Guidance Notes on Change of Registered Particulars

Supporting documents required for application for change of registered particulars(cont’d):Registered particularDocuments required(f) Name and address of the In the case of a change in the certificateregistration certificate holder holder:1. Letter from the existing certificate holderagreeing to transfer the named registeredproducts to the new certificate holder2. Letter from the new holder agreeing toaccept the named registered products3. Letter from the overseas manufacturerconfirming the transfer and naming theproducts to be transferred4. Original registration certificates5. Copy of Business Registration Certificateof the new certificate holderIn the case of a change in the name and/oraddress of the existing holder only:1. Copy of amended Business RegistrationCertificate2. Copy of Certification of Incorporation onChange of Name3. Original registration certificates of ALLregistered products(g) Dose formNone: a new application for registration isrequired(h) Quantity or quantities of the dose 1. Printed new label, or prototype label readyform contained in its unit for printingpackage or unit packages 2. Proposed label with change(s) underlinedor highlighted4. New specifications (if changed, pleaserefer to (b) above)6. Stability test data*(i) Name and quantity of active None: a new application for registration isingredientsrequired(j) Name and quantity of excipients 1. New master formula from themanufacturer2. New master formula with change(s)underlined or highlighted3. New specifications (please refer to (b)above)4. Stability test data*(k) Indication, dosage and route ofadministration1. New package insert or label showing thechange (please refer to (c) and/or (d)above)2. Clinical data to support the change3. Official evidence of approval of thechange by health authorities* Stability test data of the product at one of the following Temperature (C)/RelativeHumidity (RH) conditions:September 2011