Gripe water

Sligo1

mirrorwall14 wrote: »

I emailed that site and the response is it isn't licensed. If the moderators don't mind I'll post the replies (with identification removed)?

It's mad that it's fairly widely available

Did they say it was definitely classified as a medicinal product tho?

greenman09

I have an unopened gripe water bottle if anyone is near dublin 24 and wants it. We don't use it and with the wee one now 6 months we shouldn't need it.

Sligo1

Back at work today and was just chatting to the pharmacist again. She said she discussed the licensing issue with the senior pharmacists here in the hospital I work for and said they were of the same opinion as her. That since the alcohol has been taken out there is no medicinal ingredients in the current solution of gripe water so it is "probably" not really a licensing issue at all. I said someone rang the websites number and they replied that it's not licensed. And she just said again, that it is probably not licenced because it doesn't need a license anymore due to there being no alcohol or medicinal products in it.

angeldelight

I got a reply from the HPRA today - gripe water is classified as a medicinal product in ROI and there are no formulations of it licensed for sale

Sligo1

angeldelight wrote: »

I got a reply from the HPRA today - gripe water is classified as a medicinal product in ROI and there are no formulations of it licensed for sale

Did they say what ingredient in it was classified as medicinal?

angeldelight

No I didn't ask - I asked is it still classified as a medicinal product now that the alcohol has been removed and is there a licensed product currently available on the market. They very succinctly replied yes it is and no there isn't

Sligo1

That's cleared that up then

Sligo1

angeldelight wrote: »

No I didn't ask - I asked is it still classified as a medicinal product now that the alcohol has been removed and is there a licensed product currently available on the market. They very succinctly replied yes it is and no there isn't

Ok so I've just rung them directly. And they said its nothing to do with a licensing issue. They said it is a commercial/marketing issue. They said there is no medicinal products in it. And they said if I want that in writing to just email them.

I reiterated what the hospital pharmacists had said and the lady agreed. And repeated it wasn't a licensing issue. It is a marketing issue. And it is not illegal.

angeldelight

That's interesting as it does conflict slightly with what the person who emailed me said. If it is a medicinal product as they said in the email then it needs a license to sell it. The reason for there being no license may be that no company has applied for one for commercial reasons but regardless of the reason - a medicinal product must have a license for sale.

Even though there's no drug in it if it's a medicinal product it has to have a license... Some honey and lemon cough bottles as another example don't have a drug in them but are licensed for sale in Ireland and so can be sold OTC.

It's a bit concerning that the HPRA are giving conflicting info

Sligo1

angeldelight wrote: »

That's interesting as it does conflict slightly with what the person who emailed me said. If it is a medicinal product as they said in the email then it needs a license to sell it. The reason for there being no license may be that no company has applied for one for commercial reasons but regardless of the reason - a medicinal product must have a license for sale.

Even though there's no drug in it if it's a medicinal product it has to have a license... Some honey and lemon cough bottles as another example don't have a drug in them but are licensed for sale in Ireland and so can be sold OTC.

It's a bit concerning that the HPRA are giving conflicting info

I'll email them tonight and ask. I may have misheard as I had 2 screaming kids in background. But what she definitely 100% said was it wasn't a licensing issue but a commercial/marketing one. And she told me to email them to receive a written explanation of why.

contrary_mary

I'm purely speculating here as I haven't used gripe water or seen the packaging but does it make any medicinal claims (e.g. does it use statements like "treats" / "helps control the symptoms of" / "traditionally used for treatment of")? If so then it meets the definition of a medicinal product and requires a license.

Re. the licensing issue my understanding is that the manufacturers have made a commercial decision not to apply for a license to place it on the Irish market. It is the same situation for Calgel. So the license has not been denied in Ireland (i.e. there is no licensing issue) - just that the manufacturers have decided it doesn't make financial sense to them.

Sligo1

contrary_mary wrote: »

I'm purely speculating here as I haven't used gripe water or seen the packaging but does it make any medicinal claims (e.g. does it use statements like "treats" / "helps control the symptoms of" / "traditionally used for treatment of")? If so then it meets the definition of a medicinal product and requires a license.

Re. the licensing issue my understanding is that the manufacturers have made a commercial decision not to apply for a license to place it on the Irish market. It is the same situation for Calgel. So the license has not been denied in Ireland (i.e. there is no licensing issue) - just that the manufacturers have decided it doesn't make financial sense to them.

Yes the product does say those things. And yep, the way you describe the licensing issue makes sense. That's probably what the lady on the phone was trying to articulate to me....

cyning

https://www.facebook.com/permalink.php?story_fbid=923977170986826&id=108436049207613&substory_index=0

Came across this link on Facebook: so the chemist are saying this Gripe water is licensed, and the box specifically says food supplement does that mean it doesn't need to be licensed anymore I wonder?