by the Undersecretary of Public Health, which creates the National Pandemic Response Commission COVID-19 and leaves without effect the Advisory Council COVID-19.
This resolution creates the National Pandemic Response Commission COVID-19, in response to a new management model for the SARS-CoV-2 pandemic, and determines its operation, integration, remuneration and termination, and leaves without effect the Exempt Resolution No. 131 dated March 11, 2020, which created the working group called COVID-19 Advisory Council.
It also states that the objective of this Commission will be to assist the Ministry of Health in the formulation of policies and the implementation of strategies and practices for the prevention, diagnosis, approach and treatment of COVID-19, in order to avoid its spread in our country.
Exempt Resolution No. 923 of 2022, of the Ministry of Agriculture, which amends Exempt Resolution No. 9,074 of 2018, which establishes conditions and requirements for authorizing microbial pesticides for commercialization, is published.
On March 4, 2022, it was published in the Official Gazette the Exempt Resolution No. 923 of 2022, of the Ministry of Agriculture, which amends Resolution No. 9.074, of 2018, which establishes conditions and requirements to authorize microbial pesticides for commercialization.
In consideration of the global trend towards the development and preference of microbial pesticides, as these are considered as an alternative with less impact on human health and the environment in relation to conventional chemical synthesis pesticides and, faced with the need to regulate the production and quality of biological pesticides of microbial origin that are authorized and marketed in Chile, Resolution Exempt No. 9. 074 of 2018, incorporating standards that seek to establish protocols and methodologies for the identification of microorganisms present in a microbial pesticide, as well as to determine the quality parameters of a microbial pesticide.
In this sense, protocols, methodologies and parameters were incorporated for the following methods or processes:
1. Methodology for identification and characterization of the microorganism;
2. Methods of analysis or techniques to (i) identify the microorganism to the established level of specificity, (ii) determine the content of the microorganism in the produced material to be used in the manufacture of formulated products, and (iii) determine contaminating microorganisms or relevant impurities, when applicable;
3. Documents supporting human health effects and effects on non-target organisms, for the authorization of microorganisms; and,
4. Analytical methods, application data, effect on human health and effects on non-target organisms, for the evaluation of formulated products based on microorganisms.
Exempt Resolution No. 1,012 of 2022 of the Ministry of Agriculture is published, which prohibits the registration, manufacture, importation, distribution, sale, possession and use of certain antimicrobials in animals, and revokes Exempt Resolution No. 5,340 of 2020.
On March 2, 2022, Exempt Resolution No. 1,012 of 2022 of the Ministry of Agriculture was published in the Official Gazette, which prohibits the registration, manufacture, importation, distribution, sale, possession and use of certain antimicrobial products and repeals Exempt Resolution No. 5,340 of 2020.
The modification has its origin in the current worldwide concern about the use of antimicrobials in animal health and, since certain classes of antimicrobials have been classified by the World Health Organization as critically important or very important for human health, generating the need to restrict their use in veterinary medicine. Thus, it was resolved to prohibit the registration, manufacture, importation, distribution, sale, possession and use of the following classes of antimicrobials in animals:
– Pseudomonic acids.
– Carbapenemics and other penemics.
– Carboxypenicillin and Ureidopenicillin, including combinations with beta-lactamase inhibitors.
– Third and fourth generation cephalosporins in combination with beta-lactamase inhibitors.
– Fifth generation cephalosporins.
– Phosphonic acid derivatives.
– Rifamycins (except Rifamixin).
In addition, Exempt Resolution No. 5,340 of 2020 of the Agriculture and Livestock Service, which prohibits the use of fosfomycin in broiler chickens, was revoked.
Decree No. 405, of 1983, of the Ministry of Health, Regulation of Psychotropic Products, is amended.
Decree No. 405, of 1983, of the Ministry of Health, Regulation of Psychotropic Products, is amended.
On January 6, Decree No. 43, dated November 4, 2021, which modifies Decree No. 405, dated 1983, of the Ministry of Health, which contains the Regulation of Psychotropic Products, was published in the Official Gazette.
The purpose of these amendments is to include within the psychotropic substances prohibited in the territory, five new substances that have been detected by the Illicit Analysis Section of the Institute of Public Health, which correspond to “New Psychoactive Drugs” (NDP) according to the UN. This refers to those that are created by drug trafficking organizations in clandestine laboratories.
