Glossary entry (derived from question below)
Spanish term or phrase:
autorización de agotamiento
English translation:
grandfathering authorization
Added to glossary by
Robert Carter
Sep 11, 2018 21:50
5 yrs ago
10 viewers *
Spanish term
Autorización de agotamiento
Spanish to English
Medical
Medical: Pharmaceuticals
Regulaciones
"La autorización de agotamiento es el permiso temporal que concede la autoridad sanitaria competente, para que el interesado agote, como su nombre lo indica, el producto o material de etiquetado o empaque cuya información difiere a la vigente, debido a la renovación, negación de la renovación, modificación y/o vencimiento del registro sanitario y/o a las disposiciones vigentes".
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Proposed translations
(English)
3 +2 | grandfathering authorization | Robert Carter |
4 | authorization to use up (product, labelling material, packaging) | Wilsonn Perez Reyes |
References
marketing authorisation | José Patrício |
Change log
Sep 25, 2018 05:27: Robert Carter Created KOG entry
Proposed translations
+2
4 hrs
Selected
grandfathering authorization
I can't find a specific reference to the term "grandfathering authorization" in this context, but grandfathering is the term for products already in the supply chain at the time new legislation enters into force regarding packaging requirements, etc. The US Government uses the term "grandfathering exemption", but perhaps the term "grandfathering authorization" or "product grandfathering authorization" would better explain the situation we have here, plus it differentiates it from US policy usage.
According to the ‘Grandfathering Policy’ guidance document, medical products that are packaged without a traceable product identifying 2D barcode before the DSCSA deadline of 27 November 2018, but are in the supply chain after that date, can continue to be distributed.
https://www.securingindustry.com/pharmaceuticals/fda-publish...
A package or homogenous case of product that is not labeled with a product identifier shall be exempted from certain requirements in section 582 (i.e., grandfathered) where there is documentation that it was packaged by a manufacturer before November 27, 2018.
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegula...
According to the ‘Grandfathering Policy’ guidance document, medical products that are packaged without a traceable product identifying 2D barcode before the DSCSA deadline of 27 November 2018, but are in the supply chain after that date, can continue to be distributed.
https://www.securingindustry.com/pharmaceuticals/fda-publish...
A package or homogenous case of product that is not labeled with a product identifier shall be exempted from certain requirements in section 582 (i.e., grandfathered) where there is documentation that it was packaged by a manufacturer before November 27, 2018.
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegula...
4 KudoZ points awarded for this answer.
Comment: "Selected automatically based on peer agreement."
2 hrs
authorization to use up (product, labelling material, packaging)
(to) use up = agotar
Peer comment(s):
neutral |
philgoddard
: I think this is right, but I also think there must be a better way of expressing it.
47 mins
|
Reference comments
2 hrs
Reference:
marketing authorisation
autorização de introdução no
mercado de um medicamento
which marketing authorisations have already been granted - https://ec.europa.eu/health/sites/health/files/files/eudrale...
[...]
the marketing
authorisation holder for an immunological veterinary medicinal product
https://www.linguee.com/portuguese-english/translation/medic...
mercado de um medicamento
which marketing authorisations have already been granted - https://ec.europa.eu/health/sites/health/files/files/eudrale...
[...]
the marketing
authorisation holder for an immunological veterinary medicinal product
https://www.linguee.com/portuguese-english/translation/medic...
Peer comments on this reference comment:
neutral |
Rachel Fell
: what has "agotamiento" to do with this?
1 hr
|
"agotamiento" means authorization
|
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