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LIST OF DOCUMENTS REQUIRED FOR REGISTRATION OF A NEW PRODUCT

1. Copy of the Marketing Authorisation in the country of origin mentioning the unit formula and the shelf life, it must be the latest one and must have been issued within the 5 recent years.

2. Pharmaceutical documentation + expert report (signature + CV)

3. clinical, toxicological and pharmaceutical studies for innovative product and bibliography studies and publications for generics

4. A legalized price certificate mentioning the public/ hospital price, wholesale price, the selling price and the importer margin. (a model can be sent upon request).

5. A benchmark of the wholesale price, the selling price and the hospital price (if it's applicable) in the following countries (Spain, France, Portugal, Belgium, Greece, Turkey, Saudi Arabia). (a model can be sent upon request)

6. Information mentioning the weigh in g of the product as it will be marketed (including the packaging and the leaflet) this will help to work out the price, the nature immediate packaging to be marketed in Morocco.

7. A SPC (Summary of Product Characteristic) translated in French would be helpful

8. A summary of clinical, toxicological and pharmaceutical studies

9. List of countries where the product is registered or marketed

10. Fiche signalétique (SPC in French) + Note de Synthèse in French (could be prepared by Sothema for no-speaking-French partner )

11. 6 samples of the marketed product.

12. mock-up or Draft of the packaging and the leaflet (to be marketed in Morocco)

13. In a further step, samples for analysis will be requested by MOH by writing.