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Peptides Explained

European Union

Peptides and EU law: the rules behind every national law

In short

About 7 minutes for the short version; 10 with every detail open.

  • EU law sets the basic rules for medicines in every EU country. Each country adds its own.
  • A product is a medicine if it is sold as one, or if it acts like one.
  • No medicine may be sold in the EU without a licence from the EU or a national regulator.
  • The main exceptions are narrow: one named patient, a group of very ill people, or a trial.
  • A big reform of EU medicines law is close. On 22 October 2026 it was not yet law.
Last reviewed
A tall office tower with a grid of dark windows under a blue sky, with a metal sculpture by the entrance.
The EU's medicines agency has its home in this tower in Amsterdam. Photo: MrAronymous (Wikimedia Commons) CC BY-SA 4.0 Image details

Each section starts with the short answer. The rest is folded under “In detail”.

Why does EU law matter for peptides?

It sets the rules that Dutch, Belgian and German medicines law all follow.
EU medicines law works in layers. The EU sets common rules; each country applies and enforces them.
LayerExamplesWhat it does
EU directivesDirective 2001/83/EC, the EU code for medicinesSets the definition of a medicine, the licence rule and the advertising rules. Each country writes them into its own law.1
EU regulationsRegulation 726/2004 (EU-wide licences), Regulation 536/2014 (clinical trials)Apply directly in every EU country.2,3
EU Court of JusticeRulings on what a “medicine” is, or what counts as advertisingExplains what EU rules mean; national courts must follow it.4,5
National bodiesCBG and IGJ (Netherlands), FAMHP (Belgium)Grant national licences, check the market, fine and seize.6,7,8,9,10

So the core rules on this page apply in every EU country. Penalties, enforcement and some exceptions differ by country. See the Netherlands and Belgium.

What counts as a medicine

What makes a product a medicine in EU law?

Being offered as a treatment, or being able to change how the body works through a drug-like effect.
A product can be a medicine in two ways. A 'not for human use' label settles neither. Directive 2001/83/EC, article 1(2), as explained by the EU Court of Justice.
By presentation (article 1(2)(a))By function (article 1(2)(b))
Can claims, pictures or a website make it a medicine?Yes What counts is the impression an ordinary, well-informed person gets, even from hints.11No This test looks at what the substance can do in the body.12
Must science show that it works?No A product that does little can still be offered as a medicine.11Yes It must be able to change body functions in a way that really matters.12
Does a “research use only” label decide it?No A label is only one part of how a product is presented.11No The label does not change what the substance does.12,4

Sometimes a product could be a medicine and also something else, such as a food supplement. Then medicines law wins, once its medicine status is clear.1,12 Authorities decide case by case.4 More on labels: research use only.

In detail What the EU Court of Justice has said

Van Bennekom (1983). A Dutch case about vitamin pills. “Presentation” must be read broadly. A product is presented as a medicine when it is recommended as such on labels, in leaflets or by word of mouth. It is also presented as one when an ordinary, well-informed person gets that clear impression, even if it is only implied. The pill or capsule form can be strong evidence, but not the only evidence.11

Hecht-Pharma (2009). A product is not a medicine “by function” if, used as intended, it cannot change body functions in a way that really matters. The “in doubt, medicines law wins” rule only applies once its medicine status is shown.12

D. and G. (2014). A case about synthetic cannabinoids. Authorities decide case by case, looking at what the product contains and what it does as far as science can show. They also look at how it is used, how widely it is sold, how well people know it, and its risks. The “function” test covers substances that can benefit health, not substances taken only to get high.4

The licence rule

Can a medicine be sold without a licence?

No. Every medicine needs a licence, from the EU or from one country.
Some medicines must have an EU-wide licence. Others can have a national one. Directive 2001/83/EC article 6 and Regulation (EC) No 726/2004 article 3 and annex I.
EU-wide licence (centralised procedure)National licence
Valid in every EU country?Yes One licence for the whole EU.2No Valid in the country that granted it.1
Required for biotech medicines, and for new medicines for diabetes, cancer and some other serious diseases?Yes These must go through the EU route.2No Not possible for these.2
Can a product with neither licence be sold legally?No Not as a medicine.1No Not as a medicine.1

Semaglutide (Wegovy) and tirzepatide (Mounjaro) have EU-wide licences.13,14 BPC-157 and TB-500 have no EU-wide licence.15 We know of no EU country that has licensed them either.