Thus, the following substances are incorporated into “Schedule I: Drugs” of Title V “Of the list of Psychotropic Drugs”:
1. 6-APB 6-(2-aminopropyl) benzofurano
2. 2CB-Butterfly o 2CB-FLY 8-Bromo-2,3,6,7-benzo-dihidro-difuran-etilamina
3. 5-MAPB 5-(2-metilaminopropil) benzofurano
4. 4-APB 1-(1-benzofuran4-il) propan-2-amina
5. MDAI 5,6-Metilendioxi-2-aminoindano
By means of Exempt Resolution No. 02453, dated December 02, 2021, the Institute of Public Health (ISP) approved the Instructions on Procedure for the Collection of Fines applied in Sanitary Proceedings instructed by the ISP.
For the ISP it is necessary to publish and approve these Instructions due to the enactment of Law No. 21.388 that modifies the Sanitary Code regarding the collection of fines, which allows the General Treasury of the Republic (Treasury) to enforce such fines.
Thus, the guidelines provided by these instructions are as follows:
Within five working days from the date of notification of the sentence that applies the fine or resolves the appeal for reversal filed, the Chief Legal Counsel must issue a Memorandum addressed to the Subdepartment of Financial Management (Subdepartment), communicating: (i) the identification of the sanctioned party, (ii) number and date of the Exempt Resolution containing the sanitary summary judgment, (iii) number and date of the Exempt Resolution resolving the appeal for reconsideration of the sanitary summary if any, (iv) amount of the fine collected and (v) the corresponding notifications of the Exempt Resolutions.
1. The Subdepartment shall have a maximum period of 20 working days to carry out all extrajudicial collection efforts. No extension of the deadline for the payment of the fine may be granted, except for the 5-day period established in article 168 of the Sanitary Code.
2. In case payment is not received within the above term, this Subdepartment shall incorporate the information in the Treasury’s computer system, so that it may proceed with the collection of the fines.
3. Once the fine has been paid, the Subdepartment will send a copy of the proof of payment to the Legal Department, by means of a memorandum, so that it may be included in the procedural file, thus finalizing the collection process.
4. If after that, the amounts of the fines are modified as a result of a pronouncement of the Courts of Justice, hearing a claim action, the Legal Department shall inform the Subdepartment so that the penalties are removed from the Treasury system.
5. Finally, it provides an interpretation regarding the processing of sanitary summaries in relation to the publication of Law No. 21.388, stating that:
a. With respect to sanitary summary proceedings in which collection actions have been initiated before the Courts of Justice and have been notified to the defendant prior to the entry into force of Law No. 21.388, the processing shall continue in accordance with the rules of Title I of Book Three of the Code of Civil Procedure.
b. With respect to the sanitary summaries held by the Subdepartment, which have not initiated collection actions or have not been notified prior to the enactment of Law No. 21.388, they must be incorporated into the Treasury system.
On October 28, 2021, Law No. 21.388 was published in the Official Gazette, which amends the Sanitary Code in relation to the collection of fines with respect to the resolutions that establish infringements and determine fines.
Prior to this amendment, the resolutions establishing infringements and determining fines had executive merit and were enforced in accordance with Articles 434 and following of the Code of Civil Procedure. Now, this new law establishes that they will continue to have executive merit, but will be enforceable by the General Treasury of the Republic, in accordance with Article 35, paragraph 2 of Decree Law No. 1.263 of the Financial Administration of the State.
With respect to this modification, the following should be taken into account:
1. The delay in the payment of these fines shall accrue the interest and readjustments established in Article 53 of the Tax Code.
2. The Treasury may also offset the debts of taxpayers with their credits against the Treasury, extinguishing the obligations until the concurrence of the lesser value.
3. Facilities may be granted for the payment of fines by the Treasury Service in accordance with the provisions of Article 192 of the Tax Code.
4. Fines will no longer be for the benefit of the sanitary entities, but for the benefit of the tax authorities, thus extending their benefit.
Finally, the fines that will be affected by these provisions will be all those that present unpaid balances of payments and whose executive demand has not been notified, even when the fines derive from sanitary summaries initiated prior to the publication of this law.
Ministry of Health approves the new Manual that establishes the General Accreditation Standard for Institutional Providers that provide Dental Care and its Measurement Guideline.
On September 16, the Ministry of Health published in the Official Gazette the Exempt Decree N°52, dated September 1, 2021, which approves the new Manual that establishes the General Accreditation Standard for Institutional Providers that provide Dental Care, with its respective Checklist.
These documents are the result of an inter-institutional working group and the participation of public and private centers in order to ensure the quality of health services provided to the population.
