Gibraltar Merchant Account (Tesofensine)

Gibraltar Merchant Account for Online Pharmacies Selling Tesofensine: Regulatory Requirements Explained

If you operate an online pharmacy in Gibraltar selling Tesofensine through an e-commerce storefront, securing a Gibraltar merchant account and Merchant ID requires compliance with payment processing standards and Gibraltar’s pharmaceutical regulatory framework, which is heavily influenced by United Kingdom (UK) and European Union (EU) standards despite its post-Brexit status as a British Overseas Territory. Tesofensine, a serotonin-noradrenaline-dopamine reuptake inhibitor developed for obesity, remains unapproved as a medicinal product as of March 2025, classifying it as a high-risk product for online sales. This section outlines Tesofensine’s regulatory requirements in Gibraltar, the pre-qualification process for a merchant account, and what e-commerce pharmacies need to prepare.

Tesofensine’s Regulatory Status in Gibraltar

Tesofensine, originally developed by NeuroSearch, has not progressed beyond Phase III trials for obesity due to mixed efficacy results and side effect concerns, and it was abandoned as a commercial drug by the early 2010s. As of March 07, 2025, Tesofensine lacks approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA), the European Medicines Agency (EMA), or the U.S. FDA. In Gibraltar, the Gibraltar Health Authority (GHA) regulates medicines under the Medicines Act 2002, which mirrors the UK’s Human Medicines Regulations 2012 (SI 2012/1916) with local adaptations via the Medicines (Prescription Only Medicines) Order 2003. For Tesofensine to be legally marketed as a medicinal product, it would require a marketing authorisation, typically aligned with UK or EMA standards.

The authorisation process involves:

• Marketing Authorisation: Submission of a dossier with clinical trial data, manufacturing details, and safety profiles to the MHRA (via mutual recognition post-Brexit) or a Gibraltar-specific process under the Medicines Act 2002. No such authorisation exists for Tesofensine by 2025, as its development stalled.
• Prescription Status: If approved, Tesofensine would likely be classified as a Prescription Only Medicine (POM) under the Medicines (Prescription Only Medicines) Order 2003, requiring a prescription from a Gibraltar- or UK-registered healthcare professional due to its pharmacological effects.
• Labelling: Compliance with the Medicines Act 2002 and UK-aligned standards, mandating English labelling with dosage, ingredients, and warnings (e.g., risks of hypertension or psychiatric effects).

Without marketing authorisation, Tesofensine cannot be legally sold as a medicine in Gibraltar. Online pharmacies may market it as a “research chemical” or “supplement,” but if intended for human therapeutic use, it falls under medicinal product rules, prohibited under Section 5 of the Medicines Act 2002. The GHA and Gibraltar Customs Service enforce these regulations, targeting unauthorised sales with fines or seizures, often in coordination with UK authorities.

Pre-Qualification for a Gibraltar Merchant Account with Tesofensine

For an e-commerce pharmacy selling Tesofensine, pre-qualifying for a Gibraltar merchant account involves meeting financial and regulatory criteria, with significant challenges due to its unapproved status. Payment processors like PpsRX, which handle high-risk transactions, evaluate:

1. Business Legitimacy and Documentation

• Required Documents: Business registration (e.g., certificate from the Gibraltar Registry of Companies), proof of address, and ideally a pharmacy licence from the GHA or recognition by the Gibraltar Pharmacy Council. For Tesofensine, processors may request documentation justifying its sale, such as research-use disclaimers.
• Challenge: Without marketing authorisation, proving legitimacy is difficult, often leading to rejection unless a non-medicinal status (e.g., supplement without therapeutic claims) is clearly established.

2. High-Risk Classification

• Tesofensine sales are high-risk due to:
  
  • Lack of regulatory approval, raising legal and liability concerns if sold for human use.
  • Potential chargebacks from customers disputing efficacy or side effects (e.g., cardiovascular risks or mood changes).
  • E-commerce risks like fraud, card-not-present transactions, and cross-border sales, particularly to the UK or EU.
• Processors assess transaction history, fraud prevention tools, and risk mitigation strategies to determine eligibility.

