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Frequently Asked Questions
 

(A) Account Registration

  • A1 How can I become a registered user of PLAMMS ?

    Applicants can register for PLAMMS via either of the following ways:


    a. Applicants can download the account registration form for PLAMMS from the following website:
    [http://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/Account_Registration_Form_(PLAMMS)_E.pdf?v=kkn9ini]

    After filling in all the required details, applicant should send the completed registration form by post or deliver by hand to the office at PLAMMS Service Team, Drug Information and Import/Export Control Division, Department of Health, Suite 2002-05, 20/F, AIA Kowloon Tower, Landmark East, 100 How Ming Street, Kwun Tong, Kowloon.

    b. Applicants can directly complete the registration online. To access the PLAMMS log-in page for new account registration, please use the following link:
    [ https://www.drugoffice.gov.hk/PlammsInterWeb/jsp/init.action ]


    Either way, confirmation of registration will be sent to applicants via the email provided in the registration form.

  • A2 What are the system requirements for using PLAMMS?

    System requirements are as follows:

    1. Web browser: Internet Explorer 11.0 or above
    2. Web browser settings: Accept cookies and enable JavaScript
    3. Java Runtime Environment (JRE) 1.6.x or above
    4. Adobe Flash Player 13 or above

  • A3 With ONE Hongkong Post e-Cert, can ONE company apply for a few primary accounts for different departments to handle import and export licence applications?

    No. EACH Hongkong Post e-Cert, Personal or Organisational, can only apply for ONE primary account in PLAMMS. Upon successful application, user can create secondary accounts for multiple staff if needed.

  • A4 For current PLAMMS users, do we need to register for PLAMMS II again?

    No. With valid Hongkong Post e-Cert, current PLAMMS users’ data, including enlisted drugs and previous licence details, will be automatically migrated to PLAMMS II.

  • A5 How can I check on the status of my application?

    On the dashboard there will be a table showing the status and number of on-going licence applications e.g. pending and approved licences. There is also a message to inform you whenever that is a change in the status of licence application.

  • A6 Can I create a licence application, edit it, save it and return to it to finalise it in multiple sessions?

    Yes. You may save and close a licence application at any time. To return to the licence application, simply select the licence application draft from the dashboard and proceed.

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(B) Drug Enlisting

  • B1 How can I enlist an unregistered pharmaceutical product (UPP) containing same ingredient with two different strengths (e.g. ABC Capsules 10mg and ABC Capsules 20mg) in a single application?

    Products with same ingredient but different strengths should be regarded as individual products, and therefore should be enlisted in separate application.

  • B2 How can I make amendments to enlisted drug details?

    Any change to enlisted drug presentation details, including pack size, requires a new application.
    (e.g. one for 50 tablets per box and one for 100 tablets per bottle)

  • B3 How can I enlist pharmaceutical product of different pack sizes?

    Pharmaceutical product with different pack sizes should be enlisted separately.
    (e.g. one for 50 capsules per bottle and one for 100 capsules per bottle)

  • B4 How can I apply import and export licences for pharmaceutical raw materials via PLAMMS?

    Similar to UPP, applicant is required to enlist unregistered pharmaceutical raw materials before submitting application for import and export licence for re-export purpose.

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(C) Opening Balance

  • C1 What is Opening Balance?

    Opening Balance is a function to report the actual stock of all newly enlisted unregistered pharmaceutical product. Users are required to input the initial amount (i.e. ‘zero’ stock or actual physical stock) of the enlisted item. PLAMMS will not accept any application for Import/ Export Licence before Opening Balance has been inputted.

  • C2 When should I report Opening Balance?

    As soon as possible after each newly enlisted unregistered pharmaceutical product.

  • C3 How can I adjust the incorrect amount of the Opening Balance?

    The registered user shall submit an adjustment request to the Drug Office of Department of Health with the reasons stated therein and supporting documents. The Drug Office will consider the request on case by case basis.

    To support your adjustment application, please submit the following:
      (a) A letter giving reasons, product name and total amount for adjustment.
      (b) An inventory record of the pharmaceutical product.

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(D) Import and Export Licence application

General

  • D1 Do I need to be a holder of valid drug dealer’s licences to apply for import or export licence via PLAMMS?

