Corridor · Sourcing Intelligence
Akunudo screens manufacturers of Rosuvastatin 10mg for Tunisia registration before you ever see them — certification, stability zone for the climate, and dossier format clear first; commercial fit second. Identities stay sealed until NDA, so you can source without tipping your hand.
No manufacturer in the corridor matches this exact spec for Tunisia right now.
Submit a mandate and we'll match it the moment a qualified manufacturer enters the corridor — and alert you.
Not a directory to wade through — a brokered, anonymized corridor. We only fully win when your deal closes.
Market access · Tunisia
A state-centric system: a foreign manufacturer registers via a local representative, and the Agence Nationale du Médicament et des Produits de Santé (ANMPS, now operational) grants a five-year AMM. Decisively, the Pharmacie Centrale de Tunisie (PCT) holds a legal monopoly on importing medicines — the single import gateway. Prices are regulated (homologation), built cost-plus on a PCT/wholesale/pharmacy margin grid and benchmarked against a reference basket; CNAM reimburses listed drugs on tiered rates. The system is mid-reform: a 27 Jan 2026 order opened a reliance/recognition route and eCTD becomes mandatory across mid-2026.
The ANMPS (created by Law 2023-2 and now operational) is exclusively charged with granting the AMM under the order published in JORT no. 11 of 27 January 2026; the Minister of Health retains only exceptional powers (health emergencies, or medicines materially affecting the CNAM budget). The technical committee advises and the national control lab handles quality.
CTD (accepted in French or English); electronic submission becomes mandatory in 2026 — per the ANMPS roadmap, e-submission from 1 May 2026 and exclusively eCTD from 1 June 2026. Confirm the channels on the ANMPS portal.
Yes — a foreign manufacturer must act through a Tunisian local representative/authorised importer who files the AMM; and, decisively, the PCT holds a State monopoly on importing medicines, so physical importation runs through the PCT regardless.
Newly yes — an order (arrêté) in JORT no. 11 of 27 Jan 2026 authorises the agency to rely on evaluation reports from recognised authorities and adds priority/exceptional routes; however EMA, US-FDA and WHO-PQ are not named in the text and the implementing criteria are still pending publication on the ANMPS portal. A WHO-model CPP and country-of-origin authorisation are required. Confirm which authorities qualify.
GMP compliance is mandatory and a valid GMP certificate plus CPP must be supplied; whether the authority conducts its own foreign-site inspection versus relying on the certificate appears discretionary — confirm with the authority.
Orientation intelligence compiled from public regulator and analyst sources as of the dates shown — not legal or regulatory advice. Rules change; confirm specifics (fees, timelines, baskets, eligibility) with the authority before acting. (Authority: ANMPS — Agence Nationale du Médicament et des Produits de Santé (operational; exclusively grants the AMM since the order in JORT no. 11 of 27 Jan 2026); imports via the Pharmacie Centrale de Tunisie (PCT); as of 2026-06.)