Legal document

Product Disclaimer

Operator: FIRSTSTONE TRADING sp. z o.o.
Version: 2.0
Effective date: 2026-06-06
Last updated: 2026-08-09
Language: Polish
Legal contact: compliance@purepoint.pl

Document version: 2.0 Effective date: 6 June 2026 Service Operator: FIRSTSTONE TRADING spółka z ograniczoną odpowiedzialnością Target slug: /zastrzezenie-produktowe/ Review cycle: quarterly (next review: 6 September 2026)

For research purposes only. Not for human or animal consumption. For research purposes only. Not for human or animal consumption.

§ 1. PURPOSE OF THE DOCUMENT AND ITS PLACE WITHIN THE STORE’S LEGAL FRAMEWORK

This Product Disclaimer (hereinafter: the “Disclaimer” or the “Document”) forms an integral part of the system of legal documents in force in the online store operated at the address https://purepoint.pl (hereinafter: the “Store” or the “Service”) by FIRSTSTONE TRADING sp. z o.o., with its registered office in Poznań (hereinafter: the “Operator”, the “Seller” or “FIRSTSTONE”).
The Document clarifies, supplements and operationalises the provisions of: – the Research Disclaimer (document LEGAL-PP-01-v2-20260606, available at https://purepoint.pl/zastrzezenie-badawcze/), – the Store Terms and Conditions (document LEGAL-PP-03-v2-20260606), in particular § 5 of the Terms and Conditions defining the subject matter of the service and the scope of the product offering, – the Acceptable Use Policy (document LEGAL-PP-13-v2-20260606), – the Compliance Information (document LEGAL-PP-08-v2-20260606).
The purpose of the Document is to indicate, precisely and transparently: – which categories of substances the Seller offers for sale, – which categories of substances are categorically excluded from the Store’s commercial offering on account of their status as a medicinal product within the meaning of the pharmaceutical law of the Republic of Poland and the European Union, – which functional and communication restrictions the Seller imposes upon itself in respect of selected categories of Products in order to avoid the risk of misleading the buyer as to the permissible use of a substance, – which recommendations, advice and suggestions the Seller does not provide and is not entitled to provide — in particular medical, pharmaceutical, nutritional, cosmetic or sports/training recommendations, – what the internal procedure is for managing the portfolio of offered SKUs (Stock Keeping Units), including the SKU Risk Matrix, the quarterly review procedure and the manner of communicating changes to Qualified Buyers.
The provisions of this Document apply to every transaction concluded through the Store — regardless of the purchase channel (storefront, e-mail order, wholesale order), regardless of the Buyer’s legal status (entrepreneur, scientific institution, public entity), and regardless of the place of delivery (the territory of the Republic of Poland or other countries in which the Operator carries out sales in accordance with the Shipping Policy — document LEGAL-PP-05-v2-20260606).
Entering into a legal relationship with the Seller — in particular placing an order, creating an account in the Store or accepting the Research Disclaimer — means that the Buyer: – has read the content of this Document in its entirety, – understands the legal consequences arising from the classification of a Product into a particular risk category, – accepts the functional restrictions and the absence of any recommendations going beyond information of a research/laboratory nature, – assumes full responsibility for the manner in which the purchased Research Material is used — within the limits laid down in the Act of 23 April 1964, the Civil Code (consolidated text: Journal of Laws 2025 item 1610 [VERIFY — discrepancy with the Research Disclaimer, which cites Journal of Laws 2025 item 250; harmonise the correct publication number]; hereinafter: the “KC”) and in other mandatorily applicable provisions of law.
In the event of any conflict between the provisions of this Document and the provisions of the Store Terms and Conditions or the Research Disclaimer, the more restrictive provisions shall prevail (compliance-first principle). This principle reflects the primacy of the interest of regulatory compliance over sales economics and forms part of the legal risk management system adopted by the Operator.
The Document is subject to a regular quarterly review conducted by the Operator’s Compliance Officer. Any material change in the legal landscape (a decision of the European Medicines Agency [EMA], a decision of the Food and Drug Administration [FDA], an update of the World Anti-Doping Agency [WADA] Prohibited List, a communication of the Chief Pharmaceutical Inspector [GIF], guidance of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products [URPL], a decision of the President of the Personal Data Protection Office [UODO] or of the Office of Competition and Consumer Protection [UOKiK]) results in an update of the Document — in accordance with the communication procedure described in § 11 below.

§ 2. DEFINITIONS

For the purposes of this Document, the following terms have the meanings assigned to them below:

Product — a physical item offered by the Seller in the Store, having an assigned SKU identifier, a catalogue description and an assigned risk category (GREEN / YELLOW / RED — see § 3 of the Document). Each Product constitutes a Research Material within the meaning of the Research Disclaimer and does not constitute a medicinal product, a dietary supplement, a cosmetic product or a medical device.
Research Material — a chemical substance, peptide, biologically active compound or laboratory reagent, offered solely for in vitro scientific applications, described on the outer packaging and label as “for research purposes only” / “wyłącznie do celów badawczych”, not holding the status of a medicinal product authorised for marketing in the territory of the Republic of Poland or the European Union, and not intended for use in humans or animals.
KOP-Committee (Product Assessment Committee) — an internal advisory body of the Operator composed of the Compliance Officer, the Operator’s legal counsel (or a standing external adviser) and the Product Manager responsible for the product range. The Committee recommends the classification of each new SKU into a risk category, verifies the current classification of SKUs on a quarterly cycle, and formulates recommendations to suspend, remove or reclassify SKUs in the event of a regulatory change trigger. Terminological note: the acronym “KOP-Committee” in this Document denotes solely this internal body and is deliberately distinguished from the abbreviation “KOP” (Qualified Profile Declaration) used in the Research Disclaimer (§ 4) to denote the set of declarations of the Qualified Buyer — these are two different concepts.
SKU Risk Matrix — an internal operational register maintained by the Operator’s Compliance Officer, containing for each offered SKU: the commercial name, the chemical name of the active substance, the regulatory status in PL/EU/USA, the status on the WADA List, the date of the last assessment, the date of the next review, the risk category and the rationale for classification. The Matrix is not published externally in its full form — Qualified Buyers have access only to the classification status of the specific SKU they intend to purchase, upon submitting an enquiry to the address compliance@purepoint.pl.
Categorical exclusion — an absolute, non-derogable refusal to include a given substance in the Seller’s offering, which is not subject to individual waiver. A categorical exclusion has its legal basis in the status of a given substance as a medicinal product authorised for marketing in the EU/USA (and thereby as a substance whose placing on the market requires obtaining a pharmaceutical wholesale authorisation in accordance with the Act of 6 September 2001, Pharmaceutical Law — consolidated text: Journal of Laws 2025 item 750; hereinafter: the “PF”) or in pre-registration status (Phase III clinical trials leading to the registration of a medicinal product). Substances covered by a categorical exclusion are not and will not be offered by the Seller under any circumstances.
In vitro — the use of a substance solely under laboratory conditions, outside a living organism (Latin in vitro — “in glass”), in isolated biological systems such as cell cultures, tissues, subcellular fractions or cell-free systems. The Seller supplies Research Materials solely for such applications. Any use going beyond the scope of in vitro — in particular administration of the substance to a human organism (in vivo, ex vivo with re-administration), clinical, therapeutic, diagnostic or cosmetic use — falls outside the scope of the intended purpose of the Product and constitutes a breach of the provisions of the Research Disclaimer and may give rise to criminal and administrative liability on the part of the Buyer.
Qualified Buyer — within the meaning of § 4 of the Research Disclaimer — an adult natural person conducting business activity, a legal person or an organisational unit without legal personality to which a statute confers legal capacity, conducting research and development, scientific, laboratory or educational activity and acquiring Research Material solely in connection with that activity, for the purpose of its use under in vitro conditions.
Compliance Officer — an employee or associate designated by the Operator’s management board, responsible for overseeing the compliance of the Store’s activity with the provisions of pharmaceutical law, consumer protection, personal data protection, and the provisions concerning anti-money laundering and export sanctions. The Compliance Officer is the contact person for Qualified Buyers in matters concerning SKU classification, verification procedures and the Store’s legal documents. Contact: compliance@purepoint.pl.
Medicinal product — within the meaning of Art. 2 point 32 PF — a substance or mixture of substances presented as having properties for the prevention or treatment of diseases occurring in humans or animals, or administered with a view to making a diagnosis, or with a view to restoring, correcting or modifying physiological functions of the body through pharmacological, immunological or metabolic action. Placing a medicinal product on the market without the required authorisation constitutes a prohibited act.
Active substance (Active Pharmaceutical Ingredient — API) — a substance or mixture of substances intended for use in the manufacture of a medicinal product, which becomes its active ingredient. The manufacture of and trade in active substances is subject to a separate licensing regime (Art. 51a–51b PF).
WADA Prohibited List — the List of Prohibited Substances and Methods of the World Anti-Doping Agency, updated annually and entering into force on 1 January of the given calendar year. The WADA List forms the basis of the anti-doping control system in organised sport and is binding upon persons connected with sports federations that are signatories to the World Anti-Doping Code.
PF — the Act of 6 September 2001 — Pharmaceutical Law (consolidated text: Journal of Laws 2025 item 750).
KC — the Act of 23 April 1964 — the Civil Code (consolidated text: Journal of Laws 2025 item 1610 [VERIFY — discrepancy with the Research Disclaimer, which cites Journal of Laws 2025 item 250; harmonise the correct publication number]).
KK — the Act of 6 June 1997 — the Penal Code (consolidated text: Journal of Laws 2025 item 17).
UPK — the Act of 30 May 2014 on Consumer Rights (consolidated text: Journal of Laws 2024 item 1796).
RODO — Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation).