    Yes. According to legal requirements, drug dealer’s licence is required for trading of pharmaceutical products. Therefore, the registered user of PLAMMS, depending on the nature of your business, should hold relevant licences required under the Pharmacy and Poisons Ordinance (Cap. 138), Antibiotics Ordinance (Cap. 137) and Dangerous Drugs Ordinance (Cap. 134).

  • D2 How can I submit late application for import licence for Pharmaceutical Products via PLAMMS?

    PLAMMS provides 24 hours import and export licence application with self-printing of approved licences for traders thus it is expected that the need for application for retrospective licence application would be minimized. However, if the situation arises, there is a function in PLAMMS to allow registered user to submit late import licence application. The Drug Office will consider each application on case by case basis.

  • D3 What should I do if I know the quantity of the drug in the soon arriving shipment will exceed the declared quantity on the import licence?

    You should apply for a new import licence and void the approved import licence before the arrival date of the goods.
    Please be reminded that according to Section 6C(1) of the Import and Export Ordinance (Cap. 60), subject to the Import and Export (General) Regulations, no person shall import any article specified in the First Schedule to the Regulations except under and in accordance with an import licence issued under Section 3. Any person who contravenes Section 6C (1) shall be guilty of an offence and shall be liable on conviction to a fine of $500,000 and to imprisonment for two years.

  • D4 How can I input addition information of the shipment such as description of carton in the import or export licence via PLAMMS?

    You can input additional information such as description of carton of the shipment in the *Description of goods* input field in the import or export licence application input screen.

  • D5 How can I submit late import licence application for UPP?

    You can submit late import licence application for UPP. Whether an import licence will be granted retrospectively is considered on a case by case basis. The following supporting documents are generally required:
    (a) A letter giving reasons for the late lodgement of the licence application, in the case of import, the letter should state whether or not the shipping, airline or transportation company has already released the goods;
    (b) If you have not taken delivery of the goods, and original written confirmation from the carrier company or its cargo agent; and
    (c) The relevant Bill(s) of Lading or Air Waybill(s) and invoice(s).


    REMINDER
      1. Under the Import and Export Ordinance, no person shall import or export any prohibited article except under and in accordance with a licence issued by the Trade and Industry Department and that any person who contravenes this Ordinance shall be quality of an offence.
      2. The retrospective issue of an import licence or export licence is without prejudice to any legal or administrative action the Trade and Industry Department may deem appropriate against the importer or exporter for having failed to comply with the Import and Export Ordinance.

  • D6 How can I apply for import licence before import clearance of the pharmaceutical products?

    You can apply for Import Licence via PLAMMS before the date of arrival.

  • D7 Does an import licence issued via PLAMMS cover more than one shipment?

    Each import licence issued via PLAMMS can only cover ONE shipment. To cope with other shipment(s), you are advised to apply for the required import licence(s) before Date of Arrival of each shipments. Any unused licence should be voided via PLAMMS.

  • D8 How to cancel unused export licence after the Departure Date?

    Time allowed for online cancellation of any unused export licence via PLAMMS is the same day or before the Departure Date. If you missed the last minute to cancel an unused export licence online, you shall submit an application to PLAMMS Service Team. To support your application, please submit the following:
    (a) A letter giving reasons with supporting record/document e.g. record of cancellation of the shipment such as official cancellation letter or email)
    (b) Export licence number and detail information on the licence
    (c) An inventory record of the pharmaceutical product(s).

  • D9 How can I make amendments to approved import or export licence when there are some urgent changes to shipment information?

    PLAMMS system operates 24 hours a day, providing a simplified and continuous Import and Export Licence application service. Registered Users can apply for a new licence to cope with the unexpected changes to shipment information before the Date of Arrival and then void the unnecessary licence via PLAMMS.

  • D10 What should I do if the actual flight number was different to the number entered on approved licence?

    Refer to question D9, registered users should apply for a new licence to cope with the unexpected changes to shipment information before the Date of Arrival and then void the approved licence which is not required via PLAMMS.

  • D11 What should I do if there is a change in Importer’s Declaration?

    All registered PLAMMS users must make declaration(s) with care. If a change in declaration is needed, a new import licence should be applied to fit business need.

  • D12 Can other applicants access or view my licence application submitted through PLAMMS?

    No. Applicants can only access or view their own applications and licences.

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Dangerous Drugs

  • D13 Does PLAMMS II cover Dangerous Drug (DD) import licence of non-pharmaceutical products?

    Yes. You can apply for DD import licence for non-pharmaceutical products via PLAMMS II.

