AMMPS: what Morocco's medicines agency expects of packaging
In Morocco, medicines have a new regulator: an agency has taken over from the former ministry directorate. For a laboratory, the practical question stays the same. What must the authorisation dossier say about its bottle?
By Tecmom editorial team · 2 min read
An agency created by Law 10-22
The AMMPS, the Moroccan Agency for Medicines and Health Products (Agence marocaine du médicament et des produits de santé), was created by Law No. 10-22. The business press presented it as a break with the former Directorate of Medicines and Pharmacy (DMP), and the Ministry of Health as a tool of medicine sovereignty.
Its remit is gradually widening. Since 16 June 2025, according to Médias24, it has taken over pharmaceutical authorisation duties previously held by the General Secretariat of the Government. In June 2026, Parliament adopted Law No. 27-26, which amends the medicines code and strengthens its authorisation, control and inspection duties.
Packaging has its place in the dossier
Decree No. 2-14-841 on marketing authorisation, in force since 20 February 2016, introduced the CTD (Common Technical Document) format in Morocco. This format, defined by the ICH, places quality data in Module 3.
Packaging appears there twice. Section 3.2.P.7 describes the container closure system: the materials of the primary packaging, the packaging that touches the medicine, and their specifications. Section 3.2.P.8 presents the stability studies, carried out in the packaging intended for sale.
What is expected of plastic packaging
For a plastic bottle or cap, the European guideline on plastic immediate packaging materials details what a dossier documents: the material's composition, its compliance with pharmacopoeia monographs and, depending on the risk, extractables and leachables.
Much of this data comes from the packaging manufacturer: material data sheets, declarations, certificates of analysis.
Changing the bottle means changing the dossier
Because the packaging is written into the dossier, changing it means varying the authorisation. As early as 2017, manufacturers complained about having to go before the committee for a simple change of presentation. See change control.
For the laboratory, the consequence is simple: a primary packaging supplier is chosen for the long term, and it must be able to document its material, its controls and its changes. That is the purpose of ISO 15378, which applies good manufacturing practice to packaging materials.
The agency changes, the principle remains: in Morocco as elsewhere, a medicine's bottle is not chosen after the authorisation. It is part of it.
Glossary
- AMMPS
- Moroccan Agency for Medicines and Health Products, created by Law No. 10-22.
- Marketing authorisation
- The permission to place a medicine on the market.
- CTD
- Common Technical Document: the international format of the authorisation dossier, defined by the ICH.
- Primary packaging
- Packaging in direct contact with the medicine.