PLANT PROTECTION PRODUCTS REGULATION SERVICES IN MOROCCO
The National Food Safety Office (ONSSA) is the authoritative body responsible for pesticide regulation in accordance with Law No. 42-95. This authority is responsible for the import, manufacture, storage, and marketing of pesticides.
Application Types:
The application types include, but are not limited to, the following types.
· Approval of active substance and product
· Renewal application for active and product
· Modification and withdrawal of active substance approval
· Renewal application
· Marketing authorization
· Modification and withdrawal of PPP authorization
Key Services:
Strategic Advice and Guidance: Auxilife offers strategic advice and guidance for your specific product in Morocco. This includes developing a clear regulatory strategy on the appropriate registration category and ensuring all requirements for registration with ONSSA are met. Our guidance is aligned with Moroccan regulations, which are progressively harmonizing with EU and OECD standards.
Advice on Data Requirements and Data Gap Analysis: Our experts help you navigate the variable data requirements for different application types with ONSSA. We will assist in a data gap analysis to identify missing studies or information that you may need to generate for a successful registration, taking into account the specific guidelines and referencing documents.
Data Generation Management and Study Monitoring: Auxilife can manage the process of generating the necessary data by working with laboratories that are either accredited by ONSSA or comply with internationally recognized standards like GLP (Good Laboratory Practice). We monitor these studies to ensure they meet the specific requirements for efficacy and safety.
Placing Efficacy and Residue Trials: ONSSA requires that field trials be conducted in Morocco to prove a product's efficacy and determine residue levels under local conditions. We assist applicants in finding and working with ONSSA-accredited laboratories for these required efficacy and residue trials.
Dossier Preparation, Submission, and Post-Submission: We provide comprehensive assistance for the preparation and submission of your dossier to ONSSA. This includes ensuring all required documents are translated into French and are correctly compiled according to the official format. We also provide full support for managing the dossier after submission.
Follow-up on the Dossier under Evaluation: We provide continuous follow-up on your dossier's evaluation status with ONSSA. This is particularly important given that the registration process can involve provisional registration followed by a period of local trials, and we will help respond to any deficiencies or questions that arise during this multi-stage review.