PharmaActdDossiers service can assist with project management and registration of such products and have valuable experience in this area. We can work with you to guide you through the necessary requirements under the Directive that you will have to comply with. We can either prepare for you or help you to prepare a submission for a traditional herbal medicinal product, including vital pre-submission discussions with the Health Authorities.
Our services include the following:
- Preparation and review of Traditional Herbal Registration Dossiers
- Preparation of Patient information leaflet (PIL), writing, proof reading, and user testing: for compliance with labelling laws.
- Registration of traditional herbal medicines
- Product Rationale on scientific basis
- Import/Export registration
