The Marketing Authorization (AMM — Autorisation de Mise sur le Marché) is the essential prerequisite for commercializing any medicine in Morocco. Granted by the AMMPS (Moroccan Agency for Medicines and Health Products), it is obtained after submitting a complete technical dossier through the Tarkhiss platform. This guide walks you through the entire process, from dossier preparation to obtaining your Moroccan MA.
Since 2024, all Marketing Authorization applications in Morocco must be submitted electronically via the Tarkhiss platform. The dossier must follow the CTD (Common Technical Document) format, Modules 1 to 5, in accordance with guideline AMMPS-LD EA-018.
What is a Marketing Authorization (MA) in Morocco?
The Marketing Authorization (AMM) is an administrative and scientific approval granted by AMMPS, allowing a holder to commercialize a medicine on the Moroccan territory. No medicine — whether chemical, biological, biotechnological, or generic in origin — may be placed on the market without a valid Moroccan MA.
The MA covers a specific medicine, for a defined therapeutic indication, a specific pharmaceutical form and dosage. It is granted in the name of a holder (pharmaceutical company or approved importer) and must be renewed every five years.
Who Can Submit an MA Application in Morocco?
An MA application may be filed by:
- Moroccan pharmaceutical companies approved by the Ministry of Health.
- Medicine importers holding a valid import authorization.
- Foreign companies represented by a locally approved Moroccan agent.
In all cases, the applicant must have an active account on the Tarkhiss platform (AMMPS's official portal for electronic submissions) and must have paid the corresponding registration fees.
Types of MA Procedures in Morocco
1. Standard National Procedure
This is the classic route for medicines without a prior MA in a reference country. The complete dossier (CTD Modules 1 to 5) is evaluated by AMMPS's scientific teams. This procedure applies to generics, locally manufactured medicines, and new chemical entities intended primarily for the Moroccan market.
2. Regulatory Recognition Procedure (Simplified Route)
Introduced by LD EA-018, this route applies to medicines already approved by an AMMPS-recognized reference authority: EMA (European Union), FDA (United States), Health Canada, TGA (Australia), or MHRA (United Kingdom). It enables accelerated evaluation by leveraging the assessment report from the country of origin (Module 1, section 1.9). Timelines are significantly shorter than the standard national procedure.
3. Five-Year Renewal Procedure
Every Moroccan MA must be renewed every five years. The renewal dossier must include a complete PSUR/PBRER and, according to the 2019 Decree, an updated bioequivalence study for immediate-release oral forms.
The regulatory recognition procedure can reduce evaluation timelines from 12–24 months to 6–12 months depending on the dossier profile. This is the preferred route if your product holds a current EMA or FDA MA.
Required Documents: The 5 CTD Modules
The Moroccan MA dossier is structured according to the CTD (Common Technical Document) format, organized into five complementary modules:
Module 1 — Morocco-Specific Administrative Information
- 1.1: MA application form (Annex 1, new AMMPS model) listing all manufacturing, testing, packaging, and release sites.
- 1.2: SmPC, patient leaflet, and labeling mockups (bilingual Arabic/French, mandatory AMMPS templates).
- 1.3: Expert information (declaration of the technical signatory).
- 1.4: Administrative documents: CPP, MA from the country of origin, GMP certificate, proof of registration fee payment.
- 1.7 (new): Information on contaminant substances — nitrosamines (ICH M7), elemental impurities (ICH Q3D), residual solvents (ICH Q3C).
- 1.8: Pharmacovigilance — Pharmacovigilance Plan, Risk Management Plan (RMP), PSUR/PBRER.
- 1.9 (new): Assessment report from the authority of the country of origin (EPAR, Summary Basis of Approval…).
- 1.10 (new): Data protection for safety and efficacy data.
Module 2 — Summaries and Tabulated Data (QOS)
Overall quality summary (OQS/RGQ), non-clinical and clinical overviews. The OQS must mirror Module 3 exactly. Structured from 2.1 to 2.7, with subsections 2.3.S (active substance) and 2.3.P (finished product) explicitly numbered.
Module 3 — Pharmaceutical Quality
Complete information on the active substance (3.2.S) and finished product (3.2.P): pharmaceutical development, manufacturing process, controls, stability. Section 3.2.R (new) is reserved for Morocco-specific regional information. CEPs (Certificates of Suitability to the European Pharmacopoeia) are accepted if valid.