§ 3. PRODUCT CLASSIFICATION — THREE-TIER RISK MATRIX

The Operator applies to each substance under consideration for sale a three-tier risk matrix (3-tier SKU Risk Matrix), based on objective legal/regulatory and pharmaceutical criteria. The classification is binding — no SKU is made available to Buyers without being assigned to one of the three categories.
Risk categories applied by the Operator:

3.1. 🟢 GREEN — Products available for sale without additional requirements

Substances qualified into the GREEN category meet all of the following criteria jointly: – no status of a medicinal product authorised for marketing in the territory of the European Union (no EMA authorisation, no URPL authorisation under the national procedure, no authorisation under the MRP/DCP procedure), – no status of a medicinal product authorised by the Food and Drug Administration (USA), the Ministry of Health, Labour and Welfare (Japan), the Therapeutic Goods Administration (Australia) or another comparable regulatory authority of an OECD country, – no Phase III clinical trial currently being conducted (or a later phase) aimed at registration as a medicinal product in the EU/USA, – not included in the list of controlled substances under the Act of 29 July 2005 on Counteracting Drug Addiction (consolidated text: Journal of Laws 2025 item 124), – not included in the list of new psychoactive substances pursuant to the Regulation of the Minister of Health of 17 August 2018, – not included in the list of drug precursors or explosives precursors subject to a separate licensing regime.
GREEN substances are offered in full scope, on the general terms of the Store Terms and Conditions, without the need to obtain additional declarations from the Buyer beyond the standard Qualified Buyer declaration that the Product is intended for in vitro research.
The GREEN category includes — by way of example and non-exhaustively — the following peptides and compounds: – TB-500 (Thymosin Beta-4 fragment) — a regenerative peptide, not registered as a medicinal product in the EU/USA, no Phase III, not listed on the WADA List as an individually named substance (classified into category S0 as a non-approved substance — which concerns sports applications only), – BPC-157 (Body Protection Compound) — a regenerative peptide, pre-clinical status, not registered, – Epithalon (Epitalon) — a tetrapeptide investigated in the context of its effect on telomerase, not registered, – GHK-Cu (Glycyl-L-Histidyl-L-Lysine — Copper Peptide) — a copper peptide historically used in in vitro research, – MOTS-c — a mitochondrial peptide in the pre-clinical research phase, – MGF (Mechano Growth Factor) and PEG-MGF — research forms of IGF-1Ec, – HGH Fragment 176-191 — a growth hormone fragment, not registered as a medicinal product.
The classification of each of the above SKUs is subject to quarterly review and may change in the event of a regulatory trigger (see § 10 of the Document).

3.2. 🟡 YELLOW — Products available with additional compliance declarations

Substances qualified into the YELLOW category are those which: – do not hold the status of a medicinal product authorised for marketing in the EU/USA, – are not in Phase III clinical trials leading to registration, – BUT are listed on the WADA Prohibited List as an individually named substance in class S2 (growth factors and their releasers), S4 (hormone modulators) or S5 (diuretics and masking agents), – or on account of their pharmacological profile are susceptible to promotional use in a manner suggesting application beyond the scope of in vitro (e.g. use in training, supplementation, cosmetics, tanning), – or are subject to increased regulatory monitoring by the GIF, URPL or UOKiK in connection with the market practices of competitors.
YELLOW substances are offered with the following additional obligations on the part of the Seller: – an extended catalogue description containing an explicit warning of WADA-listed status, – an obligation to obtain from the Buyer an extended declaration of research purpose (beyond the standard Qualified Buyer declaration), – a prohibition on conducting any promotional content for the Product in an excluded functional context (see § 5 of the Document), – an obligation to indicate in the SKU description the WADA class to which the substance is assigned, – an obligation to re-review the classification each quarter, taking into account the update of the WADA List that enters into force on 1 January of each year.
The YELLOW category includes — by way of example and non-exhaustively: – Ipamorelin — a selective ghrelin mimetic / GHRP-mimetic, WADA class S2.2.2 (growth hormone releasing peptides), – CJC-1295 (with and without DAC modification) — a GHRH analogue, WADA class S2.2, – GHRP-2 and GHRP-6 — growth hormone releasing peptides, WADA class S2.2.2, – Hexarelin — a GHRP hexapeptide, WADA class S2.2.2, – Melanotan II — an α-MSH analogue, high risk of promotion in the context of “tanning without the sun” (see § 5 para. 3 let. c), – IGF-1 LR3 (Long-R3) — an IGF-1 analogue, WADA class S2.3 (IGF-1 releasing factors).

Note: PT-141 (bremelanotide) does NOT belong to the YELLOW category and is not offered — its FDA status (Vyleesi) results in a 🔴 RED classification and categorical exclusion from the offering (see § 4 para. 4.4).

3.3. 🔴 RED — Products categorically unavailable for sale

Substances qualified into the RED category are those which meet at least one of the following criteria: – hold the status of a medicinal product authorised for marketing in the territory of the European Union (an EMA authorisation under the centralised procedure, MRP, DCP or the URPL national procedure), – hold the status of a medicinal product authorised by the Food and Drug Administration of the United States of America, – are in an advanced phase of clinical trials (Phase III or later) leading, in high probability, to registration as a medicinal product in the EU/USA within a horizon of the next 24 months, – are included in the list of controlled substances within the meaning of the Act on Counteracting Drug Addiction or in the list of new psychoactive substances, – have been deemed, by a decision of the Compliance Officer based on a recommendation of the KOP-Committee, to be substances with an unacceptable regulatory risk profile (e.g. in connection with ongoing GIF proceedings concerning the peptide market, a UOKiK decision concerning competitors’ market practices, or a CJEU ruling affecting the classification of a substance).
RED substances are not and will not be made available to Buyers by the Seller under any circumstances — regardless of: – the Buyer’s legal status (including the status of a scientific or public institution), – the Buyer’s possession of a pharmaceutical wholesale authorisation or an authorisation to manufacture medicinal products (a Buyer holding such an authorisation should make purchases from entities holding a distribution authorisation for medicinal products, and not from the Seller of Research Materials), – the quantity and value of the potential order, – the delivery deadline or commercial terms, – any declaration by the Buyer as to the purpose of the purchase.
The list of RED substances is the subject of § 4 of the Document below and is updated on a quarterly cycle and immediately in the event of a regulatory trigger.

