Semaglutide and tirzepatide are the active substances of medicines authorised in the European Union, and those medicines are dispensed only on a doctor's prescription. That single sentence explains most of the confusion around these two molecules: the question is not whether they work, but in what capacity anyone is allowed to sell them.
What exactly is authorised?
Semaglutide is the active substance of Ozempic, authorised in the European Union on 8 February 2018. The indication on the product information is type 2 diabetes in adults, as an addition to diet and exercise. The European Medicines Agency product page states plainly that the medicine can be obtained only with a prescription.
Tirzepatide is the active substance of Mounjaro, authorised on 15 September 2022. It has two indications: type 2 diabetes, and weight management in people with obesity or with overweight and weight-related complications. Here too the product information states that the medicine is dispensed on prescription only.
| Feature | Ozempic | Mounjaro |
|---|---|---|
| Active substance | Semaglutide | Tirzepatide |
| EU authorisation | 8 February 2018 | 15 September 2022 |
| Indications | Type 2 diabetes | Type 2 diabetes and weight management |
| How it is dispensed | Prescription only | Prescription only |
Why do these molecules in particular need a prescription?
The reason is what they do to the body. Both medicines act on gut hormone receptors, slow gastric emptying and change the sense of fullness, while also affecting glucose handling. The mechanism is taken apart in the article on GLP-1 and the incretins, and the differences between the three molecules of that family in the comparison of semaglutide, tirzepatide and retatrutide.
An intervention of that kind requires assessment before it starts and observation while it runs. A doctor checks for contraindications, chooses the dose and responds when adverse effects appear. That is why the regulator did not release these medicines for free sale, even though both substances have phase 3 clinical trials behind them. Tirzepatide additionally acts on a second receptor, which is covered in the article on tirzepatide and the GLP-1 and GIP receptors.
What does the label "research material" mean?
The label describes how something is sold, not what the molecule is. Semaglutide sold as a research reagent is the same substance that a pharmacy dispenses as a prescription medicine. What changes is everything around it: there is no patient information leaflet, none of the quality control required for marketing authorisation, and no dose established in trials for that particular preparation.
The legal consequences on the selling side are covered separately, in the article on the legal status of peptides. In short: how a product is labelled does not change the status of the substance inside it.
How does a medicine differ from research material?
The difference comes down to who is answerable for the dose and for the quality. With a medicine, the company that registered it is answerable, and so is the doctor who prescribed it. With research material nobody is, because the product is not intended for administration to people.
The second difference concerns what is known about the contents of the vial. A medicine has a defined strength and a purity declaration confirmed at authorisation. With research material what remains is the manufacturer's certificate of analysis; how to read one and how to spot a counterfeit is shown in the article on recognising fake peptides.
What this means for you
If you are looking for treatment of obesity or diabetes, the route runs through a doctor and a pharmacy, not through a reagent shop. If, on the other hand, the molecule itself and its research interest you, we have a metabolic peptides category. It holds semaglutide and tirzepatide, described without dosing protocols and without therapeutic promises.
Frequently asked questions
Is semaglutide a prescription medicine in the European Union?
Yes. It is the active substance of Ozempic, authorised on 8 February 2018, and the European Medicines Agency product page states that the medicine can be obtained only with a prescription.
Since when has tirzepatide been authorised in the European Union?
Since 15 September 2022, as Mounjaro. The indications are type 2 diabetes and weight management in people with obesity or overweight with complications.
Does the label "research material" change the status of the substance?
No. The label describes how the product is sold, not the properties of the molecule. Semaglutide remains the same substance that a pharmacy dispenses as a prescription medicine.
How does a research preparation differ from a pharmacy medicine?
By the absence of a patient leaflet, the absence of the quality control required for marketing authorisation, and the absence of a dose established for that preparation in clinical trials.
Why do these medicines require a prescription at all?
Because they change gastric emptying, the sense of fullness and glucose handling, which calls for assessment before starting and observation during use.
Where this information comes from
The authorisation dates, the indications and the prescription-only status of Ozempic and Mounjaro come from the European Medicines Agency product pages for those medicines. The description of the mechanism comes from the same product information. These pages were checked on 6 September 2026.
This is information about the regulatory status of substances, not medical advice and not an encouragement to use them. Products on this site are sold as research materials, and treatment decisions are made by a doctor.
Sources
- Ozempic (semaglutide). European public assessment report (EPAR), European Medicines Agency, authorised 8 February 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/ozempic
- Mounjaro (tirzepatide). European public assessment report (EPAR), European Medicines Agency, authorised 15 September 2022. https://www.ema.europa.eu/en/medicines/human/EPAR/mounjaro