  • D14 How to apply for Form 3 (import) or Form 6 (export) licence after completing the application for DD import and export licence?

    If the goods to be imported/exported are classified as both DD and pharmaceutical product, the same information submitted for DD import/export licence application will automatically be transferred to the Form 3 (import)/Form 6 (export) licence application upon approval of related DD licence. You can print both DD import/export licence and the related Form 3/ Form 6 licence at your own workplace. Applicants are reminded to apply for the relevant licences before date of arrival/departure.

Healthcare and medical research professionals

  • D15 What is the legal requirement for import of an unregistered drug for treatment of a particular patient?

    For details, please refer to Drug Office FAQ 20 (http://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/faq.html), according to regulation 36(1) of the Pharmacy and Poisons Regulations (PPR), pharmaceutical products must be registered before they can be sold, offered for sale or distribute or possessed for the purposes of sale, distribution or other use in Hong Kong.

    The above requirement is not applicable in the case of possession or use where the pharmaceutical product or substance is possessed or is to be used for the purpose of treatment by a registered medical practitioner of a particular patient in accordance with regulation 36(1A)(ab) of the PPR.

    Under the Import and Export Ordinance (Cap. 60), all imports of pharmaceutical products must be covered by import licences. For every single importation, the importer needs to apply for an Import Licence (Form 3) from the Drug Information and Import/Export Control Division of Department of Health.

  • D16 What are the required documents for importing an unregistered drug for treatment of a particular patient?

    For details, please refer to Drug Office FAQ 21 (http://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/faq.html), applicants are required to submit the following:

    a.  Letter of a registered medical doctor stating the drug’s name, required quantity and patient’s information at least with his/her full name

    b.  Certificate of Analysis of the drug issued by the manufacturer

    c.  Product information, e.g. product insert d.  Proof of registration of the drug in overseas (If the drug has not been registered anywhere in the world, clinical documents to support the safety and efficacy of the drug)

    e.  Drug trader licence of the importer, e.g. Wholesale Dealer Licence

    f.  Duly completed Import Licence (Form 3).

    Each import licence application may be granted on a case by case basis.

  • D17 Is it necessary to provide the original copy of doctor’s letter for the application of UPP importation for the treatment of particular patient?

    Yes. The original doctor’s letter must be provided when the application is initiated by a holder of Wholesale Dealer Licence on behalf of a registered doctor in Hong Kong.

  • D18 What are the requirements for registered veterinary surgeons to import medicines for animals under his/her care?

    A registered veterinary surgeon can register as a PLAMMS user to apply import licences for the medicines used in the treatment of animals under his/her care.

    Alternatively, a registered veterinary surgeon can also appoint a holder of Wholesale Dealer Licence to handle the application for him/her.

  • D19 What are the required documents for importing an unregistered drug for treatment of a particular animal by a registered veterinary surgeon?

    Applicants are required to submit the following supporting documents:

    1. Registration certificate of the veterinary surgeon
    2. Valid practising certificate of the veterinary surgeon
    3. Product information e.g. Material Safety Data Sheet (MSDS) or product insert

  • D20 When applying import licence for medicines used in clinical trial, is it necessary to upload a copy of the Clinical Trial certificate?

    Yes. A copy of the certificate for Clinical Trial is required as one of the supporting documents.

  • D21 If the Clinical Trial certificate holder is the principal investigator, e.g. registered medical practitioner, does he/she need a Hongkong Post e-Cert (Personal) to apply for import licence, can any organisation make application on his/her behalf?

    Yes. The principal investigator needs a Hongkong Post e-Cert (Personal) to apply for import licence. A holder of Wholesale Dealer Licence can make application on his/her behalf with the provision of an authorisation letter from the principal investigator.

(E) Report shipment and ledger

  • E1 When should I report shipment after the importation of UPP?

    A registered user should report the actual imported shipment within 14 days after the importation of the UPP via the “Report Shipment Quantity (Import)” function of PLAMMS. Under this function, the actual imported quantity of the concerned pharmaceutical product, its batch number and expiry date are required to be furnished. Each time after completion of report shipment, the quantity of corresponding batch of the enlisted pharmaceutical product will be updated in the ledger records of PLAMMS.

  • E2 How can I adjust the quantity of reported shipment?

    You shall submit an adjustment request to the Drug Office of Department of Health in writing. The Drug Office will consider the request on case by case basis.

