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ForumsInternationalEU EMA compounding guidance — need advice Page 2

EU EMA compounding guidance — need advice

VanRx_Mike Fri, Aug 1, 2025 at 2:21 PM 10 replies 1,220 viewsPage 2 of 2
Dr.CardioMD
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Dec 2023
Cleveland, OH
Aug 1, 2025 at 5:11 PM#6

Netherlands (my home country): Ozempic is covered under the basisverzekering (mandatory basic insurance) for T2D. You pay your eigen risico (deductible, currently €385/year) and then it's fully covered.

Wegovy: available since mid-2025, NOT covered by basic insurance. Some aanvullende verzekeringen (supplementary policies) from CZ and Zilveren Kruis have started covering it with prior authorization for BMI 40+ patients.

And to reiterate: compounded semaglutide does not exist as a legal option here. The IGJ (Inspectie Gezondheidszorg en Jeugd) would shut down any pharmacy attempting it within days.

50 11kim_atl_prep, sarah_TO, wendy_avl and 47 others
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carl_compliance
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Nov 2024
Raleigh, NC
Aug 1, 2025 at 5:28 PM#7

Italy: Interesting case. Ozempic is in Classe A of the AIFA formulary (fully reimbursed by SSN) for T2D. The nota AIFA 100 restricts it to patients who've failed metformin.

But here's the Italian twist: we have significant supply issues. AIFA has had Ozempic on its "carenze" (shortage) list intermittently throughout 2025-2026. When your farmacia doesn't have it, they can't just compound an alternative — you wait, or your doctor switches you to dulaglutide (Trulicity) which is more consistently available.

The Italian pharmacist underground joke: "Ozempic è come il tartufo — prezioso e introvabile." (Ozempic is like truffle — precious and impossible to find.)

16 19BrianDallas92, labquiet_amy, emily_PDX and 13 others
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alex_tucson
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May 2024
Tucson, AZ
Aug 1, 2025 at 5:45 PM#8

Great contributions everyone. The summary for EU-based forum members:

  1. Compounding is not a viable option in the EU. Don't try to replicate US approaches.
  2. Brand-name drugs are dramatically cheaper than in the US — even without insurance, you're looking at €175-320/month vs $1,000+ in America.
  3. T2D coverage is universal across essentially all EU member states.
  4. Obesity coverage varies widely — Nordics lead, France and most of Western Europe are pending, Southern/Eastern Europe lags behind.
  5. If you're importing peptides from non-EU sources (US, China), be aware that customs seizure is likely and penalties can include criminal charges in some jurisdictions.
Last edited: Aug 1, 2025 at 7:45 PM
34 5BrianDallas92, labquiet_amy, emily_PDX and 31 others
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