Glossary entry

Spanish term or phrase:

Periodo de validez

English translation:

shelf life

Added to glossary by sebaspedlp
Dec 31, 2016 00:45
7 yrs ago
16 viewers *
Spanish term

Periodo de validez

Homework / test Spanish to English Medical Medical: Pharmaceuticals trabajo para facultad
6.3 Periodo de validez
24 meses.

6.4 Precauciones especiales de conservación
Consérvese en lugar fresco y protegido de la luz a temperatura no mayor a 25º C.
6.5 Naturaleza y contenido del recipiente

Podría ser ¿Shelf-life? o ¿validity period?

http://www.proz.com/kudoz/spanish_to_english/medical_general...

http://www.proz.com/kudoz/spanish_to_english/medical_pharmac...

es la descripción de un medicamento el resumen de como fue realizado

He leído esto entre otras cosas pero sigo sin entender cuál sería la correcta, muchas gracias

Proposed translations

+3
37 mins
Selected

shelf life

Agree with one of your interpretations.
Note from asker:
Thank you so much
Peer comment(s):

neutral Muriel Vasconcellos : 'Shelf life' is not legally binding. The validity period of a drug is based on an approval process.
40 mins
agree Andy Watkinson
1 hr
Thank you, Andy.
agree Anne Schulz : "shelf life" is what is used in EMA templates, and this text looks suspiciously like an EMA product information
5 hrs
Thanks, Anne.
agree Robert Carter : Anne's reference seals the deal for me - it's an exact match.
16 hrs
OK, thanks Robert.
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4 KudoZ points awarded for this answer. Comment: "Thank you so much! Happy new year!"
1 hr

validity period/approval duration

If it's followed by a date, we say 'expiry/expiration date' or 'valid until', but since it's expressed in months, then it's 'validity period' in pharmaceutical terminology.

'Shelf life' is vague; it's what you would see on a loaf of bread. Here you're talking about the approval process and the period for which the drug is approved and allowed to be sold.

See: http://www.linguee.com/english-spanish/search?source=auto&qu...

Examples:

About 168,000 results (0.32 seconds)
Search Results

Frequently Asked Questions Injectable Drug Program - Moda Health
https://www.modahealth.com/pdfs/faq_injectables.pdf
For drugs other than those included on posted list, prior authorization requirements and .... The **approval duration or validity **depends on the medication.

https://www.ncbi.nlm.nih.gov/pubmed/16460606
by I De Giorgi - ‎2005 - ‎Cited by 2 - ‎Related articles
**Sterility validity period of vials** after multiple sampling under vertical laminar ... Drug Packaging/methods; Drug Packaging/standards*; Environmental Monitoring/ ...

https://books.google.com/books?isbn=1420020021
Isadore Kanfer, ‎Leon Shargel - 2016 - ‎Medical
If any drug does not fall under the ambit of a new drug, licenses could be issued by the state licensing authority. ... **Increased validity period of license**. 3.

Registration renewal of imported drugs (incl. pharmaceutical products ...
eng.sfda.gov.cn › Home › Regulatory Guide
I. Project name: Imported Drug Registration. II. ... Copies of "Imported Drug Registration Certificate" or "Pharmaceutical .... (4) **Shortened validity period of drugs**;

Note from asker:
Thank you!
Peer comment(s):

neutral Andy Watkinson : Several of your references would appear to be used when referring to licence/license validity periods. Not the same.
55 mins
Only one of the four refers to the license.
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Reference comments

2 hrs
Reference:

FDA - Shelf life

The best way to verify long-term stability would be to stockpile supplies, let them sit for years, and even decades, and then test them. My American colleagues can thank their government for doing just such testing- the Department of Defense/FDA Shelf Life Extension Program has been in place for over 20 years.

https://sciencebasedmedicine.org/the-drug-expiry-date-a-nece...

Again, FDA:
On the Shelf Life of Pharmaceutical Products
https://www.ncbi.nlm.nih.gov › NCBI › Literature › PubMed Central (PMC)
by R Capen - ‎2012 - ‎Cited by 12 - ‎Related articles
Jun 23, 2012 - Since 1979, the Food and Drug Administration (FDA) has required that all prescription drugs have a shelf life (or expiration date) indicated ...
Note from asker:
Thank you so much! HAppy new year!!
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6 hrs
Reference:

EMA templates

Your text does look like a medicinal product information based on the templates from the European Medicines Agency EMA. Their templates are available in all European languages on http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation... and are binding for all marketing authorization applications and procedures.

(Scroll down and select "QRD product-information template version 10" in the language of your choice from the drop-down menu).
Note from asker:
Thank you so much! Very helpful!! Appreciate your help!! Happy new year!
Peer comments on this reference comment:

agree Robert Carter : Thanks for your insight, Anne, happy new year!
11 hrs
Thank you Robert, happy new year to you, too!
Something went wrong...
7 hrs
Reference:

More on "shelf life"

"Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
[...]
4. Use of terms
The following working definitions or explanations are offered for a number of the terms used in this text. [...]
Shelf-life (expiration dating period or validity period): The period of time during which a drug product is expected, if stored correctly, to remain within specification as determined by stability studies on a number of batches of the product. The shelf-life is used to establish the expiry date of each batch."
http://apps.who.int/medicinedocs/en/d/Jh1813e/3.2.4.html

"UNICEF
Technical Requirements for Pharmaceutical Products
[...]
Shelf life and Storage
1. The assigned shelf life and recommended storage conditions should reflect the outcome of stability studies, as per WHO guidelines and be printed on labels and leaflets. Acceptable temperature excursions should be specified."
https://www.unicef.org/french/supply/files/UNICEF_Technical_...

I think either "shelf life" or "validity period" would be acceptable.
Note from asker:
Thank you so much for your help! Happy new year!
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