The export of pharmaceuticals—especially herbal medicines—is a major opportunity for economic growth and global health cooperation. However, entering international markets requires obtaining various export licenses for pharmaceuticals, ensuring that products meet regulatory requirements, safety standards, and GMP certification.
Introduction
The export of pharmaceuticals—especially herbal medicines—is a major opportunity for economic growth and global health cooperation. However, entering international markets requires obtaining various export licenses for pharmaceuticals, ensuring that products meet regulatory requirements, safety standards, and GMP certification.
A fundamental requirement is GMP certification, which ensures that the pharmaceutical product is manufactured under strict quality, safety, and hygiene standards. Without a GMP-compliant facility, a product cannot be considered eligible for export.
All pharmaceutical products made in Iran must obtain approval from the Iran Food and Drug Administration (IFDA). This includes submitting detailed technical documentation, safety and efficacy reports, product labeling, and formulation.
Each export destination has its own regulations for pharmaceuticals. To enter those markets, companies must obtain a marketing authorization, which often involves scientific documentation, clinical data, samples, and proof of quality control.
To officially export pharmaceuticals, a company must secure an export license from the Ministry of Health and clearance from Iran Customs. This involves providing customs declarations, sales invoices, quality certificates, and shipping documentation.
Prepare complete technical documentation (formulation, tests, labeling)
Obtain GMP certification for the production facility
Get product approval from IFDA
Review and comply with the regulations of the target market
Submit for marketing authorization in the destination country
Secure final export license and customs clearance
Complex and time-consuming documentation
Regulatory differences across countries
High costs for registration and certification
Limited access to accredited testing laboratories
Specialized accelerators and export consulting firms can simplify the process. These entities help startups and pharmaceutical manufacturers prepare proper documentation, navigate international regulations, and develop go-to-market strategies.
Keywords: pharmaceutical export consulting, export accelerator, herbal medicine startups, international market entry
Understanding and complying with export license requirements is essential for any pharmaceutical company, especially those focused on herbal products. By meeting regulatory requirements, securing GMP certification, and aligning with international standards, Iranian manufacturers can successfully enter the global pharmaceutical market.
