Registering a product in the destination market: six stages, and how long each takes

If you are a distributor evaluating an Iranian supplier, the question behind every other question is timing: when can this product legally be sold in my market?

Suppliers answer that question with a single number, and single numbers are where the disappointment starts. Below is the breakdown — six stages, what each one actually requires, and the range to plan for.

Stage 1 — Deciding the regulatory pathway

Before anything else, the product has to be classified in your market: medicine, supplement, medical device, or raw material. That decision belongs to your regulator, not to the supplier, and the same formulation can be classified differently in two neighbouring countries.

Everything downstream branches from here. A supplement usually needs a lighter file and clears faster. The same formulation classified as a medicine needs the full dossier.

Typical: 2 to 6 weeks. With a local agent who has worked with the regulator before, the answer comes in the second week. Without one, most of that time goes into finding the right person rather than getting the answer.

Stage 2 — Building the dossier

In most markets the registration dossier follows the CTD format — the Common Technical Document, a standard structure that organises the file into five modules: administrative, summaries, quality, non-clinical and clinical.

The module that takes the time is quality: active-substance specification, manufacturing process, analytical method validation, and stability data — results from storing the product under controlled conditions at set intervals, which is what justifies the stated shelf life.

This is where timelines break. Stability data cannot be accelerated. If a supplier does not have it, the time to generate it is added to the whole path, and no amount of commercial pressure changes that.

Typical: 6 to 16 weeks where the data already exists. Where it does not, add the study period on top.

Ask for the stability protocol early. A supplier who can send it the same week is a supplier who has done this before.

Stage 3 — Translation and legalisation

The dossier has to be in your market's language, and part of it needs an official chain of authentication: chamber of commerce, foreign ministry, and in many countries your own embassy. That chain is called legalisation.

Nothing here is technical, which is exactly why it is underestimated. In practice this is the stage with the most rework: one missing stamp means the document goes back and the chain restarts.

Typical: 3 to 8 weeks, and it should run in parallel with Stage 2. A supplier running it sequentially has quietly added a month to your timeline.

Stage 4 — The local licence holder

Most countries do not let a foreign manufacturer hold a registration directly. A local entity has to own it: an appointed agent, a distributor, or the manufacturer's own registered company.

If that entity is going to be you, understand what you are taking on. In many systems the marketing authorisation is issued in the holder's name, and transferring it later is a partial restart. Settle in writing, before signing anything: whose name the authorisation carries, and what happens to it if the relationship ends.

Typical: 4 to 12 weeks to appoint and contract. Registering a standalone entity takes longer.

Stage 5 — Regulatory review

The file goes in, and from this point nobody on either side controls the clock. What remains controllable is response time.

There is almost always at least one round of questions — a deficiency letter. A supplier who answers within a week and one who answers within a month multiply that difference across the whole project.

Typical: 4 to 12 months, varying sharply by country and classification. It is the longest stage and the one with the least to say about it.

Stage 6 — Authorisation and first shipment

The authorisation is issued. The first shipment still has work in it: the CPP — Certificate of Pharmaceutical Product, issued by the country of origin to confirm the product is authorised there — plus the batch certificate of analysis, an import permit, and in some markets re-testing of samples on arrival.

Typical: 3 to 10 weeks from authorisation to the first cleared consignment.

What this adds up to

With the parallelisable stages actually run in parallel, and complete stability data in hand, a realistic range from start to first shipment is 9 to 20 months. A shorter figure usually means one of the stages above is missing from the plan rather than from the work.

Three things stretch it, and all three are visible before you commit:

1. Incomplete stability data. Ask for the protocol and the current time points first, not last.
2. No local licence holder settled until Stage 5. The file cannot be submitted without one.
3. Legalisation started after the dossier is finished instead of alongside it.

Next step

If you are assessing a specific supplier or product, the assessment form asks the twelve questions that determine which of these six stages is your constraint. It takes about three minutes, and you get a written answer within two working days that names the bottleneck and the first thing to do about it.