Effective Date: 25/02/2025
1. Purpose
Medina Remedies Limited is committed to complying with all applicable national and international regulations, standards, and guidelines governing the distribution of pharmaceuticals. This policy ensures:
- Adherence to Kenyan pharmaceutical laws and global regulatory requirements.
- Compliance with ISO 9001 (Quality Management) and ISO 13485 (Medical Devices, if applicable).
- Ethical practices in procurement, storage, distribution, and customer interactions.
2. Scope
Applies to:
- All employees, contractors, and partners involved in the supply chain.
- Procurement, warehousing, transportation, and distribution of pharmaceutical products.
- Documentation, reporting, and quality control processes.
3. Regulatory Framework
We comply with the following regulations and standards:
| Jurisdiction | Regulations/Standards |
|---|---|
| Kenya | – Pharmacy and Poisons Act (Cap 244) – Kenya Food, Drugs, and Chemical Substances Act – Data Protection Act (2019) |
| International | – WHO Good Distribution Practices (GDP) – ISO 9001:2015 (Quality Management) – ISO 14001:2015 (Environmental Management, if applicable) |
4. Compliance Commitments
A. Product Licensing & Documentation
- Ensure all distributed pharmaceuticals are licensed by the Pharmacy and Poisons Board (PPB) and Kenya Food and Drug Authority (KFDA).
- Maintain accurate records of:
- Supplier certifications.
- Batch numbers, expiry dates, and storage conditions.
- Import/export permits for international shipments.
B. Quality Assurance
- Implement ISO 9001-compliant quality management systems (QMS).
- Conduct regular audits of suppliers, warehouses, and logistics partners.
- Validate cold chain processes for temperature-sensitive products (e.g., vaccines, biologics).
C. Ethical Practices
- Prohibit bribery, corruption, or unethical procurement practices (aligned with Anti-Counterfeit Act, 2008).
- Report adverse drug reactions (ADRs) to the Pharmacovigilance Department of PPB.
D. Recall Management
- Establish a recall procedure compliant with WHO GDP Guidelines.
- Notify regulators and customers immediately in case of product recalls.
E. Data Protection
- Secure customer, patient, and partner data in compliance with Kenya’s Data Protection Act (2019).
5. Roles & Responsibilities
| Role | Responsibilities |
|---|---|
| Compliance Officer | Oversee regulatory adherence, conduct audits, and liaise with authorities. |
| Quality Assurance Team | Monitor product quality, manage recalls, and maintain ISO certifications. |
| Management | Allocate resources for compliance training, audits, and system upgrades. |
| Employees | Report compliance concerns and follow documented procedures. |
6. Training & Awareness
- Mandatory Training:
- Annual regulatory updates (e.g., PPB guidelines, ISO revisions).
- GDP and Good Storage Practices (GSP) for warehouse staff.
- New Hires: Orientation on compliance protocols during onboarding.
7. Audits & Corrective Actions
- Internal Audits: Conducted quarterly to assess compliance with PPB, ISO, and WHO standards.
- External Audits: Third-party audits biennially for ISO recertification.
- Corrective Actions: Address non-conformities within 14 days of identification.
8. Incident Reporting
- Report regulatory breaches (e.g., expired products, data leaks) to the Compliance Officer within 24 hours.
- Document incidents and corrective actions for regulatory review.
9. Partnerships & Third-Party Compliance
- Verify that suppliers, transporters, and distributors comply with:
- Kenyan pharmaceutical laws.
- ISO standards (if applicable).
- WHO GDP Guidelines.
10. Documentation & Record-Keeping
- Retain records for 5 years (or as mandated by law), including:
- Licenses and permits.
- Audit reports and corrective action plans.
- Training logs and incident reports.
11. Consequences of Non-Compliance
- Internal: Disciplinary action, retraining, or termination for deliberate violations.
- External: Legal penalties, license revocation, or reputational damage.
12. Policy Review
This policy is reviewed annually or after significant regulatory changes.
13. Contact
Email: [compliance@medinaremedies.co.ke]
Phone: (+254) 724 553 242
Signed: Jamal Bare
Jamal Bare
Managing Director, Medina Remedies Limited
Date: 25/02/2025