§ 4. CATEGORICAL EXCLUSIONS 🔴 RED — LIST OF SUBSTANCES EXCLUDED FROM SALE

The Operator places on the market solely substances not registered as medicinal products in the jurisdictions of key importance to this activity (EU, USA, United Kingdom, Switzerland, Japan, Australia). The substances below are categorically excluded from the Store’s commercial offering — with the legal rationale for each exclusion decision.

4.1. Semaglutide (semaglutyd) — a GLP-1 analogue

Regulatory status: Semaglutide is the active substance of medicinal products registered by the European Medicines Agency (EMA) under the centralised procedure: – Ozempic — EMA authorisation number EMA/H/C/004174, registered to Novo Nordisk A/S (Denmark), indication: treatment of type 2 diabetes in adults, – Wegovy — EMA authorisation number EMA/H/C/004917, registered to Novo Nordisk A/S (Denmark), indication: treatment of obesity as an adjunct to a reduced-calorie diet and increased physical activity in adults with a body mass index (BMI) ≥ 30 kg/m² or ≥ 27 kg/m² with at least one weight-related comorbidity, – Rybelsus — the oral form of semaglutide, EMA authorisation EMA/H/C/004915, indication: treatment of type 2 diabetes.
FDA status (USA): the corresponding FDA authorisations (NDA) — Ozempic, Wegovy, Rybelsus — held by Novo Nordisk Inc.
Legal basis for the categorical exclusion: semaglutide constitutes the active substance of a medicinal product authorised for marketing in the territory of the Republic of Poland and the European Union. Placing a medicinal product on the market (or an active substance for the manufacture of a medicinal product) without the required authorisation constitutes a prohibited act under Art. 124 para. 1 of the Act of 6 September 2001 — Pharmaceutical Law (consolidated text: Journal of Laws 2025 item 750): whoever, without the required authorisation, places a medicinal product on the market shall be subject to a fine, a penalty of restriction of liberty or deprivation of liberty for up to 2 years.
In view of the above regime of criminal liability and the fact that the Operator does not hold a pharmaceutical wholesale authorisation or any other legal title entitling it to trade in medicinal products — semaglutide is not and will not be offered by the Seller.
The classification of semaglutide as a RED product is permanent and not subject to revision until the expiry of patent protection and the loss of medicinal product status, which is not anticipated within the planning horizon of this activity.

4.2. Tirzepatide (tirzepatyd) — a dual GIP/GLP-1 agonist

Regulatory status: Tirzepatide is the active substance of medicinal products registered by the European Medicines Agency and the Food and Drug Administration: – Mounjaro — EMA authorisation number EMA/H/C/005620, registered to Eli Lilly Nederland B.V. (Netherlands), indication: treatment of type 2 diabetes in adults, – Zepbound — FDA authorisation to Eli Lilly and Company (USA), indication: treatment of obesity in adults. In the European Union, Mounjaro also holds an approved indication for the treatment of obesity on the basis of an extension of the EMA authorisation.
Legal basis for the categorical exclusion: tirzepatide is the active substance of a medicinal product authorised for marketing in the EU/USA. The legal regime is identical to the regime for semaglutide described in § 4 para. 4.1.3 above — placing it on the market without the required authorisation constitutes a prohibited act under Art. 124 para. 1 PF.
Tirzepatide is not and will not be offered by the Seller. The exclusion decision is permanent.

4.3. Retatrutide (retatrutyd) — a triple GLP-1/GIP/glucagon agonist

Regulatory status: Retatrutide is a substance in Phase III advanced clinical trials conducted by Eli Lilly and Company. The key trial identified by ClinicalTrials.gov number NCT05882045 (TRIUMPH-1) evaluates the efficacy of retatrutide in the treatment of obesity. The substance does not yet hold an EMA or FDA authorisation, but is within the immediate registration horizon (pre-EMA / pre-FDA status).
Legal basis for the categorical exclusion: in accordance with the Operator’s internal policy, substances in Phase III clinical trials leading, in very high probability, to registration as a medicinal product within a horizon of 18–36 months are classified as 🔴 RED in advance of the registration decision. The rationale is: – anticipatory regulatory risk: registration may occur during the SKU’s sales cycle, which would necessitate the immediate withdrawal of the substance from sale with logistical and compliance consequences, – reputational risk: offering a substance within the immediate registration horizon may be perceived as an attempt to occupy a grey area of the market before the entry of a medicinal product — which is contrary to the Operator’s compliance-first principle, – enforcement risk: the GIF and URPL may take control measures against entities offering substances in pre-registration status.
Retatrutide is not and will not be offered by the Seller until it is permanently confirmed that the substance will not be registered as a medicinal product — which, within the current planning horizon, is not realistic.

4.4. Bremelanotide (PT-141, bremelanotyd) — a melanocortin receptor agonist

Regulatory status: Bremelanotide is the active substance of a medicinal product registered by the Food and Drug Administration: – Vyleesi — FDA authorisation to Palatin Technologies Inc. (USA), indication: treatment of acquired, generalised hypoactive sexual desire disorder in pre-menopausal women (HSDD — Hypoactive Sexual Desire Disorder).
Although bremelanotide does not currently hold an EMA authorisation in the territory of the European Union, its status as a medicinal product registered in the jurisdiction of an OECD country (USA) results in its classification as the active substance of a medicinal product within the meaning of the Operator’s internal policy. Placing the active substance of a medicinal product on the market without the appropriate authorisation constitutes a breach of the regime of Art. 51a–51b PF (trade in active substances) and potentially of Art. 124 para. 1 PF (if the substance were to be classified as a medicinal product in the functional sense).
Legal basis for the categorical exclusion: the result of a comprehensive assessment by the KOP-Committee taking into account: FDA status as the decisive criterion, the risk of classification as the active substance of a medicinal product, the risk of functional interpretation as a medicinal product.
Bremelanotide is not and will not be offered by the Seller. The classification is permanent.

4.5. Oxytocin (oksytocyna) — a neuropeptide with hormonal action

Regulatory status: Oxytocin is the active substance of a number of medicinal products authorised for marketing both in the European Union and in Poland under the URPL national procedure: – Syntocinon — a medicinal product registered by Alfasigma S.p.A. (Italy), indication: induction and augmentation of labour, prevention and treatment of post-partum haemorrhage, – Oxytocin Polfa — a medicinal product registered under the national procedure by Warszawskie Zakłady Farmaceutyczne Polfa S.A., indication: induction of labour, strengthening of uterine contractile activity, treatment of post-partum haemorrhage, – Pitocin — FDA authorisation (USA) to JHP Pharmaceuticals.
Legal basis for the categorical exclusion: oxytocin is a classic active substance of a medicinal product authorised for marketing in the EU/PL/USA with a long registration history. Placing oxytocin on the market without a pharmaceutical wholesale authorisation constitutes an offence punishable under Art. 124 para. 1 PF — whoever, without the required authorisation, places a medicinal product on the market shall be subject to a fine, a penalty of restriction of liberty or deprivation of liberty for up to 2 years.
Oxytocin is not and will not be offered by the Seller under any circumstances.

4.6. Survodutide (survodutyd) — a dual GLP-1 / glucagon receptor agonist

Regulatory status: Survodutide is a substance in Phase III clinical trials conducted by Boehringer Ingelheim International GmbH. The key trials include, among others, NCT06077864 (SYNCHRONIZE™-1) evaluating survodutide in the treatment of obesity, and further trials in non-alcoholic fatty liver disease (NASH/MASH).
Legal basis for the categorical exclusion: identical to the case of retatrutide (§ 4 para. 4.3.2) — the substance is in Phase III clinical trials with a very high probability of registration within a horizon of 18–36 months. Survodutide is classified as 🔴 RED in advance of the registration decision on account of: – anticipatory regulatory risk, – reputational risk associated with the perception of offering a pre-registration substance as an attempt to occupy a grey area, – enforcement risk on the part of the GIF/URPL.
Survodutide is not and will not be offered by the Seller.