3. E-Commerce and Pharmacy Compliance

• Website Standards: The storefront must feature SSL encryption, terms of service, refund policies, and explicit disclaimers about Tesofensine’s unapproved status. Therapeutic claims are prohibited under Section 5 of the Medicines Act 2002, aligned with the MHRA’s Blue Guide, and the Consumer Protection Act 2011 requires transparency.
• Import Compliance: If imported, Tesofensine requires a Wholesale Dealer’s Licence from the GHA under the Medicines (Import and Wholesale) Regulations 2004. Without authorisation, imports are illegal and seized by Gibraltar Customs, reflecting UK-aligned controls post-Brexit.

4. Merchant ID Assignment

• Upon pre-qualification, a Merchant ID is issued for payment processing. For Tesofensine, strict conditions like high reserve funds or transaction limits may apply due to its elevated risk profile.

Preparing for a Merchant ID Application in Gibraltar

To apply for a Merchant ID through a processor like PpsRX, e-commerce pharmacies selling Tesofensine should prepare:

• Business Records: Full documentation proving legal operation in Gibraltar, including a Registry of Companies certificate and, if applicable, a GHA-issued pharmacy licence.
• Regulatory Rationale: Evidence supporting Tesofensine’s legal status (e.g., supplement classification with no medicinal claims or research-use labeling), though this may not satisfy processors for human-targeted sales.
• Sales Data: Estimates of monthly transaction volumes, ideally from prior peptide or supplement sales, to demonstrate financial stability.
• Banking Details: A Gibraltar business bank account (e.g., with Gibraltar International Bank or NatWest International) for fund deposits.
• E-Commerce Infrastructure: Proof of a compliant storefront with secure payment gateways and fraud prevention measures.

Processors are likely to reject applications if Tesofensine is marketed as a medicine without authorisation, as this violates Gibraltar’s regulations and increases legal risks.

Unique Challenges for Tesofensine in Gibraltar

Tesofensine’s regulatory requirements present distinct obstacles for e-commerce pharmacies:

• Unapproved Status: Without marketing authorisation, legal sale as a medicine is prohibited. Marketing as a supplement avoids medicinal rules but prohibits therapeutic claims, while human use risks enforcement under the Medicines Act 2002.
• E-Commerce Oversight: The GHA collaborates with UK authorities (e.g., MHRA) and Gibraltar Customs to monitor online sales, targeting unapproved drugs under the Border Control (Medicines) Regulations 2021, with Tesofensine’s stalled history increasing scrutiny.
• Small Market Dynamics: Gibraltar’s small population (approx. 34,000) amplifies reliance on cross-border trade, complicating compliance with UK and EU import/export rules post-Brexit.

Gibraltar’s Broader Pharmaceutical Oversight

The GHA conducts post-market surveillance under the Medicines Act 2002, monitoring adverse reactions and illegal sales in coordination with the MHRA’s Yellow Card Scheme. Violations can lead to fines up to £5,000 per offence, unlimited penalties in serious cases, or imprisonment under Section 16, alongside product seizures. The Consumer Protection Act 2011 enforces fair trade practices, while pharmacies must register with the GHA and comply with the Pharmacy and Poisons Act 1935, limiting unapproved sales like Tesofensine.

Conclusion

Securing a Gibraltar merchant account for an e-commerce pharmacy selling Tesofensine is challenging due to its unapproved status and Gibraltar’s UK-aligned regulatory framework. Without marketing authorisation, Tesofensine cannot be legally marketed as a therapeutic product, necessitating careful positioning as a supplement or research chemical to avoid enforcement. Pharmacies must provide extensive documentation and a defensible sales model, though processor approval remains uncertain without regulatory clarity. For more information on navigating this process, PpsRX offers resources via its contact-back request or pre-qualification forms, available on this page.

‍