Overview of Vaccines & Biological Products Department Activities

 

A. Processing, granting marketing authorization and post approval changes for vaccines (human and veterinary) and biological products (Innovator biological products, biosimilars, Plasma Derived Medicinal Products (PDMPs), and others intended for sale on the Ghanaian market and/or export.

This includes;

• Processing applications for new, renewal, and variation applications
• Dossier evaluation meetings
• Presentation and report on dossier evaluation outcomes at product registration meetings
• Correspondence with applicants and local agents
• Issuance of marketing authorization certificates
• Revocation of marketing authorization certificates
• Maintaining the Drug Register (for vaccines and biological products)
• Drafting and reviewing of guidelines and codes of practice
• Stakeholder’s engagement on matters relating to marketing authorization and variations of vaccines and biological product
• Vetting of brand names for Vaccines and Biological Products
• Processing of regular and irregular permits for vaccines and biological products
• Processing of import/export applications for pathological materials

 

B. Processing of applications of blood and blood components, including plasma for fractionation (Product and/or Process Approval) – Blood Facility Licensure and Listing of blood and blood components

This includes:

• Processing of blood facility new, renewal and variation licensure applications
  
• Maintaining the Register for blood facility licensed and listed blood and blood components
  
• Issuance of blood facility license certificates
  
• Revocation of blood facility license certificates
  
• Correspondence with applicants
  
• Drafting and reviewing of guidelines and codes of practices
  
• Stakeholder’s engagement on matters relating to blood facility licensure and listing of blood and blood components

C. Processing and granting of lot release for vaccines and other biological products

This includes;

• Processing approvals for lot release applications
  
• Maintaining the Register for Released Lots
  
• Correspondence with applicants and local agents
  
• Issuance of lot release certificates
  
• Revocation of lot release certificates
  
• Drafting and reviewing of guidelines and codes of practice
  
• Stakeholder’s engagement on matters relating to lot release of vaccines and other biological products 

 

D. Training/Capacity Building

• AUDA NEPAD designated Regional Center of Regulatory Excellence on Vaccine Regulatory Oversight
• Training on vaccine regulation to other NRAs, industry and academia