By Mariana Chacoff and Sarah Santana
The global COVID-19 pandemic outbreak has been crushing the global public health and the economy throughout the world since the beginning of the year, when the coronavirus started spreading from China to different regions and countries.
Public policies are being structured to minimize the negative impacts in many different areas, as well as to guarantee conditions to continue fighting the disease while keeping the economy alive.
ANVISA, the Health Surveillance Agency of the Brazilian Ministry of Health, is taking the lead regarding measures concerning sanitary control of production and consumption of products in need of health surveillance. These measures address the processes, inputs and technologies related to these products, as well as the control of ports, airports, borders and customs enclosures.
A set of measures in the past weeks facilitated procedures from drug testings to importing and exporting of products, through temporary mechanisms for certifying good practices within the framework of registering active pharmaceutical inputs, medicines and health products. The main actions relevant to exporting companies are:
- Notice: RDC 356/2020
Objective: Simplifying the requirements for manufacturing, importing and purchasing priority medical devices for use in healthcare services.
What it means in practice:
- Producers and importers are excused from obtaining the Company Operation Authorization (“Autorização de Funcionamento de Empresa – AFE”) and from notifying activities to Anvisa, as well as other sanitary authorizations.
- The products covered by the new rules include surgical masks, goggles, face shields, N95 respirators, PFF2 or equivalent protection masks, and disposable hospital garments (waterproof and non-waterproof aprons and cloaks). Products such as valves, caps and props (disposable shoes), as well as breathing circuits and connections, also entered the list.
- The rules do not exempt companies from other obligations relating to the control of medical devices, as well as their technical standards.
Valid for: 6 months
- Notice: RDC 349/2020
Objective: Prioritize and expedite the analysis and regularization of personal protective equipment (PPE), pulmonary ventilators, and other strategic medical devices.
What it means in practice:
- For cases in which the producer does not yet have Anvisa’s Good Manufacturing Practices Certificate (“Certificação de Boas Práticas de Fabricação”), Anvisa will accept the Medical Device Single Audit Program certification (MDSAP) or Quality Management System Certification ISO 13485 as a substitute.
- Also, the proof of registration, free trade certificate or equivalent document required pursuant to the Brazilian legislation may be replaced by a written statement1 issued by the requesting company’s legal and technical responsible personnel. The statement should declare that the product is regularized and commercialized in a member of the International Medical Device Regulators Forum (IMDRF).
- The conditions mentioned above are also applicable to requests for changing the manufacturer/producer of medical devices.
- The products subject to these rules are also exempt from having certification within the framework of the Brazilian Conformity Assessment System (SBAC).
- Registers granted upon the provisions of the notice will be valid for one year from its publication.
- The regularization requests should still be based on documentation provided under RDC 185/2001 and RDC 40/2015.
- The declarations necessary for the requests for registration and notification of these products are exempt from legalizations or apostiling. If documents are in English or Spanish language, there will be no need for a sworn translation.
Valid for: 180 days
- Notice: RDC 348/2020
Objective: Expand alternatives for the prevention, treatment and detection of the disease, and avoid shortages of products.
What it Means in Practice:
This decision defines norms to expedite the analysis of registration requests for medication and biological products used for the prevention and treatment of the new coronavirus. Rules also involve the tolerance for changes after the registration, i.e., whenever the company makes adjustments to the original medication or biological product. Anvisa also established norms regarding the registration of products for performing laboratory diagnosis of the virus (in vitro).
Companies are ONLY allowed to request registration based on this facilitated process if there is a clear risk of shortage for such medications and biological products with impact to the public health and that the benefit-risk relation is favourable to approval.
Post-registration changes for medicines and biological products:
Upon the presentation of a Term of Commitment following RDC 317, 2019, Anvisa may allow for:
- the replacement or inclusion of a new manufacturer of the active pharmaceutical ingredient (“API”), or of a new therapeutic indication or expansion of use related to the treatment, prevention and control of complications resulting from COVID-19, and of the manufacturing site, as well as for
- changes related to the API or drug analysis methods that are not immediately implemented, to the API production process, and, finally,
- an extension of the shelf life of drugs whose stability studies are completed.
Anvisa will dispose of 30 days to respond to such request.
Registration of medicines and biological products:
- These requests may be deferred by further supplementation of data and additional proofs through a Term of Commitment (based on RDC 317/2019). For an importer to request an amendment to the petition, it should submit as annexes to it (i) a term of commitment signed by the importer’s technical responsible or legal representative, (ii) a detailed schedule for submission of additional data and proofs; and (iii) a risk assessment made by the requesting company to show favourable benefit-risk relation to the approval of the request.
- The amendment may be filed anytime before the technical analysis of the request.
- Electronic/digital signatures are allowed for all documentation.
Product registration for in vitro diagnosis: The absence of any performance study or data restriction must be justified with technical reasons that allow for the assessment of the results’ reliability and the product’s diagnosis effectiveness .
Registers granted upon the provisions of the notice will be valid for one year from its publication, except for products included in the situation which stability assessment is presented by comparison with like products and in compliance with other criteria described in the regulation (under art. 11 of this provision).
The labelling of the products must contain the wording: Approved for Emergency Use (“Aprovado para Uso Emergencial“) until the registration change is approved.
For cases in which the company does not comply with the obligations set out in the term of commitment, it will be subject to: (i) in the case of post-registration changes, the cancellation of the post-registration change and/or the suspension of the production or import of the medication until it is regularized; and (ii) in the case of registrations, the cancellation of the registration and/or suspension of the production of the medication until it is regularized.
Valid for: 6 months