DEPARTMENT OF HEALTH
PHARMACEUTICAL SERVICE
PHARMACEUTICALS REGISTRATION
SECTION
Guidance
Notes on Change of Registered Particulars
of a Registered Pharmaceutical Product
1. Under
the Pharmacy and Poisons Regulations, when a pharmaceutical product is
registered, 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 unit
packages;
(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 particular
2. A
pharmaceutical product is registered if and only if none of the above
registered particulars has changed without approval. If any one of the above particulars has
changed without approval, the product will have been changed. It will not be regarded under the
Pharmacy and Poisons Ordinance as registered.
3. Applications
for change of any one of the registered particulars, except the items underlined
in paragraph 1 above (i.e. the name of the product, the dose form, or the
active ingredients), are made following these Guidance Notes and using the
attached application form.
4.
However,
the items underlined in paragraph 1 above (i.e. the name of the product,
the dose form, or the active ingredients) cannot be changed. Such change will result in the product
being considered as a new one, and application for its re-registration is required.
Please see “A Guide to the Re-registration of Pharmaceutical Products”.
How to apply for a change?
5. Applications
for change of a registered particular should be made using the attached
application form and submitting the completed form to:
Pharmaceuticals
Registration Section
3/F, Public
Health Laboratory Centre,
Shek Kip
Mei, Kowloon,
Hong Kong. (Enquiries:
2319 8458)
6. The
completed application form should be submitted along with the supporting
documents, as indicated in the table on the next page.
7. If the
application is approved, the applicant will be informed of it in writing and of
the effective date of the change.
8. Prior
to the effective date, the applicant should recall all products with the old
particulars. As explained in
paragraph 2 above, these products will no longer be regarded as registered
after the effective date.
9. In
general, no fees are charged.
However, if it is a change of name or address of the registration
certificate holder and the holder wishes to amend such details on the
registration certificate, a signature fee (currently $155 per certificate) will
be charged.
Supporting documents required for application
for change of registered particulars:
|
The particular to be changed |
Documents required
|
|
(a) Name of product |
None: a new application for
registration is required |
|
(b) Specifications |
1. Proposed
new specifications 2. Master
formula, if changed 3. Stability
data, if shelf-life or storage condition changed |
|
(c) Label |
1. Printed new
label, or prototype label ready for printing |
|
(d) Package insert |
1. Proposed package
insert with the words to be changed underlined and highlighted 2. A clean
copy of the proposed new package insert 3. Approval
from health authorities (for change of indication or dosage only) |
|
(e) Name
and address of the manufacturer |
1. Certified
true copy of the manufacturer’s Good Manufacturing Practices (GMP)
Certificate 2. Original or
certified true copy of free sale certificate of the product issued by country
of origin, (for change of country of origin only) 3. Printed new
label, or prototype label ready for printing showing the change Note: for addition of new
source(s): new application(s) for registration is required. |
|
(f) Name
and address of the registration certificate holder |
In the case of a change in the certificate holder: 1. Letter from
the existing certificate holder agreeing to transfer the named registered
products to the new certificate holder 2. Letter from
the new holder agreeing to accept the named registered products 3. Letter from
the overseas manufacturer confirming the transfer and naming the products to
be transferred 4. Original
registration certificates 5. Copy of
Business Registration Certificate of the new certificate holder In the case of a change in the name and/or
address of the existing holder only: 1. Copy of
amended Business Registration Certificate 2. Copy of
Certification of Incorporation on Change of Name 3. Original
registration certificates (if amendment of these is desired) |
Supporting documents required for application
for change of registered particulars (cont’d):
|
Registered particular |
Documents
required
|
|
(g) Dose form |
None: a new application for
registration is required |
|
(h) Quantity
or quantities of the dose form contained in its unit package or unit packages |
1. Printed new
label, or prototype label ready for printing 2. Up-to-date
specifications (if changed) 3. Stability
test data *(real-time or accelerated conditions) |
|
(i) Name
and quantity of active ingredients |
None: a new application for registration is
required |
|
(j) Name
and quantity of excipients |
1. New master
formula from the manufacturer 2. New
specifications 3. Stability
test data *(real-time or accelerated conditions) |
|
(k) Indication,
dosage and route of administration |
1. New package
insert or label showing the change (see (d) or (c) above) 2. Clinical
data to support the change 3. Official
evidence of approval of the change by health authorities |
*For products due for renewal on or after 1
January 2006, and products the application for registration of which was
submitted after 1 January 2001. If accelerated
data is provided, the expiry date of the product will be limited to 2 years,
but real-time data is still required when the product is due for renewal. The following Temperature/Relative
Humidity conditions may be used:
|
|
Real
Time Testing Condition |
|
(i) |
|
|
(ii) |
|
|
(iii) |
(with appropriate labelling of storage
condition in Chinese & English) |
|
|
Accelerated Testing Condition |
|
(iv) |
|
(Other temperature/relative humidity conditions
could be adopted where justified)
|
|