Do you notice a slowing of your pharmaceutical product’s supply chain? Your solution is the pharmaceutical exporter and importer AEO certificate. It speeds up the customs clearance rate, provides international trustworthiness, and allows compliance. Here in this entire guide, we describe how pharmaceutical businesses can obtain AEO certification under the CBIC system. We explain the eligibility, documents, step-by-step process, and so on.
What Is the AEO Certificate?
AEO is an Authorised Economic Operator, which the Central Board of Indirect Taxes and Customs (CBIC) grants. It certifies organisations that show good internal controls, customs compliance, supply chain security, and financial standing.
For pharma manufacturers, exporters, or importers, AEO status provides early release of life-saving shipments like drugs, APIs, medical devices, and vaccines—particularly during acute health requirements and breakdown of the supply chain at the global level.
AEO Eligibility Criteria for Pharma Businesses
Pharma businesses, whether manufacturers, distributors, or traders, may apply for AEO if:
- They have an active Importer Exporter Code (IEC)
- They have over 3 years of import-export experience
- They must not have severe Customs, GST, DGFT, Drugs & Cosmetics Act, or other statutory material violations
- They have secure storage, quality standard operating procedures, and audited accounts
AEO Tier System
| AEO Tier | Description | Key Features |
| AEO-T1 | Minimum Entry Level | Online application, no physical audit |
| AEO-T2 | Intermediate Tier | Site visits, SOP verification, security audit |
| AEO-T3 | Top Tier | Detailed examination, international recognition, and the highest benefits |
Documents Required to Apply for AEO – Pharmaceuticals
The pharmacy industry needs the following documents as per CBIC guidelines:
- IEC Certificate
- Drug Manufacturing/Import License(Form 25/28, Form 41/10 as the case may be)
- CDSCO Registration Certificate
- GST Certificate
- Company PAN Card
- MSME Certificate (if registered)
- Certificate of Incorporation
- Audit Reports of the Last 3 Financial Years
- Pharmaceutical Supply Chain Process Map
- SOPs for Import/Export Operations
- Site Plan of Manufacture, Warehouse & Admin Units
- Company Letterhead Declaration
- Solvency Certificate issued by a scheduled bank
- GMP or WHO-GMP Certificate
Step-by-Step Process to Get an AEO Certificate
Step 1: Select Your AEO Tier
Select depending upon the size of your organisation, regulatory history, and preparedness:
- AEO-T1 – Suitable for small-to-mid-sized importers/exporters
- AEO-T2– Mid-to-large pharma firms with strong compliance infrastructures
- AEO-T3- Well-established pharma MNCs or firms having impeccable reputation
Step 2: Registration on the AEO Portal
Join on aeoindia.gov.in and create your login credentials.
Step 3: Fill Application Forms
You will need to complete:
- Annexure A – Basic Application Form (all levels)
- Annexure B– Security Self-Assessment Questionnaire (T2 & T3 only)
Step 4: Uploading Required Documents
Upload the required digital copies on the portal in PDF format. Ensure:
- The file name is the same as the document
- No expired certificates
- SOPs are process-specific (e.g., cold chain storage, temperature-sensitive shipping, etc.)
Step 5: Site Verification & Assessment
AEO-T1: Only document scrutiny online
AEO-T2 & T3:
- Physical site verification
- Review of compliance SOP
- Your warehouse, QA/QC, and logistics staff meeting
AEO Processing Time
| Tier | Estimated Processing Time |
| AEO-T1 | 30 Working Days |
| AEO-T2 | 60–90 Working Days |
| AEO-T3 | 120+ Working Days |
Advantages of AEO Certificate to the Pharma Sector
- Quicker pharma consignment clearance from customs
- Decreased inspection and sampling of sensitive goods
- Priority container scanning treatment
- Mutual recognition by international customs: international customs (MRAs)
- Lower financial guarantees for customs transactions
- Easy global exports of drugs and devices
Why appoint a professional for an EO Application?
AEO application, particularly for pharma firms, includes:
- Technical SOPs (temperature control, batch release procedures)
- Legal and customs papers
- Warehouse and logistics planning
- CDSCO and GMP alignment
Appointing a regulatory consultant such as ELT Corporate ensures:
- Effective writing of SOP, specific to pharma supply chains
- Error-free uploads of documents
- Simpler interface with customs authorities
- Faster approval with guided handholding
Conclusion
AEO certification is a serious move in establishing a reliable pharmaceutical export/import business. It raises your international reliability, streamlines operational delays, and enhances port clearance effectiveness.
Whether for exporting lifesaving drugs or importing raw material, AEO certification makes you viable in a regulated market.
Do you need support for annexures, SOPs, or the application process?
Reach ELT Corporate today or WhatsApp our experts a message for complete support on AEO for Pharmaceuticals
