Periodo de validez

English translation: shelf life

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Spanish term or phrase: Periodo de validez
English translation:shelf life
Entered by: sebaspedlp
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00:45 Dec 31, 2016
Spanish to English translations [PRO]
Medical - Medical: Pharmaceuticals / trabajo para facultad
Spanish term or phrase: Periodo de validez
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
sebaspedlp
Argentina
Local time: 00:22
shelf life
Explanation:
Agree with one of your interpretations.
Selected response from:

Barbara Cochran, MFA
United States
Local time: 23:22
Grading comment
Thank you so much! Happy new year!
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +3shelf life
Barbara Cochran, MFA
4validity period/approval duration
Muriel Vasconcellos
Summary of reference entries provided
FDA - Shelf life
Andy Watkinson
EMA templates
Anne Schulz
More on "shelf life"
Charles Davis

  

Answers


37 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +3
shelf life


Explanation:
Agree with one of your interpretations.

Barbara Cochran, MFA
United States
Local time: 23:22
Native speaker of: Native in EnglishEnglish
PRO pts in category: 4
Grading comment
Thank you so much! Happy new year!
Notes to answerer
Asker: Thank you so much


Peer comments on this answer (and responses from the answerer)
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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1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5
validity period/approval duration


Explanation:
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**;



Muriel Vasconcellos
United States
Local time: 20:22
Works in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 255
Notes to answerer
Asker: Thank you!


Peer comments on this answer (and responses from the answerer)
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

Reference information:
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 ...

Andy Watkinson
Spain
Native speaker of: Native in EnglishEnglish
Note to reference poster
Asker: Thank you so much! HAppy new year!!

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6 hrs peer agreement (net): +1
Reference: EMA templates

Reference information:
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).


    Reference: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation...
Anne Schulz
Germany
Specializes in field
Native speaker of: German
PRO pts in category: 19
Note to reference poster
Asker: Thank you so much! Very helpful!! Appreciate your help!! Happy new year!


Peer comments on this reference comment (and responses from the reference poster)
agree  Robert Carter: Thanks for your insight, Anne, happy new year!
11 hrs
  -> Thank you Robert, happy new year to you, too!
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7 hrs
Reference: More on "shelf life"

Reference information:
"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.

Charles Davis
Spain
Native speaker of: Native in EnglishEnglish
PRO pts in category: 124
Note to reference poster
Asker: Thank you so much for your help! Happy new year!

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