Jul 2, 2016 06:27
7 yrs ago
Italian term
an "angel" to many clients
Native in: Italian
Works in: English to Italian, Italian to English, French to Italian
decreto officina
Italian to English
Law/Patents
Law (general)
Pharmaceuticals
Lo studio di validazione è organizzato in conformità con le regole di “Good Manufacturing Practices”, ed è disegnato in funzione della natura del processo produttivo messo in atto dal produttore XXXX, autorizzato alla produzione di specialità medicinali con Decreto Officina n° aM – XXX.
Proposed translations
(English)
| 3 -1 | (AmE) Pharma Manufacturing Consent Decree; (BrE approx.) Good Lab Practice - Statutory Instrument |
Adrian MM. (X)
|
| 5 -1 | Manufacturer Licence (UK) Manufacturing Authorisation (Ireland) |
kmaciel
|
References
| Previous question |
philgoddard
|
Proposed translations
-1
1 day 15 hrs
Selected
(AmE) Pharma Manufacturing Consent Decree; (BrE approx.) Good Lab Practice - Statutory Instrument
Otherwise refer to Phil G's weblink for the previous answer.
The only thing for sure is that an 'Office Decree' is a literal translation
cf. the IATE website French 'equivalent':
Medical science [COM] Full entry
FR
officine
EN
Manufacturing Pharmacy
The only thing for sure is that an 'Office Decree' is a literal translation
cf. the IATE website French 'equivalent':
Medical science [COM] Full entry
FR
officine
EN
Manufacturing Pharmacy
4 KudoZ points awarded for this answer.
Comment: "Thanks!
"
-1
2 days 22 hrs
Manufacturer Licence (UK) Manufacturing Authorisation (Ireland)
See the heading "procedura" at the following site:
http://www.salute.gov.it/portale/ministro/p4_8_0.jsp?lingua=...
See for the UK:
https://www.gov.uk/guidance/apply-for-manufacturer-or-wholes...
For Ireland:
https://www.hpra.ie/homepage/medicines/regulatory-informatio...
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Note added at 5 days (2016-07-07 10:54:00 GMT) Post-grading
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REPLY TO ADRIAN:
A statutory instrument is defined as "a form of delegated or secondary legislation" - it does require parliamentary authority!
A consent decree in American English is issued by a judge. See the article you yourself cited as reference.
Oficina in this context refers to the manufacturing facility or production/processing site.
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Note added at 5 days (2016-07-07 13:31:30 GMT) Post-grading
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REPLY TO ADRIAN
A "decreto officina" has nothing to do with judgements. It is emphatically NOT a statutory instrument in any sense of the term.
It is merely an administrative authorisation permitting the operator of a specific manufacturing facility to manufacture medicines at that specific worksite/facility subject to good manufacturing practies. I.E. Upon being satisfied that the site meets good manufacturing practices, the related govt. dept. issues a Manufacturer Licence or a Manufacturing Authorisation from production of medicines at that facility/site/officina.
It is that simple. I fail to see how the fact that "officina" is "pharmaceutically related" or that you have "drafted consent decrees" or that an SI "can be passed by a UK Minister" adds an iota of support to your convoluted recommended translation!
http://www.salute.gov.it/portale/ministro/p4_8_0.jsp?lingua=...
See for the UK:
https://www.gov.uk/guidance/apply-for-manufacturer-or-wholes...
For Ireland:
https://www.hpra.ie/homepage/medicines/regulatory-informatio...
--------------------------------------------------
Note added at 5 days (2016-07-07 10:54:00 GMT) Post-grading
--------------------------------------------------
REPLY TO ADRIAN:
A statutory instrument is defined as "a form of delegated or secondary legislation" - it does require parliamentary authority!
A consent decree in American English is issued by a judge. See the article you yourself cited as reference.
Oficina in this context refers to the manufacturing facility or production/processing site.
--------------------------------------------------
Note added at 5 days (2016-07-07 13:31:30 GMT) Post-grading
--------------------------------------------------
REPLY TO ADRIAN
A "decreto officina" has nothing to do with judgements. It is emphatically NOT a statutory instrument in any sense of the term.
It is merely an administrative authorisation permitting the operator of a specific manufacturing facility to manufacture medicines at that specific worksite/facility subject to good manufacturing practies. I.E. Upon being satisfied that the site meets good manufacturing practices, the related govt. dept. issues a Manufacturer Licence or a Manufacturing Authorisation from production of medicines at that facility/site/officina.
It is that simple. I fail to see how the fact that "officina" is "pharmaceutically related" or that you have "drafted consent decrees" or that an SI "can be passed by a UK Minister" adds an iota of support to your convoluted recommended translation!
Peer comment(s):
| disagree |
Adrian MM. (X)
: 1. officina is pharmaceutically related 2. I have drafted consent judgments myself for use in the London Royal Courts of Justice & 3. an SI can be passed by a UK Minister - that's the whole point of delegated/subordinated legislation.
2 days 7 hrs
|
|
well, then a consent decree is issued by a judge and is not a decree law. SI are passed by govt. depts. WITH PARLIAMENTARY AUTHORITY - Parliament delegates the authority. The DECRETO OFFICINA is an admiistrative authorisation.. Not judgement.
|
Reference comments
9 hrs
philgoddard
United States
United States
Native in English
Specializes in field
United States
Six languages into flawless English
Native in: English
Works in: German to English, French to English, Spanish to English, and 4 more.
Related KudoZ points
:
341
Reference:
Previous question
Though I don't really understand the answer or the explanation.
Note from asker:
| Thank you so much Philgoddard! I had missed that one : ) |
Peer comments on this reference comment:
| neutral |
Adrian MM. (X)
: I saw that link and had considered using it, but didn't as being useless.
4 days
|
| agree |
kmaciel
: Previous answer was invented, much like the answer to this one. A decreto officina is no more and no less than a Manufacturer Licence (UK) or a Manufacturing Authorisation (Ireland). It authorises a specific FACILITY (officina) to produce medicines.
4 days
|
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