INOPP Forum
Pharmacovigilance Requirements in Morocco
Quote from VigiServe Admin on November 28, 2020, 7:58 AMIn Morocco, the pharmacovigilance system is transitioning under the new Agence Marocaine des Médicaments et des Produits de Santé (AMMPS) (formerly DMP), working in coordination with the Centre Anti Poison et de Pharmacovigilance du Maroc (CAPM). The framework is moderately developed, aligning with WHO standards and the Arab GVP guidelines.
1. Clinical Safety (Clinical Trials)
Clinical trials are regulated by AMMPS and require ethics and regulatory approval (Law 28-13).
Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs). Timelines align with ICH E2A and Arab GVP:
Fatal or Life-Threatening: Within 7 calendar days.
Other Serious Unexpected: Within 15 calendar days.
Periodic Reporting: Development Safety Update Reports (DSURs) or annual updates are typically required.
Submission: Reports go directly to AMMPS/CAPM via forms or email.
2. Post-Marketing Pharmacovigilance
Personnel & Infrastructure:
Local QPPV: Required in practice. Marketing Authorization Holders (MAHs) are expected to appoint a qualified person (physician/pharmacist) resident in Morocco or a local contact.
PSMF: There is no explicit requirement to register a PV System Master File, but system documentation must be available for inspections ("Docs Locally").
Incident Reporting (ICSRs):
Timelines:
Serious: Within 15 calendar days.
Non-Serious: Within 90 calendar days.
Risk & Periodic Reporting:
PSURs: Not rigidly standardized for all products; typically submitted during registration renewals, variations, or upon request.
RMPs: Mandatory for new active substances, biologics, or high-risk products (aligned with Arab GVP Module V).
Summary of Requirements
Component Requirement in Morocco Regulatory Authority AMMPS / CAPM Framework Law 17-04 / Arab GVP Local QPPV / PSMF Yes / Docs Locally Safety Reporting 15 days (Serious) / 90 days (Non-Serious) Clinical Reporting SUSARs (7/15 days) Submission Language French
In Morocco, the pharmacovigilance system is transitioning under the new Agence Marocaine des Médicaments et des Produits de Santé (AMMPS) (formerly DMP), working in coordination with the Centre Anti Poison et de Pharmacovigilance du Maroc (CAPM). The framework is moderately developed, aligning with WHO standards and the Arab GVP guidelines.
1. Clinical Safety (Clinical Trials)
Clinical trials are regulated by AMMPS and require ethics and regulatory approval (Law 28-13).
-
Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs). Timelines align with ICH E2A and Arab GVP:
-
Fatal or Life-Threatening: Within 7 calendar days.
-
Other Serious Unexpected: Within 15 calendar days.
-
-
Periodic Reporting: Development Safety Update Reports (DSURs) or annual updates are typically required.
-
Submission: Reports go directly to AMMPS/CAPM via forms or email.
2. Post-Marketing Pharmacovigilance
-
Personnel & Infrastructure:
-
Local QPPV: Required in practice. Marketing Authorization Holders (MAHs) are expected to appoint a qualified person (physician/pharmacist) resident in Morocco or a local contact.
-
PSMF: There is no explicit requirement to register a PV System Master File, but system documentation must be available for inspections ("Docs Locally").
-
-
Incident Reporting (ICSRs):
-
Timelines:
-
Serious: Within 15 calendar days.
-
Non-Serious: Within 90 calendar days.
-
-
-
Risk & Periodic Reporting:
-
PSURs: Not rigidly standardized for all products; typically submitted during registration renewals, variations, or upon request.
-
RMPs: Mandatory for new active substances, biologics, or high-risk products (aligned with Arab GVP Module V).
-
Summary of Requirements
| Component | Requirement in Morocco |
| Regulatory Authority | AMMPS / CAPM |
| Framework | Law 17-04 / Arab GVP |
| Local QPPV / PSMF | Yes / Docs Locally |
| Safety Reporting | 15 days (Serious) / 90 days (Non-Serious) |
| Clinical Reporting | SUSARs (7/15 days) |
| Submission Language | French |
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