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Guidance Notes on Change of
Registered Particulars
of Registered Pharmaceutical
Products/Substances
Version Feb 2023
Pharmacy and Poisons Board of Hong Kong
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Guidance Notes on Change of Registered Particulars of Registered Pharmaceutical Products/Substances Page 1
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Contents
1. Registered particulars of a registered pharmaceutical product/substance................... 3
2. Change of registered particulars .................................................................................... 3
3. How to apply for change of registered particulars ........................................................ 4
4. General requirements .................................................................................................... 4
5. Implementation of the approved change(s) .................................................................. 6
6. Fees ................................................................................................................................ 6
7. Required supporting documents ................................................................................... 6
8. Disclaimer..................................................................................................................... 12
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Guidance Notes on Change of Registered Particulars of Registered Pharmaceutical Products/Substances Page 2
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1. Registered particulars of a registered pharmaceutical product/substance
1.1 According to the Pharmacy and Poisons Regulations (Cap. 138A), the following
particulars of a registered pharmaceutical product/substance are also registered with the
Pharmacy and Poisons Board:
1.1.1 the name of the pharmaceutical product/substance;
1.1.2 the specifications of the pharmaceutical product/substance;
1.1.3 the label of the pharmaceutical product/substance;
1.1.4 the package insert of the pharmaceutical product/substance, if any;
1.1.5 the name and address of the manufacturer;
1.1.6 the name and address of the registration certificate holder;
1.1.7 the dose form of the pharmaceutical product;
1.1.8 the quantity or quantities of the dose form contained in the unit package or
unit packages of the pharmaceutical product;
1.1.9 the name and quantity of all active ingredients of the pharmaceutical product;
1.1.10 the name and quantity of all excipients of the pharmaceutical product; and
1.1.11 the proposed indication, dosage and route of administration of the
pharmaceutical product
2. Change of registered particulars
2.1 A pharmaceutical product/substance is registered if and only if the above registrable
particulars are those which correspond exactly with the registered particulars of the product
or substance. If any of the above particulars has been changed without approval, the
pharmaceutical product/substance will not be regarded as registered under the Pharmacy
and Poisons Regulations.
2.2 Applications for change of any registered particulars must be made following these
Guidance Notes. Please note that the registered particulars underlined in paragraph 1.1
cannot be changed, which include the name of the pharmaceutical product/substance; the
dose form of the pharmaceutical product and the name and quantity of all active ingredients
of the pharmaceutical product. Such change(s) would render the pharmaceutical
product/substance considered as unregistered, and the applicant may apply for registration
as a new pharmaceutical product/substance accordingly. For details, please refer to the <
Guidance Notes on Registration of Pharmaceutical Products/Substances >.
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Guidance Notes on Change of Registered Particulars of Registered Pharmaceutical Products/Substances Page 3
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3. How to apply for change of registered particulars
3.1 The Drug Office of the Department of Health provides executive and professional
support to the Pharmacy and Poisons Board. The registration certificate holder should submit
online application for change of registered particulars (CORP) to the Drug Office via the
Pharmaceutical Registration System 2.0 (PRS 2.0) at
https://www.drugoffice.gov.hk/prs2-ext/client_authentication.jsp
3.2 During the application process, applicants would need to upload the supporting
document(s) as specified in Table 1. The uploaded documents should be in text searchable
Portable Document Format (PDF) file whenever practicable.
3.3 The original or certified true copies of certain supporting documents, for example, the
manufacturer’s Good Manufacturing Practice (GMP) certificate, Free Sale Certificate (FSC) or
Certificate of a Pharmaceutical Product (CPP), should also be submitted with a covering letter
stating the application reference number (i.e. CORP- HKXXXXX-XXXXXXXXX) to the following
address:
Drug Registration Unit
Drug Evaluation and Import/Export Control Division
Drug Office, Department of Health
Suites 2002-05, 20/F, AIA Kowloon Tower, Landmark East
100 How Ming Street, Kwun Tong, Kowloon,
Hong Kong
(Enquiries: 3974 4175)
4. General requirements
4.1 In each CORP application, applicant should provide a letter summarising all the
proposed changes and listing out the submitted documents. Please also specify in the PRS
2.0 if the application involves a pharmaceutical product/substance supplied to the
Department of Health with contract or under direct purchase agreement.
