Pharmaceutical Wholesale, Distribution & Export

Data Protection and Privacy Statement

Last Updated: April 2024

1. Introduction

UKPharmaExpo Ltd ("we," "us," "our," or "Company") is committed to protecting your personal data and respecting your privacy. This Privacy Policy explains how we collect, use, disclose, and otherwise process personal information in connection with our websites and services.

2. Data Controller

UKPharmaExpo Ltd is the data controller responsible for your personal data. Our contact details are available in the Contact section of this website.

3. Legal Basis for Processing

We process personal data on the following legal bases:

• Consent: Where you have explicitly consented to processing
• Contract: Where processing is necessary to perform a contract
• Legal Obligation: Where processing is required by law
• Legitimate Interests: Where processing is necessary for our legitimate business interests

4. Data We Collect

We may collect the following categories of personal data:

• Contact Information: Name, email address, phone number, company name, job title
• Business Information: Company details, business address, industry sector
• Technical Data: IP address, browser type, device information, cookies
• Interaction Data: Pages visited, time spent, actions taken on our website

5. How We Use Your Data

We use your personal data for:

• Responding to your enquiries and providing services
• Processing orders and managing customer relationships
• Compliance with legal and regulatory obligations
• Improving our website and services
• Marketing communications (with your consent)
• Fraud prevention and security

6. Data Sharing

We may share your data with:

• Service providers and business partners necessary to provide our services
• Regulatory authorities when required by law
• MHRA and other healthcare regulators for compliance purposes

We do not sell your personal data to third parties.

7. Data Retention

We retain personal data for as long as necessary to fulfill the purposes outlined in this policy, or as required by law. Typically, we retain business enquiry data for up to 3 years.

8. Your Rights

Under GDPR, you have the right to:

• Access your personal data (Right of Access)
• Correct inaccurate data (Right of Rectification)
• Request deletion of your data (Right to be Forgotten)
• Restrict processing (Right to Restrict Processing)
• Receive data in a portable format (Right to Data Portability)
• Object to processing (Right to Object)

To exercise any of these rights, please contact us at enquiries@ukpharmaexpo.co.uk.

9. International Transfers

Your data is processed and stored within the UK and European Economic Area. If we transfer data outside the EEA, we implement appropriate safeguards.

10. Security

We implement appropriate technical and organizational measures to protect your personal data against unauthorized access, alteration, disclosure, or destruction.

11. ICO Registration

UKPharmaExpo Ltd is registered with the Information Commissioner's Office (ICO) under Data Protection Act registration: [Reference to be added]

12. Contact Us

For privacy-related enquiries, please contact: enquiries@ukpharmaexpo.co.uk

Our Cookie Policy

Last Updated: April 2024

1. What Are Cookies?

Cookies are small text files stored on your browser or device when you visit a website. They help websites remember information about your visit and improve your experience.

2. Cookies We Use

Functional Cookies: These cookies enable core website functionality such as navigation, form submission, and remembering your preferences. They are essential for the website to operate properly.

• Session cookies: Maintain your session during your visit
• Preference cookies: Remember your cookie consent choice
• Navigation cookies: Enable smooth navigation through the website

Analytical Cookies: These help us understand how you use our website, allowing us to improve functionality and content (only used with your consent).

3. Cookie Consent

When you first visit our website, we display a cookie consent banner. You can:

• Accept: Consent to functional and analytical cookies
• Decline: Use the website with only essential functional cookies

You can change your cookie preferences at any time by clicking the cookie settings link in the footer.

4. Third-Party Cookies

We do not currently use third-party cookies from advertising or tracking networks.

5. Managing Cookies

You can control cookies through your browser settings. Most browsers allow you to refuse cookies or alert you when cookies are being sent. For more information, visit www.allaboutcookies.org

6. Contact Us

For questions about our cookie policy, contact: enquiries@ukpharmaexpo.co.uk

Terms & Conditions for UKPharmaExpo Ltd

Last Updated: April 2024

1. Introduction

These Terms & Conditions ("Terms") govern your access to and use of the UKPharmaExpo Ltd website and services. By accessing this website, you agree to be bound by these Terms.

2. Intended Audience

This website is intended exclusively for healthcare professionals, pharmaceutical businesses, registered pharmacies, and other authorized suppliers within the pharmaceutical supply chain. This website does not sell medicines directly to the public.

3. Use of Website

You agree to use this website only for lawful purposes and in a way that does not infringe the rights of others or restrict their use and enjoyment of the website.

4. Intellectual Property

All content on this website, including text, graphics, logos, and images, is the property of UKPharmaExpo Ltd or its content suppliers and is protected by copyright and other intellectual property laws.