Thus, the General Standard classifies its demands and requirements in different considerations, which depend on the scope of evaluation of the accreditation process. Thus, the areas to be evaluated correspond to the following: (1) Respect for patient dignity (PD); (2) Quality management (CAL); Clinical management (GCL); (3) Access, timeliness and continuity of care (AOC); (4) Human resource competencies (HR); (5) Records (REG); (6) Equipment safety (EQ); (7) Facility safety (INS); and, (8) Support services (AP).
On the other hand, each scope of dental care evaluation considers different components, characteristics and verifiers. To summarize:
i. Components are the operational aspects that contribute to fulfilling the intent of the scope.
ii. The characteristics disaggregate the component into smaller areas of analysis in the evaluation, where it is specified what is to be evaluated.
iii. Verifiers are the specific requirements to be measured in order to qualify compliance with each characteristic.
Finally, the detailed evaluation of the provider will be expressed in a fieldwork table in which the required measurable elements will be assessed.
Ministry of Health incorporates portable automatic external defibrillators into health control system
On September 16, 2021, the Ministry of Health published in the Official Gazette Exempt Decree No. 42, dated August 31, 2021 (hereinafter the “Decree”), which incorporates portable automatic external defibrillators into the sanitary control regime established in article 111 of the Sanitary Code and in the Regulations for the Control of Products and Elements for Medical Use, approved by Decree No. 825 of 1998 of the Ministry of Health.
These defibrillators correspond to medical devices designed to analyze the heart rhythm, identify fatal arrhythmias and administer an electric shock, if necessary, in order to restore a viable heart rhythm, with high levels of safety.
In addition, with respect to these medical devices, the Decree states that:
a. For the purposes of verification of conformity and corresponding certification, the portable automatic external defibrillators shall be grouped in class IV, in accordance with article 20 of the Regulation.
b. The verification of conformity shall be carried out by means of the review of background information and documents required in Title IV of the Regulation.
c. The certificate of verification of conformity shall be granted by an entity authorized by the Institute of Public Health or by the latter in its absence.
Finally, it is established that this Decree will become effective 6 months after its publication in the Official Gazette.
Public Health Institute approves Guide for Technology Transfer of Pharmaceutical Production Processes
By means of Exempt Resolution No. 1746, dated September 6, 2021, the Institute of Public Health (ISP) approved the Guide for the Technological Transfer of Pharmaceutical Production Processes (hereinafter “the Guide”), prepared by the National Drug Agency Department.
The purpose of the Guide is to provide guidelines to carry out an adequate technological transfer of a pharmaceutical production process, and to specify the requirements and background information needed to accredit it.
For WHO, this transfer is a logical procedure that controls the transfer of any process along with its documentation and professional expertise between development and manufacturing or between manufacturing sites. This can occur at any stage of the life cycle of the process, and is caused by the change of site or location from where it was originally implemented to some alternative site.
Thus, the Guide:
1. applies to (i) pharmaceutical products that require accreditation of the transfer from a pilot plant to an industrial scale manufacturing plant and, (ii) to pharmaceutical products for which accreditation of the transfer of the production process to a new plant is required, either by a change or inclusion of a new manufacturing site.
2. It establishes that the process is made up of different sequential stages that include (i) a preliminary evaluation and (ii) a preparation of a protocol by the issuing or originating pharmaceutical laboratory to develop and approve the technology transfer process, which establishes the technical aspects, tests, analysis methods and acceptance criteria, and considers the appropriate statistical tools to analyze the results.
3. Provides that once the productive process has been transferred and validated, the results shall be documented in a technology transfer report, prepared by the originating unit and the receiving unit, in order to constitute documented evidence that the process was successfully carried out.
|Should you require additional information on this matter, please contact Andrea Abascal (email@example.com), and/or Rocío Vergara (firstname.lastname@example.org).|
Ministry of Public Health approves the Technical Bases of the Quality Evaluation Program in Radiotherapy (PECRT)
By means of Exempt Resolution No. 1723, dated September 3, 2021, the Institute of Public Health (ISP) approved the Technical Bases of the Radiotherapy Quality Evaluation Program (PECRT), of the National Agency Department of Medical Devices, Innovation and Development.
The aim is to contribute to the radiological protection of the patient, evaluating the provision of radiotherapy in terms of its quality and the quality of the equipment and sources used.
In order to do so, the PECRT Bases are in charge of:
1. Establishing the guidelines for the control and verification of equipment and medical devices associated with radiotherapy.
2. Verify the quality of the operation of the equipment in the radiotherapy establishments.
3. Verify the technical infrastructure in radiotherapy establishments.
4. Contribute to the strengthening of the quality assurance programs (QAP) implemented by the radiotherapy establishments.
