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KudoZ home » French to English » Medical: Pharmaceuticals

faire suit à la révision du CEP

English translation: is due to revision of the CEP (European Pharmacopoeia certificate of suitability)

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
French term or phrase:faire suit à la révision du CEP
English translation:is due to revision of the CEP (European Pharmacopoeia certificate of suitability)
Entered by: Jonathan MacKerron
Options:
- Contribute to this entry
- Include in personal glossary

02:21 Nov 7, 2007
French to English translations [PRO]
Medical - Medical: Pharmaceuticals
French term or phrase: faire suit à la révision du CEP
"...la modification proposée corréspond à une modification de type IA no. 15 et non à une modification de type IA no. 4 car la modification du nom du producteur *fait suite à la révision du CEP*."
Don't quite grasp the practical implications of this phrase - thanks in advance for your suggestions.
J.
Jonathan MacKerron
is due to revision of the CEP (European Pharmacopoeia certificate of suitability)
Explanation:
CEP is certificat de conformité à la Pharmacopée Européenne or certificate of suitability.

Lots of info about the CEP here, and you can see that it is left as CEP in English: http://www.edqm.eu/site/News_and_General_Information-625.htm...
"What are the CEP's for?
Certificates of Suitability (CEP) are recognised by all signatory states of the European Pharmacopoeia Convention and by the European Union. Other countries have also chosen to recognise them. CEP can be used by the manufacturers of pharmaceutical products in their applications for marketing authorisation to demonstrate the compliance of the substance used with the monographs of the European Pharmacopoeia and Directives 2001/83/EC and 2001/82/EC"

--------------------------------------------------
Note added at 8 hrs (2007-11-07 10:33:53 GMT)
--------------------------------------------------

A variation #15 is submission of a new or updated CEP http://www.gmp-compliance.com/daten/download/Keitel.pdf
"Variation No. 15
• Submission of a new or updated CEP
– Normally: IA
(currently approved or new manufacturer)
– Exception: IB
- sterile substance
- substances in veterinary mp. for use in animal species susceptible to TSE"

http://www.hma.eu/120.html "We wish to submit a new CEP for an active ingredient (#15) but the CEP does not state a retest period and we have stability data to support a retest period. Can we tick condition 3 and include the stability with the Type IA #15?"


--------------------------------------------------
Note added at 12 hrs (2007-11-07 15:17:26 GMT)
--------------------------------------------------

Check out number 15 at this link, http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-... - it tells you which documents have to be submitted and it does include the updated certificate of suitability. I don't know this stuff inside out, but my understanding is that if an active ingredient has a CEP and some info in it is being changed then a variation application would be made and the proposed new CEP would have to be submitted to the national authority in charge of marketing authorisation.
Selected response from:

Helen Genevier
France
Local time: 19:17
Grading comment
Thanks for the extra information, which prompts me to select your suggestion - thanks to all who contributed
4 KudoZ points were awarded for this answer

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Summary of answers provided
4 +2is due to the revision of the prospective study contract
Drmanu49
4is due to revision of the CEP (European Pharmacopoeia certificate of suitability)
Helen Genevier
4follows on from the revision of the ....liz askew


Discussion entries: 1





  

Answers


23 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
is due to the revision of the prospective study contract


Explanation:
CEP, Contrat d'Etude Prospective. CEPH, Centre d'Etudes du Polymorphisme Humain. ... CERFA, Centre d'Enregistrement et de Révision des Formulaires ...
www.univ-lyon1.fr/12851265/0/fiche___pagelibre/&RH=anagramm... - 67k -

La Commission Paritaire Nationale de l'Emploi (CPNE) de la pharmacie d'officine et l'État ont estimé nécessaire de réaliser un contrat d'études prospectives (CEP) - à un horizon de dix à quinze ans - avec trois objectifs principaux :

Project Title:, Risk Factors for Violent Victimization of Women: A Prospective Study. Grant/Contract Number:, 98-WT-VX-0028. Type of Project:, Research ...
www.acf.hhs.gov/programs/cb/pubs/compendium/nija/nija4.htm - 17k


Drmanu49
France
Local time: 19:17
Specializes in field
Native speaker of: Native in EnglishEnglish, Native in FrenchFrench
PRO pts in category: 1029
Notes to answerer
Asker: Thanks, elsewhere in the text they talk of "dépôt du CEP révisé" - would dépôt here denote something like "filing of" here?


Peer comments on this answer (and responses from the answerer)
agree  ormiston: yes, is the reason behind it
5 hrs
  -> Thank you.

agree  Diane de Cicco: oui, "faire suitE à"
1 day4 hrs
  -> Thank you SDDC.
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6 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
follows on from the revision of the ....


Explanation:
It is a typo for

Faire suite a...

http://64.233.183.104/search?q=cache:LNbXnsy1YscJ:www.answer...


--------------------------------------------------
Note added at 6 hrs (2007-11-07 08:35:08 GMT)
--------------------------------------------------

CEP could=
Certificate of European Pharmacopeia

[DOC] QUALITE File Format: Microsoft Word - View as HTML
Nom et adresse du producteur (site de production); Déclaration de conformité aux BPF/GMP ... Attribution CEP (Certificate of European Pharmacopeia) ...
pharma.nancy.free.fr/main/zip/uv_f10.doc - Similar pages


liz askew
United Kingdom
Local time: 18:17
Works in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 413
Login to enter a peer comment (or grade)

8 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
is due to revision of the CEP (European Pharmacopoeia certificate of suitability)


Explanation:
CEP is certificat de conformité à la Pharmacopée Européenne or certificate of suitability.

Lots of info about the CEP here, and you can see that it is left as CEP in English: http://www.edqm.eu/site/News_and_General_Information-625.htm...
"What are the CEP's for?
Certificates of Suitability (CEP) are recognised by all signatory states of the European Pharmacopoeia Convention and by the European Union. Other countries have also chosen to recognise them. CEP can be used by the manufacturers of pharmaceutical products in their applications for marketing authorisation to demonstrate the compliance of the substance used with the monographs of the European Pharmacopoeia and Directives 2001/83/EC and 2001/82/EC"

--------------------------------------------------
Note added at 8 hrs (2007-11-07 10:33:53 GMT)
--------------------------------------------------

A variation #15 is submission of a new or updated CEP http://www.gmp-compliance.com/daten/download/Keitel.pdf
"Variation No. 15
• Submission of a new or updated CEP
– Normally: IA
(currently approved or new manufacturer)
– Exception: IB
- sterile substance
- substances in veterinary mp. for use in animal species susceptible to TSE"

http://www.hma.eu/120.html "We wish to submit a new CEP for an active ingredient (#15) but the CEP does not state a retest period and we have stability data to support a retest period. Can we tick condition 3 and include the stability with the Type IA #15?"


--------------------------------------------------
Note added at 12 hrs (2007-11-07 15:17:26 GMT)
--------------------------------------------------

Check out number 15 at this link, http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-... - it tells you which documents have to be submitted and it does include the updated certificate of suitability. I don't know this stuff inside out, but my understanding is that if an active ingredient has a CEP and some info in it is being changed then a variation application would be made and the proposed new CEP would have to be submitted to the national authority in charge of marketing authorisation.

Helen Genevier
France
Local time: 19:17
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 289
Grading comment
Thanks for the extra information, which prompts me to select your suggestion - thanks to all who contributed
Notes to answerer
Asker: Helen, your suggestion seems more probable in my specific context, i.e. company name change. Would a CEP have to be filed with a national authority along with a request for a name change?

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