In detail What a licence brings with it

A licence is more than permission to sell. It comes with duties that protect the people who use the medicine:

A product sold without a licence carries none of these duties. See research use only.

The narrow exceptions

Are there exceptions to the licence rule?

Yes, a few narrow ones. Mainly: one patient with a medical need, very ill groups, and trials.
Each exception is narrow and needs a doctor or a formal programme. Directive 2001/83/EC article 5(1); Regulation (EC) No 726/2004 article 83; Regulation (EU) No 536/2014.
Named patient (Directive, article 5(1))Compassionate use (Regulation 726/2004, article 83)Clinical trial (Regulation 536/2014)
For one named patient?Yes On a doctor’s order, under the doctor’s personal responsibility.1No For a group of seriously ill patients.2No For the people taking part in the trial.3
Must the medicine be in formal development?No Not in EU law; national rules add conditions.1,17Yes A licence application or trials must be under way.2Yes The trial itself is the development.3
Can cost or convenience be the reason?No Only medical reasons count.18No Only for patients who cannot be treated well with approved medicines.2No No one may be pushed to take part, also not with money.3

A pharmacy may also make a medicine itself for one patient, on a prescription. The licence rule does not cover that either.1,19 How these work in practice in the Netherlands: legal routes.

In detail The named-patient exception, as the EU Court reads it

Article 5(1) lets a country make an exception “to fulfil special needs”. The medicine must be supplied on a genuine order from a health professional, for one patient under their direct personal responsibility.1

In 2012 the EU Court of Justice explained how narrow this is. Exceptions are read strictly. “Special needs” means individual cases with medical reasons. The doctor must have examined the patient and prescribed on purely medical grounds. It only applies when no approved equivalent is on the market. Money is not enough of a reason.18

In detail Compassionate use and clinical trials

Compassionate use. A country may give an unlicensed medicine to a group of very ill patients. Their disease is long-term, seriously disabling or life-threatening. They cannot be treated well with an approved medicine. This route is for medicines that can get an EU-wide licence. The medicine must have an EU licence application, or be in clinical trials. The country must tell the EMA.2

Clinical trials. Since 31 January 2022 one EU law covers trials of medicines, through one online system, CTIS.20 A trial may only run if its expected benefits justify the risks. Everyone in it must give informed consent after a clear explanation. You can leave at any time, without giving a reason and without any harm to you.3

Advertising

Can unlicensed medicines be advertised?

No. And prescription medicines may not be advertised to the public at all.
What EU law treats as advertising for medicines, and what it does not.
Counts as advertisingDoes not count
Any information, canvassing or inducement meant to promote prescribing, supply, sale or use of a medicineThe label and the patient leaflet
Advertising to the public, or to doctors and pharmacistsAnswers to a specific question about a medicine, without promotion
Free samples, gifts and paid events meant to promote prescribingFactual notices, such as a pack change or a side-effect warning, without product claims
Information about health or disease that does not refer, even indirectly, to a medicine

Source 1

Countries must forbid all advertising for a medicine without a licence. They must also forbid advertising prescription medicines to the public.1 An independent writer can be advertising too, if the purpose is to promote.5

Fake medicines and online pharmacies

How does the EU protect people from fake medicines?

With a code on each pack of prescription drugs, and a logo for legal sellers online.
The EU's rules against fake medicines took effect step by step from 2013. When each rule started to apply across the EU. Belgium, Greece and Italy had until 2025 for the safety code.

  • Falsified Medicines Directive

    applies since 2 January 2013

  • EU logo for legal online sellers

    in every EU country by mid-2015

  • Safety code and seal on prescription packs

    since 9 February 2019; in Belgium, Greece and Italy by 2025

Sources Directive 2011/62/EU amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of falsified medicinal products; Commission Implementing Regulation (EU) No 699/2014 of 24 June 2014 on the design of the common logo to identify persons offering medicinal products for sale at a distance to the public and the technical, electronic and cryptographic requirements for verification of its authenticity; Commission Delegated Regulation (EU) 2016/161 supplementing Directive 2001/83/EC by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use21,22,23 Checked

A legal online seller must be allowed to supply medicines, be registered, and show the EU logo. The medicines it sells must be legal in the buyer’s country.1 So no seller can legally offer an unlicensed peptide with that logo. Most prescription medicines carry a unique code and a seal that pharmacies check.1,23

In detail How the logo and the safety code work

The logo is the same across the EU, and shows which EU country the seller is based in. Clicking it should lead to the national list of registered sellers.1,22

The safety code is a unique number on each pack, plus a seal that shows if the pack was opened. Pharmacies scan the code to check that the pack is genuine.1,23 Belgium, Greece and Italy already had their own pack checks. They could wait, but had to switch by 9 February 2025 at the latest.23 A vial sold outside the legal supply chain has no such check. See product risk.

