http://portal.anvisa.gov.br/alimentos/processos-regulatorios.
Published new models for declaration of the holder about the product regularization
The National Health Surveillance Agency (Anvisa) published, at its website, new models for Declaration of the Holder about the Product Regularization (DDR), document that authorizes the importation of products by third parties. Check all the new models at: http://portal.anvisa.gov.br/registros-e-autorizacoes/portos-e-aeroportos.
Published new codes for renewal of certificate of correct manufacturing, distribution and storage of products
Since 06/18/2018, 11 new subject codes for renewal of Certificate of Correct Manufacturing for health, cosmetic and sanitary products and Certificate of Correct Distribution and Storage of health products request are available at Anvisa’s website. With this improvement, the distribution and analysis of renewal requests will be more efficient, giving that the renewal requests will now be considered as secondary petitions, linked to the last certification process issued by ANVISA.
Bar code becomes mandatory for traceability labels of stents and hip and knee implants
Becomes mandatory, under the terms of RDC No. 232/2018, the inclusion of a linear or two-dimensional bar code on traceability labels for single identification of stents for coronary arteries, pharmacological stents for coronary arteries, and implants for hip and knee arthroplasty. The traceability labels containing the bar code on medical device packaging must be made by the manufacturer or importer, and the failure to comply with such measures will constitute a sanitary infraction.
Anvisa publishes new rules about drugs and biological products outsourcing
Anvisa published, on 06/25/2018, the RDC No. 234, which provides for the outsourcing of production stages, analyzes of quality control, transport and storage of drugs and biological products. From that date, biological products will be characterized in such outsourcing procedures along with other drugs.
This resolution is applicable to manufacturers, packers, importers, distributors, logistics operators, carriers, warehouses and quality control laboratories for drugs and biological products, as well as outsourcing quality control analyzes of pharmaceutical inputs, for manufacturers of drugs and biological products.
From the publication of the resolution, and provided that the outsourcing contract is duly formalized and clearly defined under the terms of the RDC, all stages can be outsourced, which until then was not allowed.
In addition, the contracted entity may subcontract, in whole or in part, the object of the contract, if there is a prior assessment and approval by the contracting entity, a previously forbidden practice. Depending on the stage to be outsourced, the subcontracted entity must have the specific licenses and/or authorizations, when necessary.
Legislative committee approves new legislation on the registration and use of agrochemicals
The special committee of the House of Representatives approved on 06/25/2018, a report that changes the text of the legislation on the use and registration of pesticides in Brazil. To enter into force, the text still needs to be approved by a Plenary Session of the House of Representatives and then by the Senate. Then it follows to the presidential sanction.
The main changes are listed below:
1) agrochemicals come to be referred in law as “agricultural pesticides”;
2) the deadline to start production and marketing of the new product, given the registration, becomes two years;
3) temporary registration authorization may be granted for products already registered in three other OCDE countries that adopt the FAO code, even without the complete review by the Brazilian regulatory agencies;
4) the authorization of the registrations is now centralized in the Ministry of Agriculture – Anvisa and Ibama now only homologate the registrations;
5) authorizes the approval of products with teratogenic, carcinogenic or mutagenic characteristics, once proven the low risk;
6) predicts that the amounts collected with the registration evaluation fee may constitute resources to the Federal Agricultural Fund (FFAP);
7) the prior registration of the pesticide in a federal agency is limited to its active principle
8) the Federal Government will legislate on the destruction of packaging;
9) in the risk analysis, only products with “unacceptable risk” are now barred.
New law requires blue color cup for sugar-free drinks in the state of São Paulo
The Law No. 16.796/2018 requires that all commercial establishments in the State provide predominantly blue color disposable cups, with the visible inscription “zero sugar”, for use in soda machines. This measure is intended to avoid errors with diabetic customers.
New law in the state of Rio de Janeiro prohibits municipality of receiving medicines that are less than 80% of the validity limit date
After Law No. 6.378/2018 come into force, the municipality of Rio de Janeiro is prohibited from receiving medicines that have exceeded 20% percent of its validity in onerous purchases. This measure was created to reduce the waste of such products.
Waiting queue for the analysis of generic drugs registration requests will clear
Anvisa announced on 07/05/2018 that the waiting queue for the analysis of generic drugs registration requests will be eliminated until the end of August. According to Anvisa, the elimination of the queue is a consequence of the improvement of the registration analysis process and a series of strategies adopted to improve its performance, complying with the Law No. 13.411/2016, which provides transparency and predictability to the processes of concession and renewal registration and post-registration change.
New rules for regularization of personal hygiene products, cosmetics and perfumes are published
In accordance with RDC No. 237, published on 07/17/2018, the following products shall be considered as grade 2, (subject to registration): (i) suntan lotion, (ii) sunscreen, (iii) children’s sunscreen (iv) antiseptic hand gel, (v) hair straightening product, (vi) hair straightening and dyeing product, (vii) insect repellent, and (viii) children’s insect repellent.
The Resolution establishes several innovations in the process of regularization of mentioned products, such as the fact that the holder of a registered product may that wants to regularize it as exempt from registration should re-register it as such.
The standard comes into force 60 days after its publication, on 09/15/2018.
Resolution on procedures for importation, in character of exceptionality, of products subject to sanitary surveillance without registration in anvisa is republicated
According to the decision of Anvisa’s Board of Directors at a Public Ordinary Meeting (ROP 016/2018), held on 07/03/2018, the Resolution RDC No. 203/2017 was republished. Such resolution provides on the criteria and procedures for importation, in character of exceptionality, of products subject to sanitary surveillance without registration in Anvisa,. Now, in the list of products authorized for importation, the term “vaccines” has been changed to “immunobiological”, giving a wider range to other products, such as serum and immunoglobulin, for example.
Resolution that regulates the ethical specificities of clinical research of strategic interest for the SUS is published
The National Health Council (“CNS”) published the Resolution No. 580/2018 of the, which regulates the specificities of item XIII.4 of Resolution CNS No. 466/2012, on the ethical aspects of research of strategic interest to the System Unified Health System (SUS).
Among the innovations brought by the new standard, stands out that, from its publication, the researches considered of strategic interest for the SUS will be sent for initial appreciation in the National Commission of Ethics in Research (CONEP) and may have special treatment and urgency nature.
This differentiated procedure will be used for research protocols that address public health emergencies and/or that subsidize the implementation of health policies, actions, programs and services that respond to issues of public interest in the health area.
The standard also states that the researches should have its first evaluation carried out in up to 10 business days.
Bill of law in Minas Gerais prohibits use of animals in cosmetic tests
Bill of Law No. 23.863/18 of the Legislative Assembly of Minas Gerais (“ALMG”) prohibits the use in the State of animals for the development, experimentation and testing of perfumes and cosmetics and personal hygiene products and its components.
At first, the bill had been vetoed by the governor because, in his opinion, it is the responsibility of the National Council for the Control of Animal Experimentation (Concea) to deal with standards for the use of animals for testing, but in July, ALMG overturned the veto and forwarded the bill for promulgation by the governor.