5. To carry out interventions to control the operation of radiotherapy establishments.
Likewise, the evaluations to be carried out in each radiotherapy establishment alternate according to the calendar established for each Group of establishment (A or B) and are divided into face-to-face or remote modality.
Finally, it approves the following annexes that must accompany the evaluation to be carried out, called: (a) Database of radiotherapy establishments; (b) Radiotherapy treatment modalities; (c) Schedule for sending PGC documents to the ISP; (d) Dosimetric data for teletherapy-photon equipment; (e) Dosimetric data for teletherapy-electron equipment; (f) Immobilization and positioning devices; and (f) Brachytherapy applicators.
Ministry of Health approves Official List of Classification of Substances according to the Regulation on Classification, Labeling and Notification of Chemical Substances and Hazardous Mixtures.
On August 23, 2021, the Official List of Classification of Substances (hereinafter “List”) was published in the Official Gazette by Exempt Resolution No. 777, dated August 16, 2021, of the Ministry of Health, according to the provisions of article sixth of DS No. 57/2019 of the Ministry of Health, which approves the Regulation on Classification, Labeling and Notification of Chemical Substances and Hazardous Mixtures (hereinafter the “Regulation”).
In this regard, the List sets forth the hazard classes and categories of such substances, according to the following items: (i) Chemical name; (ii) CAS Number; (iii) Classification, hazard class and category codes; (iv) Classification, hazard indication codes; (v) Specific concentration limits, M and ETA factors; (vi) Notes related to the identification, classification and labeling of substances; and, (vii) Notes related to the classification and labeling of mixtures.
The above should be considered as referential when classifying chemical substances. Likewise, manufacturers and importers must prove the classification of substances not included in this list according to the provisions of Titles II and III of the Regulation.
Finally, for the classification of mixtures, the classification of the substances listed and classified in this resolution shall be used as a basis, without prejudice to the provisions of Articles 6 and 7 of the Regulation.
Ministry of Health modifies Mineral Water Regulation and reduces the level of arsenic in mineral waters intended for consumption.
On August 23, Resolution No. 23 of the Ministry of Health was published in the Official Gazette, amending Decree No. 106 of 1997, of the same authority, which establishes the Mineral Water Regulations.
In this sense, the purpose of this amendment is to make compatible the provisions of Article 160 of the Food Sanitary Regulation with the Mineral Water Regulation, by reducing, in the latter instrument, the arsenic limit from 0.05 mg/l to 0.01 mg/l in bottled mineral waters intended for consumption or sale.
Thus, as of this publication, bottled mineral waters intended for consumption or sale must come from natural, officially recognized sources, meet the bacteriological conditions required for drinking water, have a degree of mineralization of less than 1.5 grams per liter and not exceed the limit of 0.01 mg/l of arsenic.
Ministry of Agriculture modifies the list of ingredients authorized to produce animal feed or supplements.
On August 25, 2021, Exempt Resolution No. 5.091, dated August 13, 2021, of the Ministry of Agriculture, in collaboration with the Undersecretariat of Agriculture and the National Directorate of the Agriculture and Livestock Service, was published in the Official Gazette, amending Exempt Resolution No. 6.612, which establishes the list of ingredients authorized to produce animal feed or supplements.
In this sense, the following modifications are made:
1. The denomination ” wastage” is added, which refers to those products that are not suitable for commercialization, but are not expired, altered, adulterated, contaminated or falsified and that do not cause damage to human or animal health.
2. It is added as a new group “products and by-products of the animal feed industry”, which includes as an ingredient the wastage products.
3. It is established that this new group, for its commercialization, must have a guarantee of Total Protein (TP), Crude Fiber (CF) and Ethereal Extract (EE).
4. Finally, it is established that the establishments that produce, store, distribute, use, transport, sell or dispose of the ingredients of this new group must (i) demonstrate that they do not affect the health of the animals, the safety of the products obtained from them, or the environment; (ii) communicate the beginning of the activities to the Service; (iii) have an updated LENAA resolution for all the activities in which it performs; and (iv) deliver to the Service a series of documentation.
Law No. 21.363 establishes rules on the marketing and advertising of alcoholic beverages and advertising of alcoholic beverages.
On August 6, 2021, Law No. 21.363 was published, which establishes rules on the commercialization and advertising of alcoholic beverages, and others indicated therein. In view of the above, Law No. 19.925 on the sale and consumption of alcoholic beverages was amended as follows:
1. Sale of alcoholic beverages
A prohibition on the sale of alcoholic beverages in gasoline stations or gas stations that do not have a license that allows their sale is established. It establishes the prohibition of entry of minors under 18 years of age to cabarets, canteens, bars, taverns and discotheques where alcoholic beverages are sold, when it is the main commercial license of the premises, that is, if a restaurant has an annexed license of bar, it will be the first one that will take precedence. In addition, in those establishments, an identity card must be required to enter the premises. Along with the above, in all premises where alcohol is sold, at the time of sale, an identity card must be requested from any person wishing to purchase an alcoholic beverage.
