HERBAL PRODUCT REGISTRATION
Natural products are tiny molecules that are produced naturally by any creature including primary and secondary metabolites. They include ting molecules, for example, urea, and complex structures, for example, Taxol. As they may just be isolable in little amounts, have interesting biological activity as well as chemical structures, natural product synthesis represents an interesting challenge in organic chemistry.
The broadest meaning of natural product is anything which is produced by life, and including the likes of the biotic materials (e.g. silk, wood), bio-based materials (e.g. corn-starch, bioplastics), bodily fluids (for example milk, plant exudates), and other natural materials (for example soil, coal).
Natural products are those chemical substances or compounds which are isolated from the living organism. It may be in the form of primary or secondary metabolites. Plant optional metabolites are organic phytochemicals or compounds which are not directly involved in normal development, growth, or reproduction of the plan.
The compounds are characterized into four different groups as indicated by their biosynthetic origin: alkaloids, polyketides, phenylpropanoids, and terpenoids. Since over 200,000 structures of normal products from plants are known, just chose compounds and groups are present.
- A copy of the certificate of registration of the manufacturer in the Ministry of Health UAE.
- An Application Form for registering a Herbal product.
It must be filled-in through a company except for Agent’s information that is filled-in through the Agent in the UAE.
- A Free Sale Certificate (FSC) or Certificate of Pharmaceutical Product (CPP).
It must be issued by the competent authority stamped and signed by the authorized person as well as attested from the UAE Embassy and in the country of origin. It must contain:
- Name and address of the manufacturer.
- Product trade name
- Product license/registration number and date in the country of origin.
- A statement confirming that the product is produced under GMP conditions.
- Composition (active and inactive ingredients with their quantities (not in the percentage) per unit dose).
- Shelf life and storage conditions.
- A statement that the product is freely sold in the country of origin.
**If the above information is not included in the Certificate of Pharmaceutical Product, a separate document that must be legalized by the competent authority is required.
4. Leaflet (Package insert)
It must be given by the competent authority stamped and signed by the authorized person and it should contain:
- Product trade name, form, and pack size.
- Manufacturer name and address.
- Full composition.
- Dosage, route, and instruction of administration.
- Adverse effects.
- Interactions and contraindications.
- Special precautions or warnings.
- Storage conditions.
- Date of last revision of the leaflet.
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