Entering the health and pharmaceutical industry in Iran requires a solid understanding of the legal and regulatory framework.
Entering the health and pharmaceutical industry in Iran requires a solid understanding of the legal and regulatory framework. Without proper knowledge of the authorities involved and the required licenses, startups and companies may face costly delays or legal obstacles. This article outlines the key institutions, licensing processes, and legal pathways necessary to operate successfully in this sector.
The Ministry of Health is the central policymaker in Iran’s health sector. It oversees public health programs, sets national standards, and supervises all institutions involved in the development, production, and distribution of medical products.
A key subdivision under the Ministry, the IFDA is responsible for issuing licenses related to drugs, supplements, herbal medicines, cosmetics, and medical devices. Any pharmaceutical product entering the market must go through a registration and evaluation process with the IFDA.
To legally manufacture or market pharmaceuticals in Iran, companies must obtain several approvals, including:
Company Establishment License
Operation License
GMP Certification (Good Manufacturing Practice)
Product-specific Manufacturing Licenses
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Each of these requires detailed documentation, lab analyses, and sample product evaluations.
Innovations such as novel formulas, drug compositions, and brand names must be registered with the Iranian Intellectual Property Office under the Judiciary. This ensures legal protection and exclusive rights to exploit the invention or brand.
Startups can benefit from innovation ecosystems, including tech parks, accelerators, and incubators. These entities offer legal guidance, regulatory navigation, and even tax exemptions. Working with legal advisors in health law can greatly reduce risk and increase chances of success.
Understanding Iran’s legal health framework is not only essential for compliance but also accelerates commercialization. Companies that proactively engage with the legal system are better positioned to scale, protect their innovations, and compete in both domestic and international markets.