2. Advertising of alcoholic beverages
A new article 40 bis is created in the Alcohol Law, which establishes that all alcoholic beverages with an alcohol content of more than 0.5 and which are intended to be commercialized in Chile must have warnings on the container and its packaging about the harmfulness of its consumption, regulating also the advertising of such beverages through a new regulation. Violation of this provision will be sanctioned with a fine of between 5 and 200 UTM and confiscation of beverages. This provision will come into force one year after the regulation is published.
Likewise, a block of alcoholic beverage advertising on television between 22:00 and 06:00 hours and on radio between 16:00 and 18:00 hours will be created. Violation of this provision will be sanctioned with a fine of between 20 and 200 UTM. This provision will come into force 36 months after the regulation is published.
Repeated offenses may double the fine.
Finally, the advertising of alcoholic beverages is prohibited in sports activities that are not of a world, continental or regional nature.
The regulations must be issued one year after the publication of this law.
On May 24, 2021, the Ministry of Health introduced the Mobility Pass, which will come into effect this Wednesday, May 26, 2021, and which certifies that people have completed their vaccination process for COVID-19 and that they are not in a period of mandatory isolation.
According to the Ministry of Health, the Mobility Pass will have the following terms:
1. What is the Mobility Pass?
– It is a unique and personal QR Code, which, when scanned, will inform whether the Mobility Pass is enabled or not at that moment.
– It is a dynamic certificate, i.e. it will not be enabled if the person is a confirmed, probable or close contact case.
2. What does the Mobility Pass allow?
– Free movement in a commune in Quarantine (Step 1) or in Transition (Step 2), respecting all the regulations and other restrictions of the Step-by-Step Plan.
– Make interregional trips within Chile between communes that are at least in Step 2, respecting the restrictions of the activities associated with the place where it is located.
3. How to obtain the Mobility Pass?
– The Mobility Pass can be obtained through the website mevacuno.gob.cl, by e-mail or with the Clave Única (Unique Code), or by means of a printed copy in clinics or vaccination points.
– However, people over 70 years of age may use, as an alternative to this voucher, their “Vaccination Card” together with their identity card.
4. Who can access this Pass?
– Those over 18 years of age who have completed 14 days since the inoculation of the second dose of the Pfizer-BioNTech, Sinovac and AstraZeneca vaccines.
– Those over 18 years of age who are 14 days old since the inoculation of the single dose of the CanSino vaccine.
– Minors under 18 years of age will be able to access the privileges provided by the Pass, as long as they are accompanied by their mother, father or guardian with an authorized mobility pass.
5. What measures are not modified by this Pass?
– The capacity for social gatherings and the prohibition to participate in them in Quarantine and Transition.
– Curfew enforcement.
– The capacities and restrictions of operation and restricted activities of the Step-by-Step Plan.
– The prohibition of in-person work for workers who are not permitted to do so.
– Individual self-care measures.
6. Who can request the reading of the Pass?
– The sanitary or supervising authority, when controlling the mobility in a Quarantine commune.
– The personnel that controls the access and carrying of movement permits in places that are authorized to operate in quarantine and transport operating companies.
– The sanitary or supervisory authority, in customs controls or sanitary cordons.
Finally, it should be noted that the Mobility Pass can be presented digitally or physically.
On April 6, 2021, Exempt Resolution No. 42/2020 was published in the Official Gazette, which approves the Regulation of the National Cancer Law that pays posthumous tribute to Dr. Claudio Mora.
The application of the Regulation is intended for actions, policies and programs, referring to all types of cancer, both in the adult and child population, from prevention to palliative care, including those incorporated as health problems in the Explicit Health Guarantees Regime (GES) and in the Financial Protection System for High Cost Diagnoses and Treatments, as well as in any other means that implies coverage for the public health sector.
In order to comply with this, it is established that the Regulation will be governed by the principles of cooperation, protection of personal data, participation in civil society and humanization of treatment, regulated in the National Cancer Law.
Based on these principles, the Regulation regulates and creates different programs and institutions, such as the National Cancer Plan, Cancer Research, the National Oncology Network, the National Cancer Registry and the National Cancer Commission.
