Company License

Wholesale Distribution Authorization (WDA) License:

• Requirements: To obtain a WDA license, businesses must meet specific criteria set by the Medicines and Healthcare products Regulatory Agency (MHRA). These requirements include having suitable premises, appropriate storage facilities, qualified personnel, and adherence to Good Distribution Practice (GDP) guidelines.

• Application Process: Businesses need to submit an application to the MHRA, providing detailed information about their operations, premises, and quality management systems. The MHRA conducts inspections and assessments to verify compliance with the required standards before issuing the license.

• Compliance with GDP: WDA license holders must adhere to GDP guidelines, which cover various aspects such as storage conditions, temperature monitoring, traceability, quality management systems, and transportation. Compliance ensures the integrity, safety, and quality of distributed medicines.

Controlled Drug License:

• Licensing Requirements: Businesses involved in handling or distributing controlled drugs must obtain a controlled drug license from the Home Office. The license requirements vary depending on the schedules of controlled drugs being handled.

• Licensing Categories: Controlled drug licenses are categorized into different tiers based on the level of control and security required. These tiers range from Schedule 2 to Schedule 5, with Schedule 2 being the highest level of control.

• Compliance with Regulations: Controlled drug license holders must comply with the Misuse of Drugs Regulations, which outline specific requirements for storage, record-keeping, security measures, and reporting. Compliance ensures the safe handling and distribution of controlled drugs.

Record Keeping and Documentation:

• License Records: It is essential to maintain accurate records of WDA and controlled drug licenses, including license numbers, issue dates, and expiration dates.

• Auditable Documentation: Businesses should keep auditable documentation related to the licenses, such as application forms, inspection reports, and any correspondence with regulatory authorities.

Compliance Monitoring and Renewals:

• Ongoing Compliance: WDA and controlled drug license holders must maintain ongoing compliance with regulatory requirements, including GDP guidelines and regulations related to controlled drugs.

• Renewal Process: Licenses have expiration dates, and businesses need to initiate the renewal process in advance to avoid any disruption in operations. The renewal process may involve inspections, audits, and submission of updated documentation.

Compliance Monitoring and Renewals:

• Ongoing Compliance: WDA and controlled drug license holders must maintain ongoing compliance with regulatory requirements, including GDP guidelines and regulations related to controlled drugs.

• Renewal Process: Licenses have expiration dates, and businesses need to initiate the renewal process in advance to avoid any disruption in operations. The renewal process may involve inspections, audits, and submission of updated documentation.

Reporting and Compliance Audits:

• Reporting Obligations: License holders must report incidents, such as theft, loss, or damage of controlled drugs, to the relevant authorities promptly. Compliance with reporting obligations is essential for maintaining regulatory compliance.

• Audits and Inspections: Regulatory authorities, such as the MHRA and Home Office, may conduct audits or inspections to assess compliance with licensing requirements. These audits can be scheduled or unannounced.