On February 11, 2015, the Brazilian Health Surveillance Agency (ANVISA) published Resolution 07/2015, updating the requirements for registration of cosmetics, personal care products and perfumes.
The resolution, which entered into force in late February, aims at simplifying and speeding up the registration process for these products. Therefore, products covered by the new resolution will be exempt from registration before ANVISA, although they will still be subject to prior notification to the agency informing about marketing intention.While the registration process needs about 60 days to complete, the advance notification to ANVISA for registration-free products will take only about 48 hours.
Products not covered by the resolution, and that still have to be registered with ANVISA due to their higher health risk,include tanning, hair straightening and sunscreen products, as well as insect repellents, antiseptic hand gels and children’s products.
This new measure does not modify the safety requirements for cosmetics, personal care products and perfumes, as these products will still be monitored through periodic and random verification of processes, market surveys and analysis of products available on the market.
Source: http://portal.anvisa.gov.brRead More
The Brazilian Health Surveillance Agency (ANVISA) published in October the Resolution of Executive Direction (RDC) No 59/2014 that sets the rules for naming drugs and defines important terms such as “modifiers” or “umbrella trademarks.”
The resolution, which came into force upon publication,repeals a 2003 ANVISA Resolution on the labeling of medicines, which then included a requirement for a new drug name to differentiate in at least three letters from any other similar registered drug name in order to avoid confusion. Instead, the new Resolution 59/2014 states that in order to be accepted a new drug name “must be graphically and phonetically different enough with regard to other registered drug names.”
The resolution applies to all products subject to registration or simplified notification, except for generic and immunotherapy pharmaceuticals. However,it is not mandatory for pharmaceuticals already registered with ANVISA to request the adjustment of their trademarks in order to comply with the resolution.
If you want to read the complete resolution, please click here.
Source: http://sinfar-rj.org.brRead More
The recent publication of resolution (RDC) 60/2014 updates and harmonizes the technical criteria of quality, safety and efficacy for the registration of drugs classified as new, generic and/or similar. The rule replaces Resolutions RDC No. 136/2003, 16/2007 and RDC No. 17/2007.
As a starting point for the harmonization and updating of standards, the resolution takes into consideration ongoing problems that were not addressed by existing regulation. This change also was required for the implementation of the electronic drug register of the Brazilian Health Surveillance Agency (ANVISA).
Source: http://www.anvisa.gov.brRead More
On August 2, 2014, the first Seminar about Regulation of Pharmaceutical Products and Medical Devices in Brazil and Japan began in the city of Sao Paulo. The event was aimed at sharing experiences and knowledge related to sanitary surveillance in both countries, establishing cooperative actions regarding Brazilian and Japanese pharmacopoeias, exchanging of information concerning working routines to speed up the registration procedures of drugs and health products, etc.
The main topics addressed in the seminar were drug and medical device regulation, Good Manufacturing Practices, biological products, pharmacopoeia, pharmacovigilance, technological vigilance and regulation/supervision of ports, airports and borders.
Source: http://portal.anvisa.gov.brRead More
Regarding the existing conflict between ANVISA and the BPTO on the examination of pharmaceutical patent applications; civil action filed for the nullity of the Legal Opinion 210/PGF/AE/2009 was dismissed.
The Civil action was filed by the District Attorney. The decision issued on September 2013 has the same arguments as the interlocutory appeal Nr. 20120201008196; which declares ANVISA prior consent to the determination of whether patent applications regarding pharmaceutical process and products may be harmful to human health. The District Attorney may appeal this decision.
To understand the conflict it is worth mentioning the following facts:
– Law 9279/96 gives ANVISA the right to issue a prior consent for the granting of patent applications regarding pharmaceutical processes and products. Therefore ANVISA established in a Resolution the requirements needed.
– Legal Opinion Nr. 210 declares that the District Attorneys Office understands that the objective of a prior consent by ANVISA is to avoid the production and marketing of products that are potentially harmful to human health and not to analyze the patentability requirement.
Source: www.anvisa.gov.brRead More
Next September 24th, the authority in charge of the regulation of pharmaceutical products in Brasil (ANVISA) will conduct a public hearing in order to discuss applicable criteria for drug trademarks in the future.
The aim of this meeting is to minimize false interpretations, errors or confusions concerning origin,nature,composition or quality of drugs. In 2010, the first version of the proposal had been submitted to public consultation, which made it possible to advise the interested parties on this topic.
One criterion suggested by ANVISA is that trademarks must observe sufficient graphic and phonetic distinction from previously registered drugs, food and cosmetics. Furthermore, it proposes that drug trademarks shall preferably consist of one single word with Portuguese pronunciation directly related to its spelling.
It is also discouraged the use of prefixes or suffixes of scientific denominations that are distinctive for different chemical classes of medicine; abbreviations, single letters or arbitrary series of letters without evident meaning for the consumer, or words or expressions that can induce to one’s comprehension that the drug products are harmless, natural, free from or with little collateral damages. The trademark should not suggest superior quality than real or special properties not sufficiently proved, neither induce to self-medication.
Moreover, it indicates that the recognition of a certain trademark by the Brazilian PTO does not imply an automatic right to use it in the sanitary registration granted by ANVISA.
Source: ANVISARead More
ANVISA – RDC 30/2012
The Brazilian Agency follows the new standards for sunscreens adopted by Member Countries of Mercosur. This Resolution states that the minimum value of Sun Protection Factor (SPF), which measures protection against UVB rays, will go from 2 to 6 and the protection against UVA must be at least a third of the value of the SPF stated on the product.
The new rules also increase the levels of testing required to prove the effectiveness of the shield. Claims such as “water resistance” will have to be proved by specific methodologies defined in the text. Manufacturers are allowed to indicate the terms “water resistant”, “extra water resistant”, “water/sweat resistant” or “water/perspiration resistant” on their labels only if they prove such characteristics.
Sunscreen labels are also subject to changes in the required information. All sunscreen labels must give guidance on the need for reapplication, even the most resistant to water. Furthermore, any claim of a 100% protection against solar radiation or any indication that the product has not to be reapplied is forbidden.
The deadline for the manufacturers to meet the new standard is two years.