Quick answer: peptide regulation in the EU, UK and Australia starts from the same rule: a peptide sold for use in people is a medicine that needs a marketing authorization, and most are prescription-only.[1][4] Australia has gone furthest, banning compounded GLP-1 “replicas” from 1 October 2024 and, in June 2026, making unapproved peptides such as BPC-157 and retatrutide a TGA compliance priority.[10][8]
Below we take each region in turn: what the law says, who enforces it, and what has changed recently. For more context, see our FDA and regulation hub, Canada peptide regulations and the full peptide legality by country table.
At a glance
| European Union | United Kingdom | Australia | |
|---|---|---|---|
| Main law | Directive 2001/83/EC and Regulation 726/2004 | Human Medicines Regulations 2012 | Therapeutic Goods Act 1989 and the Poisons Standard |
| Regulator | EMA plus national agencies | MHRA | TGA |
| Prescription status | Set at authorization | Prescription-only medicine (POM) | Schedule 4 (prescription only) |
| Unlicensed route | Magistral preparations, named-patient use (national) | “Specials” under regulation 167 | Special Access Scheme, Authorised Prescribers |
| Compounded GLP-1s | Varies by country | Specials only for a patient’s special clinical need | Banned since 1 October 2024 |
| Research peptides | Unauthorized medicines | Unlicensed medicines | Unapproved; many are Schedule 4 |
European Union: EMA and national regulators
What the law says. Directive 2001/83/EC, the EU “Community code” for human medicines, requires a marketing authorization before a medicinal product is placed on the market. Articles 70 and 71 set out when a medicine must be prescription-only, including when it is normally given by injection or poses a risk without medical supervision.[1]
Who regulates. The European Medicines Agency (EMA) assesses medicines through the centralised procedure, and peptides made by biotechnology, such as semaglutide, go through EMA. National agencies (Germany’s BfArM, France’s ANSM and others) enforce the rules on the ground, license pharmacies and handle personal imports, which differ from one member state to the next.
Compounding. Article 3 of the Directive excludes “magistral formula” preparations (made in a pharmacy for an individual patient’s prescription) and “officinal formula” preparations from the authorization requirement.[1] There is no EU-wide list of allowed bulk substances like the U.S. has for 503A and 503B compounding.
Fakes. In October 2023, EMA warned that falsified pens labelled as semaglutide 1 mg had been found at wholesalers in Austria and Germany, detected because their serial numbers were inactive.[2] That safety-feature system comes from the EU’s falsified medicines rules.
What’s changing. EU institutions reached a political deal on a new pharmaceutical package on 11 December 2025. The Council adopted its position on 28 September 2026, and the Parliament still had to vote at last check.[3] The deal replaces today’s “8+2+1” regulatory protection with a baseline of 8 years of data protection plus 1 year of market protection, extendable to an 11-year maximum, and is expected to apply about two years after publication.[3] Our peptide patents and exclusivity guide explains how these periods interact with patents.
United Kingdom: MHRA
What the law says. The Human Medicines Regulations 2012 require a marketing authorization for medicines placed on the UK market, restrict the sale and supply of prescription-only medicines (POMs), and ban advertising POMs to the public.[4]
Specials. Regulation 167 lets a licensed manufacturer or importer supply an unlicensed “special” to meet an individual patient’s special clinical needs, on an unsolicited order from a qualifying prescriber.[5] The MHRA’s Guidance Note 14 says “special need” means the patient’s clinical needs. It does not include cost, convenience or operational reasons.[5]
Enforcement in 2025-2026. The MHRA’s Criminal Enforcement Unit seized more than 5,000 illegally traded GLP-1 products in 2025, among illegal medicines worth almost £45 million.[7] On 14 October 2026 it seized more than 12,000 counterfeit retatrutide and tirzepatide pens in Birmingham, and it said that retatrutide “has not been authorised for use in the UK.”[6] The MHRA advises people to get medicines only from a registered pharmacy with a valid prescription.[6]
Australia: TGA
What the law says. The Therapeutic Goods Act 1989 requires medicines to be on the Australian Register of Therapeutic Goods (ARTG) before supply. The Poisons Standard decides how a substance is scheduled. Schedule 4 means prescription only. BPC-157 is in Schedule 4 and in Appendix D, clause 5, which makes possession without authority illegal.[11]
Compounded GLP-1s. In May 2024 the Health Minister announced that GLP-1 receptor agonists would be removed from the pharmacy compounding exemption from 1 October 2024. The aim was to stop compounded “replicas” of semaglutide and tirzepatide, which the TGA had not evaluated.[10] Other compounded medicines were not affected.[10]
Personal importing. On 7 May 2026 the TGA warned about importing unapproved peptides. It said importing them under the Personal Importation Scheme is allowed only if the goods are clearly and accurately labelled, and it flagged powders or unmarked vials labelled with codes as red flags.[9] Schedule 4 medicines brought in under the scheme generally need a valid Australian prescription and are limited to about three months’ supply.
June 2026 crackdown. On 19 June 2026, the TGA and Australia’s Chief Medical Officer said they were “increasingly concerned” about unapproved peptides. They cited TGA reports and hospital data linking them to serious harms, including liver damage and severe allergic reactions, and named BPC-157, GHK-Cu, TB-500, retatrutide and CJC-1295.[8] Unapproved peptides were made a priority focus for TGA compliance.[8]
How the three compare with the U.S.
All three regions classify injectable peptides as medicines, not supplements, and none accepts a “research use only” label as a reason to sell them to the public. The U.S. is the outlier on compounding: FDA keeps formal bulk-substance categories and holds advisory committee votes on individual peptides. Our FDA peptide ban 2026 guide covers that system. Australia has acted most directly, with a compounding ban and a named-peptide warning. The UK leans on criminal enforcement against counterfeit and unlicensed pens. The EU leaves most enforcement to member states.
For athletes, the national rules sit on top of anti-doping rules. Most of these peptides are banned in sport regardless of country (see peptides on the WADA prohibited list).
Gaps and things to check
- EU personal imports differ by member state, so check your national medicines agency.
- The EU pharma package was not yet in force at the time of writing.[3]
- The TGA’s Poisons Standard is updated several times a year, so confirm a substance’s current schedule on the Federal Register of Legislation.
This is general information, not legal advice. Talk to a pharmacist, doctor or lawyer in your own country about your situation.