    To support your adjustment application, please submit the following:
    (a) A letter giving reasons with the product name and total quantity for adjustment.
    (b) An inventory record of the pharmaceutical product.
    (c) The relevant Bill(s) of Lading or Air Waybill(s) and invoice(s).

  • E3 Is it necessary to report shipment after the shipment of UPP has been exported?

    No. Once the application for export licence has been submitted, the quantity of EACH UPP according to the export licence would be deduced from the ledger balance. Unless you void the export licence on or before the departure date, the quantity of UPP as per export licence would be automatically deduced after the departure date.

  • E4 What happens when we started using PLAMMS for an UPP?

    In order to ensure the ledger balance of each enlisted product tally with its actual stock, once a company has started to apply import or export licence for any enlisted UPP via PLAMMS, the company should not apply import/export licence for that enlisted drug in paper mode again. Since 1 July 2016, manual submission of I/E licences of UPP for re-export purpose is no longer accepted at the counter of Drug Office.

  • E5 What is the relationship between ‘Report Shipment’ and ‘Ledger balance’ of PLAMMS?

    The quantity of each batch of enlisted drug in the ledger balance of PLAMMS could only be updated after completion of report shipment.

  • E6 How should short shipment be handled?

    Refer to question E1, a registered user should report the actual imported quantity within 14 days after the importation via the “Report Shipment Quantity (Import)” function of PLAMMS.

    Please note that this can only apply to short shipments. If the imported quantity is larger than the quantity on approval licence, please apply for a new licence accordingly before the Date of Arrival.

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(F) Others

  • F1 What are the supporting document(s) and their format requirements for PLAMMS applications?

    Commonly required supporting documents for pharmaceutical products or medicines:

    - Packaging (the actual sales pack)
    • A replica of the outer sales pack (e.g. the sales box)
    • 2D artwork design in full colour; and
    • Cutting and folding presented where necessary.


    - Labels
    • A replica of the immediate packaging (e.g. the label on the bottle, two sides of the blister pack)
    • 2D artwork design in full colour


    - Product information
    • Product Insert (PI)
    • Patient Information Leaflet (PIL)
    • Summary of Product Characteristics (SmPC)
    • Material Safety Data Sheet (MSDS): for veterinary products


    File formats for supporting document submission:

    Applicant should prepare and submit the relevant supporting documents in one of the following formats:

    - File type of product information: PDF(searchable PDF)/ .doc/ .docx
    - File size: no more than 3MB for each file

  • F2 How can I apply export period extension for unregistered pharmaceutical products (UPP) imported for re-export purpose?

    For unregistered pharmaceutical product (UPP) imported for re-export purpose, a holder of Wholesaler Dealer Licence (WDL) shall export the products within 1 year from the date of importation. If any remaining stock of UPP cannot be exported within 1 year from the date of importation, a holder of WDL must apply for ‘Export Period Extension’ or ‘Drug Disposal’ for the remaining UPP before the due date of the export period under the ‘Batch’ Function. For details, please contact PLAMMS Support Team at plammsinfo@dh.gov.hk

  • F3 How should I deal with unwanted/unserviceable UPP?

    For disposal of unserviceable or expired UPP, please refer to the "Guidelines on disposal of unserviceable/expired medicines for all licensees" in the website of the Drug Office under "Guidelines and Forms".

    Before the disposal, please contact Drug Office and follow the general steps below:
      (a) Make sure that all stock of the concerned batch(es) has become unserviceable or expired
      (b) Contact PLAMMS Support Team
      (c) Provide the following supporting documents through email (plammsinfo@dh.gov.hk) or facsimile (Fax No.: 28034962)
      i. A letter requesting ledger adjustment arising from disposal and the disposal plan
      ii. Copy of the certificate with waste producer number (WPN) issued by the EPD
      iii. An inventory record of the pharmaceutical product
    Drug Office will review the supporting documents and reply if they are satisfactory
      (d) Proceed with the disposal through an authorized chemical waste collector according to the aforesaid Guidelines
      (e) Submit an application for ‘Drug disposal’ and upload documents related to the disposal (including the trip ticket) via the ‘Batch’ function of PLAMMS

    Drug Office will review your application and adjust the balance of the batch of disposed UPP in PLAMMS if the submitted documents are satisfactory.

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Drug Information and Import/Export Control Division
Department of Health Drug Office
May 2024
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