Life Sciences & Healthcare
ANVISA extends the suspension of deadlines until the pandemic ends
updated on Jul 13 at 11:40 am
On July 10, 2020, ANVISA RDC No. 398/2020 was published, in order to amend ANVISA RDC No. 355/2020, which suspended deadlines concerning public approval requirements by ANVISA for 120 days. The new wording of the norm extends such suspension, as well as the suspension of termination of installment payments for default and of administrative charges of procedures which limitation periods exceed one year, until the Ministry of Health acknowledges that the Emergency in Public Health of National Importance caused by the COVID-19 pandemics is over.
The norm also has added a section to suspend the summons regarding sanitary infractions and the subpoena regarding decisions issued in administrative-sanitary procedures, matters that had not been mentioned by ANVISA RDC No. 355/2020 in its original wording.
Another subject disciplined by ANVISA RDC No. 398/2020 is the extensions of the term until which big and medium companies could prove their economic value in order to get discounts on ANVISA fees. The deadline has been postponed to August 31, 2020, the same deadline to companies that have received an infraction notice sent by ANVISA during the period of March 23, 2020 to August 20, 2020 to present to the entity the documentation for economic capacity evaluation for purposes of determining the administrative penalty, in case it should be imposed.
Finally, the new norm has supressed the distinction between physical and digital procedures in connection to the attainment of copies: the former wording suspended the supply of copies and support in request for examination of physical procedure files, except when indispensable for assuring proof and the right of the applicant, by means of specific justification, which authorized the forwarding of digitalized files to the applicant’s e-mail.
From now on, the supply of copies of administrative procedures is allowed via e-mail or other electronic mean, without the distinction between physical, digital or digitalized files. Moreover, access to confidential information shall only be allowed to the direct party directly interested in the process and/or its attorney-in-fact, as long as proved their legitimacy.
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ANVISA publishes new regulation on the importation of products by healthcare facilities
updated on Jun 08 at 03:51 pm
On May 13, 2020, the National Health Surveillance (ANVISA) published the ANVISA Resolution RDC No. 383/2020, which sets forth the new regulation on the direct importation of products subject to health surveillance by healthcare facilities (hospitals, ambulatories, doctor offices and clinics) or through its foundations and linked civil society organizations of public interest or event through health insurance companies.
In addition to the direct importation, the Resolution sets forth that healthcare facilities may outsource the importations to dully licensed companies, that is, legal entities that hold sanitary license before local sanitary authorities and Operating License (in Portuguese, “Autorização de Funcionamento de Empresa – AFE”) before ANVISA.
According to Resolution, the holder of the above-mentioned importation permit must (i) hold the sanitary licenses for the importation of products subject to health surveillance, as mentioned to the outsourced companies; (ii) appoint a technical responsible; (iii) import through bonded warehouse that holds sanitary license and AFE for warehousing of products subject to health surveillance; and (iv) comply with other requirements and documents that set forth by the applicable legislation on the importation of products, such as the ANVISA Resolution RDC No. 81/2008, which determines the technical regulation on the importation of products for health surveillance purposes.
The ANVISA Resolution RDC No. 383/2020 sets forth the documents that must be filled within the importation proceeding, including a declaration from the product’s MA Holder authorizing the activity, which must be linked only with a healthcare facility, which is also prohibited from transferring such right.
Therefore, the Resolution sets forth a detailed regulation on the importation of products subject to health surveillance by healthcare units, provided that they must comply with other applicable and current regulation.
CLINICAL TRIALS AND THE IMPACT OF COVID-19 - ANVISA EDITS TECHNICAL NOTE
updated on Mar 30 at 10:56 am
By means of the Technical Note (NT) No. 3/2020, the National Health Surveillance Agency (ANVISA) has published orientations to sponsors, research centers and investigators involved in the conduction of clinical research and bioequivalence studies, given the COVID-19 pandemic.
The pandemic may affect the research and studies by making it more difficult to comply with the clinical protocol as approved by the ethical and regulatory panels, due to possible infections of participants by the novel coronavirus, to their isolation, quarantine or even to travel restrictions, etc.
ANVISA has advised sponsors, centers and investigators to modify the clinical protocol when necessary, communicating the participants of the research or study. The alteration of the protocol shall be informed in the annual clinical research report, which shall also contain the reason of the alteration, the potential impacts on the research and participants, as well as measures taken to manage potential interruption to the investigation, among other information.
As long as aiming at preserving the participant’s protection, the alteration may be exempt from authorization from ANVISA, though if they result in alteration of statistics analysis and/or data management plans the sponsor shall consider discussing it with ANVISA by means of the official service channels, reporting in the statistics analysis plan how the protocol deviations related to COVID-19 shall be treated with regard to the pre-established analysis.
It may be possible to interrupt the investigation, or to discontinue a participant if so demanded by the actual situation.
