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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.