In five of these six markets you are not allowed to hold your own authorisation. Somebody local holds it for you — and which entity that is, how many of them there must be, and whether it can ever be moved are three different answers in every market. Getting this shape right is cheap. Undoing it is not.
It is usually said with relief. Somebody else did the paperwork, it cost nothing, the product is on sale. What has actually happened is that the permission to sell your product in that country now belongs to the company you sell it through — and in most of these markets you cannot simply take it back.
That is not a cautionary tale. It is a set of published rules, and they differ market by market in ways that are not intuitive. Saudi Arabia will not let two representatives hold the same device group, so replacing yours is a regulatory act rather than a commercial one. The Emirates go the other way and require at least two importers by statute, which means an exclusive Emirati distribution agreement is in tension with the law that governs it. South Africa issues the licence to a natural person who can resign. Nigeria permits transfer and publishes no way to do it.
Choosing the holder at the start costs a conversation. Changing it later costs a negotiation — with the party who has the least reason to help you, at the moment your relationship with them has already broken down.
This page sets out what each regulator actually permits, so that the conversation happens before the signature rather than after.
Four questions asked of every market for each product type. The fourth is the one nobody asks until it is too late.
Read the bottom row across all twelve. Two of these cells say yes with a published procedure. Three say yes with no published procedure at all, which in practice means at the regulator's discretion and your outgoing partner's goodwill. The rest are unresolved or route-dependent. Nowhere in these six markets is moving an authorisation a form you fill in.
Ranked by how much of the structure you are permitted to own yourself. The bar is our reading of the published rules, not a regulator's score — it is a way of seeing the shape, and every row is sourced below.
The colour is a single-hue ramp and carries no meaning beyond position on this list; every row is labelled directly because that is the only honest way to use a sequential palette.
These are the provisions that decide who owns the permission, and they are rarely in the clause headed "Regulatory". We read the draft you were sent; this is what we look for.
Sometimes framed as a convenience and sometimes as a legal necessity. It is a necessity in some of these markets and a choice in others, and the difference is the whole of this page. Where it is genuinely required, the answer is not to accept it — it is to separate the entity that holds the licence from the entity that sells.
The most common defect, and the most expensive. If the agreement says nothing, the default is whatever the regulator's rules say, and in Nigeria those rules permit a transfer while publishing no procedure for making one. An agreement that ends without a written, costed handover of the authorisation ends with your market access in someone else's cabinet.
The governing decree-law requires the holder of the marketing right to appoint at least two licensed importers for the same product, and all appointed establishments are required actually to import during the calendar year. A single-importer exclusivity clause is in tension with the statute it operates under, and EDE announced in February 2026 that it was activating the mechanism.
In Nigeria the practical route to changing agent, as described by local counsel rather than by NAFDAC, begins with revoking the previous power of attorney. An instrument drafted to be hard to revoke is drafted to make that route hard. We do not let a client sign a five-year power of attorney on a distributor's template.
Legal nearly everywhere and unwise nearly everywhere. It means the entity that sells your product also controls the appointment that permits it to be sold. In Saudi Arabia, where SFDA requires confirmation that no other representative holds the same device group, replacing that company becomes a regulatory exercise conducted at the worst possible moment.
The 2016 regulations define the Authorised Representative as a natural person resident in South Africa, and SAHPRA's guidance says the licence is issued in that individual's name. A clause that does not name them, and does not say what happens when they leave, leaves your licence attached to a person you have never met.
Official fees are published in every one of these markets. A partner recovering them from you should be able to show what was paid and to whom. Where we run the project, they are invoiced at cost with the receipt.
Every question the regulator asked and every answer given is the institutional memory of your authorisation. If you do not hold it, the next adviser rebuilds it from nothing, and you pay for that twice.
We are not your lawyers and this is not legal advice. It is a regulatory reading of what the published rules make possible, and it belongs next to your solicitor's review rather than instead of it. Where a clause matters enough, we say so in writing and you take it to counsel.
Our default in Saudi Arabia, the UAE, Egypt and Nigeria. Adds a small annual cost and removes the largest structural risk on this page.
Highest control, highest fixed cost, and a tax and corporate question as much as a regulatory one. Worth modelling before you assume it is out of reach.
We will do it if you instruct us to, and we will put the consequences in writing first. It is occasionally the right answer — for a small market, a short term, or a partner you already own part of.
Why we do not hold authorisations ourselves. It would be a better business for us and a worse deal for you: it makes leaving us a regulatory exercise, which is the exact failure this page is about. We take no commission from a representative we appoint, and no share of your sales.
This is a third of the enquiries we get, and the honest first answer is that it depends on a rule you can read in an afternoon — which is why we start by reading it rather than by quoting.
Not what you were told. The certificate, the applicant of record, the expiry, and whether the regulator's published register agrees with your file. In more than one of these markets that check has produced a surprise.
Us, in days not weeksEgypt publishes a procedure. Nigeria permits transfer and publishes none. South Africa publishes a route for a pending application and we could not locate one for a granted certificate — we report that as procedure-not-located, not as impossible. The answer changes what is worth attempting.
Us, in writingWhere transfer needs the outgoing partner's cooperation and they will not give it, the alternative is a fresh registration in your own name — full fee, full clock, from a weaker negotiating position. Sometimes that is still the cheaper answer. You should see both numbers.
Us, with youMost of these end in a negotiated handover, because the distributor usually wants something too. A few end in a refiling. We have not yet seen one end well where nobody checked until the relationship had already failed.
SharedUsually not. In several of these markets it genuinely must sit with a local licensed entity. The question they are not answering is whether that entity has to be them — and in every market on this page, it does not.
No, by choice. We appoint and manage one; we do not hold your licence. Holding it would make leaving us a regulatory exercise, and that is the problem this service exists to prevent.
It varies by market and by how many products sit under the appointment; the licence and annual charges are published and we pass them through at cost. It is a small annual line against the cost of a re-registration, which is the thing it is insuring against.
Two, necessarily. Saudi Arabia wants a single representative with exclusivity confirmed to the regulator; the Emirates require at least two importers by statute. One distributor agreement cannot satisfy both, and a template written for one will breach the other.
For a Turkish medicine, yes or an appointed Turkish holder — article 6(1) admits nothing else. Elsewhere it is a cost-and-control decision rather than a legal one, and we model it rather than assume it.
That is the best possible time, and it is the cheapest version of this work. Structure first, dossier second. The reverse order is what fills our inbox.
If a draft distribution agreement is in front of you, send it and we will tell you which of the clauses above are in it and what they do in that specific market. If nothing is signed yet, better still.
Mutual NDA signed before you send anything, and we do not approach any party named in your documents without your written instruction.
If you cannot answer that in one sentence for every market you sell in, that is the work. It usually takes days rather than weeks, and it is the cheapest thing on this site to get right.
What we could not confirm, and are not going to assert. A Nigerian law firm describes the practical route to a change of agent — writing to NAFDAC to revoke the previous power of attorney and introduce the new one, on notarised instruments — and cites no NAFDAC authority for it; we report that as unpublished practice. The same source states that a foreign manufacturer's registration certificate is issued in the local agent's name. We could not confirm that from any NAFDAC document and we do not assert it, while noting that if it is right it matters more than anything else on this page. In South Africa we could not locate a published procedure for transferring a granted certificate of registration for a medicine; the variations addendum is the likely home and we could not retrieve it. Treat that as procedure-not-located rather than transfer-impossible.
Each rule sits in fuller context on the market page it comes from: all twelve are here.