Our Commitment to Regulatory Compliance
At Aptine Medicines Ltd, regulatory compliance forms the foundation of our business. As a UK-registered pharmaceutical broker, we are committed to maintaining the highest standards of quality, integrity and transparency throughout every brokerage activity.
Our Quality Management System has been developed to support compliance with UK medicines legislation and recognised Good Distribution Practice (GDP) principles applicable to pharmaceutical brokering.
MHRA Registered Pharmaceutical Broker
Aptine Medicines Ltd is registered with the UK Medicines and Healthcare products Regulatory Agency (MHRA) as a pharmaceutical broker.
MHRA Broker Registration Number: BRKR 61715
Our brokerage activities are conducted in accordance with applicable UK legislation governing the brokering of medicinal products for human use.
Compliance with Good Distribution Practice (GDP)
Although Aptine Medicines does not physically store, transport or distribute medicines, we recognise the importance of Good Distribution Practice (GDP) principles in protecting the integrity of the pharmaceutical supply chain.
Aptine Medicines adheres to MHRA GDP guidelines relevant to pharmaceutical brokering.
Our quality system supports:
Risk-based supplier and customer qualification
Documentation and record management
Quality management procedures
Staff training and competency
Complaint handling
Corrective and Preventive Actions (CAPA)
Internal quality review and continuous improvement
Secure handling of business records
These procedures help ensure that brokerage activities support the safe and lawful supply
of authorised medicinal products.
Compliance with UK Medicines Regulations
Our operations are conducted in accordance with applicable UK medicines legislation governing pharmaceutical brokerage.
We maintain documented procedures designed to ensure:
Compliance with applicable UK regulatory requirements
Verification of trading partners before business commences
Appropriate documentation of brokerage activities
Management of quality incidents and complaints
Record retention in accordance with regulatory expectations
Protection of supply chain integrity
International Regulatory Compliance
Aptine Medicines facilitates pharmaceutical transactions only where appropriate regulatory requirements can be met by all parties involved.
For supplies to Zimbabwe, we work with customers operating within the regulatory framework of the Medicines Control Authority of Zimbabwe (MCAZ) and support transactions involving appropriately authorised organisations.
Where applicable, customers are responsible for ensuring that medicines are lawfully imported and comply with local regulatory requirements.
Supplier and Customer Verification
Protecting the pharmaceutical supply chain begins with robust due diligence.
Suppliers and customers are fully verified before business relationships are established.
Our verification procedures may include:
Confirmation of regulatory licences and authorisations
Verification of company registration details
Assessment of trading status
Review of compliance history where appropriate
Ongoing monitoring of approved trading partners
Business is conducted only with organisations that meet our qualification requirements.
Product Traceability
Maintaining accurate records is essential for patient safety and regulatory compliance.
Full traceability is maintained for all brokerage transactions.
Our documented procedures include records of:
Approved suppliers
Authorised customers
Products requested
Transaction documentation
Communications relating to brokerage activities
Quality and compliance records
These records support transparency and facilitate regulatory oversight where required.
Supply Chain Integrity
Aptine Medicines is committed to protecting the integrity of the pharmaceutical supply chain.
To support this commitment:
We only work with licensed suppliers and authorised customers.
All medicines are shipped directly from the supplier to the authorised customer.
We do not manufacture, store, own or physically handle medicinal products.
We maintain documented procedures to support regulatory compliance and quality assurance throughout the brokerage process.
Quality Management System
Our Quality Management System is designed to promote continuous improvement and regulatory compliance.
The system includes documented procedures covering:
Quality management responsibilities
Document control
Supplier and customer qualification
Training and competency
Complaint management
Recall communication procedures
Risk management
Corrective and Preventive Actions (CAPA)
Internal audits and management review
These procedures are reviewed periodically to ensure they remain effective and reflect current regulatory expectations.
Our Regulatory Commitment
Aptine Medicines is committed to conducting all brokerage activities ethically, transparently and in accordance with applicable regulatory requirements.
Our objective is to support the safe, secure and compliant supply of authorised medicines by working only with appropriately authorised trading partners and maintaining a quality system that reflects MHRA expectations for pharmaceutical brokers.