Finally, this regulation establishes that people have the right to diagnostic confirmation and treatment, in accordance with their social security system, when there is a well-founded suspicion of suffering from any type of cancer, and the right to genetic counseling, which must be provided by the medical team in case personal, environmental or family risk factors for suffering from this disease are detected.
On April 6, 2021, it is published in the Official Gazette the extract of the Exempt Resolution N°499, dated March 25, 2021, which approves the Guide for Clinical Evaluation of Medical Devices, of the Department of the National Agency of Medical Devices, Innovation and Development of the Institute of Public Health (ISP).
This Guide provides technical guidance to manufacturers to perform the clinical evaluation of a medical device (with the exception of in vitro diagnostic medical devices), regulating, among other things, the moments in which the clinical evaluation must be performed and the duties of the manufacturer to inform the frequency with which its medical device must be updated in its clinical evaluation.
Likewise, the Guide establishes several stages for carrying out this clinical evaluation, which are divided into five, namely, definition of the scope and planning of the clinical evaluation; identification of the data; evaluation of the data; analysis of the clinical data; and, the clinical evaluation report.
Finally, it establishes different annexes, within which are regulated (a) clinical evaluations applicable to medical devices intended for unmet medical needs; (b) analysis of clinical data, in consideration of safety principles, conformity assessment, performance principles and principles of acceptability of undesirable side effects; (c) a checklist for the release of the clinical evaluation report; (d) a declaration of interests of the evaluators; and, (e) the post-marketing clinical follow-up that must be made.
ISP approves Basis for Supplier Assessment Programme for the Determination and Control of Occupational Noise Exposure
On 17 March 2021, an extract of the Exempt Resolution No. 334, dated 01 March 2021, was published in the Official Gazette, through which the Institute of Public Health approves the Bases of the Supplier Assessment Programme for the Determination and Control of Occupational Exposure to Noise.
This evaluation programme responds to the Occupational Exposure to Noise Protocol (PREXOR), as the mechanism to guarantee the quality associated with the performance of environmental evaluations in the workplace.
It is for this reason that compliance with this programme will be mandatory for those who wish to be providers in the determination and control of occupational noise exposure.
Likewise, ISP will be considered as the National Reference Laboratory in Occupational Health, providing a tool to these suppliers that will contribute to guarantee the quality of their Occupational Noise Assessments.
The Ministry of Health declares as special cosmetic hand sanitizers with antibacterial action ingredients as follows:
On March 10, 2021, Exempt Resolution No. 199, dated February 26, 2021, of the Ministry of Health was published in the Official Gazette, which declares that products intended for hand sanitizing, with antibacterial action ingredients, correspond to a special cosmetic, called “hand sanitizer”, considering that, due to the sanitary emergency caused by the outbreak of COVID-19, the use of this type of products by the population increased.
In this regard, it should be noted that, according to the Regulation of the National Cosmetics Control System, a special cosmetic corresponds to those that carry a risk in its use due to its formulation, concentration of active ingredients or its purpose, requiring a special indication of use.
On this basis, the new Resolution establishes the ingredients that this new special cosmetic may contain in its formulations.
Likewise, the margins under which such products may be promoted are determined, which, among other things, may not make reference to actions of sanitary products or biocides for human hygiene, make recommendations for use as cleaning and/or disinfection of inanimate surfaces, or directly or indirectly attribute therapeutic properties, or include certain words in its labeling.
For those holders of cosmetic registrations or notifications of products intended for hand hygiene that contain the ingredients indicated in the Resolution, a term of 120 days from the publication in the DO of this resolution is established, to carry out the modifications in the formulations, labeling, promotion and registration of the same.
The same term is established for those “hand sanitizers” that have cosmetic registration and are promoted with the phrase “eliminates 99.9% of bacteria” or other similar ones, to submit the scientific-technical support studies to the ISP.
MINSAL establishes definitions and guidelines to apply measures to facilitate the acquisition of medicines in the context of a health alert due to an epidemic or pandemic.
On January 20, 2021, Exempt Resolution No. 24, dated January 12, 2021, was published in the Official Gazette, which establishes measures to facilitate the acquisition of medicines in the context of a health alert due to an epidemic or pandemic, in accordance with Article 1 of Law No. 21,267.
In this regard, it states that the prescriptions that have been issued since August 8, 2019 will be valid for dispensing in any establishment until August 8, 2021 or until six months after the end of the alert, in case it is extended.
Likewise, it determines that pharmaceutical products may be dispensed by any establishment authorized to do so, showing a copy of the prescription that prescribes them, either in digital or physical format.