4.2 Please make sure that all the required documents set out in Table 1 have been provided.
Please keep your submission in a precise and concise way and avoid redundant documents.
Applications with inaccurate data entry, or those with the submitted documents fail to meet
the requirements will be not be accepted and the applicant will be required to follow up, such
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as making amendments, justifications or clarifications on the application or the submitted
documents.
4.3 For change(s) to the product label, package insert, product specification or master
formula, please submit a copy in track change mode based on the approved version, as well
as a clean copy of the document.
4.4 Supporting documents to substantiate the proposed change(s) may include reputable
reference, pharmacopoeia monograph, evidence of approval of the proposed change(s) by
drug regulatory authorities, stability test data, analytical report, risk assessment report,
bioequivalence data, comparability assessment, etc. Applicants should highlight relevant
sections of the supporting documents for easy reference.
4.5 Apart from the required documents set out in Table 1, further information or
documentary evidence may be required on a case-by-case basis in order to assure the safety,
efficacy and quality of the pharmaceutical product/substance with the proposed change(s).
4.6 Multiple submissions for change of the same change category/registered particular
within a certain timeframe* is NOT recommended. It will only be considered on a case-by-
case basis. Applicant should revise the existing application to incorporate latest change, or
to apply for subsequent change after the existing application has been approved and
implemented. Should two applications be unavoidable, applicant is required to provide
justification.
(* There is a submitted application (a) still under evaluation or (b) approved but not yet
implemented)
4.7 If the application is approved, applicant will be informed of the details of approval and
the effective date in writing.
4.8 In general, prior to the effective date of the proposed CORP, the applicant should recall
all pharmaceutical products/substances with the old particulars from the market. As stated
in paragraph 2.1, these pharmaceutical products/substances will no longer be regarded as
registered pharmaceutical products when the new registered particular(s) is in effect.
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5. Implementation of the approved change(s)
5.1 If the registration certificate holder needs to change the effective date of the approved
CORP, application for change of implementation date (CIMP) should be submitted at least 5
working days before the approved change(s) comes into effect. Unless otherwise justified,
postponement of implementation date should not be more than 1 year.
5.2 Registration certificate holder should set the proposed effective date or apply for CIMP
based on accurate stock level estimation and logistic arrangement, which could help to
minimise the number of CIMP applications.
5.3 With effect from 1 December 2021, the default effective date of CORP applications will
be 1 year from the date of approval.
5.4 For CORP applications submitted on or after 1 December 2021, applicants can only
select the effective date as 1 week or 1 year from the date of approval.
5.5 Unless otherwise justified, for CORP approved on or after 1 December 2021, the
applicant can apply for CIMP no more than twice, and the CORP shall be implemented within
2 years after approval.
6. Fees
6.1 For the change of the name or address of registration certificate holder, a signature
fee of $155 will be charged for each registration certificate.