Module 4 — Non-Clinical Data
Pharmacological, toxicological, and pharmacokinetic studies. Annexes A/B/C now incorporate ICH tabulated data models (new since LD EA-018).
Module 5 — Clinical Data
Clinical study reports, bioequivalence studies, post-marketing data. Section 5.3.6 "Post-Marketing Experience" is now formalized and mandatory for products with significant market experience.
The Tarkhiss Platform: Mandatory Electronic Submission
Since 2024, Tarkhiss is AMMPS's official portal for all regulatory submissions in Morocco. This platform manages:
- Electronic submission of MA dossiers (new applications, renewals, variations).
- Real-time tracking of your dossier status.
- Official communication between the applicant and AMMPS (supplementary information requests, decision notifications).
- Online payment of registration fees.
The dossier submitted on Tarkhiss must be organized as compressed PDF files (as per Annex 6 of LD EA-018), split into distinct parts: MA Commission, Quality Control, Pharmacovigilance, and Bioequivalence.
Create your Tarkhiss account in advance and verify that your local agent has the necessary access rights. An incomplete dossier at the time of electronic submission may result in immediate rejection by the system, with no possibility of online correction.
AMMPS Timelines: What to Expect
| Procedure Type | Indicative Timeline |
|---|---|
| Standard national procedure (new medicine) | 18 to 36 months |
| National procedure (generic) | 12 to 24 months |
| Regulatory recognition (EMA/FDA) | 6 to 12 months |
| Five-year renewal | 6 to 18 months |
| Type I variation (minor) | 2 to 6 months |
| Type II variation (major) | 6 to 18 months |
These timelines are indicative. They may be extended if supplementary information requests ("AMMPS questions") are issued. Each such request suspends the official clock, which restarts from zero upon the applicant's response.
Pre-Submission Checklist for Tarkhiss
- Annex 1 application form (new LD EA-018 model) completed with all manufacturing, testing, packaging, and release sites.
- Valid GMP certificate for each manufacturing site.
- CPP (Certificate of Pharmaceutical Product) issued by the country of origin.
- Valid MA from the country of origin (for imported products).
- Proof of registration fee payment to AMMPS.
- SmPC compliant with AMMPS template (Annex 3), bilingual Arabic/French.
- Patient leaflet compliant with AMMPS template (Annex 4), bilingual.
- Labeling mockups compliant with AMMPS template (Annex 5).
- Section 1.7 (contaminant substances — nitrosamines, elemental impurities) completed.
- Risk Management Plan (RMP) if required by AMMPS.
- PSUR/PBRER for biological products or those subject to enhanced pharmacovigilance.
- Assessment report from the country of origin (section 1.9) for the regulatory recognition route.
- Dossier organized as compressed PDFs per Annex 6 of LD EA-018.
Practical Tips to Maximize Your Approval Chances
1. Anticipate AMMPS Questions
Review your Moroccan MA dossier with the eyes of an evaluator. The most common sources of questions are: finished product specifications (Module 3), justification of impurity limits, and consistency between the SmPC and the clinical data in Module 5.
2. Pay Close Attention to Module 1
Module 1 is country-specific. An error in the application form, an expired CPP, or a labeling mockup that does not comply with the AMMPS template is a frequent cause of rejection or supplementary information requests. Check each administrative document individually.
3. Leverage the Regulatory Recognition Route
If your product holds an EMA or FDA MA, do not wait until you are in the standard national procedure to raise this argument. Include the EPAR (or equivalent) assessment report in section 1.9 from the outset and explicitly state the recognition route in your application form.
4. Prepare Your Moroccan Pharmacovigilance Plan
AMMPS requires a Pharmacovigilance Plan adapted to the Moroccan context, even if a European RMP already exists. Verify that your local pharmacovigilance contact (CLPV) is properly designated and that their contact details are up to date in the dossier.
REQMA's AMM Builder module automatically generates the CTD file tree compliant with LD EA-018, applies the official templates (SmPC, patient leaflet, labeling) and checks your dossier for completeness before submission on Tarkhiss. Fewer omissions, fewer supplementary requests, controlled timelines.
This article is provided for informational purposes and summarizes the regulatory requirements applicable to MA dossiers in Morocco in 2025-2026. It does not replace reading the official AMMPS texts or consulting a qualified regulatory affairs expert. Always verify the latest version of applicable guidelines with the competent authority.