However, in the case of the delivery of medicines in which copies of prescriptions in digital or physical format are used, which include products subject to legal control by means of a withheld prescription or check, prior to the delivery of the products, they must be validated in the electronic system of the Ministry of Health, called “System for the Validation of Graphic Prescriptions”, which will be applicable to non-assistance establishments that sell medicines directly.
It also establishes a series of responsibilities to which the prescriber of the digitalized prescription will be subject, among them, to incorporate into the electronic system the respective medical prescription together with eliminating those prescriptions issued that do not correspond to check prescriptions, having to render them unusable and destroy them.
Finally, the malicious use of prescriptions presented in digitalized form or physical copy, including the falsification or adulteration by modification of the indications of the document or its use in the repeated acquisition and in unjustified quantities with respect to the prescription, will be sanctioned according to Book X of the Sanitary Code and the Penal Code.
In case you require additional information on this matter, please contact: Andrea Abascal (email@example.com) and/or Rocío Vergara (firstname.lastname@example.org).
MINSAL updates Technical Norm Nº127, on Good Manufacturing Practices for Pharmaceutical Products (GMP), regarding the requirements for the manufacture of radiopharmaceutical products.
On December 30, 2020, Exempt Decree No. 65/2020 was published in the Official Gazette, which updates Technical Standard No. 127 on “Good Manufacturing Practices (GMP) for the Pharmaceutical Products Industry”, adding an Annex No. 6, which provides guidelines aimed at establishing the essential requirements for the manufacture of Radiopharmaceutical Products, thus complementing the standards already established for sterile and non-sterile pharmaceutical products, regulated by the same Standard.
Considering that the manufacture and handling of radiopharmaceuticals are potentially hazardous operations, it is essential that the establishments that manufacture these products comply with Annex No. 6, effectively ensuring the quality of the manufacturing process, taking into account the particular characteristics of this type of products.
To ensure this purpose, Annex N°6 regulates in detail the following issues:
1. Area of application.
2. Personnel of radiopharmaceutical production laboratories.
3. Facilities and conditions to be met by laboratories.
4. Equipment used in the manufacture of radiopharmaceuticals.
5. Radiopharmaceutical production process.
6. Packaging and labeling.
7. Production and distribution records.
8. Quality assurance and control.
The update of Technical Standard N°127 will become effective 6 months after its publication.
Should you require further information on this matter, please contact: Andrea Abascal (email@example.com) and/or Rocío Vergara (firstname.lastname@example.org).
On October 6, 2020, an excerpt of Exempt Resolution No. 3853/2020 of the Institute of Public Health (ISP) was published in the Official Gazette, establishing requirements for the notification and execution of market withdrawal activities for the holders of health registrations and participants in the distribution chain of pharmaceutical products, whether they are voluntary withdrawals or withdrawals instructed by the ISP.
For these purposes, withdrawal activities are classified as Class 1, Class 2 and Class 3, according to the potential health risk that the product involved may represent.
Bearing in mind the above, pharmaceutical product recall activities shall be governed by the following rules:
A. The beginning of the withdrawal shall be notified by electronic means, in the following opportunities:
Once the suspicion or verification of failure or deviation of quality is known, or since the cancellation of the sanitary records, within a maximum period of 24 hours.
Within a period not exceeding 48 hours, accompanying the written records of the notification to each one of the establishments of the distribution chain.
B. In the case of Class 1 withdrawals, the owner of the records shall have the obligation to send a warning message to consumers informing them of the dangers or harmfulness of the lots of the product subject to withdrawal.
C. Obligations are determined for the establishment that has received one or more lots subject to withdrawal shall, establishing standards according to whether it has made previous distribution or not.
D. The holder of the sanitary registration shall submit to the PSI the follow-up reports of the withdrawal from the market and, once the withdrawal is finished, shall submit a conclusive report.
E. The destruction of the medicines shall be the responsibility of the holder of the health registration, according to the regulations in force.
On September 30, 2020, Exempt Resolution No. 3422, dated August 25, 2020, of the Institute of Public Health (“ISP”) was published, which instructs holders of health registrations, and applicants for such registrations, to declare the plant species of the starch used as an excipient in the pharmaceutical products containing it in their formulation.
As of that date, the qualitative and quantitative formula expressions of all the pharmaceutical products applying for a health registration, which contain starch in their formulation, must expressly state the vegetable species from which the starch comes, and also state the byproducts that come from modified starch. All this, in the special form indicated by the resolution.
Likewise, in the case of products already registered, the holders of such registrations shall have until September 30, 2021, to comply with the aforementioned, and shall submit to the PSI the information of the vegetable species from which the starch comes, in the special form indicated by the resolution, including the starch by-products that are indicated.