7. Required supporting documents
Table 1: Required supporting documents for each category of the proposed change(s)
Proposed Change(s) Supporting Document(s)
1. Specifications
1.1 Change in specification(s) i. Proposed specifications a
ii Other supporting documents, if applicable d
1.2 Change in shelf-life or i. Stability test data b
container closure system ii. Proposed specifications, if applicable a, c
1.3 Change in storage iii. Proposed label and package insert, if
condition applicable c
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Proposed Change(s) Supporting Document(s)
iv. Other supporting documents, if applicable d
2. Label e
2.1 Change in label i. Proposed label
ii. Other supporting documents, if applicable d
3. Package Insert e
3.1 Change in package insert i. Proposed package insert
3.2 Addition of package insert ii. Other supporting documents, if applicable f
4. Manufacturer g
4.1 Change in name and / or i. Soft copy and the original/certified true copy
address of the current of the manufacturer’s PIC/S GMP certificate
manufacturer ii. Proposed label and package insert, if
applicable c
(This category is for iii. Updated master formula and specification
administrative change only issued by the manufacturer with the new
which there should be no name and/or address (depending on the role
change in the physical of the manufacturer)
location of the iv. Declaration letter and/or updated
manufacturing site) manufacturing flow chart indicating the a)
manufacturing process , b) name, address and
role of the manufacturer(s) involved and c)
proposed updates h
v. Other supporting documents, if applicable d, h
4.2 Change to new i. Letter issued by the current manufacturer to
manufacturer acknowledge the change to the new
manufacturer
ii. Soft copy and original/certified true copy of
the manufacturer’s PIC/S GMP certificate
iii. Soft copy and original/certified true copy of
FSC/CPP of the pharmaceutical
product/substance issued by the drug
regulatory authority of the country of origin,
unless otherwise justified (if change of place
of origin appeared on the label is involved)
iv. Proposed label and package insert, if
applicable c
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Proposed Change(s) Supporting Document(s)
v. Updated master formula and specifications
issued by the new manufacturer (depending
on the role of the new manufacturer)
vi. Declaration letter and/or updated
manufacturing flow chart indicating the a)
manufacturing process , b) name, address and
role of the manufacturer(s) involved and c)
proposed updates h
vii. Other Supporting documents, if applicable d, h
5. Registration Certificate Holder
5.1 Change in name and/or i. Soft copy of the updated business registration
address of the current certificate
registration certificate ii. Soft copy of the Certification of Incorporation
holder on the change of name (for incorporated
companies only)
(This category is for iii. Original Certificate(s) of Drug/ Product
administrative change Registration of all the registered
under the same business pharmaceutical product(s)/substance(s)
registration certificate involved
number)
5.2 Change to new registration i. Soft copy of valid business registration
certificate holder certificate of the new registration certificate
holder
ii. Original letter from the current registration
certificate holder agreeing to transfer the
named registered pharmaceutical
products/substances to the new registration
certificate holder (please specify the 12 digits
business registration certificate number in the
letter)
iii. Original letter from the new registration
certificate holder agreeing to accept the
named registered pharmaceutical
products/substances
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Proposed Change(s) Supporting Document(s)
iv. Original letter from the manufacturer/overseas
marketing authorization holder in record listing
the registered pharmaceutical
product(s)/substance(s) to be transferred, (i)
confirming the change of registration
certificate holder and (ii) authorising the new
certificate holder to handle all the post-
marketing activities in Hong Kong for the
named product(s)/substance(s).
v. Original Certificate(s) of Drug/Product
Registration of all registered pharmaceutical
product(s)/substance(s) involved
6. Quantity of the Dose Form in the Unit Package(s) (i.e. Package Size)
6.1 Change in package size i. Proposed label, if applicable
(including the deletion of ii. Proposed package insert, if applicable c
registered package size) iii. Stability test data, if applicable b
6.2 Addition of package size i iv. Proposed specifications, if applicable a, c
v. Other supporting documents, if applicable d
7. Excipients
7.1 Change in name and / or i. Proposed master formula a
quantity of excipients ii. Stability test data b
iii. Proposed specifications, if applicable a, c
iv. Other supporting documents, if applicable d
8. Indication / Dosage / Route of Administration
8.1 Change in indication i. Proposed label and package insert, if
8.2 Change in dosage applicable c
8.3 Change in route of ii. Other supporting documents f, j
administration
* For change(s) to the product label, package insert, product specification or master formula,
please submit a copy in track change mode based on the approved version, as well as a clean
copy of the document.
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Explanatory notes:
a. The release specification and shelf-life specification (if applicable) of the finished product
issued by the manufacturer. Please also refer to the <General Requirements for Master
Formula and Specifications for Non-Biological Products >.
b. Completed real time stability data at one of the following real time testing conditions, or
on-going real time stability data together with at least 6 months’ accelerated stability data is
required to establish the product’s proposed shelf-life and packaging material.
