Guidance Notes on Change of Registered Particulars

DEPARTMENT OF HEALTHDRUG OFFICEDRUG REGISTRATION AND IMPORT/EXPORT CONTROL DIVISION<strong>Guidance</strong> <strong>Notes</strong> on Change of Registered Particularsof a Registered Pharmaceutical ProductRegistered particulars of a registered pharmaceutical product1. Under the Pharmacy and Poisons Regulations, when a pharmaceutical product isregistered, certain particulars are included in the registration. These particulars are:(a) the name of the pharmaceutical product;(b) the specifications of the pharmaceutical product;(c) the label of the pharmaceutical product;(d) the package insert of the pharmaceutical product, if any;(e) the name and address of the manufacturer;(f) the name and address of the registration certificate holder;(g) the dose form;(h) the quantity or quantities of the dose form contained in its unit package or unitpackages;(i) the name and quantity of all its active ingredients;(j) the name and quantity of all its excipients; and(k) its proposed indication, dosage and route of administration.Change of a registered particular2. A pharmaceutical product is registered if and only if none of the above registeredparticulars has been changed without approval. If any one of the above particularshas been changed without approval, the product will not be regarded as registeredunder the Pharmacy and Poisons Ordinance.3. Applications for change of any one of the registered particulars, except the itemsunderlined in paragraph 1 above (i.e. the name of the product, the dose form, or theactive ingredients), are made following these <strong>Guidance</strong> <strong>Notes</strong> and using the attachedapplication form.4. However, the items underlined in paragraph 1 above (i.e. the name of the product, thedose form, or the active ingredients) cannot be changed. Such change will result in theproduct being considered as a new one, and a new application for registration is required.Please see “<strong>Guidance</strong> <strong>Notes</strong> on Registration of Pharmaceutical Products/Substances”.September 2011

How to apply for a change?5. Applications for change of a registered particular should be made using the attachedapplication form and submitting the completed form to:Drug Registration and Import/Export Control DivisionDrug OfficeDepartment of Health3/F, Public Health Laboratory Centre,382 Nam Cheong Street,Shek Kip Mei, Kowloon,Hong Kong. (Enquiries: 2319 8458)6. The completed application form should be submitted along with the supportingdocuments, as indicated in the table on the next page. Please indicate theimplementation date (day/month/year) for the proposed change of registeredparticular(s) in the application form. Any application without supportingdocument(s) or with document(s) which are obscure or not clearly underlined orhighlighted to indicate the particular change(s) will not be accepted.Approval7. If the application is approved, the applicant will be informed of it in writing and of theeffective date of the change.8. Prior to the effective date, the applicant should recall all products with the oldparticulars. As explained in paragraph 2 above, these products will no longer beregarded as registered after the effective date.Fee9. In general, no fees are charged. However, if it is a change of name or address of theregistration certificate holder, a signature fee (currently $155 per certificate) will becharged for the amendment of such details on the registration certificate.September 2011

Supporting documents required for application for change of registered particulars:The particular to be changedDocuments required(a) Name of product None: a new application for registration isrequired(b) Specifications 1. A clean copy of the proposed newspecifications2. Proposed new specifications with change(s)underlined or highlighted3. Master formula (if changed, please refer to (i)and (j) below)4. Stability data*, if shelf-life or storagecondition changed(c) Label1. Printed new label, or prototype label readyfor printing2. Proposed label with change(s) underlined orhighlightedNote: for addition of new presentation(s): for anyone registered pack size, new application(s) forregistration is required.(d) Package insert1. A clean copy of the proposed new packageinsert2. Proposed package insert with the words to bechanged underlined and highlighted3. Approval from health authorities (for changeof indication, dosage and route ofadministration)(e) Name and address of the 1. Certified true copy of the manufacturer’smanufacturerGood Manufacturing Practices (GMP)Certificate2. Original or certified true copy of free salecertificate of the product issued by country oforigin, (for change of country of origin only)3. Printed new label, or prototype label readyfor printing4. Proposed label with change(s) underlined orhighlighted5. Letter issued by the current manufacturer toacknowledge the change to the newmanufacturer6. Updated master formula issued by the newmanufacturer7. Updated specifications issued by the newmanufacturerNote: for addition of new source(s): newapplication(s) for registration is required.September 2011

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

Real Time Testing Condition(i) 30C2C/75%5% RH(ii) 30C2C/65%5% RH(iii) 25C2C/60%5% RHAccelerated Testing Condition(iv) 40C2C/75%5% RH for 6 months **** At least 3 months’ real-time stability test protocol must be made available at the time ofsubmission for application made on or after 1 April 2011.Other temperature/relative humidity conditions could be adopted where justified.Appropriate labeling of storage conditions in English & Chinese shall be provided on thesales pack.September 2011