Who regulates what: EOF, the EMA and the Greek framework for peptides

The short answer is that no authority regulates "peptides" as a category. Neither Greek nor EU law treats peptides as a distinct regulatory object, in the same way that there is no "law on esters" or "law on alkaloids". A given substance's status follows from two things: how it is presented, and what purpose it is supplied for. Article 1(2) of Directive 2001/83/EC defines a medicinal product either by presentation or by function, and it is that definition — not molecular weight, not amino acid sequence — that switches the competence of EOF and the EMA on or off ^[1].

The practical consequence for anyone handling laboratory material is that the useful question is not "is this permitted?" but "which framework is this material in, and what documentation does that framework require?". The same sequence can sit simultaneously inside three different regulatory systems — pharmaceutical, chemical and sporting — which do not talk to one another and do not always reach the same conclusion. What follows describes all three, with the articles and figures that trigger each.

Why there is no "peptide legislation"

EU law is horizontal: it regulates functions and uses, not chemical families. Insulin, oxytocin, vasopressin and ciclosporin are all peptides and all authorised medicines. A tetrapeptide in a face cream falls under cosmetics legislation. A synthetic sequence manufactured and supplied as a chemical reagent falls under chemicals legislation. A shared molecular characteristic does not create a shared status.

This is why searches for "an EOF announcement about peptides" rarely turn up anything substantive. EOF issues market-surveillance notices regularly for unauthorised preparations sold online — typically supplements or "natural" products found to contain undeclared pharmaceutical actives. Those are enforcement acts against named products, not a decision creating a peptide category. The absence of such a decision is not a gap; it is the expected output of a system that classifies by purpose.

The definition that decides everything: Article 1(2) of Directive 2001/83/EC

The definition has two alternative limbs. By presentation: any substance or combination of substances "presented as having properties for treating or preventing disease". By function: any substance that may be used with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis ^[1]. Either limb on its own is sufficient.

The presentation limb is the one that surprises people. It does not require the product to actually act — only to be presented as if it does. A claim on a label, a leaflet or a sales page is enough to move material out of the chemical frame and into the pharmaceutical one, with everything that follows: a marketing authorisation required before supply, manufacturing requirements, pharmacovigilance. In practice, a borderline product is classified more often by how it is described than by what it contains.

The Directive also supplies a tie-breaker. Article 2(2) provides that where a product may fall both within the definition of a medicinal product and within the scope of other EU legislation, the pharmaceutical rules prevail ^[1]. There is no neutral zone: doubt resolves towards the stricter framework. In Greece the Directive is transposed by Joint Ministerial Decision DYG3a/G.P.32221/2013 (Government Gazette B' 1049 of 29 April 2013), which is the text the national administration actually cites ^[6].

EMA or EOF? Who authorises what

Regulation (EC) No 726/2004 establishes the centralised procedure and creates the European Medicines Agency. Article 3(1) provides that no medicinal product listed in the Annex may be placed on the market without a Union marketing authorisation ^[2]. The Annex mandatorily covers biotechnology-derived products — those made using recombinant DNA technology — orphan medicines, advanced therapies, and new active substances for specified indications including diabetes, cancer and neurodegenerative disorders.

That explains why the high-profile peptide medicines of recent years, such as the GLP-1 analogues used in diabetes and obesity, were authorised centrally: they fall inside the Annex's mandatory scope. The authorisation is granted by the European Commission following a scientific opinion from the EMA, and it is valid in every Member State at once. EOF neither grants nor withdraws those authorisations.

For anything outside the mandatory scope, authorisation happens nationally — through EOF for the Greek market — or through the mutual recognition and decentralised procedures between Member States. The distinction that matters to someone in Greece is functional: the EMA assesses, EOF polices the market. Whatever circulates, is advertised, is imported or is seized on Greek territory goes through EOF, regardless of who signed the authorisation.

What EOF actually does

The National Organization for Medicines was established by Law 1316/1983 as a public-law legal entity supervised by the Ministry of Health ^[7]. Its remit is wider than the name suggests: human and veterinary medicines, food supplements and foods for particular nutritional uses, cosmetics, medical devices and biocides. Material can come to EOF's attention through any of those gates, not only the pharmaceutical one.

• Marketing authorisation for medicines outside the centralised procedure, plus manufacturing and wholesale distribution licences ^[1].
• Market surveillance: sampling, laboratory testing, batch recalls and public notices about unauthorised preparations.
• Control of advertising and presentation — the point at which the presentation limb of Article 1(2) becomes an enforcement act ^[1].
• Authorisation of clinical trials conducted in Greece, under the EU clinical trials regulation.
• Cooperation with customs on imports of substances that may fall under pharmaceutical legislation.

