SPC section 4.2 : safety and efficacy have/has (not) (yet) been established

A client asked me to check a phrase I had translated. The client had noticed that the word I had used,  “on“,  is not included in the Finnish centralised template (Version 9, 03/2013).


EN: Safety and efficacy have been established in patients with a Body Mass Index) > 30 kg/m2

FI: Turvallisuus ja teho on varmistettu potilailla, joiden painoindeksi (BMI) > 30 kg/m2.

EN template: < The <safety> <and> <efficacy>  of {X} in children aged {x to y} <months> <years> [or any other relevant subsets, e.g. weigt, pubertal age, gender] <has> <have>  not  <yet> been established.

FI template: <{X-valmisteen} <turvallisuutta> <ja> <tehoa> {x-y} <vuoden> <kuukauden> ikäisten {tai mitkä hyvänsä muut sopivat määreet, kuten paino, puberteetti-ikä, sukupuoli} lasten hoidossa ei ole <vielä> varmistettu.

My comment:  The FI template has only the negative form “ei ole” (has/have not). The affirmative verb form “on” (has/have)  is not present in the FI template.  However, I think the original EN template phrase is meant to be negative only (there are no less than/greater than signs around the word “not”.)

Another note:  the EN template has <months> <years>, whereas the FI template has <vuoden> <kuukauden> (the other way round; vuoden = year(s),  kuukauden= month(s)).

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