As one of the largest economies in Central Africa, Angola is a strategic market for pharmaceutical companies. Gaining INABEC Drug Approval is the critical gateway to this opportunity. The process, governed by the National Institute for Health Regulation and Equipment (INABEC), demands precision and local knowledge. OMC Medical specializes in Pharma Registration Angola and provides this definitive guide.
The Regulatory Landscape in Angola
INABEC is the national regulatory authority tasked with ensuring that all human and veterinary medicines in Angola are safe, effective, and of high quality. Securing an Angolan Marketing Authorization from INABEC is mandatory before any product can be imported or sold.
The Pharmaceutical Registration Process: A Step-by-Step Overview
- Appoint a Local Marketing Authorization Holder (MAH)
All foreign manufacturers must have a local entity, the Marketing Authorization Holder (MAH), registered in Angola. This MAH is legally responsible for the product and must hold the necessary Pharmaceutical Import License Angola. OMC Medical can assist in establishing this critical local presence.
- Dossier Compilation and Legalization:
The registration application is based on a comprehensive CTD-style dossier, submitted entirely in Portuguese. A key administrative hurdle is the legalization of documents. Essential components include:
- Module 1 (Administrative): Includes application forms, a Power of Attorney, and a Free Sale Certificate from the country of origin. The FSC must be legalized by the Angolan Consulate.
- Module 2 (Summaries): Quality, non-clinical, and clinical overviews and summaries.
- Module 3 (Quality): Detailed chemical, pharmaceutical, and biological documentation.
- Module 4 (Non-Clinical) and Module 5 (Clinical): Study reports and data.
- GMP Certificate: A GMP Certificate for the manufacturing site(s), issued by a competent authority, is mandatory and must also be legalized.
- Submission and Scientific Review:
The complete Drug Dossier Angola is submitted to INABEC. The agency’s technical committee conducts a thorough assessment of the quality, safety, and efficacy data. This review process is meticulous and can be lengthy.
- Price Approval:
Unlike some markets, Angola requires a separate price approval for pharmaceutical products. The MAH must submit a pricing application to the relevant body, which will be reviewed alongside the registration.
- Grant of Marketing Authorization:
After a successful scientific review, price approval, and payment of all fees, INABEC grants the Marketing Authorization (MA). This Medicine Registration Angola is typically valid for five years and is renewable.
- Post-Marketing Commitments:
The MAH must maintain a robust pharmacovigilance system to monitor drug safety and report any adverse reactions to INABEC. Any changes to the product information or manufacturing process must be submitted to INABEC as a variation.
How OMC Medical Facilitates Your Angolan Market Entry
The INABEC Regulatory Process is complex, with specific legal and linguistic requirements. As your dedicated partner, OMC Medical provides comprehensive Pharma Registration Angola services:
- End-to-end management of your INABEC Drug Approval application.
- Assistance in appointing or acting as your local Marketing Authorization Holder.
- Dossier gap analysis, compilation, and professional translation into Portuguese.
- Handling of critical document Legalization at the Angolan Consulate.
- Direct liaison with INABEC throughout the entire process.
- Strategic support for pricing and reimbursement applications.
Partner with OMC Medical Pharma Angola experts to navigate the regulatory landscape with confidence and ensure your medicines reach the Angolan population efficiently.
