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Portuguese to English translations [PRO] Medical - Medical: Pharmaceuticals / special medicinal products
Portuguese term or phrase:com supressão de ativos
This is an ANVISA Resolution on the registration of medicinal products. This one phrase has me stumped. ("Ativos" refers to the active ingredients, of course.)
Para os medicamentos registrados em outras categorias, a adequação a esta Resolução deverá ocorrer no momento da renovação de registro do produto.
§ 1o Para as petições que estejam protocoladas na Anvisa, serão concedidas três meses para protocolo de adequações necessárias ao cumprimento do disposto nesta Resolução, contados a partir da data de sua publicação. § 2° Será aceita a adequação de formulações **com supressão de ativos**, desde que comprovada segurança, eficácia e qualidade para a nova formulação, nos termos desta Resolução. § 3o Serão concedidos 12 meses de prazo para protocolo das adequações que tratam do relatório de estabilidade para as novas formulações, a partir da data de publicação desta Resolução. § 4o Para os casos em que as alterações da formulação impliquem em novos estudos de segurança e eficácia para o medicamento, serão concedidos 18 meses de prazo para protocolo do relatório conclusivo, nos termos dispostos nesta Resolução, a partir da data de sua publicação.
Diretor-Presidente - Ministério da Saúde bvsms.saude.gov.br/.../saudelegis/...Translate this page Ministry of Health RESOLUÇÃO - RDC Nº 24, DE 14 DE JUNHO DE 2010. Dispõe sobre o registro de medicamentos específicos. A Diretoria Colegiada da Agência Nacional de ...
I did a Google search with: "Será aceita a adequação de formulações com supressão de ativos desde que comprovada segurança eficácia e qualidade para a nova formulação nos termos desta Resolução" between ("s) and I chose advanced options and Portuguese language sites
If you go to: www.bvsms.saude.gov.br/.../res0024_14_...and hit Translate this page you will get the whole ANVISA Resolution translated in a pretty good translation. I am wondering if someone used Google Translate or WordFast Anywhere to translate the Resolution online and then corrected the MT and the whole translation ended up in the online memory. Or maybe the computers really are getting smarter ;-]
Translation by the Google Search website (hit Translate this page)
§ 2 The suitability of formulations with the suppression of active ingredients will be accepted as long as the safety, efficacy and quality is proven for the new formulation, pursuant to this Resolution
Diretor-Presidente - Ministério da Saúde bvsms.saude.gov.br/.../res0024_14_...Translate this page Ministry of Health RESOLUÇÃO - RDC Nº 24, DE 14 DE JUNHO DE 2010. Dispõe sobre o registro de medicamentos específicos. A Diretoria Colegiada da Agência Nacional de ...
Great arguments except the original source language term is in Portuguese "supressão " and this whole discussion is an attempt to decipher what the author meant when he wrote the term in Portuguese. So giving English definitions of "Supression" mean nothing. and: sup·press səˈpres/ verb past tense: suppressed; past participle: suppressed partly or wholly eliminate Suprimir 2 tirar (uma parte) de (um todo); cortar; retirar Dic Houaiss
Supression = compelte elimination of the item. Just thought of a better solution for this. "The suppression of any active ingredient" or "fomulas that exclude any active ingredient". Using "any" may resolve the issue (?).
Suppression: Complete stoppage. It means that the formulation has a list of active ingredients registered in its license. If you prove that the suppression of one or two in the formulation poses no hazard and in no way affects the principal objective of the formulation, then only an ammendment of the license will suffice, as against having to apply for a new license should the formulation be considered too different from the original in terms of content and purpose.
>Asker: Actually, I was asking for further insight, considering the rest of the text. >Perhaps you could look at my discussion entries and let me know if you agree with >those interpretations.
To be very honest with you - I do not know what the writer of the original text meant to express. It could be the "Total elimination" of one of the active ingredients of a formulation - or it could mean "lesser quantities of an active ingredient" than in the original formulation. The problem is that the people who write these texts try to sound erudite, complicated, pompous etc - and forget to transmit the correct information clearly. The same thing happens with Technical Norms - you end up having to guess at what the writer really meant.
>I'm wondering if it might mean 'attenuated'. In the case of a vaccine it could also mean 'attenuated'.
Adapted formulas that (partially) exclude active principles may be accepted, provided the... I mean, you could add this "partially", but it's not in the original. So the ambiguity could be faithfully translated from the original as well, as it is ambiguous in PT as well.
it surely sounds like these products have several active principles, and the standard implies one or more of them may be removed, provided it doesn't affect the results of the treatment. So, you're absolutely right, you have to be careful not to sound ambiguous. Supression does mean elimination, so one could assume these products do have more than one active ingredient, and the standard is allowing the producer to eliminate one or some of them, but not all, for sure.
You've hit on one of the reasons why I posted the question--namely, that without the active principle/ingredient, it has no purpose, as you say. The suggestion you posted makes sense, but I hesitate to add a term that's not in the original, as legal documents are very delicate.
I'm also struggling with 'supressão' because, as Airmail has pointed out, it can mean eliminate *both* partly or entirely, and I doubt that the original intent was to be ambiguous. I'm wondering if it might mean 'attenuated'.
You put it either way, you'll give the idea that all active ingredients are suppressed, which is not the original idea, IMO. "Supressão de ativos" means some active ingredents or part of them may be excluded, but not all. A medicament without any active principle would have no effect. So the problem with your suggestions is the article "the", which gives the idea of "all" in this case.
Automatic update in 00:
Answers
4 hrs confidence:
formulas excluding (original) active principles
Explanation: I believe the item mentiones that new formulas excluding active principles from the original formula shall be accepted, provided they are safe and effective.
Mario Freitas Brazil Local time: 20:47 Native speaker of: English PRO pts in category: 8
-------------------------------------------------- Note added at 15 hrs (2014-08-10 01:53:41 GMT) --------------------------------------------------
>Thanks, Airmail. I'm curious: The literal translation doesn't make sense to me. >Could you explain?
I actually gave you two suggestions and the respective dictionary references.
airmailrpl Brazil Local time: 20:47 Native speaker of: English, Portuguese PRO pts in category: 32
Notes to answerer
Asker: Thanks, Airmail. I'm curious: The literal translation doesn't make sense to me. Could you explain?
Asker: Actually, I was asking for further insight, considering the rest of the text. Perhaps you could look at my discussion entries and let me know if you agree with those interpretations.
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