BIOLOGICAL PRODUCTS REGISTRATION IN UAE
Each biological and combination products (therapeutical as well as diagnostic products that combine devices, drugs, and/or biological products) are intensely regulated by the United Arab Emirates Ministry of Health (MOH). Registration of a drug should be done by the MOH before you are importing the same inside the United Arab Emirates market (Pharmaceuticals Law 1983).
Biologics Establishment Registration
Each operator or owners of establishments that manufacture blood products must register with the Food and Drug Administration, according to section 510 of the Federal Food, Drug, as well as Cosmetic Act, except they are exempt under 21 CFR 607.65.
Biological products are a different class of products as well as are commonly huge, tough molecules. These products may be produced by biotechnology in a living system, such as an animal cell, plant cell or microorganism, and are frequently much difficult to characterize than tiny molecule drugs.
If you are an importer, manufacturer, or initial distributor of medical devices, you need to register your settlement with the Food and Drug Administration. Log on to FURLS (Food and Drug Administration Unified Registration and Listing System) to register and also list your information. An operator or owner should have an account ID and the password to access FURLS.
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