Almost every day, ANVISA publishes some standard or clarification in order to bring products related to the crisis caused by COVID-19 to the market more quickly, but in the midst of this avalanche of standards, we must understand the basics to be able to make the most of this window of opportunity, in order to obtain regularization of products. For this reason, Inovatie compiled the main standards and highlighted the most important topics.
LAW 13.979 / 2020: provides for measures to deal with the public health emergency resulting from the coronavirus, which lists the exceptional measures that can be adopted by the Government to protect the community, such as isolation, quarantine, determination of mandatory measures such as exams and vaccination and entering and leaving the country.
This Law underwent a recent change with the publication on May 29, of Law 14.006 / 2020, which establishes a period of 72 (seventy-two) hours for Anvisa to authorize the import and distribution of any materials, medicines, equipment and supplies from the health sector registered by the Food and Drug Administration (FDA - USA), European Medicines Agency (EMA - Europe), Pharmaceuticals and Medical Devices Agency (PMDA - Japan) or by the National Medical Products Administration (NMPA - China). It is not yet known how this will be implemented in practice, because, despite the fact that the law establishes a 72-hour deadline for registration, the legal provision that established that period was vetoed by the President on the grounds of violating the private competence of the Executive power.
RDC 346/2020: Defines extraordinary and temporary criteria and procedures for the certification of good manufacturing practices for products related to the emergence of Coronavirus
· The certification of good manufacturing practices remains in force for the products where it is required;
· Information from Foreign Regulatory Authorities will be temporarily accepted replacing the health inspections carried out by Anvisa if they come from member countries of the PIC / S (Pharmaceutical Inspection Cooperation Scheme) for certifications related to medicines and pharmaceutical supplies; MDSAP (Medical Device Single Audit Program) for certifications related to healthcare products; or Program to rationalize international GMP inspections of active pharmaceutical ingredients / active substance manufacturers for certifications related to pharmaceutical ingredients;
· Instituted the temporary and emergency use of remote inspection mechanisms, replacing the face-to-face health inspection;
· In cases where it is not possible to carry out certification through the alternative mechanisms included in the standard, the General Management of Sanitary Inspection and Inspection is authorized to issue a Temporary Certification.
RDC 347/2020: Defines the extraordinary and temporary criteria and procedures for exposure to the sale of antiseptic preparations or sanitizers, due to the emergence of international public health related to SARS-CoV-2 for 70% ethyl alcohol (w / w ); glycerinated ethyl alcohol 80%; alcohol in gel; 75% glycerinated isopropyl alcohol; hydrogen peroxide 10 volumes and 0.5% chlorhexidine digliconate.
RDC 348/2020: Defines the extraordinary and temporary criteria and procedures for handling requests for registration and post-registration of medicines, biological products and products for in vitro diagnosis due to the new Coronavirus.
· Specific rules for registration of the regulatory category must be met;
· Registration may be deferred upon further completion via the Term of Commitment, as provided in RDC317 / 19;
· An addendum to the registry must be filed prior to the beginning of the analysis, the term of commitment, detailed schedule for the presentation of data and additional evidence and risk assessment carried out by the applicant company;
· For in vitro diagnosis, the absence of any performance study or data restriction must be justified with technical reasons that allow the assessment of the reliability of the results and the diagnostic effectiveness of the product;
· The validity of the registration, granted with a term of commitment, will be of 3 years for medications, and one year for in vitro diagnostic products.
· If the commitments made in the commitment term are not fulfilled, the company that owns the registration will be subject to the cancellation of the registration.
RDC 349/2020: Defines the extraordinary and temporary criteria and procedures for the treatment of regularization of personal protective equipment, medical equipment such as pulmonary ventilator and other medical devices identified as strategic due to the emergence of the new Corona virus.
· Regularization requests must be accompanied by the documentation provided for in RDC 185/2001 and RDC 40/2015. The absence of any requirement must be justified with technical reasons that allow the safety and efficacy of the product to be assessed;
· For situations in which the manufacturing company does not have the Good Manufacturing Practices Certification issued by Anvisa, the Medical Device Single Audit Program (MDSAP) or ISO 13485 Quality Management System Certification will be exceptionally replaced.
· The proof of registration or free trade certificate may be replaced by a simple declaration issued by the Legal and Technical Responsible persons of the requesting company, informing that the product is regulated and marketed in member jurisdiction of the International Medical Device Regulators Forum (IMDRF);
· The products covered by this Resolution are exempted from certification under the Brazilian Conformity Assessment System (SBAC);
· The registrations granted under the terms of this Resolution will be valid for 1 (one) year and within that period they must present the additional information and appropriate certifications.
· The necessary declarations for the procedural instruction are exempt from consularization or apostille;
· If situations are observed that indicate deviation in quality, safety or effectiveness, Anvisa must be notified within 5 (five) business days;
RDC 355/2020: Provides for the suspension of procedural deadlines for the requirements of public acts to release responsibility from Anvisa due to the emergency related to SARS-CoV-2 until 03/23/2020.
RDC 356/2020: Provides, in an extraordinary and temporary way, on the requirements for the manufacture, import and acquisition of medical devices identified as priority for use in health services, due to the emergency related to SARS-CoV-2.
· The manufacture and import of surgical masks, particulate respirators N95, PFF2 or equivalent, goggles, face shields, disposable hospital garments, caps and props, valves, circuits and respiratory connections for use in healthcare services are exceptional and temporarily exempt from the Company Operation Authorization, notification to Anvisa, as well as other health authorizations.
· The above exemption does not exempt the manufacturer and importer from complying with the requirements applicable to sanitary control, applicable technical standards, from carrying out post-market controls and complying with regulations applicable to the post-market.
· Lists ABNT technical requirements and standards that must be followed for the products in question.
· Allows the acquisition of these essential articles to combat COVID-19, new and not regulated by Anvisa, as long as they are regulated and marketed in member jurisdiction of the International IMDRF, by public and private bodies and entities, as well as health services, when similar devices regulated by Anvisa are commercially available.
RDC 366/2020: Provides for the import of products for in vitro diagnosis of Corona virus during the public health emergency of international importance arising from the New Corona virus.
RDC 392/2020: Defines the extraordinary and temporary criteria and procedures for applying exceptionalities to specific requirements of Good Manufacturing and Import Practices for Medicines and Pharmaceuticals, due to reasons proven to be related to the emergence of the Corona virus. Exceptions can only be implemented for companies already certified in GMP by ANVISA, based on formally documented risk management and are divided into 2 types:
· Notification and immediate implementation listed in article 7 as a change in the quality control location, exemption from quality control in imported products and with temperature control implemented.
· Those of implementation subject to Anvisa's assessment and favorable opinion, which are those not included in article 7, which ANVISA has a period of 8 days to manifest itself and the period without manifestation may be implemented.
It is important when consulting the rules to verify that it is the most up-to-date version as these RDCs and the documents with Questions & Answers are undergoing frequent updates in order to address the doubts and new demands that keep coming up with the emergence of COVID, and that all those exceptional measures being taken will expire after the epidemic ends. Finally, one point that as a health professional and consultant I feel obliged to emphasize is that ANVISA has fulfilled its responsibility to facilitate the regularization of these products and the activities of companies, but it is also necessary for companies that are willing to take advantage of this wave know that you must assume the responsibilities, because the health market deals with a much more valuable asset than just a business opportunity.
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