4.7. Other substances covered by categorical exclusion (supplementary list)

Notwithstanding the principal exclusions referred to above, the Operator also covers by categorical exclusion the following substances (a non-exhaustive list, subject to quarterly supplementation):

Liraglutide (liraglutyd) — the active substance of the medicinal products Victoza (EMA/H/C/001026, Novo Nordisk) and Saxenda (EMA/H/C/003780, Novo Nordisk) registered for type 2 diabetes and obesity.
Dulaglutide (dulaglutyd) — the active substance of the medicinal product Trulicity (EMA/H/C/002825, Eli Lilly Nederland B.V.).
Exenatide (eksenatyd) — the active substance of the medicinal products Byetta (EMA/H/C/000698) and Bydureon (EMA/H/C/002020), AstraZeneca AB.
Insulin glargine, lispro, aspart, detemir, degludec and other insulin analogues — the active substances of medicinal products authorised for marketing in the EU/USA to Sanofi-Aventis, Eli Lilly, Novo Nordisk and other marketing authorisation holders.
Tesamorelin (tesamorelin) — the active substance of the medicinal product Egrifta (FDA NDA to Theratechnologies Inc.), registered for the treatment of lipodystrophy in HIV patients.
Somapacitan (somapacytan) — the active substance of the medicinal product Sogroya (EMA/H/C/004956, Novo Nordisk), registered for the treatment of growth hormone deficiency in adults.
Mecasermin (mekasermina) — recombinant human IGF-1, the active substance of the medicinal product Increlex (EMA/H/C/000704, Ipsen Pharma).
Sermorelin (sermorelina) — a historical active substance of medicinal products in the USA (Geref Diagnostic — withdrawn), still subject to classification as the active substance of a medicinal product.
Cagrilintide (kagrylintid) — a substance in Phase III clinical trials of Novo Nordisk (in combination with semaglutide as CagriSema, REDEFINE trials).
Orforglipron (orforglipron) — an oral GLP-1 agonist in Phase III clinical trials of Eli Lilly.

The above supplementary list is subject to quarterly review by the KOP-Committee and to ongoing monitoring of communications from the EMA, FDA, GIF and URPL. The list is not closed in nature — any substance meeting the criteria for 🔴 RED classification from § 3 para. 3.3 of the Document is added to it automatically.

§ 5. FUNCTIONAL EXCLUSIONS 🟡 YELLOW — PROHIBITED USES IN COMMUNICATION

In respect of Products classified into the 🟡 YELLOW category, the Operator imposes upon itself additional communication restrictions, the purpose of which is to make it impossible to suggest to Buyers uses going beyond the scope of in vitro. The restrictions encompass a prohibition on conducting promotional, advertising, informational and educational content in specified functional contexts — divided into four categories of peptides.

5.1. Regenerative peptides (BPC-157, TB-500, Thymosin Alpha-1 and derivatives)

The Operator does not and will not conduct any promotional content concerning regenerative peptides in the following contexts: – “post-exercise recovery”, “recovery after training”, “post-workout recovery”, – “tendon regeneration”, “joint regeneration”, “ligament regeneration” in the context of use in humans, – “anti-aging”, “slowing of ageing”, “rejuvenation”, – “acceleration of healing” in a clinical context (wounds, sports injuries, post-traumatic injuries), – “treatment of hernia”, “treatment of injury”, “treatment of Achilles tendon rupture” or other disease entities, – “athlete supplementation”, “peptide for the athlete”, “peptide for the competitor”.
Every catalogue description of a regenerative peptide compulsorily contains information that the substance is offered solely for in vitro research into the molecular mechanisms described in the pre-clinical literature, without any suggestion of clinical use in a human or animal.

5.2. GH peptides (growth hormone releasers and GH fragments)

This category includes, among others: Ipamorelin, GHRP-2, GHRP-6, Hexarelin, CJC-1295 (with and without DAC), HGH Fragment 176-191, Tesamorelin (note: tesamorelin is the active substance of the medicinal product Egrifta — classified 🔴 RED).
The Operator does not and will not conduct any promotional content in the following contexts: – “muscle growth”, “increase in muscle mass”, “mass gain”, “muscle building”, – “fat loss”, “fat burning”, “reduction of adipose tissue”, “weight loss”, – “body recomposition”, “recomposition of the body”, – “training peptide”, “pre-workout peptide”, “post-workout peptide”, – “peptide cycle”, “peptide stack”, “bulk”, “cut” in a bodybuilding context, – “peptide for active men”, “peptide for strongmen”, – any references to testosterone, growth hormone or IGF-1 as a suggestion of hormonal effects in humans.
Catalogue descriptions of GH peptides compulsorily contain information about the WADA class to which the substance is assigned — in particular class S2.2.2 (Growth Hormone Releasing Peptides, GHRP) or S2.3 (IGF-1 releasing factors).

5.3. Melanocortin peptides (Melanotan II, MT-II, α-MSH analogues)

This category includes in particular Melanotan II (MT-II) and α-MSH analogues other than bremelanotide (PT-141 — classified 🔴 RED on account of FDA registration as Vyleesi).
The Operator does not and will not conduct any promotional content in the following contexts: – “tanning without the sun”, “sunless tanning”, “tanning without sunlight”, – “self-tanner”, “self-tanning”, “bronzer”, – “obtaining a tan”, “intense tan”, – “beauty peptide”, “cosmetic peptide”, – “libido”, “sexual arousal” (note: stimulating libido is an indication of the medicinal product Vyleesi — 🔴 RED classification for bremelanotide), – any content suggesting cosmetic, aesthetic or sexological use of the substance.
Catalogue descriptions of melanocortin peptides compulsorily contain information that the substance is offered solely as a research material for in vitro work and that the scientific literature describes the risk profile of this class of compounds (including dermatological and cardiovascular data) — together with an unequivocal reminder of the prohibition on any human or animal exposure (§ 5 para. 5.5 and the Research Disclaimer § 5).

5.4. Longevity and mitochondrial peptides (Epithalon, MOTS-c, NAD+ derivatives, SS-31)

This category includes: Epithalon, MOTS-c, SS-31 (Elamipretide — note: pre-registration status, subject to quarterly review of classification), NMN (β-Nicotinamide Mononucleotide) as a research material, NR (Nicotinamide Riboside) as a research material.
The Operator does not and will not conduct any promotional content in the following contexts: – “anti-aging therapy”, “anti-aging treatment”, “anti-ageing therapy”, – “longevity therapy”, “longevity treatment”, – “rejuvenation of the organism”, “turning back the biological clock”, – “life extension”, “living 120+”, “living 150 years”, – “cell therapy”, “regeneration of mitochondria in humans”, – any references to studies in humans as a recommendation for use.
Catalogue descriptions of longevity peptides compulsorily contain information that the available scientific data come from pre-clinical in vitro studies and animal models — without extrapolation to clinical applications in humans.

5.5. General rule concerning all functional exclusions

The above division into four categories is operational in nature and does not exhaust the full scope of communication restrictions. The general rule reads: the Operator does not and will not conduct any content suggesting the use of Research Material in a human, an animal or for clinical, cosmetic, supplementation or training purposes — regardless of the product category.
The prohibition concerns: – SKU catalogue descriptions, – blog content, educational articles, SEO content, – communication on social media, – newsletters sent to subscribers, – direct commercial communication (e-mail, chat, helpline), – promotional materials at offline points of contact (if any).
The Compliance Officer conducts periodic control of the compliance of the content published in the Store with these functional exclusions. Any breaches are removed without delay.

