Registration

Registration of Medicines

The Scentryphar can provide guidance for companies operating in the medical drugs area. It contains directions on how to submit applications for registering drugs, modifications, exemptions and renewals. It also provides information about the documentation required and instructions on how to complete the application forms.
Procedures Manual for Registration of New Medicines

Documents required for registration of a new product

This is applicable to those products falling within the following categories:

1. A product resulting from:
a) An alteration in the concentration of active substance or of its pharmacokinetic properties
b) an active substance not registered for the purpose for which it was intended
c) withdrawal of the active component of a product already registered
d) substitution of the active component of a product already registered.

2. A product resulting from new molecular entities

3. A new salt, despite the corresponding molecular body having already been authorized.

4. Two or more active unregistered substances , combined in the same product.

List of documents required for registration and  further information - contact us.