Law No. 21.267 establishes measures to facilitate the acquisition of medicines in the context of a health alert.
On September 22, 2020, Law No. 21.267 was published in the Official Gazette, establishing measures to facilitate the acquisition of medicines in the context of a health alert, whether due to an epidemic or a pandemic. In specific terms, the Law provides for the following measures, in the event of a health alert being declared in the event of an epidemic or pandemic:
A. Pharmaceutical products may be dispensed by any establishment authorized to do so, it is sufficient that the consumer shows a copy of the prescription that prescribes the medicine, in physical or digital format, in any of its forms.
B. Those prescriptions issued 6 months before the declaration of health alert or during its validity, will be valid until 6 months after the end of the alert.
C. The requirement that the electronic prescription must be signed by an advanced electronic signature is eliminated.
The above measures shall not exempt the establishment from its obligation to complete the corresponding records, according to the nature of the medicine and the provisions of the respective regulations.
Finally, it is established that the malicious use of prescriptions presented in digital form will be punished according to Book X of the Health Code, the Criminal Code and Law No. 20,000.
Decree of the Ministry of Health modifies Technical Norm Nº208, on storage and transport of refrigerated and frozen medicines
On September 21, 2020, Exempt Decree No. 49/2019 of the Ministry of Health was published in the Official Gazette, amending Exempt Decree No. 48/2019, of the same portfolio, which approves Technical Standard No. 208 on the storage and transportation of refrigerated and frozen medicines. This modification is intended to redefine the scope of the Norm, since its formulation was based on recommendations of the WHO for “High Production and Distribution” establishments, but not for the Assistance Network; and, in addition, to exclude from its scope pharmacies, medicine cabinets and pharmaceutical warehouses, since its provisions are new, given its position in the logistic chain.
In this way, the reference to pharmacies, first-aid kits and master prescriptions is eliminated from the third paragraph of article 1, and a fourth paragraph is added that expressly declares that the Technical Standard will not be applicable to the mentioned establishments.
Decrees of the Ministry of Health introduce modifications to the regulation of pharmaceutical products in terms of health records and therapeutic equivalence
On August 21, 2020, Decrees No. 54 and No. 65 of the Ministry of Health were published in the Official Gazette, introducing amendments to Decree No. 3/2010, of the same portfolio, which approves the Regulations of the National System of Control of Pharmaceutical Products for Human Use, regarding health registrations and therapeutic equivalence, respectively.
In relation to Decree No. 54, in order to reduce the processing time of health registrations, mainly, in the case of medicines registered in International Regulatory Agencies, the following amendments are determined:
A. During the processing of a health registration, if the evaluation carried out by the Institute of Public Health (ISP) is unfavorable, it may grant a period of time for the applicant to correct accessory issues or submit sufficient information. If the period of time elapses and these objections have not been corrected, the PSI will proceed with the rejection of the registration application, without a favorable pronouncement from the Ministry of Health being necessary.
Nevertheless, the applicant may initiate a new registration procedure within 6 months from the date of notification of the rejection of the registration, and the PSI will have a period of 3 months to verify the background of the new application.
B. The abbreviated registration procedure may be initiated ex officio by the PSI or at the request of the interested party, and no longer requires a substantiated resolution from the Ministry of Health.
C. It is established that the total period to resolve the application for the simplified registration procedure will be a maximum of 5 months, counting from the entry of the application.
D. The accelerated registration procedure is created, which will be available to those medicines registered with Highly Supervised Drug Regulatory Agencies, whose processing may not exceed 3 months from the receipt of the application. Along with the recognition of the registration of the pharmaceutical product, the authorizations and certifications granted by the Agencies, such as the Good Manufacturing Practices, will also be recognized.
Biological products are exempted from the abbreviated procedure, unless there is a well-founded resolution by the Ministry of Health; and when there are public health reasons that prevent it, which will be qualified by a well-founded resolution by the Ministry of Health.
E. A new cause is incorporated to request the modification of the registration of pharmaceutical products, namely, the change of manufacturer, of active ingredients and modifications of the production process.
F. The possibility of requesting the authorization of a new drug manufacturer is incorporated, keeping the already authorized one. In this case, a new health registration number will be assigned, maintaining the other authorized aspects.
With respect to Decree No. 65, in order to facilitate and make more flexible the registration of bioequivalent medicines, a new article 221 bis is incorporated, providing that therapeutic equivalence will be understood to be demonstrated with respect to those pharmaceutical products that have obtained certification of this quality before any of the Highly Supervised Medicine Regulatory Agencies; as well as those that have been prequalified by the World Health Organization.