Morocco: AMMPS Publishes New Guideline on Donations of Medicines and Medical Devices
Publication date: 12 January 2026
The Moroccan Agency for Medicines and Health Products (AMMPS) has officially published a new Guideline on Donations of Medicines and Medical Devices, reinforcing Morocco’s regulatory framework governing humanitarian and development-related donations in the health sector.
This guideline, published under reference AMMPS-LD EA-005 (Version 1.0), is available on the official AMMPS website and aligns with World Health Organization (WHO) recommendations and Moroccan pharmaceutical legislation.
Strengthening the Regulatory Framework for Health Donations in Morocco
Donations of medicines and medical devices play a key role in international and national health solidarity, particularly in situations of public health emergencies, natural disasters, or development aid initiatives.
The AMMPS guideline aims to ensure that all donated products meet quality, safety, relevance, and transparency requirements, while preventing risks related to inappropriate donations, waste, or non-compliant products.
Objectives and Scope of the AMMPS Guideline
The guideline establishes a structured regulatory framework designed to:
Define the regulatory, technical, and administrative requirements for accepting donated medicines in Morocco;
Guarantee the quality, safety, and effectiveness of donated products;
Enhance traceability, transparency, and accountability throughout the donation lifecycle;
Prevent waste, excessive storage, or costly destruction of non-compliant products.
Scope of application:
Donations of human medicinal products imported from abroad;
Donations conducted at national level in exceptional circumstances, such as natural disasters.
Key Stakeholders and Responsibilities
The guideline clearly defines the roles of all parties involved in donation operations, including:
Donors: governmental institutions, NGOs, pharmaceutical companies, international organizations, or individuals;
Beneficiaries: public hospitals, university hospitals, state healthcare institutions, local authorities, the Moroccan Red Crescent, or public-interest health associations;
Supervising Pharmacist: responsible for reception, quality control, storage, and traceability of donated products;
AMMPS: responsible for dossier evaluation, authorization, regulatory control, and inspections.
Core Regulatory Principles Governing Donations
All donations must:
Be based on a clearly identified medical need, aligned with Morocco’s epidemiological profile;
Comply with national health policies and administrative procedures;
Originate from reliable and compliant sources, meeting both donor-country and Moroccan quality standards;
Obtain prior authorization from the AMMPS before importation.
Authorization Process and Compliance Requirements
In accordance with Article 23 of Law 17-04 (Medicines and Pharmacy Code), donations are subject to a prior declaration and authorization process, including:
Submission of the donation request at least 30 days before shipment;
Manufacturing in compliance with Good Manufacturing Practices (GMP);
Proof of commercialization in the country of origin;
A minimum remaining shelf life of 12 months at the time of importation;
Proper labeling (INN, strength, pharmaceutical form, batch number, expiry date);
Compliance of medical devices with Law 84-12.
The AMMPS issues a written authorization or a justified refusal within 30 days, and donated products must be delivered within 30 days following authorization.
Special Cases, Traceability, and Enforcement
Specific regulatory procedures apply to:
Narcotic and psychotropic substances;
Medical devices;
Donations made during health emergencies.
All donated medicines must remain fully traceable up to final distribution, and periodic utilization reports may be requested by the AMMPS. Non-compliance may result in rejection, destruction at the responsible party’s expense, or regulatory sanctions.
Regulatory Impact and Public Health Protection
Through this publication, the AMMPS strengthens a clear, harmonized, and internationally aligned regulatory framework, enhancing Morocco’s national regulatory system and contributing to the long-term protection of public health.
Conclusion and Regulatory Support Services
The publication of this new AMMPS Guideline on Donations of Medicines and Medical Devices marks a significant step toward strengthening regulatory governance in Morocco. By aligning national requirements with WHO recommendations and international best practices, the AMMPS provides stakeholders with a clear and structured framework to ensure that donation activities effectively contribute to public health protection while minimizing regulatory and operational risks.
For international donors, NGOs, pharmaceutical companies, and healthcare institutions, compliance with these requirements is essential to avoid delays, refusals, or costly non-compliance situations.
Our Regulatory Services
Simon MedTech Solutions supports organizations involved in the donation of medicines and medical devices to Morocco by providing:
Regulatory analysis of donation projects and eligibility assessment
Preparation and review of AMMPS donation dossiers
Verification of GMP, labeling, shelf-life, and traceability compliance
Liaison with Moroccan regulatory authorities
Support for exceptional cases (medical devices, controlled substances, emergency donations)
Our approach is pragmatic, compliant, and aligned with both Moroccan regulations and international standards.
Contact us to assess your donation project and ensure a smooth, compliant authorization process with the AMMPS.