The NT also provides that, except if the investigation itself holds regard to COVID-19, the sorting procedures for the disease in clinical research participants do not need to be reported to ANVISA as an amendment to the protocol. Anyhow, ANVISA states that “there is no prohibition from a sanitary point of view to deliver directly the experimental drug to the clinical research participant at their residence in case it is supposed to be used at home, as long as the participant is properly advised as to the use by the research center and that all necessary records are kept, including drug delivery receipts, so that traceability of all information and maintenance of the adequate transport and storage conditions are assured. All these measures shall be informed at the annual study report”.
Specifically concerning bioequivalence studies, its postponement is suggested in case they have not started yet, as well as those that have already initiated, but have not performed planned admissions yet (the impact of this postponement must be included in the final reports).
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E-PRESCRIPTION AND REMOTE SALE OF CONTROLLED DRUGS ARE PARTIALLY ALLOWED
updated on Mar 27 at 11:38 am
RDC No. 357/2020 allows the remote delivery of controlled drugs, provided that certain requirements are met. The permit is temporary, for six months, and can be extended as long as the COVID-19 crisis lasts.
Some restrictions remain. For example, the purchase and sale of medicines to be delivered remotely over the Internet remains prohibited.
The resolution also increases the permitted quantities of drugs subject to special control.
In addition to publishing the Resolution, the National Health Surveillance Agency (ANVISA) published a statement on its website, recognizing that the digital signature with ICP-Brazil certificates will be accepted, but only for some of the controlled drugs (see here – Portuguese only).
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ANVISA PROVIDES FOR SUSPENSION OF SOME DEADLINES AMID COVID-19 CRISIS
updated on Mar 24 at 06:55 pm
In line with the Provisional Measure (MP) No. 928/2020, ANVISA RDC No. 355/2020 suspends some procedural term for 120 days. It is applicable to deadlines concerning public approval requirements, procedures related to sanitary infractions, as well as to the statute of limitation regarding punitive intention purposes in sanitary administrative procedures, except for those of a fiscal nature.
The Resolution also suspends the provision of copies of procedure documents and examination request services, “except if indispensable to guarantee and prove the applicant’s right, as justified and specifically motivated”. As to digital procedures, online applications shall be admitted if the applicant proves their identity and powers.
The norm shall not take effects, however, on deadlines for compliance with requirements in procedures in connection with marketing authorization (MA) for inputs, drugs and biological products, nor their post-MA modifications (except for inputs), etc. In those specific cases, deadlines before ANVISA shall not be altered, without prejudice to the possibility of requesting the procedure’s temporary closure in case the company shall not be able to comply with the relevant requirements.
Moreover, this suspension shall not be applicable to field actions and connected measures, and shall not be adopted in case there is the need for ANVISA to take actions against blatant infractions to the regulation or against the new coronavirus.
During the period when the Resolution is in force, all documents shall be digitally signed.
ANVISA RDC No. 355/2020 shall be in force for 120 days, being subject to further renewal(s) for further one hundred and twenty days, for as long as the public health emergency due to COVID19 lasts.
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ANVISA SIMPLIFIES ACCESS TO HEALTH PRODUCTS TO COMBAT COVID-19
updated on Mar 24 at 04:31 pm
In an extra edition of the Official Gazette of March 23, 2020, the National Health Surveillance Agency (ANVISA) published the Resolution RDC No. 356/2020, which determines the waiver of Federal Operating Permits (AFE) and other health authorizations for companies that manufacture and import “surgical masks, particulate respirators N95, PFF2 or equivalent, goggles, face shields, disposable hospital garments (waterproof and non-waterproof aprons/cloaks), caps and flaps, valves, circuits and respiratory connections for use in services of health".
These are less risky medical products, used to combat the international public health emergency related to the novel coronavirus. The new rule also exempts such products from regularization before ANVISA. This is because other companies (which are not manufacturers of medical products) are making efforts to manufacture these products due to the risk of shortages.
Notwithstanding these flexibilities, ANVISA determined that the manufacturer or the importer will still be responsible for guaranteeing the quality, safety and effectiveness of the products, and must comply with all the requirements applicable to sanitary control, technical standards, and to carry out post-market controls.
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ANVISA WILL PRIORITIZE FEDERAL OPERATING PERMIT (AFE) REQUESTS REGARDING COVID-19 AND COMPANIES WILL NOT NEED TO WAIT FOR PERMIT’S PUBLICATION IN THE OFFICIAL GAZETTE
updated on Mar 20 at 9:52 pm
The National Health Surveillance Agency (ANVISA) announced on its website that it will prioritize the analysis of the Federal Operating Permits (AFE) requests for companies that carry out, or intend to carry out, activities related to products for the diagnosis, prevention or treatment of COVID-19.
The Agency also indicated that companies do not need to wait for the AFE publication in the Official Gazette (DOU) to start their activities. An official confirmation via ANVISA’s system with the authorization will be enough.
To request the prioritization, e-mail should be sent to the address coafe@anvisa.gov.br, with the subject “PRIORIDADE COVID19”. The e-mail must also indicate the request number, the Taxpayer’s Registry Number (CNPJ) of the establishment and the name of the product.
