PHARMACY AND POISONS REGULATIONS

Hong Kong Regulations

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PHARMACY AND POISONS REGULATIONS - SCHEDULE 8

FORM 1

[regulation 26(4)]

PHARMACY AND POISONS ORDINANCE

(Chapter 138)

WHOLESALE POISONS LICENCE

.................................................................. of ....................................................................... is hereby licensed to deal in wholesale poisons at ............................................................................................................................. until the ............................................................. day of ............................................................................................ 19........., inclusive, subject to the conditions endorsed hereon.

Dated this ........................ day of ........................................................ 19...........

.......................................................
for Pharmacy and Poisons Board.

CONDITIONS

(L.N. 85 of 1987; L.N. 63 of 1997)

FORM 2

[regulation 28(4)]

PHARMACY AND POISONS ORDINANCE

(Chapter 138)

FORM OF RECORDS OF TRANSACTIONS INVOLVING POISONS IN PART I OF
THE POISONS LIST TO BE KEPT BY WHOLESALE DEALERS

Name of Poisons				Unit of Quantity
Date	Nature of transaction	Supplier or to whom supplied	Invoice No.		Quantity	Balance after transaction

(L.N. 63 of 1997)

FORM 3

[regulation 29(5)]

PHARMACY AND POISONS ORDINANCE

(Chapter 138)

CERTIFICATE FOR MANUFACTURER

It is hereby certified that ..........................................................................................
.......................................................................................................................................
(Name of the pharmaceutical firm)

(1) is authorized to manufacture and market drugs and pharmaceutical products;

(2) is subject to regular inspections which have shown that it follows the requirements of good practices in manufacture and quality control of drugs and pharmaceutical products as recommended by the World Health Organization, and is included in the list established for that purpose.

HONG KONG

................................................. (Date)

.......................................................
for Pharmacy and Poisons Board.
(L.N. 63 of 1997)

FORM 4

[regulation 29(5)]

PHARMACY AND POISONS ORDINANCE

(Chapter 138)

INTERIM CERTIFICATE FOR MANUFACTURER

It is hereby certified that .........................................................................................
.......................................................................................................................................
(Name and address of manufacturer)

(1) is authorized to manufacture and market drugs and pharmaceutical products;

(2) is subject to regular inspections in respect of the manufacture of drugs and pharmaceutical products in accordance with the requirements recommended by the World Health Organization.

This certificate shall expire on ..................................................................................

Subject to the Pharmacy and Poisons Board being satisfied that the manufacturer complies with the requirements of good practices in manufacture and quality control of drugs and pharmaceutical products as recommended by the World Health Organization, a Certificate for Manufacturer may be issued on or before the expiry of this certificate.

HONG KONG

................................................. (Date)

.......................................................
for Pharmacy and Poisons Board
(L.N. 63 of 1997)

FORM 5

[regulation 29(6)]

PHARMACY AND POISONS ORDINANCE

(Chapter 138)

FREE SALE CERTIFICATE OF PHARMACEUTICAL PRODUCT

Name and dosage form of product (specify strength): .......................................................

Name and amount of each active ingredient (as provided by manufacturer): ........................
...............................................................................................................................
...............................................................................................................................
...............................................................................................................................
...............................................................................................................................
...............................................................................................................................

Manufacturer, and/or when applicable, the person responsible for placing the product on the market: .............................................................................................................
...............................................................................................................................
...............................................................................................................................

Address(es): ..................................................................................................................

It is certified that:

* This product has been authorized to be placed on the market for use in Hong Kong.

Number of permit and date of issue ..................................................................
........................................................................................................................

* This product has not been authorized to be placed on the market for use in Hong Kong for the following reasons: ........

.................................................................

........................................................................................................................
........................................................................................................................
* It is also certified that (a) the manufacturing plant in which the product is produced is subject to inspection at suitable intervals, and (b) the manufacturer conforms to requirements for good practices in the manufacture and quality control, as recommended by the World Health Organization, in respect of products to be sold or distributed within the country of origin or to be exported.

HONG KONG

................................................. (Date)

........................................................
for Pharmacy and Poisons Board.
(L.N. 137 of 1978; L.N. 449 of 1991; L.N. 63 of 1997)

FORM 5A

[regulation 29(6)]

PHARMACY AND POISONS ORDINANCE

(Chapter 138)

CERTIFICATE OF PHARMACEUTICAL PRODUCT

Name and dosage form of product (specify strength):
...............................................................................................................................
...............................................................................................................................
...............................................................................................................................
...............................................................................................................................
...............................................................................................................................

Name and amount of each active ingredient (as provided by manufacturer):
...............................................................................................................................
...............................................................................................................................
...............................................................................................................................
...............................................................................................................................
...............................................................................................................................

