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date de naissance (du médicament)

English translation: birth date

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
French term or phrase:date de naissance (du médicament)
English translation:birth date
Entered by: Gabrielle Lyons

13:03 Sep 28, 2005
French to English translations [PRO]
Medical - Medical: Pharmaceuticals / pharmaceutical regulation
French term or phrase: date de naissance (du médicament)
"les rapports periodiques actualises (SPURs) peuvent etre soumis en prenant comme reference la date de naissance internationale ou europeenne du medicament."
Gabrielle Lyons
Local time: 14:44
birth date
Explanation:
"1. What is a Periodic Safety Update Report (PSUR)?
2. What is the difference between the International birth date (IBD) and the European birth date (EBD) of my medicinal product?"

http://www.emea.eu.int/htms/human/postguidance/1998403en.pdf
Selected response from:

Helen Genevier
France
Local time: 15:44
Grading comment
obviously perfect, so closing at once
thank you
4 KudoZ points were awarded for this answer



Summary of answers provided
3 +1birth date
Helen Genevier
4birth date
Martine Ascensio


Discussion entries: 2





  

Answers


10 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
date de naissance (du médicament)
birth date


Explanation:
"1. What is a Periodic Safety Update Report (PSUR)?
2. What is the difference between the International birth date (IBD) and the European birth date (EBD) of my medicinal product?"

http://www.emea.eu.int/htms/human/postguidance/1998403en.pdf

Helen Genevier
France
Local time: 15:44
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 289
Grading comment
obviously perfect, so closing at once
thank you

Peer comments on this answer (and responses from the answerer)
agree  Conor McAuley: Yes, http://www.google.fr/search?hl=fr&q="international birth dat...
2 mins
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12 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
date de naissance (du médicament)
birth date


Explanation:
international birth date (IBD)
DOC] CVM Guidance for Industry 142: Pharmacovigilance of Veterinary ...
Format de fichier: Microsoft Word 97 - Version HTML
Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary
Update ... Each VMP should have as an International Birth Date (IBD), ...
www.fda.gov/cvm/Guidance/dguide142.doc - Pages similaires

Safety reports - [ Traduire cette page ]
Safety reports for clinical trials of investigational medicinal products (CTIMPs).
... should be aligned with the International Birth Date for the product. ...
www.corec.org.uk/applicants/apply/safety.htm - 21k - En cache - Pages similaires
PDF] Regulatory Authorities Position Paper on Pharmacovigilance of ...
Format de fichier: PDF/Adobe Acrobat - Version HTML
development, authorization and sale of veterinary medicinal products. ... a) Each
VMP should have as an International Birth Date (IBD) the date of the ...
www.nzfsa.govt.nz/policy-law/ vich/guidelines/04005-in.pdf - Pages similaires

[PDF] PVMP : MPSUR (PSU )
Format de fichier: PDF/Adobe Acrobat - Version HTML
Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic ...
Each VMP should have as an International Birth Date (IBD), the date of the ...
vich.eudra.org/pdf/07_2001/gl29_st4.pdf - Pages similaires

[PDF] Guideline on the processing of renewals in the centralised procedure
Format de fichier: PDF/Adobe Acrobat
The European Agency for the Evaluation of Medicinal Products ... International Birth
Date and PSURs should be submitted with the following frequency: ...
www.emea.eu.int/pdfs/human/regaffair/299000en.pdf - Pages similaires

[PDF] Renewals of MAs for Veterinary Centrally Authorised Products
Format de fichier: PDF/Adobe Acrobat
The European Agency for the Evaluation of Medicinal Products ... International Birth
date or the EU Birth date and the subsequent cycle for such submission ...
www.emea.eu.int/pdfs/vet/press/pp/050700en.pdf - Pages similaires
[ Autres résultats, domaine www.emea.eu.int ]

THMRS - Pharmacovigilance - psur - [ Traduire cette page ]
Data lock points may be set according to the EU Birth Date of a medicinal product
or its International Birth Date. Each PSUR should cover the period of time ...
medicines.mhra.gov.uk/ourwork/licensingmeds/ types/thmpd/psurpharmacovigilance.htm - 9k - En cache - Pages similaires

[DOC] TEMPLATE FOR PSUR SUBMISSION
Format de fichier: Microsoft Word 97 - Version HTML
Name of the Medicinal Product. Marketing Authorisation Number ... INTERNATIONAL
BIRTH DATE (IBD): <Date>. PERIOD COVERED BY THIS REPORT: ...
medicines.mhra.gov.uk/inforesources/ infolicapps/licappforms/psurtemplate.doc - Pages similaires



Martine Ascensio
France
Local time: 15:44
Specializes in field
Native speaker of: Native in FrenchFrench
PRO pts in category: 24
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