Dangerous Drugs Ordinance (Amendment of First Schedule) Order 2022

Notifying member
Hong Kong, China
Title
Dangerous Drugs Ordinance (Amendment of First Schedule) Order 2022
First published
20/10/2022
First EIF
16/12/2022
Latest published
In force to
Latest notification
G/LIC/N/3/HKG/27
List of products subject to licensing
Nature of licensing

Automatic

Non-automatic

Administrative purpose/measure being implemented
  • Other
Decription of purpose/measure being implemented

The administrative purposes of the PLAMMS are: - To provide an electronic method to facilitate the applicants who have fulfilled the administrative requirements to apply for import licence of unregistered pharmaceutical products and medicines for re-export purpose; and - To enhance the monitoring of the import and export of unregistered pharmaceutical products and medicines for prevention of illegal diversion into the local market.

Administrative body(ies) for submission of applications
Drug Import/Export Control Unit, Drug Office, Department of Health
3/F Public Health Laboratory Centre, 382 Nam Cheong Street, Shek Kip Mei, Kowloon, Hong Kong
Contact point for information on eligibility

Same as the "Administrative bodies"

Expected duration of licensing procedure
The expected duration of automatic licensing procedure is within the same working day upon completion to input all the necessary application details for the unregistered pharmaceutical products enlisted in the automatic system.
Found by secretariat
No
Related document symbols
  • G/LIC/N/2/HKG/7
  • G/LIC/N/2/HKG/14
  • G/LIC/N/2/HKG/19
  • G/LIC/N/2/HKG/22
Source
Notes
  • G/LIC/N/2/HKG/7


    Pursuant to Article 5 of the Agreement on Import Licensing Procedures, Hong Kong, China hereby notifies the full implementation of an automatic licensing system, i.e. Pharmaceuticals Licence Application and Movement Monitoring System (PLAMMS), on 1 July 2016 for application of import licence for the purpose of re-exporting pharmaceutical products and medicines which are not required to be registered under the Pharmacy and Poisons Ordinance (Cap 138, the Laws of Hong Kong) (hereunder refer as unregistered pharmaceutical products). The communication on parallel implementation of PLAMMS and manual system circulated on 6 February 2015, i.e. G/LIC/N/2/HKG/6, is hereby superseded.


    Before 7 January 2015, non-automatic (manual) import licensing procedures were used to process applications for the importation of all pharmaceutical products and medicines. In order to enhance monitoring of the import of unregistered pharmaceutical products and medicines for re-export purposes, an automatic licensing system called PLAMMS was first implemented on 7 January 2015 and was operated in parallel with the manual system as transitional arrangement. In this regard, a communication was circulated on 6 February 2015 to notify Members.


    With effect from 1 July 2016, importation of unregistered pharmaceutical products and medicines for re-export purposes can no longer be processed by the manual system and instead, must be processed by the PLAMMS automatic licensing system. Applicants are required to register as users of PLAMMS and to apply for enlisting their unregistered pharmaceutical products and medicines in the system before making the import applications. When an application to import an enlisted product is made, the application will be processed through the built-in automatic evaluation and checking system, including on validity of the applicant's trader licence, to ascertain compliance with the legal requirements before the import licence is issued. Once the application is approved, the import licence can be printed out from the applicant's computer.


  • G/LIC/N/2/HKG/14

    Implementation of phase II of Pharmaceuticals Licence Application and Movement Monitoring System (PLAMMS)

    Modification of specific details in existing procedures: Providing an electronic platform for application submission


    The Pharmaceuticals License Application and Movement Monitoring System (PLAMMS) is a web-based internet and intranet system provided for all licensees, Product registration Certificate holders and Drug Office users. Phase I of PLAMMS was launched in 2014.


    The second phase of PLAMMS further extended its scope to include import/export licence processing of registered pharmaceutical products; dangerous drugs; unregistered pharmaceutical products for the treatment of particular patients /animals by a registered medical practitioner/dentist/veterinary surgeon; pharmaceutical products for the purpose of clinical trials/medicinal test; and pharmaceutical products or substances imported by a pharmaceutical manufacturer for the purpose of manufacture of pharmaceutical products.


  • G/LIC/N/2/HKG/19


    Mandatory electronic application for import and export licences / certificates for pharmaceutical products and dangerous drugs (“IE and DD licences”) under the Pharmaceutical Licence Application and Movement Monitoring System (“PLAMMS”) and phase out of manual application submission for IE and DD licences


    Modification of specific details in existing procedures: Mandatory use of an electronic platform for application submission.


    With effect from 31 December 2021, the Drug Office, Department of Health would only accept and process applications for import and export licences / certificates for pharmaceutical products and dangerous drugs (“IE and DD licences”) submitted online via the Pharmaceutical Licence Application and Movement Monitoring System (“PLAMMS”). Manual application submission for IE and DD licences would no longer be accepted.


  • G/LIC/N/2/HKG/22


    From 16 December 2022, nine substances (i.e., brorphine, clonazolam, CUMYL-PEGACLONE, diclazepam, diphenidine, flubromazolam, isotonitazene, MDMB-4en-PINACA, and metonitazene) have been put under the same strict control as other dangerous drugs under the Dangerous Drugs Ordinance ("DDO").

    Also, from 1 February 2023, CBD has been put under the same strict control as other dangerous drugs under the DDO. The amendments aimed to deter the trafficking and abuse of these dangerous drugs and substances and help fortify Hong Kong's defence in the fight against drugs.


    https://www.drugoffice.gov.hk/eps/do/en/doc/PLAMMS_Important_Notice_2021.11_(Eng).pdf


    Annex - Products listed in G/LIC/N/2/HKG/22