LEI 6437 ANVISA PDF

Once Protalix or its designee Fiocruz has successfully received Regulatory Approval for the Licensed Product, Protalix shall have the sole authority and exclusive right to determine all regulatory plans and strategies for the Licensed Product in Brazil; provided that Protalix or its designee Fiocruz shall reasonably consider any comments on such plans and strategies that Pfizer may communicate through the Steering Committee or otherwise. Eye Bank Association of America. Recycling or reuse of plastics Source: The absorb the amount generated in each area, and are constructed of material suitable for the type of waste they process and its significance are the main focus in this type are intended to collect. Food labeling, by informing consumers about the quality and amount of nutritional constituents of products, must contribute to promote appropriate food choices and be used as a nutritional education tool for the population. It also ,ei laundry services, preventive It is the responsibility abvisa the company in question to ensure and corrective maintenance of industrial kitchen that the Waste Management Plan WMP will be updated equipment, leisure, lodging and pantry.

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Faculdade de Medicina. AEMR: study design and planning, data interpretation, final revision of the manuscript, approval of the final version. To verify the compliance with Law No. This was a cross-sectional study conducted in We analyzed the compliance to attributes of the Law No.

All compliances and non compliances verified were described in absolute and relative frequencies. We identified non compliances with the Law No. Most promotion strategies were found at drugstore websites, which are the main channels for online sales. In , the World Health Assembly adopted the International Code of Marketing of Breast-milk Substitutes aiming to restrict inappropriate advertising and protect breastfeeding.

It was the first actual attempt to fight the damaging effects of the marketing of human milk substitutes, feeding bottles and teats. Along with the development of the Code, the International Baby Food Action Network IBFAN was created, with the main purpose of promoting and protecting breastfeeding, to benefit the health of infants and toddlers 2 , 3.

To achieve this goal, IBFAN conducts periodic monitoring to verify and report the compliance with the Code and to ensure more engagement of the industries, businesses and health professionals in self-regulation by the Code. IBFAN actively opposes any unethical advertisement or marketing action that may undermine breastfeeding 2. After 13 years, parameters were introduced to regulate the production and marketing of feeding bottles, teats and pacifiers, and the National Health Surveillance Agency ANVISA changed the legal status of NBCAL, turning it into a regulation — Enforcement 4 , Resolutions 5 and 6.

In , this Law was included in Decree No. For these products, commercial advertisements in any media is prohibited, including merchandising, written, audio or visual advertisements, and gifts, besides the most widely used media today, internet advertising 4.

The internet and the social media are currently used by manufacturers of breastmilk substitutes to promote their products. Studies on this topic are still incipient but likely to increase, as access to these media also increases 11 , Despite the substantial apparatus in the Brazilian constitution and in international policies, the practice of breastfeeding has become fragile. This is aggravated by the huge amount of information on the internet on matters related to health, breastfeeding and complementary feeding.

Currently, the internet is one of the largest and most important communication channels The data also showed that in the previous three months, Due to the increased access to the internet and to the growth of online sales in Brazil, it is important to know whether there are sales or discounts on these products on the websites of commercial formula manufacturers and of companies that sell them online. Thus, our objective was to verify the compliance with Law No.

This is a cross-sectional study with the objective of analyzing the Brazilian websites of formula manufacturers and drugstore networks. This study was not submitted to Research Ethics Committees because all data are publicly accessible, complying with the National Counsil of Health, Resolution number of c.

From September to November we searched for the websites and the studied the current Legislation Law No. We examined the promotion of formula for infants up to six months , follow-up formula infants aged six to 12 months and formula for young children child aged 12 months to 36 months old. Our sample was composed of websites of formula manufacturers and drugstore networks.

The selection of major drugstore networks was based on the survey of the largest companies in the country, carried out by the Brazilian Retail and Consumption Society SBVC in d. This survey ranked the top Brazilian retail companies which had grown more than the average growth presented by the retail industry in For the present study, we selected the 15 largest drugstore networks, of ten retail groups.

These companies were selected because they have physical stores in 26 Brazilian states After this selection, we verified if the websites of each drugstore were designed for online sales.

We searched for products of the same manufacturers on all drugstore websites. Out of these 15 networks, we chose the nine that had online shops. In this case, we selected the State of Minas Gerais, where the study was conducted. Euromonitor provides data on the infant formula market and confirmed their dominance for the year of However, since Euromonitor data are restricted, being necessary to pay to get access to complete data, we opted to use results from previous recent studies.

All data were extracted from the websites by the first author of this study and the data collection was conducted in three stages: 1 listing of all trademarks of infant formula sold in Brazil; 2 accessing the websites of each one, by their trade name, in the Portuguese language; 3 inspecting the conformity of marketing and promotion of infant formulas, according to IBFAN. The quantitative and qualitative data collected were fully based in attributes of Law No. The use of images of infants on formula packaging or websites is forbidden in Brazil, being seen as a strategy to persuade parents to buy the product.

