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How do you get regulatory permission to use probiotics?

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I have finally come across a probiotics product, produced in the UK (?), and classified as a dietary supplement in the UK.

However, the regulatory aspects seem a bit complex. For example, it seems that we would need permission from the Swedish Medical Product Agency Authority before we could start to administer it to preterm infants in the NICU. It is possible that the authority would not approve it as a dietary supplement but consider it as a pharmaceutical, which means that a more complicated regulatory framework kicks in.

My question to you - how are you able to use probiotics in your units? Do you have pharmaceutical classification of probiotics or are the products used classified as dietary supplements? Do you use probiotics "off-label" without permission from authorities?

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We are using Biogaia (R) (lactobacillus reuteri) for preterm babies who are on antibiotics and other preterm babies who don't have access to early human milk feedings. We usually start it when trophic feedings are well tolerated.

The evidence in favor of probiotics is sound, and we can use it without special authorization at our hospital so we do.

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We have Biogaia approved by our authority to be used in neonates. And in my previous unit, we used it after local approval from the hospital's PTC in preterm infants with the start of the trophic feeds. And it follows the regulation of pharmaceuticals.

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