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ForumsInternationalEU EMA compounding guidance — need advice

EU EMA compounding guidance — need advice

VanRx_Mike Fri, Aug 1, 2025 at 2:21 PM 10 replies 1,220 viewsPage 1 of 2
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VanRx_Mike
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Aug 1, 2025 at 3:46 PM#1

I see a lot of US-centric discussion about compounded semaglutide on this forum, so I wanted to start a thread for Europeans to understand our very different regulatory landscape.

The fundamental difference: In the EU, compounding is governed by Directive 2001/83/EC, Article 3, which allows pharmacy compounding only for individual patients with a prescription, and only when no authorised equivalent exists on the market.

Since Ozempic and Wegovy are authorised in the EU via the EMA centralised procedure, compounding semaglutide is essentially illegal in most EU member states.

This means the US model — where compounding pharmacies make semaglutide because of "shortage" designations — simply doesn't apply here. There's no shortage exemption in EU pharmaceutical law in the same way.

So what are Europeans actually doing? Let's discuss country by country.

25 9Dr.LeslieOBGYN, MikeNYC_runner and 22 others
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Dr.PathRoch
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Rochester, MN
Aug 1, 2025 at 4:03 PM#2

Germany: You need a Privatrezept (private prescription) or Kassenrezept (insurance prescription) for any semaglutide product. Compounding pharmacies (Rezepturapotheken) will NOT touch semaglutide because the Bundesinstitut für Arzneimittel (BfArM) has been very clear about Article 3 compliance.

Prices in Germany:

  • Ozempic 1mg: ~€175/month (private pay)
  • Wegovy 2.4mg: ~€300/month (private pay)

If your Krankenkasse (statutory health insurance) covers it (more on this in another thread), you just pay the standard €5-10 Zuzahlung (copay).

The German approach is basically: if you have a prescription, the drug is available at every Apotheke. No shortage here — Novo Nordisk prioritised the EU supply chain.

9 21InsuranceTom, WendyG_ATL, SaraMom3 and 6 others
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DerekSJ_a1c
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Aug 1, 2025 at 4:20 PM#3

Spain: Ozempic is available with a receta médica (prescription) at any farmacia. It's included in the SNS (Sistema Nacional de Salud) formulary for T2D — patients pay between 0-10% depending on income level. Yes, you read that right. Some pensioners pay literally zero.

For obesity (Wegovy), it's NOT covered by SNS. Private pay is about €280-320/month.

There is zero compounding market for peptides in Spain. The Agencia Española de Medicamentos (AEMPS) is very strict. The concept of "research chemical peptides" that Americans discuss would be considered illegal drug distribution here.

4 8rachel_ABQ, traveltech_sara, AttorneyGrant and 1 other
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wei_SG
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Aug 1, 2025 at 4:37 PM#4

France: The system here is interesting. Ozempic is covered by Assurance Maladie at 65% reimbursement for T2D, with most mutuelles (supplementary insurance) covering the remaining 35%. Out of pocket for a T2D patient: essentially €0.

Wegovy launched in France in late 2025 but is NOT reimbursed yet. The HAS (Haute Autorité de Santé) gave it an ASMR V rating (no additional benefit over existing treatments), which means reimbursement negotiations with CEPS are ongoing.

Private pay for Wegovy in France: €250-290/month at a pharmacie.

What I want to stress for American friends on this forum: the EU model works differently because the brand-name drugs are actually affordable here. We don't need compounding because Novo Nordisk doesn't charge us $1,300/month like they charge Americans.

27 5RetaRick_CA, JenPlateau, SallyK_inj and 24 others
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AttorneyGrant
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Aug 1, 2025 at 4:54 PM#5

Denmark/Nordics: Home turf of Novo Nordisk, so unsurprisingly everything is available and well-covered.

  • Denmark: Ozempic covered under sygesikring for T2D. Wegovy covered since 2025 under the medicintilskud system after a Medicinrådet recommendation — patient pays about DKK 400 (~€55) per month after subsidy.
  • Sweden: Similar, covered through Tandvårds- och läkemedelsförmånsverket (TLV). Patient cost after högkostnadsskydd: about SEK 600 (~€55)/month.
  • Norway: Covered under blåreseptordningen (blue prescription scheme) for both T2D and obesity as of 2025.

The Nordics are basically the gold standard for GLP-1 access. No compounding needed, no grey market, just affordable prescriptions.

Last edited: Aug 1, 2025 at 5:54 PM
38 6Dr.GastroMayo, JakeBK_lifts, DerekSJ_a1c and 35 others
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