The promotion of feeding formula for newborns and follow-up formula is forbidden. For this study, we selected the websites of five infant formula manufacturers and nine drugstores. The mandatory warning notice for this kind of product could be seen in the product illustrations in small boxes on their labels and at the end of the website, but they were not highlighted in a prominent manner, as required by law. The other three manufacturer brands did not have a specific section for infant formulas on their websites.

On the websites that sold infant formulas, the area of access to these products, unlike the other accessible areas, had no images of children, as required by law. In addition, none of the websites had advertisements of the infant formulas or images of children Table 1.

The compulsory warning statement for most of these products was not clearly displayed. The total of non compliances is shown in Table 1. The kind and number of non compliances of drugstore websites are described in Table 2. All drugstore websites showed some kind of non compliance. In the drugstore networks selected for our study, there was a great variety of products under the same brand of infant formula.

Of all drugstores examined, we found that The warning statement was displayed, but not in a conspicuous manner, as stipulated by the law. Another important issue observed during data collection was the absence of images of children on all drugstore websites Table 2. However, we observed that for other foods, such as milk-based foods, complementary foods, and infant purees and products, there was an excessive use of images of children and wording designed to persuade parents to buy these food products for their children.

Regarding the promotion of other foods on the drugstore websites, the mandatory warning statement only appeared in Figure 1 summarizes the non compliances found in the drugstore websites. When conducting the research, we found a considerable difference between the number of infant formulas shown in the websites of drugstores and manufacturers Table 3. In this study, we found at least one non compliance with the legislation on the websites of infant formula manufacturers.

None of these websites promoted these products, and two of them used a pop-up notice to inform consumers that they do not promote infant formulas. They also did not sell products online, but provided links to other websites that sold formulas.

Most non compliances were identified at drugstore websites, maybe because the online sales are their main purpose. The Law No. We believe that this recommendation does not support the parents and the society to continue breastfeeding practices after 12 months. The analysis presented in this study is still not found in the literature, but it is well established that there are new means of promotion using the Internet.

A report by the WHO mentions that in Brazil infant and young children foods are promoted on social media because the current restrictions do not cover this means of communication 1. As aforementioned, Law No. However, they have no specific description of online sales on websites of drugstores, supermarkets, formula manufacturers or other establishments that display these products.

Decree No. In our interpretation, the irregularities found in this study fit into indirect advertising both by infant formula manufacturers and drugstores.

Manufacturers, distributors and importers are responsible for informing its commercial representatives and hired advertising agencies about the conditions of this Decree 8. Ten out of eleven of these trademarks had a presence on social media. The target audience of the messages being promoted was composed of pregnant women and mothers. This kind of marketing somehow exempts companies from the compliance with the legislation, since it is not the company itself that advertises, but the established social media.

In this case, the manufacturers and distributors are responsible for failing to meet the legal requirements for the promotion of their products. It is likely that the exposure, sales, and price reductions of infant formulas in drugstores are defined by manufacturers.

Promoting and supporting breastfeeding and child health are the goals of IBFAN, so it should contact contravening companies and inform them of the need to end unethical marketing strategies. Abrahams 15 emphasized the need for institutions engaged in promoting and protecting breastfeeding to pay special attention to new promotion strategies developed by manufacturers of human milk substitutes, monitoring them on social media.

Independently of the media used in the promotion, it can involve strategies described in the literature, like cross-promotion. This marketing practice makes it possible to use promotional means and activities in the specific environments of one product to advertise another without the costumer noticing 1.

This practice occurs due the loopholes in the current legislation. In order to decrease the promotion of these products, other items that are not currently covered could be included in the regulations We identified three main limitations of our study.

The first is that we restrained our website search to the biggest drugstores, using the SBVC Ranking. There are other smaller drugstores that sell products on their websites which we did not analyze. The second is the impossibility of assessing the percentage of products sold through the websites of manufacturers and drugstore networks. The last is the impossibility of assessing the percentage of pregnant women and mothers that access these two sources of formula: the websites of infant manufacturers and drugstores.

It is possible to see the promotion of infant formula both on the websites of manufacturers and on those of retail drugstore networks. Regarding the manufacturers, although there were warning statements in pop-ups when we searched for infant formulas in them, attention was drawn to the products.

Our study showed that almost all the websites of infant formula manufacturers presented some kind of non compliance with the Law No. The main non compliance identified on these websites was connected to advertising and sales. Our results are relevant, helping policy markers to monitor and evaluate the compliance with Law No. Santiago de Chile; cited Dec Diario Oficial Uniao. As maiores empresas do varejo brasileiro.

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Faculdade de Medicina. AEMR: study design and planning, data interpretation, final revision of the manuscript, approval of the final version. To verify the compliance with Law No. This was a cross-sectional study conducted in We analyzed the compliance to attributes of the Law No. All compliances and non compliances verified were described in absolute and relative frequencies.

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