Manufacturer, and/or when applicable, the person responsible for placing the product on the market:
...............................................................................................................................
...............................................................................................................................
...............................................................................................................................
...............................................................................................................................
...............................................................................................................................

Address(es):
...............................................................................................................................
...............................................................................................................................
...............................................................................................................................
...............................................................................................................................
...............................................................................................................................

It is certified that-
(a) this product has been registered with the Pharmacy and Poisons Board;

(b) this product has been authorized to be placed on the market for use in Hong Kong-

Number of permit:

..................................................................................................

Date of issue: .........................................................................................................

This certificate is valid for one year from the date of issue.

HONG KONG

................................................. (Date)

....................................................
for Pharmacy and Poisons Board.
(L.N. 449 of 1991; L.N. 63 of 1997)

FORM 6

[regulation 36(2)]

PHARMACY AND POISONS ORDINANCE

(Chapter 138)

APPLICATION FOR REGISTRATION OF A DRUG/
PHARMACEUTICAL PRODUCT/SUBSTANCE

Note: A specimen sales pack of the drug/product or sample of the substance and the relevant literature must be submitted together with the application. Supplementary documentation and supporting documents issued by the health authority in the Country of origin should be submitted if required.

Name of Drug/Product/Substance: (Delete as appropriate)
Dose Form/Package Size(s):
Detailed Qualitative and Quantitative Composition:
Indications:
Names of Countries in which registered/marketed:
Name of Applicant:
Business Address of Applicant:	Tel. No.
Name of Manufacturer:
Address of Manufacturer:

DECLARATION OF APPLICANT

I hereby declare that to the best of my knowledge and belief the information given in this application is correct.

Date: ................................................... Signature: ....................................................

		For Office Use Only
Date Rec'd	Forensic Classification	Fees Paid	Registration Approved	Certificate Issued	Registration

(L.N. 137 of 1978; L.N. 63 of 1997)

FORM 7

[regulation 36(5)]

PHARMACY AND POISONS ORDINANCE

(Chapter 138)

CERTIFICATE OF DRUG/PRODUCT REGISTRATION

It is hereby certified that ................................................................................................ .......................................................................................................................................

(Name and address)

has been issued with a permit No. .......................................... authorizing .........................
................................................................................................. (Name of drug/product) to be marketed for use within Hong Kong.

2. This certificate will be valid until ..................................................................... 19 ........., and thereafter for periods of 5 years at a time on renewal and subject to the payment of the registration fee.

3. No change in the formulation and commercial presentation of this product shall be made during the effectivity of this registration without the approval of the Pharmacy and Poisons Board.

HONG KONG

................................................. (Date)

......................................................
for Pharmacy and Poisons Board
(L.N. 137 of 1978; L.N. 63 of 1997)

FORM 8

[regulation 41(1)]

PHARMACY AND POISONS ORDINANCE

(Chapter 138)

CERTIFICATE

For the purposes of section 22(1)(a) of the Pharmacy and Poisons Ordinance, I, the undersigned, occupying^(a) ..................................................................................................
.............................................................................................................................................. hereby certify that I am acquainted with^(b) .................................................................
............................................. and with^(c) .........................................................................
............................................. and that^(b) ..........................................................................
.......................................................................................... is a fit and proper person to whom ^(d) .................................................................................................................... may properly be supplied by^(c) ...........................................................................................

I further certify that^(e) ............................................................................................
....................................................... is the signature of the said(e) .................................
.................................................................

..........................................................
Signature of person giving certificate

(Name in block letters) ........................................................

Date ........................................................

(a) Insert full postal address.
(b) Insert full name of intending purchaser.
(c) Insert full name of intending seller.

(d) Insert name of poison.

(e) Intending purchaser to sign here.

(L.N. 63 of 1997)

FORM 9

[regulation 41(2)]

PHARMACY AND POISONS BOARD

HONG KONG

_________

PHARMACY AND POISONS ORDINANCE

(Chapter 138)

_________

CERTIFICATE OF REGISTRATION
(Section 9(1))

Number on Register ..............................

This is to certify that .............................................................................................. whose address is ...........................................................................................................
.......................................................................................................................................
....... and whose photograph appears hereon was on the .................................................... day of.......................................................... 19........ admitted to the register of pharmacists.

Dated this ................................................ day of ..................................................... 19........

