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Registration guide

How to register a pharmaceutical product in Iraq

A practical guide for regulatory teams: the two authorities, the order of steps, the documents involved and the problems that most often cause delays.

Iraq is one of the larger pharmaceutical markets in the Middle East, and one of the more demanding to enter. The rules are clear once you know them. This guide sets them out in the order you will meet them.

Two authorities, two registrations

Iraq has two health regulators, and each one approves products only for its own territory. If you want to sell nationwide you need both registrations.

Ministry of Health, Baghdad

Regulates the fifteen federal governorates. Registration is required for sale in federal Iraq and for any Kimadia tender. Expects CTD, prefers eCTD, and applies strict CIF price caps.

KMCA, Erbil

The Kurdistan Medical Control Agency regulates the four governorates of the Kurdistan Region independently. Accepts CTD dossiers and usually reaches a decision sooner.

The path to authorisation

  1. 1

    Register the manufacturing site

    Before any product is registered, the site that makes it must be approved. This means a site master file and GMP certificates, ideally issued by a stringent regulatory authority, and possibly an inspection.

  2. 2

    Prepare the dossier

    Iraq requires the Common Technical Document format. Check it against local requirements, in particular stability data for climatic zones IVa and IVb.

  3. 3

    Committee review

    Specialist technical committees review the dossier and often send queries asking for clarification or additional data. Quick, complete answers keep the file moving.

  4. 4

    Pricing

    In Baghdad especially, the pricing committee expects you to justify the proposed CIF price with reference prices from neighbouring countries.

  5. 5

    Marketing authorisation

    Once approved, the product can be imported by your licensed local representative and distributed within that authority's territory.

Documents to prepare

Certificates issued abroad must be legalised by the Iraqi embassy in the country of issue. Start this early; it is often the slowest part of the process.

  • Certificate of Pharmaceutical Product (CPP)
  • Good Manufacturing Practice (GMP) certificate
  • Free Sale Certificate (FSC)
  • Complete CTD dossier, modules 1 to 5
  • Stability data for zones IVa and IVb
  • Bioequivalence studies, for generics
  • Pricing justification
  • Legalised agency agreement
  • SmPC and patient information leaflet in Arabic

What usually causes delays

Missing hot-climate stability data
Iraq falls in climatic zones IVa and IVb. Dossiers without real-time stability data for these conditions are one of the most common reasons for rejection.
Certificates not legalised
Unlegalised or expired CPP, GMP or free-sale certificates are returned before review even starts.
Product filed before the site
Product dossiers cannot be approved while the manufacturing site registration is still pending.
A weak pricing file
Prices without credible regional references lead to long negotiations with the pricing committee.
Labelling that does not meet local rules
Outer cartons and leaflets need accurate Arabic text in the required layout.

Want a second pair of eyes on your dossier?

Our regulatory team has taken products through both the MOH and the KMCA. Send us your product list and we will tell you where the risks are before you file.

Ask our regulatory team