Every medicine sold in Iran needs a registration with the Iran Food and Drug Administration (IFDA). A foreign manufacturer cannot hold that registration itself: it works through an Iranian company licensed by IFDA to import medicines, which files the dossier, receives the product's IRC code, imports, and remains responsible for the product on the market.

1. Choose the importer first

The importer becomes your registration holder in practice. Look for a company that already holds an IFDA import licence, has its own regulatory staff, can run pharmacovigilance, and has a distribution route to hospitals and pharmacies. Agree in writing who does what: dossier, pricing file, import permits, storage, recalls and complaints. The manufacturer then issues a letter of authorisation (LoA) naming that importer for the product.

2. Prepare the dossier

  • CTD dossier (modules 1–5 as applicable): quality data for the API and the finished product, stability for the intended shelf life and climate, and clinical or bioequivalence data where required.
  • Proof of registration in the country of origin, usually a Certificate of Pharmaceutical Product (CPP) or free-sale certificate.
  • GMP evidence for the manufacturing site; IFDA may ask for an inspection or rely on a recognised authority's certificate.
  • Artwork and labelling that can carry the Persian label and patient leaflet required for the Iranian market.

3. Registration, pricing and IRC

The importer submits the file to IFDA, answers questions and prepares the pricing file. When the product is approved it receives an IRC code, which then appears on every pack and is used for tracking in the Iranian supply chain.

4. Emergency import as a faster first step

For medicines in shortage or not yet registered, IFDA allows emergency (فوریتی) import by licensed importers against a defined need. It is a practical way to supply the market while the full registration is in progress, but it is not a substitute for it.

5. Where projects usually stall

  • A CPP or GMP certificate that has expired or does not match the exact product and site in the dossier.
  • Stability data that do not cover the shelf life or climatic zone being claimed.
  • No agreed responsibility for pharmacovigilance and recalls between manufacturer and importer.
  • Choosing an importer without regulatory staff, so questions from IFDA go unanswered for months.

Local manufacturing under licence

Iran manufactures most of the medicines it uses, and policy favours local production. For many products the stronger long-term route is manufacture under licence by an Iranian GMP plant, with the foreign company keeping the brand and the quality standard. See licensed manufacturing in Iran.

Hanpars is an IFDA-licensed importer with its own regulatory team. For the step-by-step route for Chinese manufacturers see exporting medicines and APIs from China to Iran; for what we take on as your partner, see for foreign manufacturers and regulatory affairs.