Summary
Two instruments govern medicines for human use in the European Union. Directive 2001/83/EC of 6 November 2001 is the Community code relating to medicinal products for human use, and Regulation (EC) No 726/2004 of 31 March 2004 lays down Union procedures for authorisation and supervision and establishes the European Medicines Agency 12. Together they create two routes to market, a national route under the Directive and a centralised route under the Regulation, and only the centralised route is visible in a single Union-wide register. That asymmetry is the main limitation of the EU rows in this knowledge base, and it is stated explicitly below.
Definition and the requirement for authorisation
Article 1(2) of the Directive defines a medicinal product as any substance or combination of substances presented as having properties for treating or preventing disease in human beings, or which may be used in or administered to human beings either 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.
Article 6(1) provides that "no medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State in accordance with this Directive or an authorisation has been granted in accordance with Regulation (EC) No 726/2004", read with the paediatric and advanced-therapy Regulations 1. Additional strengths, pharmaceutical forms, routes, presentations, variations and extensions belong to the same global marketing authorisation 1. Article 5(1) allows a Member State, to fulfil special needs, to exclude from the Directive medicinal products supplied in response to a bona fide unsolicited order formulated in accordance with the specifications of an authorised health-care professional and for use by an individual patient under that professional's direct personal responsibility 1.
Classification follows Articles 70 and 71: on granting an authorisation the competent authorities specify whether the product is subject to medical prescription or not, with optional sub-categories for renewable or non-renewable delivery, special medical prescription, and restricted prescription reserved for certain specialised areas 1.
Centralised and national authorisation
Article 3(1) of Regulation (EC) No 726/2004 provides that "no medicinal product appearing in the Annex may be placed on the market within the Union unless a marketing authorisation has been granted by the Union in accordance with the provisions of this Regulation" 2. Annex I lists products developed by recombinant DNA technology, by controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells, or by hybridoma and monoclonal antibody methods; advanced therapy medicinal products; products containing a new active substance for the treatment of acquired immune deficiency syndrome, cancer, neurodegenerative disorder, diabetes, auto-immune and other immune dysfunctions, or viral diseases; and products designated as orphan medicinal products 2.
Article 3(2) makes the route optionally available to a product not appearing in Annex I where the active substance was not authorised in the Union on 20 May 2004, or where the applicant shows a significant therapeutic, scientific or technical innovation or that Union authorisation is in the interest of patients' health at Union level 2. Applications under Article 3 go to the Agency, and the Union grants and supervises the resulting authorisations 2. Everything outside those categories may be authorised nationally under the Directive, and such authorisations do not appear in the Union Register.
The Union Register and the orphan register
The European Commission publishes the Union Register of medicinal products for human use, which lists centrally authorised products by active substance, together with a companion list of products no longer authorised 34. A separate Community Register of orphan medicinal products lists active designations 5.
These registers carry both the positive and the negative findings recorded here. Tirzepatide appears as Mounjaro, EU/1/22/1685 6. Searches on 21 and 22 September 2026 of the authorised list (1,544 entries) and of the list of products no longer authorised (445 entries) returned no CJC-1295 entry and no GHRH-analogue active substance 34; searches for BPC-157 and bepecin each returned "No matching entries found" 6; a search for ipamorelin returned no match while a control search for macimorelin returned EU/1/18/1337, confirming that the register resolves active-substance names 7; and neither the human register nor the orphan register (2,194 designations) contains thymosin, timbetasin, RGN-259 or RGN-137 85.
EPARs, opinions and withdrawals
For centrally authorised products EMA publishes a European public assessment report. Semaglutide is covered by three: Ozempic, EMEA/H/C/004174, authorised 8 February 2018; Rybelsus, EMEA/H/C/004953, 3 April 2020; and Wegovy, EMEA/H/C/005422, 6 January 2022 91011. Tirzepatide is covered by Mounjaro, EMEA/H/C/005620, authorised 15 September 2022, whose EPAR page records the procedural history including the variations for which EMA did not recommend a separate indication 1213.
The same publication system records applications that did not succeed. The centralised application for Egrifta (tesamorelin), EMEA/H/C/002427, was submitted by Ferrer Internacional S.A. on 31 May 2011 and withdrawn on 21 June 2012, EMA announcing the withdrawal on 26 June 2012 1415. The withdrawal assessment report records the CHMP's provisional opinion that the product could not have been approved, citing difficulty distinguishing lipodystrophy-related abdominal fat from obesity, insufficient support for the proposed visceral adipose tissue cut-off, fat reduction not shown to give a clinically meaningful health benefit, trial populations not representative of European patients, raised IGF-1 as a major safety concern, and no long-term safety data 16. The EU Clinical Trials Register holds a parallel trace for CJC-1295: record 2005-003797-25, active substance "CJC-1295 TFA salt", status prematurely ended 17.
Cosmetics and CosIng
Cosmetic products in the Union are governed by Regulation (EC) No 1223/2009. Its consolidated text dated 1 May 2026 was retrieved and searched: "tripeptide" occurs zero times, and the copper-containing entries present are individually named substances such as the copper phthalocyanine pigments restricted in hair-dye products, the Annex II entries for "Copper (nano)" and "Colloidal Copper (nano)", and the Annex IV colourant "Copper", CI 77400 18. COPPER TRIPEPTIDE-1 is nevertheless listed in the Commission's CosIng database under reference 55687, described as a copper complex of Tripeptide-1, with the function skin conditioning, no CAS or EC number, no Cosmetics Regulation provision, no other restriction and no SCCS opinion shown 19. CosIng is an information database; listing there is not an authorisation 19.
What was not verified
EU rows in this knowledge base establish the absence of a centralised authorisation, not the absence of any authorisation anywhere in the Union. National authorisations granted under Directive 2001/83/EC do not appear in the Commission registers, national registers are not on this site's source allow-list, and no allowed source retrieved documents such an authorisation for any of the compounds covered 20. Direct searches of the EMA website could not be completed during the research sessions: the site returned an authentication error to one client and a bot-verification page to another, so the Commission registers and the published EMA medicines dataset were used instead 320. Where a third party has surveyed EU status independently it is cited as such rather than relied on alone: FDA states that no product containing any form of CJC-1295 has been authorised for use in the European Union, that no product containing TB-500 has been authorised there, and that neither BPC-157 form appears in the European Pharmacopoeia 212223. For sermorelin, the EMA medicines dataset generated on 21 September 2026 contained no entry matching sermorelin, Geref or somatorelin while it did contain tesamorelin, which shows the search reached GHRH analogues; any European authorisation of Geref would have been national and none was verified 20.