............................................................
Secretary, Pharmacy and Poisons Board.
(L.N. 63 of 1997)

FORM 10

[regulation 42(3)]

PHARMACY AND POISONS ORDINANCE

(Chapter 138)

FORM OF ENTRY TO BE MADE IN THE BOOK TO BE KEPT BY
SELLERS OF POISONS IN ACCORDANCE WITH SECTION 22(3)

Date of Sale	Name and quantity of poison supplied	Purchaser's			Purpose for which stated to be required	Date of certificate (if any)	Name and address of person giving certificate (if any)	Signature of purchaser (or reference number of Signed order in case of wholesale)	Signature of registered pharmacist
		Name and number of identity card	Address	Business, trade or occupation

(L.N. 366 of 1995; L.N. 63 of 1997)

FORM 11

(Spent)

___________

FORM 12

[regulation 36B(3)]

PHARMACY AND POISONS ORDINANCE

(Chapter 138)

CERTIFICATE FOR CLINICAL TRIAL/MEDICINAL TEST*

It is hereby certified that ................................................................................................ ..............................................................................................................................................

(Name and address)

is authorized to establish a clinical trial on human beings/medicinal test on animals* in respect of
.............................................................................................................................................

(Name of Product or substance)

to be conducted by ................................................................................................................

(Name(s) of person(s) concerned)

at .........................................................................................................................................

(Name and address of institution where applicable)

.............................................................................................................................................

2. This certificate will be valid until .............................................................................. .............................................................................................................................................

HONG KONG

............................................ (Date)

.......................................................
for Pharmacy and Poisons Board.
(L.N. 63 of 1997)

FORM 13

[regulation 37A]

PHARMACY AND POISONS ORDINANCE

(Chapter 138)

APPLICATION FOR REGISTRATION AS AN
IMPORTER/EXPORTER OF PHARMACEUTICAL PRODUCTS

We wish to apply for registration as an importer and exporter of pharmaceutical products under the Pharmacy and Poisons Ordinance, Cap 138.

Name of pharmaceutical product(s)
registered by Applicant:

Name of manufacturer(s) represented by
Applicant, if any:

Description of storage room/cubicle/receptacle* :
(* Delete as appropriate)

Name of Applicant:

Business Address of Applicant: Tel. No.

Name of person in charge:

Date .............................................. Signature .................................................

(L.N. 369 of 1980; L.N. 63 of 1997)

FORM 14

[regulation 37A]

PHARMACY AND POISONS ORDINANCE

(Chapter 138)

CERTIFICATE OF REGISTRATION AS AN IMPORTER
AND EXPORTER

It is hereby certified that .........................................................................................
.......................................................................................................................................

(Name and Address of pharmaceutical firm)

.............................................................................................................................................. has been registered as an importer and exporter of pharmaceutical products and is entitled to import and export pharmaceutical products subject to the conditions endorsed hereon.

Dated this ..................................... day of .............................................. 19........

.......................................................
for Pharmacy and Poisons Board.

CONDITIONS

(L.N. 369 of 1980; L.N. 85 of 1987; L.N. 63 of 1997)

FORM 15

[regulation 24B(a)]

PHARMACY AND POISONS ORDINANCE

(Chapter 138)

APPLICATION FOR REGISTRATION OF PREMISES
UNDER SECTION 13

We ............................................................ of ........................................................

(Name of business)

..................................................................

(Address of business)

wish to apply for the registration under section 13 of the Pharmacy and Poisons Ordinance of the premises as set out in paragraph 1 of this application to conduct the retail sale of poisons at such premises.
1. Address of premises ...............................................................................................
2. Name of business at the premises ............................................................................
3. Business Registration No. .......................................................................................
4. Telephone No. of the premises ................................................................................
5. Name of registered pharmacist in whose presence or under whose supervision the retail sale of poisons is conducted under section 11(1) of the Ordinance .....................
..............................................................................................................................
..............................................................................................................................

In support of this application, we submit a copy of the certificate of registration of the pharmacist named in paragraph 5.

Signature .....................................................
Full name of signatory ..................................
Signed on behalf of ......................................
(Name of business)

Date ............................................

(L.N. 85 of 1987; L.N. 63 of 1997)

FORM 16

[regulation 24C]

PHARMACY AND POISONS ORDINANCE

(Chapter 138)

CERTIFICATE FOR REGISTRATION OF PREMISES
UNDER SECTION 13

This is to certify that the premises known as .............................................................
......................................................................... and situated at .......................................
(Name of business)
...................................................................................................................... are, for the

(Address of premises)

period from the date of this certificate until .......................................................................,

(Date of expiry)

registered under section 13 of the Pharmacy and Poisons Ordinance as being premises where the retail sale of poisons may be conducted, subject to the conditions endorsed hereon.

Dated this ......................................... day of................................................... 19..........

.........................................................
for Pharmacy and Poisons Board

CONDITIONS

(L.N. 85 of 1987; L.N. 63 of 1997)

FORM 17

[regulation 41 (2A)]

Form of logo which may be displayed under section 13A

(L.N. 85 of 1987)

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