What is changing

Is EU medicines law about to change?

Yes. A reform was agreed in December 2025. On 22 October 2026 it was not yet adopted.
The new EU medicines law: where the reform stood on 22 October 2026.
  1. 26 April 2023. The European Commission proposes a new directive and a new regulation. The directive would replace Directive 2001/83/EC.24,25
  2. 11 December 2025. Parliament and Council reach political agreement.26
  3. 1 October 2026. The Council publishes its formal position.24,25
  4. Next step. The file is waiting for Parliament’s second reading. It lists 23 November 2026 as an indicative date for the plenary vote.24,25
  5. After that. The EMA expects the new acts to enter into force in 2026, with time until 2028 for countries to change their own laws.26

Until then, the rules on this page apply. We follow the reform on what’s changing.

Contacts

Who can I contact at EU level?

The EMA for EU-wide medicines. Side effects are reported in your own country.

The EMA assesses medicines for an EU-wide licence. Its public list shows which medicines have one.15 Every EU country must make it easy for patients to report side effects to their national authority.1 In the Netherlands you report to Lareb; in Belgium, to the FAMHP.27,28

Sources

Every claim on this page links to one of these sources. Scholarly sources link to their DOI; regulatory sources to the regulator's own page.

In detail All 28 sources, numbered as in the text
  1. European Parliament and Council of the European Union (2001). Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text). Official Journal of the European Communities, L 311. Law eur-lex.europa.eu — accessed 20 October 2026 ↩
  2. European Parliament and Council of the European Union (2004). Regulation (EC) No 726/2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency (consolidated text of 28 January 2022). Official Journal of the European Union, L 136. Law eur-lex.europa.eu — accessed 22 October 2026 ↩
  3. European Parliament and Council of the European Union (2014). Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use. Official Journal of the European Union, L 158. Law eur-lex.europa.eu — accessed 22 October 2026 ↩
  4. Court of Justice of the European Union (Fourth Chamber) (2014). Judgment of 10 July 2014, Criminal proceedings against Markus D. and G., Joined Cases C-358/13 and C-181/14. EUR-Lex (CELEX 62013CJ0358). Law eur-lex.europa.eu — accessed 22 October 2026 ↩
  5. Court of Justice of the European Communities (Second Chamber) (2009). Judgment of 2 April 2009, Criminal proceedings against Frede Damgaard, Case C-421/07. EUR-Lex (CELEX 62007CJ0421). Law eur-lex.europa.eu — accessed 22 October 2026 ↩
  6. Staten-Generaal / Koninkrijk der Nederlanden (2007). Geneesmiddelenwet, artikel 40 (verbod op geneesmiddelen zonder handelsvergunning, en de uitzonderingen). wetten.overheid.nl (BWBR0021505), version in force from 9 September 2025. Law wetten.overheid.nl — accessed 22 October 2026 ↩
  7. Staten-Generaal / Koninkrijk der Nederlanden (2007). Geneesmiddelenwet, artikel 100 (toezicht: IGJ en NVWA). wetten.overheid.nl (BWBR0021505), version in force from 9 September 2025. Law wetten.overheid.nl — accessed 22 October 2026 ↩
  8. Staten-Generaal / Koninkrijk der Nederlanden (2007). Geneesmiddelenwet, artikel 101 (bestuurlijke boete). wetten.overheid.nl (BWBR0021505), version in force from 9 September 2025. Law wetten.overheid.nl — accessed 22 October 2026 ↩
  9. Belgische Staat / État belge (1964). Wet van 25 maart 1964 op de geneesmiddelen voor menselijk gebruik, artikel 6 § 1 (vergunning voor het in de handel brengen vereist). ejustice.just.fgov.be. Law ejustice.just.fgov.be — accessed 20 October 2026 ↩
  10. Federal Agency for Medicines and Health Products (FAMHP / FAGG / AFMPS) (2024). Questions and answers on seizure of postal packages due to illegal importation of medicinal products or importation of non-compliant medical devices. Regulator famhp.be — accessed 22 October 2026 ↩