§ 6. ABSENCE OF MEDICAL RECOMMENDATIONS — FULL LIST OF PROHIBITED CLAIMS

The Operator does not provide and is not entitled to provide any medical recommendations concerning the Research Materials offered in the Store. In particular, the Operator does not provide: – medical advice within the meaning of the Act of 5 December 1996 on the Professions of Physician and Dentist (consolidated text: Journal of Laws 2025 item 432), – pharmaceutical advice within the meaning of the Act of 10 December 2020 on the Profession of Pharmacist (consolidated text: Journal of Laws 2024 item 676), – physiotherapeutic, dietary or other health advice regulated by a separate statutory regime.
In the content of the Store — in SKU descriptions, on the blog, in commercial communication, in responses to enquiries from Buyers and Subscribers — the Operator does not use and will not use the following expressions or their derivatives in the context of the Research Materials offered:

Category of expression	Examples of prohibited claims
Treatment	“treats”, “cures”, “heals”, “repairs”, “restores health”, “therapy for diseases X/Y/Z”
Prophylaxis	“prevents”, “protects against”, “blocks the development of disease”, “oncological prevention”, “cardiovascular prevention”
Diagnostics	“diagnosis”, “diagnostics”, “detects disease”, “diagnostic test”, “diagnostic marker” in the clinical sense
Therapy	“hormone therapy”, “replacement therapy”, “regenerative therapy”, “anti-aging therapy”, “weight-loss therapy”
Dosing	“daily dose”, “weekly dose”, “dosing regimen”, “mg/kg body weight”, “titration protocol”
Administration	“subcutaneous administration”, “intramuscular administration”, “intravenous administration”, “injection”, “injection”, “shot”
Indications	“indications for use”, “recommended for”, “advised in the condition”, “first-line treatment”
Contraindications	“contraindications”, “do not use in”, “risk group”, “drug interactions”
Effects in humans	“effects in patients”, “clinical efficacy”, “safety in humans”, “tolerability”, “adverse reaction profile”
Clinical comparisons	“more effective than X”, “safer than Y”, “an alternative to Z” in the context of medicinal products

The above list is not closed in nature — the Operator applies the principle of total linguistic restraint in respect of any suggestion of clinical, therapeutic, prophylactic or diagnostic use.
Every Buyer seeking information on the clinical use of any substance is obliged to consult a physician, pharmacist or other authorised healthcare provider. The Operator expressly refers to such sources and declines to provide medical recommendations on its own.

§ 7. ABSENCE OF NUTRITIONAL AND SUPPLEMENTATION RECOMMENDATIONS

The Research Materials offered by the Seller do not constitute dietary supplements within the meaning of Art. 3 para. 3 point 39 of the Act of 25 August 2006 on Food and Nutrition Safety (consolidated text: Journal of Laws 2024 item 1366). Research Materials are not: – foodstuffs, – foodstuffs for particular nutritional uses, – foodstuffs for special medical purposes, – infant formulae.
The Operator does not provide and is not entitled to provide nutritional or supplementation recommendations concerning Research Materials. In particular, the Operator does not communicate: – a recommended daily allowance (RDA, NRV — Nutrient Reference Value), – a “safe supplementation dose”, – an “effective supplementation dose”, – “supplementation synergy with vitamins / minerals / amino acids”, – a “supplementation cycle”, – “combination with a diet”, – “administration with a meal / on an empty stomach / before sleep”, – any instructions concerning the manner, frequency or quantity of consumption of the Research Material.
Research Materials must not be consumed, swallowed, added to food, beverages or any preparations intended for consumption by a human or an animal. Any such use goes beyond the intended purpose of the Product and constitutes a breach of the provisions of the Research Disclaimer.
The Seller’s communication in the area of supplementation is limited solely to information that the substance is not a dietary supplement and is not suitable for consumption.

§ 8. ABSENCE OF COSMETIC RECOMMENDATIONS

The Research Materials offered by the Seller do not constitute cosmetic products within the meaning of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ EU L 342 of 22.12.2009) or within the meaning of the Act of 4 October 2018 on Cosmetic Products (consolidated text: Journal of Laws 2025 item 312). Research Materials do not have: – a CPSR safety assessment (Cosmetic Product Safety Report), – a PIF product information file (Product Information File), – a notification in the CPNP (Cosmetic Products Notification Portal), – a designated Responsible Person within the meaning of Art. 4 of Regulation 1223/2009, – cosmetic labelling compliant with Art. 19 of Regulation 1223/2009 (name of the cosmetic, list of ingredients in descending order, nominal content, date of minimum durability, warnings, function of the product).
The Operator does not provide and is not entitled to provide cosmetic recommendations. In particular, the Operator does not communicate: – “anti-aging peptide” as a cosmetic, – “skin-brightening peptide”, – “firming peptide”, – “anti-wrinkle peptide”, – “moisturising peptide”, – “peptide for acne-prone / sensitive / dry skin”, – “peptide for a DIY cream”, – “peptide for mesotherapy”, – “peptide for aesthetic injections”, – “peptide for dermatological procedures”.
Research Materials must not be used as an ingredient of self-made cosmetics (“DIY cosmetics”) or as a substance applied to the skin, mucous membranes, nails, hair or teeth of a human or an animal. Any such use goes beyond the intended purpose of the Product.

§ 9. ABSENCE OF SPORTS/TRAINING AND DOPING RECOMMENDATIONS — WADA LIST 2026

The Research Materials offered by the Seller are not sports supplements, performance-enhancing agents, training agents or agents supporting post-exercise recovery. The Operator does not provide and is not entitled to provide sports or training recommendations.
The List of Prohibited Substances and Methods of the World Anti-Doping Agency (WADA Prohibited List) for the year 2026 classifies the substances constituting the Research Materials offered by the Operator — in respect of persons connected with the anti-doping regime — in the following classes:

9.1. Class S0 — Non-approved substances

Class S0 encompasses all pharmacological substances that are not approved by any relevant regulatory authority for therapeutic use in humans (e.g. drugs in development, designer peptides, veterinary substances) and that are prohibited in sport at all times (in-competition and out-of-competition).
Practically all peptides offered by the Seller fall within class S0 of the WADA List — on account of the absence of regulatory approval for use in humans in the EU/USA (which is the basic condition for inclusion in the GREEN/YELLOW category of the Store’s offering). This concerns in particular BPC-157, TB-500, Epithalon, MOTS-c and other regenerative and mitochondrial peptides.
Consequence for persons connected with the anti-doping regime: the use of a substance from class S0 constitutes a violation of the World Anti-Doping Code resulting, as a standard, in a four-year suspension of the athlete (Art. 10.2.1 of the WADA Anti-Doping Code), without the possibility of invoking “lack of intent” or “unawareness” (the strict liability principle).

9.2. Class S2.2.2 — Growth Hormone Releasing Peptides (GHRPs)

Class S2.2.2 encompasses Growth Hormone Releasing Peptides and their agonists. The class is prohibited at all times (in-competition and out-of-competition).
Substances individually named on the WADA List 2026 in class S2.2.2: – Ipamorelin — a selective ghrelin mimetic / GHS-R agonist, – GHRP-2 (Pralmorelin) — a GH-releasing hexapeptide, – GHRP-6 — a GH-releasing hexapeptide, – Hexarelin — a GH-releasing hexapeptide, – CJC-1295 (with and without DAC modification) — a GHRH analogue, – Tesamorelin — a GHRH analogue (note: the Seller’s classification is 🔴 RED on account of FDA registration as Egrifta), – Sermorelin — a GHRH analogue (note: historical FDA registration, the Seller’s classification is 🔴 RED).
In respect of class S2.2.2 peptides offered as GREEN/YELLOW by the Seller: the Seller transparently warns Buyers that these substances are classified as prohibited in organised sport, and does not conduct promotional content in a training context (see § 5 para. 5.2).