5. Limitation of Liability

To the maximum extent permitted by law, UKPharmaExpo Ltd shall not be liable for any indirect, incidental, special, consequential, or punitive damages arising from your use of this website or services.

6. Regulatory Compliance

All services provided by UKPharmaExpo Ltd are subject to MHRA regulations, Good Distribution Practice (GDP) guidelines, and all applicable UK pharmaceutical laws.

7. Order Terms

All orders are subject to acceptance by UKPharmaExpo Ltd. We reserve the right to refuse or cancel any order that does not comply with regulatory requirements or our policies.

8. Payment Terms

Unless otherwise agreed, payment for goods must be made in accordance with terms specified in our order confirmation. Late payment may result in suspension of credit terms.

9. Product Warranties

All products supplied are warranted to be authentic, properly stored, and in compliance with applicable regulations. We do not warrant products for use outside intended purposes or outside specified storage conditions.

10. Warranties Disclaimer

This website and all content are provided on an "as-is" basis without warranties of any kind, express or implied, including fitness for a particular purpose.

11. Indemnification

You agree to indemnify and hold harmless UKPharmaExpo Ltd from any claims, damages, or expenses arising from your use of this website or violation of these Terms.

12. Governing Law

These Terms are governed by the laws of England and Wales. Any disputes shall be subject to the exclusive jurisdiction of the English courts.

13. Modifications

We reserve the right to modify these Terms at any time. Changes will be effective upon posting to the website.

14. Contact

For questions about these Terms, please contact: enquiries@ukpharmaexpo.co.uk

Formal Complaints Handling Procedure

Last Updated: April 2024

This procedure is in accordance with Good Distribution Practice (GDP) Chapter 6 requirements.

1. Overview

UKPharmaExpo Ltd maintains a comprehensive system for handling complaints regarding product quality, safety, distribution practices, or any other concerns relating to our services.

2. Who Can Complain

Any customer, healthcare professional, regulatory authority, or member of the public may lodge a complaint about our products or services.

3. How to Make a Complaint

Contact our Quality Assurance Team:

• Email: quality@ukpharmaexpo.co.uk
• Phone: +44 (0) [number to be added]
• In writing: UKPharmaExpo Ltd, [address to be added]

4. Urgent Product Safety Issues

For urgent product safety concerns or potential contaminated medicines:

Out-of-Hours Emergency Contact: [Emergency number to be added]

Report immediately to our Responsible Person for rapid investigation and action.

5. Complaint Information Required

To facilitate proper investigation, please provide:

• Your contact details
• Product name, batch number, and expiry date
• Detailed description of the issue
• When and where the product was obtained
• Your preferred contact method and response timeframe

6. Investigation and Response

Timeframe: We acknowledge receipt of complaints within 2 working days. Initial investigation completed within 10 working days for non-critical issues.

Critical safety issues: Immediate investigation and escalation to MHRA if necessary.

7. Investigation Process

• Complaint logged and categorized
• Quality and regulatory review
• Product investigation (if applicable)
• Root cause analysis
• Corrective and Preventive Actions (CAPA) if needed

8. Regulatory Reporting

Complaints involving potential safety issues are reported to the MHRA as required by law and GDP guidelines.

9. Resolution and Feedback

We will provide you with a comprehensive response detailing our findings and any actions taken. Further complaints handling information available on request.

10. Escalation

If you are dissatisfied with our response, please request escalation to our Responsible Person for further review.

11. Record Keeping

All complaints and investigations are documented and retained for regulatory audit purposes.

12. Contact

Quality Assurance: quality@ukpharmaexpo.co.uk

Whistleblowing and Confidential Reporting Policy

Last Updated: April 2024

1. Purpose

UKPharmaExpo Ltd is committed to the highest standards of ethical conduct and regulatory compliance. This policy encourages employees and business partners to raise concerns about potential violations or misconduct in a safe and confidential manner.

2. Scope

This policy applies to all employees, contractors, suppliers, and other stakeholders who have concerns about:

• Regulatory breaches or non-compliance with GDP guidelines
• Product safety or quality concerns
• Ethical violations or misconduct
• Fraud or financial irregularities
• Health and safety violations

3. Protected Disclosure

In accordance with the Public Interest Disclosure Act 1998, we protect individuals who make good faith disclosures about matters of public concern from detrimental treatment or dismissal.

4. How to Report Concerns

Internal Reporting:

• Email: whistleblowing@ukpharmaexpo.co.uk (marked "Confidential")
• Your manager or designated Responsible Person

Confidential Reporting: To ensure confidentiality, use our dedicated email address or request to discuss concerns with a senior manager in person.

