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New Pharmaceutical Labeling Rules Proposed in Brazil
By Keith R | April 10, 2009
Topics: Consumer Protection, Pharmaceutical Issues | No Comments »
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Brazil’s National Sanitary Vigilance Agency (ANVISA) is proposing changes in package labeling rules for pharmaceuticals sold in that country (as set out in ANVISA Resolution RDC 333/03) with a view to making pack labels more informative to consumers. For example, the proposals released for public consultation (until 11 May) would make medicines with a sedative effect bear a warning symbol and the words “do not drive.” Among the other things the draft rules would change include:
- Composition List: Labels would have to list all medicine ingredients — qualitatively and quantitatively for active ingredients, and qualitatively for excipients. Current rules only require listing of active ingredients.
- Manufacture Date, Expiry Date, Lot Marking: Current rules essentially allow for these to be printed on packages in any way the producer chooses, as long as they are present. The proposed new rules would no longer allow relief printing (embossing or debossing) for such information, and sets font and type rules aimed at making this information easier to find on packs.
- Accessibility: Current rules permit the inclusion of information in Braille. The proposed changes would require the provision of certain information — name of the active ingredient(s), concentration, pharmaceutical form, consumer service (SAC) contact information — that would enable a consumer to request a special package insert in Braille.
- Black Box Safety Warnings: The proposed rules will enable ANVISA to demand so-called “black box” safety alerts (a warning bordered by a black box in order to draw attention to it) on possible adverse reactions on secondary and/or primary packaging. Existing rules do not treat this issue.
- Storage Instructions: Current rules call for discussing appropriate temperature and storage conditions for pharmaceuticals on their packaging, but do not specifically address any special instructions for once a package is opened. The new rules would require such instructions to be included on packaging if post-opening conditions are different.
- Commercial Names: The new rules would not allow expressions that suggest therapeutic indications such as “plus,” “Max,” “forte” (strong), etc. , in newly registered drugs, and would require their removal from drugs that have them when their registration is renewed.
- Identification: Current rules permit use of Brazilian Common Names (Denominação Comun Brasileira – DCB), and optionally the International Nonproprietary Name (INN) or Chemical Abstracts Service (CAS) registry number. The new rules would allow only the DCB.
- Figures on Packages: Currently figures are allowed on drug packages in Brazil as long at they do not prompt errors. The new rules would only allow certain types of figures — those indicating how to use the medicine, anatomical figures, or in the case of phytotherapeutics of plant origin, a figure indicating that origin. Figures of promotional or advertising nature would be prohibited.
- Company logos: Current rules allow only the logo of the registrant. The new rules would allow the logos of all companies involved in the chain (manufacture, distribution, importation, etc.)
- Conflicting trademarks: currently trademarks are only verified for use when a drug is first registered, and not at other points, such as registration renewal. The new rules would require that whenever a conflict between marks is found, a change must be made, with the mark registered longer with Brazil’s National Industrial Property Institute (INPI) prevailing.
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Desde a Agência Nacional de Vigilância Sanitária (ANVISA):
Embalagens de medicamentos ser ão mais informativas
As embalagens de medicamentos vão ficar mais informativas. Uma proposta da Anvisa quer incluir, por exemplo, nos medicamentos com efeito sedativo, um símbolo de alerta, acompanhado da expressão “não dirigir”. As embalagens também deverão trazer informações em braile (nome do ativo, concentração, forma farmacêutica e SAC), para garantir a acessibilidade ao produto.
Essas e outras alterações sugeridas pela Consulta Pública nº08/2009 recebem contribuições até o dia 11 de maio. O objetivo da CP é que a rotulagem permita a identificação adequada do medicamento durante sua dispensação e uso, e oriente sobre o armazenamento adequado dos produtos, bem como quanto ao uso seguro do medicamento, com a disposição de informações e advertências que se fazem necessárias para o uso racional.
“A proposta foi feita para solucionar problemas que vêm sendo identificados no mercado e reclamados tanto pela população quanto por associações do setor”, afirma o diretor-presidente da Anvisa, Dirceu Raposo de Mello. “O objetivo é tornar as informações da embalagem do medicamento mais claras e úteis para o cidadão”, ressalta.
O documento também propõe que informações que já figuram nas bulas também sejam colocadas nas embalagens, tais como substâncias presentes no medicamento e mudanças nos cuidados de conservação após a abertura do produto. “Essas mudanças são importantes para que pessoas que têm alergia a algum componente da fórmula saibam disto antes de abrir a embalagem”, completa Raposo.
As contribuições podem ser enviadas pelo fórum virtual de discussão ou por meio de um formulário próprio. O formulário deve ser encaminhado para o email cp.rotulagem@anvisa.gov.br, fax: (61) 34625428, ou por correio para: Agência Nacional de Vigilância Sanitária, Gerência Geral de Medicamentos – Setor de Indústria e Abastecimento (SIA), Trecho 05, Área Especial nº 57, Brasília – DF, CEP: 71.205050.
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