Corridor · Sourcing Intelligence
Akunudo screens manufacturers of Tecar Therapy Machine for Morocco 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.
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EU-GMP listed
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Not a directory to wade through — a brokered, anonymized corridor. We only fully win when your deal closes.
Market access · Morocco
Market access is gated by a national Marketing Authorisation (AMM), now granted by the Agence Marocaine du Médicament et des Produits de Santé (AMMPS, Law 10-22), which became operational in mid-2025 and replaced the former DMP. A foreign manufacturer cannot register or import directly — it works through an approved local establishment with a responsible pharmacist, filing a CTD dossier in French. Public price is set administratively under Décret 2-13-852 via external reference pricing (lowest of a six-country basket) with regulated margins; reimbursement runs through AMO on ANAM's national reference tariff. Reform is live: a draft Law 27.26 (conditional marketing authorisation; WHO Maturity Level 3) is in passage, and the CNOPS public-sector fund is being merged into CNSS.
The Agence Marocaine du Médicament et des Produits de Santé (AMMPS, Law 10-22), which became operational in mid-2025 (it assumed establishment-licensing and AMM powers from 16 June 2025) and replaced the former DMP, grants the Autorisation de Mise sur le Marché (AMM) after technical/scientific evaluation of a dossier filed by an approved pharmaceutical establishment.
CTD structure, submitted in French; eCTD is the international direction — confirm current acceptance with AMMPS.
Yes — a foreign manufacturer cannot hold the AMM or import directly; it must work through an approved Moroccan pharmaceutical establishment with a responsible pharmacist who signs the application.
Not yet a formal one — FDA/EMA approval can support an application but is not automatically recognised. A draft Law 27.26 (in passage in 2026) would target WHO Maturity Level 3 and introduce a conditional marketing authorisation for serious/unmet-need conditions; confirm the in-force position with AMMPS.
Yes — GMP compliance is mandatory, a GMP certificate is required, and the authority may inspect manufacturing sites (including foreign sites) during the AMM review.
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: AMMPS — Agence Marocaine du Médicament et des Produits de Santé (operational since mid-2025; replaced the DMP); as of 2026-06.)