The other side: REACH, CLP and the substance as a chemical

When a substance falls outside pharmaceutical legislation, it does not land in a vacuum. Regulation (EC) No 1907/2006 (REACH) imposes a registration duty on every substance manufactured in or imported into the EU at one tonne or more per year per manufacturer or importer (Article 6). Article 3(23) defines "scientific research and development" as any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume of less than one tonne per year, while Article 9 provides a five-year exemption for product and process orientated research and development ^[4].

The one-tonne threshold explains why most laboratory-scale quantities never generate a registration dossier. It explains nothing else. The duty to supply a safety data sheet under Article 31 and Annex II of REACH applies irrespective of tonnage once the substance meets classification criteria, and Regulation (EC) No 1272/2008 (CLP) requires classification, labelling and packaging before a substance is placed on the market ^[5]. The exemption in CLP Article 1(3) covers research and development substances only where they are not placed on the market and are used under controlled conditions.

Quality and documentation: what a certificate really means

In December 2025 the EMA adopted a guideline dedicated specifically to synthetic peptides (EMA/CHMP/CVMP/QWP/367182/2025), with a legal effective date of 1 June 2026 ^[3]. It covers the manufacturing process — solid-phase and liquid-phase synthesis, fragment condensation — along with characterisation, specifications and analytical control, with particular attention to the impurities peculiar to this chemistry: deletion and insertion sequences, truncated sequences, diastereomers arising from racemisation, and residual protecting groups.

The text addresses authorised medicines and investigational medicinal products, not research-use material — and that distinction should stay explicit. It is nonetheless the clearest published statement at EU level of what "adequately characterised synthetic peptide" means, and as such it is a useful yardstick when reading an analytical certificate field by field: which impurities are reported, by which method, and at what limit of quantitation.

The second dimension of documentation is accreditation. Regulation (EC) No 765/2008 requires each Member State to appoint a single national accreditation body ^[8]; in Greece that is ESYD, established by Law 3066/2002, folded into ESYP by Law 4109/2013, and restored to independence by Law 4468/2017. The standard against which testing laboratories are accredited is ISO/IEC 17025:2017, published in Greek standardisation as ELOT EN ISO/IEC 17025 ^[9].

One point is systematically overlooked: accreditation is never general. It is granted for a defined scope — specific methods, applied to specific classes of material. A laboratory accredited for water analysis is not accredited for peptide characterisation by liquid chromatography and mass spectrometry. The checkable item is not the logo on the certificate but the attached scope of accreditation, which ESYD publishes and which can be compared against the method the report names.

Anti-doping: a parallel and independent regime

The World Anti-Doping Agency's Prohibited List includes class S2, "Peptide Hormones, Growth Factors, Related Substances and Mimetics", which is prohibited at all times — both in and out of competition ^[10]. The list is revised annually and takes effect on 1 January; the sporting rationale for prohibiting the class is separate from anything in medicines or chemicals law. In Greece the national body is EOKAN, and Law 4791/2021 harmonised Greek legislation with the revised World Anti-Doping Code.

The critical caveat is that the sporting regime is entirely independent of the pharmaceutical and chemical ones. It binds persons under the jurisdiction of sports federations, not the general public. A substance can appear in class S2 without holding a marketing authorisation anywhere in the EU, or conversely be an authorised medicine and simultaneously prohibited in sport. Conflating the two produces wrong conclusions in both directions.

Where the boundaries are genuinely unclear

It would be dishonest to present the above as a closed system. The presentation limb is assessed case by case by the national authority, and the same substance has at times been classified differently in different Member States; the tie-breaker in Article 2(2) exists precisely because the boundaries are not self-evident ^[1]. Nor is there an EU-wide definition of "research-use material" outside the REACH framework, and enforcement practice — customs, market surveillance, postal inspection — is not fully captured in the written law.

• No published EOF decision establishes a special regime for peptides as a class; anyone invoking such a blanket rule is over-reading.
• A given product's classification can change without any change to the molecule, if the way it is described changes ^[1].
• REACH and CLP duties depend on each party's role in the supply chain — manufacturer, importer, downstream user — not on the substance alone ^{[4] [5]}.
• The EMA synthetic peptides guideline taking effect on 1 June 2026 governs authorised and investigational medicines, not material outside that scope ^[3].