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This question was closed without grading. Reason: Resposta encontrada em outro lugar
Aug 9, 2014 10:36
9 yrs ago
3 viewers *
português term

com supressão de ativos

português para inglês Medicina Medicina: farmacêutica special medicinal products
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.
Proposed translations (inglês)
4 formulas excluding (original) active principles
4 formulations with suppressed active ingredients

Discussion

Muriel Vasconcellos (asker) Aug 12, 2014:
@ Airmail Thannks!
airmailrpl Aug 12, 2014:
bvsms.saude.gov.br/bvs/saudelegis/anvisa/2011/res0024_14_06_2011.html
airmailrpl Aug 12, 2014:
once more http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2011/res0024...
airmailrpl Aug 11, 2014:
once again 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
Muriel Vasconcellos (asker) Aug 11, 2014:
@ Airmail Could you post the link again? It got scrambled.
airmailrpl Aug 11, 2014:
If you.. 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 ;-]
Muriel Vasconcellos (asker) Aug 11, 2014:
@ Airmail That's a pretty good translation for a machine. I'm impressed.
Muriel Vasconcellos (asker) Aug 11, 2014:
@ Mario Here I am. Following the discussion and appreciating everyone's input. Based on what everyone has said, I'm now leaning toward:

'with suppression of one or more active ingredients'

The original doesn't have an article, so this is not really much of a departure.
airmailrpl Aug 10, 2014:
Translation by the Google Search website (hit .. 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 ...
Mario Freitas Aug 10, 2014:
@ Muriel, K-dê você?
airmailrpl Aug 10, 2014:
Great arguments except 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
VERLOW WOGLO JR Aug 10, 2014:
suppress, remove, eliminate, annul, cut, etc from the list of active ingredients reported for the formulation in the drug license application or record with the Anvisa.
Mario Freitas Aug 10, 2014:
Agree with Verlow, 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 (?).
VERLOW WOGLO JR Aug 10, 2014:
suppression 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.
airmailrpl Aug 10, 2014:
further insight >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'.
Mario Freitas Aug 10, 2014:
... 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.
Mario Freitas Aug 10, 2014:
I can't be sure, but 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.
Muriel Vasconcellos (asker) Aug 10, 2014:
@Mario 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'.
Mario Freitas Aug 10, 2014:
If 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.

Proposed translations

4 horas

formulas excluding (original) active principles

I believe the item mentiones that new formulas excluding active principles from the original formula shall be accepted, provided they are safe and effective.
Something went wrong...
6 horas
português term (edited): formulações com supressão de ativos

formulations with suppressed active ingredients

formulações com supressão de ativos => formulations with suppressed active ingredients

Alternative:
formulations with lesser quantities of active ingredients

sup·press
səˈpres/
verb
past tense: suppressed; past participle: suppressed
partly or wholly eliminate

§ 2º 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.
http://www.brasilsus.com.br/legislacoes/gm/108468-24.html?q=


--------------------------------------------------
Note added at 6 hrs (2014-08-09 17:23:24 GMT)
--------------------------------------------------

suprimir
2
tirar (uma parte) de (um todo); cortar; retirar
Dic Houaiss

--------------------------------------------------
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.
Note from asker:
Thanks, Airmail. I'm curious: The literal translation doesn't make sense to me. Could you explain?
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.
Something went wrong...
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