  11. Court of Justice of the European Communities (Fifth Chamber) (1983). Judgment of 30 November 1983, Criminal proceedings against Leendert van Bennekom, Case 227/82. EUR-Lex (CELEX 61982CJ0227). Law eur-lex.europa.eu — accessed 22 October 2026 ↩
  12. Court of Justice of the European Communities (First Chamber) (2009). Judgment of 15 January 2009, Hecht-Pharma GmbH v Staatliches Gewerbeaufsichtsamt Lüneburg, Case C-140/07. EUR-Lex (CELEX 62007CJ0140). Law eur-lex.europa.eu — accessed 22 October 2026 ↩
  13. European Medicines Agency (2026). Wegovy (semaglutide): EPAR — overview and product information. Official product information ema.europa.eu — accessed 20 October 2026 ↩
  14. European Medicines Agency (2026). Mounjaro (tirzepatide): EPAR — overview and product information. Official product information ema.europa.eu — accessed 20 October 2026 ↩
  15. European Medicines Agency (2026). Medicines (search of centrally authorised medicines and EPARs). Regulator ema.europa.eu — accessed 20 October 2026 ↩
  16. European Commission, Directorate-General for Health and Food Safety (2026). EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines. Regulator health.ec.europa.eu — accessed 22 October 2026 ↩
  17. Minister van Volksgezondheid, Welzijn en Sport (2007). Regeling Geneesmiddelenwet, artikelen 3.17, 3.17a en 3.18 (ontheffing op artsenverklaring; vrijstelling bij tekort; gebruik in schrijnende gevallen). wetten.overheid.nl (BWBR0022160), version in force from 1 January 2026. Law wetten.overheid.nl — accessed 22 October 2026 ↩
  18. Court of Justice of the European Union (Third Chamber) (2012). Judgment of 29 March 2012, European Commission v Republic of Poland, Case C-185/10. EUR-Lex (CELEX 62010CJ0185). Law eur-lex.europa.eu — accessed 22 October 2026 ↩
  19. Court of Justice of the European Union (Third Chamber) (2015). Judgment of 16 July 2015, Abcur AB v Apoteket Farmaci AB and Apoteket AB, Joined Cases C-544/13 and C-545/13. EUR-Lex (CELEX 62013CJ0544). Law eur-lex.europa.eu — accessed 22 October 2026 ↩
  20. European Medicines Agency (2026). Clinical Trials Regulation. Regulator ema.europa.eu — accessed 22 October 2026 ↩
  21. European Parliament and Council of the European Union (2011). Directive 2011/62/EU amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of falsified medicinal products. Official Journal of the European Union, L 174. Law eur-lex.europa.eu — accessed 22 October 2026 ↩
  22. European Commission (2014). Commission Implementing Regulation (EU) No 699/2014 of 24 June 2014 on the design of the common logo to identify persons offering medicinal products for sale at a distance to the public and the technical, electronic and cryptographic requirements for verification of its authenticity. Official Journal of the European Union, L 184, 25 June 2014. Law eur-lex.europa.eu — accessed 22 October 2026 ↩
  23. European Commission (2016). Commission Delegated Regulation (EU) 2016/161 supplementing Directive 2001/83/EC by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use. Official Journal of the European Union, L 32. Law eur-lex.europa.eu — accessed 22 October 2026 ↩
  24. European Parliament, Legislative Observatory (2026). Procedure file 2023/0132(COD): Medicinal products for human use (Directive, repealing Directive 2001/83/EC). Trial registration oeil.secure.europarl.europa.eu — accessed 22 October 2026 ↩
  25. European Parliament, Legislative Observatory (2026). Procedure file 2023/0131(COD): Union procedures for the authorisation and supervision of medicinal products for human use and rules governing the European Medicines Agency (Regulation). Trial registration oeil.secure.europarl.europa.eu — accessed 22 October 2026 ↩
  26. European Medicines Agency (2026). Reform of the EU pharmaceutical legislation. Regulator ema.europa.eu — accessed 22 October 2026 ↩
  27. Bijwerkingencentrum Lareb (2026). Alles over bijwerkingen melden. Web page lareb.nl — accessed 20 October 2026 ↩
  28. Federal Agency for Medicines and Health Products (FAMHP / FAGG / AFMPS) (2023). Questions and answers regarding reporting adverse reactions. Regulator famhp.be — accessed 22 October 2026 ↩