The orientation was made available at: ANVISA - Pedidos de AFE relacionados à Covid-19 terão prioridade
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ANVISA ALLOWS DRUG, SANITIZERS AND COSMETICS MANUFACTURERS TO PRODUCE AND TRADE ANTISEPTIC SUBSTANCES OR OFFICINAL SANITIZERS WITHOUT PREVIOUS AUTHORIZATION
updated on Mar 20 at 3:40 pm
On March 20, 2020, the National Health Surveillance Agency (ANVISA) published the ANVISA RDC No. 350/2020, allowing duly licensed drug, sanitizing product and cosmetics manufacturers to produce and trade antiseptic substances or officinal sanitizing products, temporarily and extraordinarily, without previous authorization.
Thus, due to the COVID-19 pandemic, drug manufactures will be able to manufacture and trade 70% ethyl alcohol, 80% glycerine ethyl alcohol, alcohol gel, 75% glycerine isopropyl alcohol and 0,5% chlorhexidine gluconate, whereas sanitizing products and cosmetics manufacturers will be able to manufacture and trade 70% ethyl alcohol. Products’ expiration date shall not exceed 180 days.
Moreover, the substitution of ingredients mentioned by the National Brazilian Pharmacopeia Form can now be replaced by others with the same pharmacotechnical function, as long as they provide the same efficiency and stability.
To maintain the manufacturing and trading of the products after the expiration of the RDC ANVISA No. 350/2020, the interested companies shall apply for the corresponding marketing authorization following the applicable regulations.
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ANVISA PUBLISHES RESOLUTION ON PROCEDURES TEMPORARILY APPLICABLE TO REGULARIZATION OF MEDICAL DEVICES DUE TO COVID-19
updated on Mar 20 at 12:22 pm
On March 20, 2020, the National Health Surveillance Agency (ANVISA) published the ANVISA RDC No. 349/2020, regulating extraordinary and temporary procedures for applications concerning the regularization of individual protection equipment, medical devices related to lung ventilation, and other medical devices recommended for COVID-19 diagnosis or treatment. The regulation shall remain in force for 180 days.
ANVISA will prioritize such proceedings and waive the presentation of documents required by the ANVISA RDC No. 185/2001 and ANVISA RDC No. 40/2015 if there is enough technical evidence of the product’s safety and efficiency. Moreover, such products will be exempt from certification by the Brazilian Conformity Evaluation System (SBAC).
Furthermore, in case of absence of the Good Manufacturing Practices Certification (CBPF), ANVISA will exceptionally accept the Medical Device Single Audit Program (MDSAP) Certification or an ISO 13485 Quality Management System Certification.
Concerning the requirement of presenting proof of register, free trade certificate or any other equivalent document (as set by the ANVISA RDC No. 185/2001), a simple declaration issued by the legal and technical responsible parties of the company informing the relevant product is regularized and traded in a jurisdiction member of the International Medical Device Regulators Forum (IMDRF) shall suffice.
Marketing authorizations, enrollment and notifications granted pursuant to the new ANVISA RDC No. 349/2020 shall be valid for one year, not subject to renewal. However, the nine remaining years in connection to the extension of the marketing authorization may be granted, in compliance with the current regulation, in case the interested company timely presents the documentation originally exempted.
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ANVISA PRIORITIZES COVID-19-RELATED PRODUCTS
updated on Mar 20 at 10:27 pm
On March 18, 2020, the National Health Surveillance Agency (ANVISA) published ANVISA RDC No. 348/2020, regulating the extraordinary criteria and procedures applicable to petitions applying for marketing authorization (MA) to drugs, biological products and products for in vitro diagnosis and post-MA modifications concerning drugs and biological products, due to public health emergency of international concern caused by the novel coronavirus.
For applications to obtain MA for drugs, the applicant needs to demonstrate that the case involves specific therapeutic indication to the prevention or treatment of the disease caused by the novel coronavirus (COVID-19) or in vitro diagnosis for SARS-CoV-2, whereas for petitions for post-MA modifications, it needs to be demonstrated that the case involves a drug that is (i) essential to support life or used in situations in which there is high risk to health and (ii) likely to be in short supply due to the coronavirus.
Post-MA modifications need to be directly connected to coronavirus and proved so by corresponding documents, being restricted to (i) substitution or inclusion of new manufacturer of the active pharmaceutical ingredient (IFA); (ii) substitution or inclusion of the drug manufacturing site; (iii) modifications regarding the methods of analysis applicable to the IFA or the drug; (iv) modifications regarding the IFA’s manufacturing process; (v) inclusion of new therapeutic indication or extension of the use of the drug; and (vi) extension of the expiration date of the drug. In case the MA holder identifies that the modification needs to be performed urgently and, thus, obtaining the documents for proof would be unreasonable, they may apply for a contingent approval before ANVISA, committing to present them in the future.
Specifically on destocking, ANVISA had already requested, by means of the Public Summon No. 5/2020, information from manufacturers and importers on which products could be in short supply in the market. In other words, ANVISA has been adopting measures continuously to assure there is enough stock of products indicated for acting against coronavirus.
In addition, by the recent Coronavirus Law (Law No. 13,979/2020), it is possible to authorize the importation of medicine which has not yet been registered in Brazil, if registered abroad and through an act of the Ministry of Health.