An authorisation is not a document you file away. It is a calendar — renewal windows, retention fees, vigilance clocks measured in hours, and requirements that change underneath a product already on sale. In most of these markets the way companies lose a registration is not misconduct or failure. It is a date.
Nobody loses a registration because the product turned out to be unsafe. They lose it because a retention fee was not paid in June, because a renewal was filed at ninety days when the regulation says one hundred and eighty, or because the person who held the licence left the company and nobody told the regulator.
South Africa is blunt about the consequence: a licence allowed to lapse is not renewed — you apply for a new one, at the new-application fee, from the back of the queue, with your product off the market in the meantime. That is the whole risk of this service in a sentence, and it is why the work is a calendar rather than a skill.
Section 15(6) of the South African Medicines Act has said for years that a registration is valid for five years. It was not systematically enforced. As of a stakeholder communication dated 21 August 2025, it is — and SAHPRA is working through the entire register on a ten-year rolling call-up, scheduling product-specific roadmaps quarterly by applicant through to 2035.
Which means an obligation that nobody in your company has ever had to meet is now scheduled, and the schedule is not yours.
Pick a market and a product type. The red panel is the consequence, because that is the part that decides how much this service is worth to you.
These are the deadlines nobody diaries, because they only start when something has already gone wrong. They are also the shortest deadlines in market access by an order of magnitude.
Bars are proportional to the deadline, which is why the first three are barely visible — that is the point. The detail that turns this into a contract question: Nigeria's post-market surveillance guideline puts duties on manufacturers, marketing authorisation holders, importers and distributors. Your Nigerian partner carries a clock you are accountable for, and whether they will meet it is decided in an agreement, not in a guideline.
Calendar days, from NAFDAC's post-market surveillance and reporting guideline for devices and IVDs effective 19 August 2025, and from SFDA's post-market surveillance requirements. Egypt: we could not find a device-specific post-market surveillance or adverse-event guideline on EDA's medical device page, and the 2026 good pharmacovigilance practice decree appears to concern medicines — we report that as not found rather than as absent.
A registration granted under one rulebook can be renewed under another. These are the changes we are currently tracking for clients, each with the document that created it.
Phased in: required with renewals since 1 June 2025, with SAHPRA aiming to have verified every licence-holder's certificate by 1 April 2028. Two consequences, and the second is not obvious — the certificate has to come from a conformity assessment body SAHPRA itself recognises. We could not read the current roster of recognised bodies; the page would not render. Whether any UK body is on it is unverified, and worth establishing before you assume your existing certificate transfers.
A full study report became a prerequisite for new registration of an imported generic from January 2026, and bioequivalence is being pushed into renewals as well. A product that has sat on the Nigerian market for fifteen years on a bibliographic file can now meet a study wall at renewal. NAFDAC's guideline of 5 May 2025 is aligned to ICH M13 and does not require the study to be run in Nigeria — we read that as foreign data being acceptable, but NAFDAC has not said so in terms, so we mark it an inference from two documents rather than a quoted rule.
EDA's UDI guideline version 2/2026 was issued and became applicable in 05/2026, alongside Chairman Decree 161 of 2025 of 27 February 2025 on unified coding and traceability. For comparison: there is no UDI requirement at all in Nigeria or South Africa — Nigeria's gazetted regulation asks only for batch, lot and serial numbers and a barcode.
TİTCK abolished the desktop assessment route. Its foreign GMP guidance gives a certificate twelve years of validity for a site in a PIC/S country against nine otherwise, and three risk-based renewals against two. Which means your inspection calendar — and the fee attached to it — is set by where your factory is, not by what you make.
Not a renewal, but the most consequential recurring event for a medicine. The only lawful price increase is the Minister's annual percentage — 1.47% for 2026 — and the update guideline of 24 October 2023 provides no out-of-cycle increase route at all. A price cut takes effect in two working days. Five years of this compounds into a number worth modelling before you launch, not after.
A maintenance engagement is a calendar we own and a person who answers when a regulator writes. It is annual, it is quoted per market and per portfolio size, and it does not roll over automatically.
Where a regulation and a guidance disagree, we work to the stricter one. South Africa's General Regulations require a renewal application at least 180 days before expiry; SAHPRA's own guidance says 90. We file to 180 and treat 90 as the administrative floor, because the cost of being wrong in that direction is a lapsed licence rather than a late one.
First we establish what the register actually says, which is not always what your file says. Whether there is a route back depends entirely on the market: Egypt grants a product holding preliminary approval to proceed with re-registration a grace period of up to four years from expiry; South Africa does not renew a lapsed licence at all.
Us, in daysAn unresponsive representative is a live regulatory exposure, not only a commercial annoyance — they hold duties the authority expects someone to discharge. We establish what is outstanding, what the authority has sent, and whether the appointment can be moved. See local representation.
Us, with youUsually one of the five above. The question is whether it bites at your next renewal or immediately, and what the cheapest compliant route is. Occasionally the honest answer is that the product should be withdrawn from that market, and we will say so.
UsLegally, whoever holds the authorisation. Practically, whoever remembers. If your distributor holds it, they also hold the decision about whether it survives — which is the argument made in full on the representation page.
Yes, and most of what we maintain we did not file. We start by reconciling the register against your records, which takes days and occasionally produces a surprise.
Quoted annually, on portfolio size and number of markets rather than on a percentage of anything. Official and retention fees are passed through at cost with receipts.
No, deliberately. Each year is quoted and agreed before it starts. A service whose whole value is watching deadlines should not rely on you forgetting one.
We run the clocks and the correspondence. We do not act as your qualified person or your pharmacovigilance system — in several of these markets that role is licensed to a named individual with prescribed qualifications, and it is not ours to hold.
You hear from us when it affects your products, with the instrument that created it and the date it bites. We do not send a monthly bulletin of everything that moved in six countries.
The first piece of work is a reconciliation: what is registered, to whom, until when, and what is outstanding. It is quick, it is quoted separately, and quite often it is the whole engagement.
Mutual NDA before you send anything. If you are not sure what you hold, that is a normal starting point and the reconciliation exists for exactly that.
Most of what ends a registration is scheduled, published and avoidable. Someone has to be watching the calendar, and it does not have to be you.
What we could not confirm. We could not find a device-specific post-market surveillance or adverse-event guideline on EDA's medical device page, and the 2026 good pharmacovigilance practice decree appears to concern medicines — we report that as not found rather than as no obligation existing, since the transfer documents require an incoming applicant to commit to the device vigilance system, so one exists. We could not read SAHPRA's current roster of recognised conformity assessment bodies, so whether any UK body is on it is unverified. SAHPRA's variations addendum was blocked on every attempt.
Each calendar sits in fuller context on the market page it comes from: all twelve are here.