9.3. Class S2.3 — Growth factors and growth factor modulators

Class S2.3 encompasses growth factors and their modulators, including analogues of insulin-like growth factor 1 (IGF-1) and mechano growth factor (MGF).
Substances individually named on the WADA List 2026 in class S2.3: – IGF-1 (Insulin-like Growth Factor 1) and its analogues — including IGF-1 LR3 (Long-R3), IGF-1 DES, – Mechano Growth Factor (MGF) and its pegylated form PEG-MGF, – Fibroblast Growth Factors (FGFs), – Vascular Endothelial Growth Factors (VEGFs), – Hepatocyte Growth Factor (HGF), – Platelet-Derived Growth Factor (PDGF) in certain forms.
In respect of growth factors offered as GREEN/YELLOW: the Seller pursues a policy identical to that for class S2.2.2 — a transparent warning and a prohibition on promotional content in a training context.

9.4. Update of the WADA List

The WADA List is updated annually and enters into force on 1 January of the given calendar year. The first version of the List for the following year is published around 1 October of the preceding year (in accordance with Art. 4.1 of the International Standard for the Prohibited List).
The Operator monitors the publication of the WADA List and carries out an update of the SKU Risk Matrix on an extraordinary basis after each publication of a new version of the List — no later than within 14 days of the date of publication of the official document in the English version. The update may result in: – moving an SKU from the GREEN category to YELLOW, if the substance is individually named on the List, – moving an SKU from the YELLOW category to RED, if the substance is registered as a medicinal product (which in parallel results in a change of status on the WADA List), – removing an SKU from the offering, if the substance becomes subject to a national trading ban.

9.5. General rule concerning sports communication

The Operator does not and will not conduct any content suggesting the use of Research Materials in the context of: – professional, amateur or recreational sport, – bodybuilding, powerlifting, crossfit, physique sports, – combat sports, team sports, endurance sports, – preparation for competitions, “off-season”, “on-season”, “prep”, – support of a training diet, “caloric surplus”, “caloric deficit”, – support of post-exercise recovery, “recovery”, “post-workout”.
Every Buyer connected with the anti-doping regime (athlete, coach, sports physician, representative of a sports federation) is obliged to independently verify the status of a substance on the current WADA List before any purchase and to retain full responsibility for compliance with the World Anti-Doping Code.

§ 10. SKU RISK MATRIX PROCEDURE — INTERNAL CATEGORISATION BY FIRSTSTONE

Every SKU considered for inclusion in the Store’s offering undergoes a mandatory classification procedure under the SKU Risk Matrix — the internal risk matrix maintained by the Operator’s Compliance Officer.

10.1. Process of initial classification of a new SKU

The initial classification procedure comprises the following stages:

Stage 1 — Identification of the substance. The Product Manager identifies the substance under consideration for the offering (chemical name, CAS Registry Number, amino acid sequence in the case of peptides, any commercial names).

Stage 2 — Regulatory scan. The Compliance Officer carries out a scan of the substance’s status in the following sources: – the EMA database (European Medicines Agency) — Public Assessment Reports, Medicines Database, – the FDA database (Food and Drug Administration) — Drugs@FDA, Orange Book, – the URPL database (Office for Registration of Medicinal Products) — the Register of Medicinal Products Authorised for Marketing in the territory of the Republic of Poland, – the ClinicalTrials.gov database — searching for active Phase II/III clinical trials, – the EU Clinical Trials Register database, – the WADA List (current as at the date of classification), – the list of controlled substances of the Act on Counteracting Drug Addiction, – the list of new psychoactive substances of the Minister of Health.

Stage 3 — KOP-Committee assessment. The Product Assessment Committee, composed of the Compliance Officer + legal counsel + Product Manager, assesses the material gathered and formulates a classification recommendation together with a legal rationale.

Stage 4 — Classification decision. The Compliance Officer issues a decision assigning the SKU to the GREEN / YELLOW / RED category. The decision is documented in the SKU Risk Matrix with the following data: – SKU identifier, – commercial and chemical name, – CAS Registry Number, – regulatory status in PL/EU/USA, – status on the WADA List (class + number), – risk category (GREEN/YELLOW/RED), – rationale for classification (brief description), – date of classification, – date of next review (3 months as a standard), – responsible person (first name and surname of the Compliance Officer).

Stage 5 — Publication in the Store. SKUs classified as GREEN are placed in the Store’s offering without additional restrictions. SKUs classified as YELLOW are placed in the offering with the additional compliance declarations described in § 3 para. 3.2 of the Document. SKUs classified as RED are not added to the offering.

10.2. Triggers for a change of SKU classification

The classification of an SKU is not permanent in nature — it is subject to change in the event of the occurrence of at least one of the following regulatory triggers:

a) EMA registration decision — the grant of a marketing authorisation under the centralised, MRP or DCP procedure for a substance in the offering. Effect: an immediate change of classification to 🔴 RED and withdrawal of the SKU from the offering on an urgent basis (no later than 7 days from the date of publication of the decision in the EMA database).

b) FDA registration decision — the grant of an FDA authorisation (NDA, BLA, ANDA) for a substance in the offering. Effect: identical to let. a) above.

c) URPL registration decision — the grant of a marketing authorisation under the URPL national procedure for a substance in the offering. Effect: identical.

d) WADA alert — the publication of an update of the WADA Prohibited List individually naming a substance that was not previously covered by class S0–S9. Effect: moving the SKU from GREEN to YELLOW (with the mandatory addition of a warning about the WADA class to the catalogue description) within 14 days of the publication of the official English version of the List.

e) UODO decision — a decision of the President of the Personal Data Protection Office affecting the scope of permissible data processing in the context of the verification of Qualified Buyers or in another scope concerning the SKU. Effect: an update of compliance procedures, possibly the suspension or modification of the SKU.

f) UOKiK decision — a decision of the President of the Office of Competition and Consumer Protection affecting market practices in the peptide sector (in particular decisions in matters of infringements of the collective interests of consumers). Effect: a revision of the classification of SKUs that may be covered by the scope of the decision.

g) GIF communication — a communication of the Chief Pharmaceutical Inspector concerning the illegal trade in pharmaceutical substances, a market alert or an interpretative clarification of the status of a substance. Effect: a revision of the classification of all SKUs that may be covered by the scope of the communication, possibly the withdrawal of the SKU from the offering on an urgent basis.

h) EMA / FDA / URPL guidance — the publication of industry guidance (guidelines, scientific advice, EMA Reflection Papers) affecting the classification of a substance. Effect: a revision of the classification of SKUs covered by the scope of the guidance.

i) Court ruling — a ruling of a Polish court or of the Court of Justice of the European Union affecting the interpretation of the provisions of pharmaceutical or consumer law in relation to the substances in the offering. Effect: a revision of the classification of all SKUs covered by the scope of the ruling.

j) Internal decision of the KOP-Committee — in the event of the occurrence of circumstances not covered by letters a–i above, but giving rise to justified compliance concerns (e.g. a series of customer enquiries indicating attempts to purchase for clinical purposes, a reputational signal, a market monitoring report) — the KOP-Committee may, on its own initiative, recommend a change of SKU classification.

10.3. Standard review cycle

Notwithstanding ad hoc triggers, the Compliance Officer conducts a quarterly review of the entire SKU portfolio. The standard review schedule comprises: – the Q1 review — the first working week of January (in parallel with the update of the WADA List), – the Q2 review — the first working week of April, – the Q3 review — the first working week of July, – the Q4 review — the first working week of October (in parallel with the publication of the preliminary WADA List for the following year).
Each quarterly review results in an update of the SKU Risk Matrix and optionally an update of this Document (if the changes concern substances individually named in the text).

10.4. SKU suspension procedure

In the event of the occurrence of a regulatory trigger resulting in a change of SKU classification from GREEN/YELLOW to RED, the Compliance Officer initiates an SKU suspension procedure comprising: – the immediate removal of the SKU from the published Store catalogue (unpublishing of the product page), – marking the SKU in the order management system as “suspended — do not fulfil”, – suspension of all unprocessed orders containing the given SKU, – contact with Buyers holding open orders, informing them of the impossibility of fulfilment, – a refund for orders impossible to fulfil within 14 days of the date of the decision to suspend (in accordance with the provisions of the Returns Policy), – archiving of the decision documentation in the SKU Risk Matrix with the annotation “SUSPENDED” and the date of the decision, – an update of blog content, SEO materials and other publications referring to the suspended SKU (removal or reclassification), – communication to Qualified Buyers holding active accounts in the Store in accordance with the procedure of § 11 of the Document.

