Regulatory Services in Morocco
Morocco
The MoH (Ministry of Health), the Government of Morocco, and the ANAM (National Health Insurance Agency) are the prime regulatory organizations accountable for Morocco’s general healthcare admission and rules. The MoH is responsible for designing and executing government guidelines on public health. The Department of Pharmacy of MoH licenses the transaction of new medications in the country based on safety and effectiveness data. Any medication, created locally or imported, even at the example level, must acquire authorization from the Department of Pharmacy, MoH, before deal or allocation (even complimentary). Moreover, this authorization is essential before any medication can be considered for repayment. The MoH declares that a license can only be allocated if the medication meets exact requirements for proper testing to emphasize effectiveness, guarantee its safeness under standard prerequisites, confirm its medicinal value, and demonstrate bioequivalence for a generic drug.
As a leading global contender, DDReg’s Regulatory Services in Morocco provides on-going support and development of customized strategies during all regulatory phases while keeping track of the most recent regulatory requirements to ensure high quality and timely submissions. We deliver reliable safety measures, ensure risk mitigation, and collaborate with experts to facilitate effortless delivery of product launches, regulatory filing and market authorizations.
DDReg Services include:
- Regulatory Strategies and Expert Views
- Regulatory Due Diligence
- Gap Analysis and Remediation
- New Product Authorizations
- Post Approval Life Cycle Management
- CMC Advisory
- API/DMF
- ICSR Processing and Submission
- Risk Management
- Aggregate Reports
- Signal Management
- QPPV Services
- Bio Waiver Justifications
- Clinical & Non-Clinical Expert Reports
- IPR Support including Worldwide Patent Status and Patent Reviews