Comprehensive Guide to Pharmaceutical Manufacturing Licensing in Iran
(Including Herbal & Chemical Drugs)
🔶 Step 1: Provisional License (Initial Approval)
🎯 Purpose:
To formally announce the intention of establishing a pharmaceutical production unit.
📌 Issuing Authority:
Vice-Chancellor for Food and Drug Affairs – local University of Medical Sciences (under the Ministry of Health)
📋 Required Documents:
Official application form (via TTAC.ir)
Legal identity documents of applicant (individual or legal entity)
Site details and project location
Technical and financial feasibility plan
Implementation timeline
Defined product categories (chemical drugs, herbal medicines, dietary supplements, traditional products)
Criminal background clearance (for individuals)
⏳ Validity:
2 years, extendable once for another 2 years
🔶 Step 2: Establishment License
🎯 Purpose:
Official permission to build a pharmaceutical factory at the specified site.
📌 Technical Requirements:
Architectural and engineering drawings (AutoCAD): production zones, labs, warehouses, QA/QC rooms, HVAC, utilities
Full compliance with GMP (Good Manufacturing Practices) standards (based on WHO guidelines)
Recruitment of a qualified Technical Manager (licensed pharmacist)
Valid contract with a cleanroom construction provider
📋 Additional Documents:
Ownership deed or official rental contract for the facility
Detailed feasibility study
Site usage approval from industrial estate or municipality
Environmental & pharmaceutical waste management plan (approved by the Environmental Protection Organization)
🔶 Step 3: Operation License
🎯 Purpose:
Final authorization for plant operation after construction and equipment installation.
📋 Prerequisites:
Completion of construction and installation of machinery
Employment of trained personnel
Full implementation of documentation system: SOPs, maintenance logs, quality control forms
🔍 On-site Inspection Includes:
Air quality, temperature, humidity, filtration
Equipment conformity and operational status
Functioning QA/QC units
Traceable batch documentation and record-keeping
Personnel hygiene and safety compliance

🔶 Step 4: Product Manufacturing License
🎯 Purpose:
Official license to manufacture a specific pharmaceutical product.
📌 Issuing Body:
Chemical Drugs: Food & Drug Administration – Department of Medicines
Herbal Drugs: Department of Natural Products, Traditional & Supplementary Medicines
📋 Required Documents:
Full CTD Dossier:
Module 1: Administrative info
Module 2: Summary of quality and efficacy
Module 3: Quality documentation (formulation, manufacturing, control methods)
Module 4: Non-clinical studies (if applicable)
Module 5: Clinical studies or comparable international evidence
Product Information:
Physical samples
Stability data (accelerated and long-term)
Product labeling, packaging designs (Label & Artwork)
Scientific references on efficacy
Active Ingredient Information:
API origin or herbal extract source
Certificate of Analysis (CoA)
Import license for foreign-sourced materials
🧪 Testing:
Samples are submitted to the national reference laboratory and must pass all tests before the license is granted.
🔷 Herbal Medicines – Special Considerations
✅ Key Features:
Clinical trials may not be required for traditional formulations
Emphasis on extract quality and identification of active components
Compliance with GACP (Good Agricultural and Collection Practices) for raw herbs
Dossier reviewed by the Department of Natural Products

📑 Unique Documentation:
Botanical identity and scientific name of plant

Herbal monograph or scientific references

Heavy metal, microbial, pesticide residue analysis

Extraction method and standardization procedures

Safety/toxicity assessment if the usage is novel

🔶 Technical Manager (Responsible Pharmacist) License
Must hold a valid Professional Pharmaceutical License

Application submitted to the FDA with supporting resume, qualifications, and legal commitment to responsibilities

🔷 Other Regulatory Licenses (as needed)

License Description
API Import Permit Required for any imported active or herbal ingredient
GMP Certificate Mandatory for export; verifies full GMP compliance
Marketing Approval Any advertising, catalog, digital promotion must be approved
Variation License Needed for any change in formulation, packaging, or source of raw material
Distribution License Collaboration with an authorized pharmaceutical distributor is mandatory
⏳ Estimated Timeline

Stage Duration
Provisional License 2–3 months
Establishment License 4–6 months
Facility Construction & Equipment 9–18 months
Operation License 1–2 months
Product Manufacturing License 3–6 months per product

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