§ 11. PROCEDURE FOR UPDATING EXCLUSIONS — COMMUNICATION WITH QUALIFIED BUYERS

Any material change in the content of this Document or in the scope of product exclusions (categorical RED or functional YELLOW) is communicated to Qualified Buyers holding an active account in the Store in the following manner:

a) E-mail message. A message addressed to the e-mail address assigned to the Qualified Buyer’s account, containing: – unequivocal information about the update of the Document (title, version, effective date), – a brief summary of the changes (which SKUs have been added to the list of exclusions, which SKUs have been moved between categories), – a link to the full content of the updated Document, – a link to the Change History (changelog) itemising the specific items changed.

b) Notification in the Store. Upon logging in to the account, the Qualified Buyer is shown a notification informing of the new version of the Document and the obligation of re-acceptance in the event of material changes being introduced.

c) Update of the Store’s legal section. The Store’s footer always presents the latest version of the Document with a visible publication date. Archival versions are available under a separate sub-link (Archive of legal documents) with a 5-year archiving period maintained.

Definition of a material change: a material change is deemed to be a change causing: – an expansion of the list of substances in the 🔴 RED category, – an expansion of the list of functional restrictions in the 🟡 YELLOW category, – a change in the purchasing procedure (Buyer qualification conditions, documents required upon purchase), – a change in the contact procedure (e-mail addresses, communication channels), – a change material to the legal relationship with the Buyer in another respect.
A non-material change — in particular a typographical correction, an editorial clarification without an effect on the scope of the parties’ rights and obligations, an update of references to legal acts in connection with the publication of new consolidated texts — does not require re-acceptance on the part of the Buyer, but is subject to standard communication via channels a) and c) above.
Date of entry into force of changes: as a standard 14 days from the date of electronic communication to Qualified Buyers. Where earlier entry into force is necessary (e.g. in the event of a sudden regulatory change resulting in an obligation to immediately withdraw an SKU) — the period may be shortened to 3 working days, with an explicit indication in the content of the communication.
Buyer’s right to withdraw from the relationship. If the Buyer does not accept the changes introduced into the Document, they have the right to: – terminate the agreement for the provision of account services in the Store with immediate effect (in accordance with the provisions of the User Account Terms and Conditions — document LEGAL-PP-09-v2-20260606), – cease further purchases in the Store, – request the permanent deletion of the account and personal data (with respect for the Operator’s archiving obligations arising from separate provisions of law).
Procedure for enquiring about SKU status. A Qualified Buyer may at any time submit an enquiry about the classification status of a specific substance to the address compliance@purepoint.pl. A response is provided within up to 5 working days and includes: – the current risk category (GREEN/YELLOW/RED), – a brief rationale for the classification, – the date of the last assessment and the date of the next review, – any functional reservations (if the substance is classified as YELLOW).

§ 12. BUYER LIABILITY CLAUSE

A Buyer who has purchased a Research Material in the Store bears full and sole responsibility for: – the manner in which the Research Material is used, – compliance with the intended purpose of the Product solely for in vitro research, – observance of the rules of safe work in the laboratory (OHS, GLP — Good Laboratory Practice), – compliance with the provisions of the law applicable to the Buyer’s registered office regarding the trade in, possession and use of chemical substances, – obtaining all required permits, concessions, licences and other legal titles necessary for the activity conducted by the Buyer, – observance of the rules of research ethics (approval of protocols by a bioethics committee, where required), – observance of the anti-doping regime (in respect of Buyers connected with sports federations), – the proper labelling, storage and disposal of the Research Material after the conclusion of the research.
Use of the Research Material contrary to its intended purpose — in particular administration to a human or an animal, placing it into further trade in a manner contrary to its intended purpose, modification of the product labelling in a manner misleading to third parties, incorporation into food, cosmetic or medicinal preparations — constitutes: – a breach of the provisions of the Research Disclaimer and the Store Terms and Conditions, – a potential breach of the Pharmaceutical Law (in the event of placing it on the market as a medicinal product without authorisation — a prohibited act under Art. 124 para. 1 PF), – a potential breach of the Penal Code (in particular Art. 165 KK — causing a danger to the life or health of many persons, Art. 286 KK — fraud), – a potential breach of the Act on Food and Nutrition Safety (if the Research Material is added to food or a dietary supplement), – a potential breach of Regulation 1223/2009 (if the Research Material is added to a cosmetic product placed on the market).
The Operator bears no liability for pecuniary and non-pecuniary damage arising from the use of the Research Material contrary to its intended purpose — to the extent permitted by mandatorily applicable provisions of law, in particular Art. 473 § 2 KC and Art. 558 § 1 KC (where they apply to the relationship with a consumer).
Limitation of the Operator’s liability towards Buyers who are not consumers (B2B) — the Operator is liable solely for damage caused by wilful misconduct and only within the limits of actual loss, excluding lost profits (see § 13 or the relevant section of the Store Terms and Conditions). This limitation does not apply to consumer claims (B2C), to which the full regime of the KC and the UPK applies without contractual limitations.
Severability clause. If any of the provisions of this section or of the Document proves to be invalid, ineffective or unenforceable — the remaining provisions remain in force. In the event of the application of an abusive clause against a consumer — the provision does not produce legal effects in accordance with Art. 385¹ § 1 KC.

§ 13. COMPLIANCE CONTACT — CHANNEL FOR ENQUIRIES ABOUT SUBSTANCE STATUS

The dedicated contact channel for enquiries concerning the classification of substances, compliance procedures, the status of a specific SKU and the interpretation of this Document is the address:

compliance@purepoint.pl

The channel is operated by the Operator’s Compliance Officer on working days, between 9:00 and 17:00 Central European Time. Standard response time: up to 5 working days.
Enquiries may concern in particular: – the current risk category of a specific SKU (GREEN/YELLOW/RED), – the rationale for the classification, – the registration status of a substance in PL/EU/USA, – the status on the WADA Prohibited List, – planned classification changes, – the interpretation of functional exclusions (§ 5 of the Document), – the procedure for obtaining a full classification report for an SKU.
Full name of the Operator and registration details — in accordance with the Impressum document (LEGAL-PP-15-v2-20260606):

FIRSTSTONE TRADING spółka z ograniczoną odpowiedzialnością – Registered office (KRS): ul. Wierzbięcice 44A/40A, 61-568 Poznań, województwo wielkopolskie Voivodeship – Correspondence address: ul. Wierzbięcice 44A/40A, 61-568 Poznań – KRS: 0001254766 – NIP: 7831958614 – – Registry court: District Court Poznań – Nowe Miasto i Wilda in Poznań, 8th Commercial Division of the National Court Register – General contact: contact@purepoint.pl – Compliance contact: compliance@purepoint.pl

Other contact channels for enquiries not related to compliance: – order handling and general matters of Qualified Buyers: contact@purepoint.pl [VERIFY address — “kontakt@purepoint.pl” was previously indicated; harmonise with the general address and remove the wording “consumer matters”, which is inconsistent with the B2B-only thesis / absence of consumer service], – matters concerning personal data protection: iod@purepoint.pl, – matters concerning AML/KYC (Anti-Money Laundering / Know Your Customer): aml@purepoint.pl.