5. External Reporting

If internal reporting is inappropriate or has been unsuccessful, you may report concerns to:

• MHRA Vigilance: vigilance@mhra.gov.uk
• Relevant regulatory authorities

6. Confidentiality and Protection

We will:

• Treat all reports confidentially
• Protect the identity of the reporter where possible
• Ensure no retaliation or detrimental treatment
• Investigate concerns thoroughly and promptly

7. No Retaliation

Any form of retaliation, victimization, or disciplinary action against someone who has made a protected disclosure is prohibited and will be treated as serious misconduct.

8. Investigation

All concerns will be investigated promptly and confidentially. Investigators will maintain the strictest confidentiality consistent with the need to conduct a proper investigation.

9. Feedback

Where appropriate and safe, reporters will be provided with feedback on the outcome of investigations and any actions taken.

10. Contact

Whistleblowing contact: whistleblowing@ukpharmaexpo.co.uk

Product Recall and Safety Alert Procedure

This procedure is established in accordance with Good Distribution Practice (GDP) Chapter 7 and the Human Medicines Regulations 2012.

1. Purpose

UKPharmaExpo Ltd maintains a documented system for the effective and rapid recall of any medicinal product from the supply chain. This procedure ensures patient safety and regulatory compliance at all times.

2. Scope

This procedure applies to all medicines distributed by UKPharmaExpo Ltd, including manufacturer-initiated recalls, MHRA Class I/II/III/IV recalls, and internal quality-triggered withdrawals.

3. Responsible Person

Our designated Responsible Person coordinates all recall activities and serves as the primary contact with the MHRA. The RP can initiate a recall independently if patient safety is at risk.

4. Recall Classification

Class I: Defect potentially life-threatening or could cause serious risk to health — immediate action required.

Class II: Defect could cause illness or mistreatment but is not Class I — urgent action required.

Class III: Defect unlikely to cause harm but recall initiated for other reasons (e.g., non-compliance with marketing authorisation).

Class IV: Caution-in-use — no recall but additional information provided to users.

5. Emergency Recall Contact

24/7 Emergency Number: [Emergency number to be added]

Quality Assurance Email: quality@ukpharmaexpo.co.uk

MHRA Defect Reporting Centre: 020 3080 6574

MHRA Drug Alert Email: drugalerts@mhra.gov.uk

6. Recall Process

Upon notification of a recall, UKPharmaExpo Ltd will: identify all affected batches and distribution records within 1 hour; notify all affected customers immediately; quarantine any remaining stock on-site; coordinate return of affected products; report to the MHRA as required; complete a root cause analysis and CAPA.

7. Record Keeping

Complete records of all recall activities, including distribution records, customer notifications, returned quantities, and investigation outcomes, are maintained for a minimum of 5 years and made available to the MHRA on request.

8. Mock Recalls

UKPharmaExpo Ltd conducts mock recall exercises at least annually to test the effectiveness of the recall system and ensure rapid response capability.

9. Contact

For recall-related enquiries: quality@ukpharmaexpo.co.uk

Medicine Returns Policy

This policy is established in accordance with Good Distribution Practice (GDP) Chapter 8 — Returned Goods, ensuring the integrity of the pharmaceutical supply chain.

1. General Principle

Returned medicinal products must be handled in accordance with a written, authorised procedure. Products should only be returned to saleable stock if the quality of the product can be confirmed.

2. Conditions for Return

Medicines may be returned to UKPharmaExpo Ltd provided that:

• The products are in their original, unopened, and tamper-evident packaging
• The products are within their stated shelf life (minimum 3 months remaining)
• Evidence is available that the products have been stored and transported in accordance with their required storage conditions
• The return is notified to our Quality Assurance team within 10 working days of delivery
• The products have not been subject to a product recall

3. Assessment of Returns

All returned products undergo a quality assessment by our Responsible Person or authorised deputy. This includes: verification of product identity and batch numbers; inspection of packaging integrity and tamper evidence; review of temperature records during the return journey; confirmation of remaining shelf life.

4. Products Not Eligible for Return

The following cannot be returned to saleable stock: cold chain products where temperature excursion has occurred or cannot be ruled out; products with damaged or missing tamper-evident seals; products past their expiry date or with fewer than 3 months remaining; controlled drugs (separate procedures apply); products subject to a safety recall.

5. Rejected Returns

Products that do not meet the return criteria will be quarantined and destroyed in accordance with environmental regulations. The customer will be notified and a record maintained.

6. Credit and Refunds

Approved returns will be credited to the customer's account within 14 working days of quality assessment approval. Refunds are processed to the original payment method where applicable.

7. How to Arrange a Return

Contact our Quality Assurance team to request a Return Authorisation Number (RAN) before sending any products back. Unauthorised returns will not be accepted.

Email: quality@ukpharmaexpo.co.uk

Phone: +44 (0) [Number to be added]

8. Record Keeping

All returns are documented and records retained for a minimum of 5 years, available for MHRA inspection.