Real Time Testing Condition
Temperature (°C) Relative humidity (RH)
30°C+/-2°C & 75%+/-5% RH
30°C+/-2°C & 65%+/-5% RH
25°C+/-2°C & 60%+/-5% RH
Accelerated Testing Condition
40°C+/-2°C & 75%+/-5% RH
o Other temperature/relative humidity conditions could be adopted if justified.
o In-use stability data should also be provided if applicable.
o Appropriate labelling of the storage conditions in English and/or Chinese shall be
provided on the sales pack.
c. Please also apply for the corresponding category(ies) of change.
d. Supporting documents for the proposed changes may include:
(i) Method of analysis;
(ii) Document(s) which complies with the following pharmacopoeias or ICH / WHO
guidelines unless otherwise justified: Pharmacopoeia of the People’s Republic of
China, British Pharmacopoeia, European Pharmacopoeia, International
Pharmacopoeia, Japanese Pharmacopoeia and/or United States Pharmacopoeia;
(iii) Reputable references;
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(iv) Documentary evidence of approval of the proposed change(s) by drug
regulatory authorities;
(v) Analytical report;
(vi) Risk assessment report;
(vii) Bioequivalence (BE) study data for specific drug(s), unless otherwise justified1;
and/or
(viii) Comparability assessment of biological products before and after changes,
unless otherwise justified.
e. Please refer to the < Guidelines on the Labelling of Pharmaceutical Products >.
f. Please refer to paragraph 6.2.16 of the <Guidance Notes on Registration of
Pharmaceutical Products/Substances > for the requirements of supporting documents for
change in package insert.
g. Points to note for change to a new manufacturer:
(i) Please refer to the definition of “Manufacturer” under the Pharmacy and Poisons
Ordinance, Cap. 138.
(ii) Please refer to paragraph 6.2.5 and 6.2.6 of the <Guidance Notes on
Registration of Pharmaceutical Products/Substances > for the requirement of the
manufacturer.
(iii) There shall only be one labelled manufacturer under the same product
registration.
h. Please refer to the requirements set out in <Supplementary Notes for Application for
Registration of Biological Products Involving Alternative / Back Up Manufacturer(s) for
Manufacturing Steps > if applicable.
i. Application for new product registration is required for the addition of new presentation(s)
of a pack size that has already been registered.
j. For any proposed change(s) in indication/dosage/route of administration which has not
been previously registered in Hong Kong, please refer to the <Guidance Notes on Registration
1
Please refer to paragraph 6.2.17 of the <Guidance Notes on Registration of Pharmaceutical
Products/Substances> for the requirement of BE data.
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of Pharmaceutical Products Containing a New Chemical or Biological Entity> for details. For
such applications, applicants are required to further provide:
(i) Clinical data in CTD format;
(ii) Evidence of approval in at least 2 reference countries 2;
(iii) Tabular listing of the worldwide approval status of the proposed change(s); and
(iv) Comparison table to compare (a) the registered, (b) the proposed, and (c) the
approved indication/dosage/route of administration in the reference countries, with
the difference highlighted or specified.
8. Disclaimer
8.1 These Guidance Notes serve as a general guide to the applicant for change of registered
particulars of registered pharmaceutical products/substances and shall not be regarded as
the complete registration requirements or authoritative statement of the relevant laws or its
interpretation on any particular case. Copies of the Pharmacy and Poisons Ordinance and its
subsidiary legislations shall be referred, which can be purchased by calling the Publications
Sales Section of Information Services Department at 2537 1910, or by email at
puborder@isd.gov.hk. Contents of the relevant legislation can also be found at the
Department of Justice’s website at https://www.elegislation.gov.hk/.
8.2 These Guidance Notes list out the documents which are generally required to
demonstrate the quality, efficacy and safety of the products. The Pharmacy and Poisons Board
reserves the right to revise these Guidance Notes at any time without giving prior notice.
Users are responsible for making their own assessment of these Guidance Notes.
2
Reference countries refer to:
Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Holland, Hungary, Ireland, Italy, Japan, Republic of Korea, Latvia, Lithuania,
Luxembourg, Malta, Poland, Portugal, Romania, Singapore, Slovak Republic, Slovenia, Spain, Sweden,
Switzerland, UK and USA
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