LEC

Russian translation: изменение (в наименовании) юрид. лица

19:30 Jan 26, 2021
English to Russian translations [PRO]
Medical - Medical: Pharmaceuticals
English term or phrase: LEC
Marketing authorization vatiations

Renewal of X (Y) 200 mg injection for Z (страна) plus
Y DS 2nd gen plus DP spec Replacement of internal I 4.65
method with relevant Ph. Eur. 2.9.19 plus updated 32P31 due to
Kalamazoo LEC

Спасибо.
Nadezhda Wenzel
Russian translation:изменение (в наименовании) юрид. лица
Explanation:
https://www.ema.europa.eu/en/documents/regulatory-procedural...
3.2.P.3.1 Manufacturer(s) (name, dosage form)
The name, address and responsibility of each manufacturer, including contractors, and each proposed
https://www.pharmatutor.org/content/september-2017/career-fo...
Familiarity with global guidelines for filing Legal Entity Changes (LEC) and run corresponding reports in the regulatory requirements database
production site or facility involved in manufacturing and testing should be provided.
Must be extremely organized as LEC projects can run across multiple products/markets.
https://www.sec.gov/Archives/edgar/data/1792044/000119312519...
The Upjohn name traces its history to 1886, when The Upjohn Company was formed in Kalamazoo, Michigan by Dr. William E. Upjohn. Pfizer acquired the brand through its acquisition of Pharmacia Corporation in 2003. The products comprising the Upjohn Business’s portfolio of 20 globally recognized brands are the result of decades of development and strategic investments.
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hawkwind
Russian Federation
Local time: 07:08
Grading comment
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3изменение (в наименовании) юрид. лица
hawkwind


  

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5 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
lec
изменение (в наименовании) юрид. лица


Explanation:
https://www.ema.europa.eu/en/documents/regulatory-procedural...
3.2.P.3.1 Manufacturer(s) (name, dosage form)
The name, address and responsibility of each manufacturer, including contractors, and each proposed
https://www.pharmatutor.org/content/september-2017/career-fo...
Familiarity with global guidelines for filing Legal Entity Changes (LEC) and run corresponding reports in the regulatory requirements database
production site or facility involved in manufacturing and testing should be provided.
Must be extremely organized as LEC projects can run across multiple products/markets.
https://www.sec.gov/Archives/edgar/data/1792044/000119312519...
The Upjohn name traces its history to 1886, when The Upjohn Company was formed in Kalamazoo, Michigan by Dr. William E. Upjohn. Pfizer acquired the brand through its acquisition of Pharmacia Corporation in 2003. The products comprising the Upjohn Business’s portfolio of 20 globally recognized brands are the result of decades of development and strategic investments.

hawkwind
Russian Federation
Local time: 07:08
Specializes in field
Native speaker of: Native in RussianRussian
PRO pts in category: 498
Grading comment
Благодарю.
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