Compliance
Regulatory statements
This compound holds no marketing authorisation as a medicinal product in any EU/EEA Member State or in the United Kingdom. It is not offered, and may not be used, for any human or veterinary application. Every order carries a research-use declaration signed by name, is screened against sanctions and embargo lists, and is checked line by line against the destination policy published for the compound.
Position per catalogue line
Marketing authorisation — all 32 lines: None — no marketing authorisation as a medicinal product in any EU/EEA Member State or in the United Kingdom. No line is offered, and none may be used, for any human or veterinary application.
Classification under the World Anti-Doping Agency Prohibited List, recorded so an institutional customer subject to anti-doping rules can screen the catalogue.
- BPC-157 — S0 — Unapproved Substances
Clearance is per SKU, not per category. Applications are made per line and recorded here as certificates issue.
A written borderline classification from the home-state authority, per line, on whether the presentation falls outside the medicinal-product definition.
Classification and notification obligations
| CLP classification (Reg. (EC) 1272/2008 Art. 4) | A classification assessment is required for every line before hazard information may be published. No line currently carries a completed assessment; hazard fields are held open on each product page. |
|---|---|
| C&L Inventory notification (CLP Art. 40) | Due to ECHA within one month of placing on the market, irrespective of tonnage. |
| Poison Centre Notification (CLP Annex VIII) | Required for any mixture classified for health or physical hazards, with a UFI on the label. The harmonised format has been mandatory since 1 January 2025. A lyophilised peptide supplied in buffer is a mixture. |
| Online display of hazard information (CLP Art. 48a) | Pictograms, signal word and the full text of H-, EUH- and P-statements are displayed on the product page itself. A link to a downloadable Safety Data Sheet does not satisfy the requirement. The application date is disputed across sources — this site is designed to the earliest date cited. |
| Safety Data Sheets (REACH Art. 31) | Supplied in 16-section format, free of charge, no later than first supply, in an official language of each Member State of destination, with updates sent to recipients from the previous 12 months. |
| Product safety and traceability (Reg. (EU) 2023/988) | Manufacturer identity and postal address, EU responsible economic operator, and product identifier are published on each product page under Art. 19. Technical file and traceability records are retained 10 years. Responsible person: designation not yet published. |
| Accident notification (GPSR Arts. 20, 35) | Notifiable incidents are reported through the Safety Business Gateway. The complaints procedure sets out how a report is handled. |
Supply controls
| Channel | Verified institutional customers only. No guest checkout route exists, and no account reaches approved status without a manual decision by a named operator. |
|---|---|
| Destination | Allow-list per compound, generated into the checkout country selector and re-checked server-side at order time. |
| Quantity | A ceiling per compound, per account, over a rolling thirty-day period. Where no ceiling has been set, ordering for that compound is blocked rather than uncapped. |
| Delivery | To the address stated on the order — institutional or, within the United States, residential. PO boxes are declined, and the address cannot be changed after the order is placed. |
| Screening | Buyer name and destination country screened against EU, UK and US consolidated lists at order time. An unavailable screen blocks the order. |
Regulatory contact
| Named contact | Not yet published — enquiries via the product-safety address below |
|---|---|
| Product safety | safety@dohrna.com · +63 927 499 4459 |
| EU responsible economic operator | Designation not yet published |