Regulatory Compliance & Certifications

CROWN HELIX LTD is a fully licensed and regulated online pharmacy committed to the highest standards of pharmaceutical care, patient safety, and regulatory compliance.

Our Regulatory Authorizations

1. General Pharmaceutical Council (GPhC) Registration

We are registered with the General Pharmaceutical Council (GPhC), the independent regulator for pharmacists, pharmacy technicians, and pharmacy premises in England, Scotland, and Wales. Our registration demonstrates our commitment to:

• Maintaining professional standards in pharmacy practice
• Ensuring patient safety and confidentiality
• Complying with pharmacy laws and ethical guidelines
• Operating under the supervision of qualified pharmacists
• Maintaining accurate records and audit trails

Verification: Our GPhC registration can be verified on the official GPhC online register at pharmacyregulation.org/registers

2. Medicines and Healthcare products Regulatory Agency (MHRA)

CROWN HELIX LTD is registered with the MHRA, the UK government agency responsible for ensuring that medicines and medical devices work and are acceptably safe. Our MHRA registration covers:

• Authorization to distribute prescription medicines
• Compliance with the Human Medicines Regulations 2012
• Adherence to Good Distribution Practice (GDP) standards
• Regular inspections and quality audits
• Pharmacovigilance and adverse event reporting

3. EU Directive 2011/62/EU Compliance

As an authorized online pharmacy, we comply with EU Directive 2011/62/EU on preventing the entry of falsified medicines into the legal supply chain. This directive established:

• The EU Common Logo for legitimate online pharmacies
• Safety features on medicine packaging (unique identifiers, anti-tampering devices)
• Wholesale distribution authorization requirements
• Import authorization for active pharmaceutical ingredients
• Falsified medicines verification systems

Quality Standards & Certifications

ISO 9001:2015 - Quality Management System

Our operations are certified to ISO 9001:2015, the international standard for quality management systems. This certification demonstrates our commitment to continuous improvement and customer satisfaction.

Good Distribution Practice (GDP)

We adhere to Good Distribution Practice guidelines (EU Guidelines 2013/C 343/01), ensuring that:

• Medicines are obtained from authorized sources
• Storage conditions maintain product integrity (temperature, humidity, light)
• Transportation maintains the cold chain where required
• Traceability is maintained throughout the supply chain
• Quality defects and recalls are managed effectively
• Falsified medicines are detected and removed

Patient Safety

Pharmacovigilance

We operate a robust pharmacovigilance system to monitor medicine safety:

• Adverse drug reaction (ADR) reporting to the MHRA Yellow Card Scheme
• Medication error reporting and analysis
• Product quality complaint handling
• Participation in medicine recalls and safety alerts

Prescription Requirements

For prescription-only medicines (POMs), we require:

• Valid prescription from a registered medical practitioner
• Patient identification and verification
• Clinical questionnaire for certain medications
• Prescription authenticity checks
• Record keeping for seven years minimum

Transparency & Accountability

Report Concerns

If you have concerns about our pharmacy services or suspect counterfeit medicines:

• MHRA: Report via gov.uk/report-problem-medicine
• GPhC: Report concerns at pharmacyregulation.org/raise-concern
• Yellow Card Scheme: Report side effects at yellowcard.mhra.gov.uk

Last updated: December 2025