Webinar on Medicine Registration in Libya

Aug 2, 2024

Webinar: Registration of Medicines in Libya

Introduction

  • Duration: 1.5 hours
  • Questions: Address in the comments section, live webinar only
  • Trainings: Over 50 planned for the next year in various countries including Vietnam, Azerbaijan, Lebanon, and Jordan
  • Contact: Suggestions via email

Speaker

  • Name: Marina Bakrowska
  • Title: Regulatory Affairs Senior Manager, International Pharma Company
  • Experience: Senior manager responsible for emerging markets like Middle East, North Africa, Central Africa, etc.

Agenda

  1. Introduction and country overview
  2. Key information on importation
  3. Regulatory requirements
  4. Manufacturing site registration
  5. Application forms
  6. Inspection process
  7. Medical device regulations
  8. Conclusion and Q&A

Libya Country Overview

  • Location: North Africa, part of MENA (Middle East and North Africa)
  • Languages: Arabic (official), Modern Standard Arabic
  • Currency: Libyan Dinar
  • Population: Not very large due to large desert areas
  • Political Situation: Unstable post-Arabic Revolution
  • Economy: Largest oil reserves in North Africa
  • Healthcare System: Severely damaged, reliant on imports
  • Regulatory Authority: Ministry of Health, Food and Drug Control Center
  • Distribution: Primarily through wholesalers, private businesses
  • Market Size: Small, high humanitarian needs

Market Entry Prerequisites

  1. Business License: Required for pharmaceuticals and related products
  2. Pharmacists Syndicate Registration: For pharmacies and drugstores
  3. Quality Control: Food and Drug Control Center
  4. Customs Clearance: Required for import/export
  5. Drug Product Registration: Required before market entry

Business Registration Options

  1. Branch Office
  2. Joint Venture Company
  3. Representative Office
  4. Operating through a Libyan Distributor (most common)

Regulatory Authority

  • Libyan Ministry of Health: Primary regulator
  • Food and Drug Control Center: Quality control and compliance
  • Pharmaceutical Syndicate: GDP examination, trainings

Regulatory Affairs Requirements

  • Historical Law: Established in 1973, not strictly followed initially
  • Two Main Procedures: Manufacturing site registration (1-2 years) and finished product registration (6 months)
  • Required Documentation: Business license, GMP certificate, CPP, manufacturing license, etc.

Site Registration Process

  1. Application Form: Includes general info, manufacturing details, personnel, quality control, etc.
  2. Supporting Documents: GMP certificate, CPP, manufacturing license, financial statements, etc.
  3. Fees: Approx. 5000 Dinars
  4. Inspection: On-site inspection required, managed by Ministry of Health
  5. Certificates: Valid for 5 years, renewal required

Drug Product Registration

  1. Requirements: Application form, CPP, price certificate, registration fees, drug master file, product samples
  2. Language: Arabic and English required for documentation
  3. Samples: Physical samples may be requested

Pharmacovigilance

  • System: Established but not fully functional
  • Department: Libyan Pharmacovigilance Department
  • Reporting: Not well established, primarily done by companies

Medical Device Regulations

  1. Registration Required: For all medical devices
  2. Documentation: Arabic and English
  3. Types: General, technical, certificates of analysis, stability studies, etc.

Conclusion

  • Challenges: Unstable political situation, damaged healthcare system, complex regulatory requirements
  • Opportunities: Large market potential due to high demand and low local competition
  • Recommendations: Work with local agents, prepare detailed documentation, be flexible