A patient brochure is to be translated to Spanish for use in the U.S. (not for Puerto Rico at this time)
Does the brochure need an English PI/approved label, a Spanish PI or both?
If used in PR, would PI in both languages be required?
[My understanding is that there is no approved patient informaton leaflet/PIL (patient labeling) because the product is not self administered; the product is for IV administration by HCPs.]
Checking regs in one place seems to support an English PI is the only version required, however, another states that if any of the "labeling" is in a foreign language, than 'all words, statements, and other information reuqired by or under authority of the act ....shall appear on the labeling in the foreign language".
If you can provide the applicable regulation citation or guidance document with your response, that would be great.
Thank you!!
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kmcneal@shire.com United States
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