§ 14. BIBLIOGRAPHY

14.1. Legal acts — Republic of Poland

The Act of 6 September 2001 — Pharmaceutical Law (consolidated text: Journal of Laws 2025 item 750) — hereinafter: the “PF”.
The Act of 23 April 1964 — the Civil Code (consolidated text: Journal of Laws 2025 item 1610 [VERIFY — discrepancy with the Research Disclaimer, which cites Journal of Laws 2025 item 250; harmonise the correct publication number]) — hereinafter: the “KC”.
The Act of 6 June 1997 — the Penal Code (consolidated text: Journal of Laws 2025 item 17) — hereinafter: the “KK”.
The Act of 30 May 2014 on Consumer Rights (consolidated text: Journal of Laws 2024 item 1796) — hereinafter: the “UPK”.
The Act of 25 August 2006 on Food and Nutrition Safety (consolidated text: Journal of Laws 2024 item 1366).
The Act of 4 October 2018 on Cosmetic Products (consolidated text: Journal of Laws 2025 item 312).
The Act of 29 July 2005 on Counteracting Drug Addiction (consolidated text: Journal of Laws 2025 item 124).
The Act of 5 December 1996 on the Professions of Physician and Dentist (consolidated text: Journal of Laws 2025 item 432).
The Act of 10 December 2020 on the Profession of Pharmacist (consolidated text: Journal of Laws 2024 item 676).
The Act of 1 March 2018 on Counteracting Money Laundering and Terrorist Financing (consolidated text: Journal of Laws 2025 item 487).

14.2. Legal acts — European Union

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ EU L 342 of 22.12.2009).
Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC — GDPR (RODO) (OJ EU L 119 of 4.05.2016, p. 1).
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ EU L 311 of 28.11.2001, p. 67, as amended).
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ EU L 136 of 30.04.2004, p. 1, as amended).
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use (OJ EU L 158 of 27.05.2014, p. 1).

14.3. EMA decisions — a selection concerning RED substances

Ozempic (semaglutide) — authorisation EMA/H/C/004174, Novo Nordisk A/S, marketing authorisation in the EU under the centralised procedure (type 2 diabetes).
Wegovy (semaglutide) — authorisation EMA/H/C/004917, Novo Nordisk A/S, marketing authorisation in the EU under the centralised procedure (obesity).
Rybelsus (semaglutide in oral form) — authorisation EMA/H/C/004915, Novo Nordisk A/S.
Mounjaro (tirzepatide) — authorisation EMA/H/C/005620, Eli Lilly Nederland B.V., marketing authorisation in the EU (type 2 diabetes, obesity).
Victoza (liraglutide) — authorisation EMA/H/C/001026, Novo Nordisk A/S (type 2 diabetes).
Saxenda (liraglutide) — authorisation EMA/H/C/003780, Novo Nordisk A/S (obesity).
Trulicity (dulaglutide) — authorisation EMA/H/C/002825, Eli Lilly Nederland B.V.
Byetta (exenatide) — authorisation EMA/H/C/000698, AstraZeneca AB.
Bydureon (prolonged-release exenatide) — authorisation EMA/H/C/002020, AstraZeneca AB.
Sogroya (somapacitan) — authorisation EMA/H/C/004956, Novo Nordisk A/S.
Increlex (mecasermin, recombinant human IGF-1) — authorisation EMA/H/C/000704, Ipsen Pharma.

14.4. FDA decisions — a selection concerning RED substances

Ozempic (semaglutide) — FDA NDA authorisation, Novo Nordisk Inc.
Wegovy (semaglutide) — FDA NDA authorisation, Novo Nordisk Inc.
Rybelsus (oral semaglutide) — FDA NDA authorisation, Novo Nordisk Inc.
Mounjaro (tirzepatide) — FDA NDA authorisation, Eli Lilly and Company.
Zepbound (tirzepatide in obesity) — FDA NDA authorisation, Eli Lilly and Company.
Vyleesi (bremelanotide) — FDA NDA authorisation, Palatin Technologies Inc.
Pitocin (oxytocin) — FDA NDA authorisation, JHP Pharmaceuticals.
Egrifta (tesamorelin) — FDA NDA authorisation, Theratechnologies Inc.

14.5. URPL decisions — a selection concerning RED substances

Oxytocin Polfa (oxytocin) — URPL marketing authorisation under the national procedure, Warszawskie Zakłady Farmaceutyczne Polfa S.A.
Syntocinon (oxytocin) — EMA authorisation / marketing authorisation in the EU, Alfasigma S.p.A. (Italy).

14.6. Clinical trials — a selection concerning pre-registration RED substances

NCT05882045 — the Phase III clinical trial TRIUMPH-1 for retatrutide, Eli Lilly and Company.
NCT06077864 — the Phase III clinical trial SYNCHRONIZE™-1 for survodutide, Boehringer Ingelheim International GmbH.

14.7. WADA Prohibited List 2026

World Anti-Doping Agency, Prohibited List International Standard 2026, in force from 1 January 2026. Full text available on the WADA website at https://www.wada-ama.org/en/prohibited-list.
International Standard for the Prohibited List — the version in force in 2026.
WADA World Anti-Doping Code 2021 with amendments in force in 2026.

14.8. Internal documents of the Operator — system context

Research Disclaimer (LEGAL-PP-01-v2-20260606) — https://purepoint.pl/zastrzezenie-badawcze/.
Store Terms and Conditions (LEGAL-PP-03-v2-20260606) — in particular § 5 concerning the subject matter of the service.
Privacy Policy (LEGAL-PP-04-v2-20260606).
Shipping Policy (LEGAL-PP-05-v2-20260606).
Returns Policy (LEGAL-PP-06a-v2-20260606).
Complaints Policy (LEGAL-PP-06b-v2-20260606).
Cookies Policy (LEGAL-PP-07-v2-20260606).
Compliance Information (LEGAL-PP-08-v2-20260606).
User Account Terms and Conditions (LEGAL-PP-09-v2-20260606).
Newsletter Terms and Conditions (LEGAL-PP-10-v2-20260606).
AML/KYC Policy (LEGAL-PP-11-v2-20260606).
Sanctions and Export Policy (LEGAL-PP-12-v2-20260606).
Acceptable Use Policy (LEGAL-PP-13-v2-20260606).
B2C / B2B Consumer Clauses (LEGAL-PP-14-v2-20260606).
Impressum — Operator Details (LEGAL-PP-15-v2-20260606).
Legal Centre — Hub (LEGAL-PP-16-v2-20260606).

§ 15. FINAL CLAUSE

In matters not regulated by this document, the mandatorily applicable provisions of Polish and European Union law shall apply. In the event of interpretative doubts, contact compliance@purepoint.pl.

CHANGE HISTORY (CHANGELOG)

Version	Publication date	Status	Scope of changes	Responsible person
1.0	22 May 2026	First publication	Initial version of the Product Disclaimer. Introduction of the 3-tier risk matrix (GREEN/YELLOW/RED). List of categorically excluded substances: semaglutide, tirzepatide, retatrutide, bremelanotide, oxytocin, survodutide. Functional exclusions across 4 categories (regenerative, GH, melanocortin, longevity). Absence of medical, nutritional, cosmetic and sports recommendations. SKU Risk Matrix procedure. Bibliography in the base version.	Compliance Officer FIRSTSTONE TRADING sp. z o.o.
2.0	6 June 2026	Current publication v2	Full integration with the system of 16 legal documents of the Store. Clarification of definitions (KOP, SKU Risk Matrix, categorical exclusion, in vitro). Erratum to Art. 124 para. 1 PF (penalty of deprivation of liberty for up to 2 years). Expansion of § 4 — legal rationale for each RED substance with full EMA/FDA authorisation numbers. Expansion of § 9 — full description of the WADA 2026 classes (S0, S2.2.2, S2.3). Addition of § 10 — a detailed SKU Risk Matrix procedure (5 classification stages + 10 change triggers). Addition of § 11 — a procedure for communication with Qualified Buyers. Update of the bibliography — a full compilation of PL/EU acts, EMA, FDA, URPL decisions, and pre-registration clinical trials. Update of the Operator’s details — full details of FIRSTSTONE TRADING sp. z o.o. (KRS 0001254766, NIP 7831958614).	Compliance Officer FIRSTSTONE TRADING sp. z o.o.

End of document — Product Disclaimer v2.0 LEGAL-PP-02-v2-20260606 purepoint.pl / /zastrzezenie-produktowe/