• Pharmaceutical products and medicines

Automatic

Same as the "Administrative bodies"

• https://www.elegislation.gov.hk/hk/cap138

• G/LIC/N/2/HKG/6
• G/LIC/N/2/HKG/7
• G/LIC/N/2/HKG/14
• G/LIC/N/2/HKG/19
• G/LIC/N/2/HKG/22

• G/LIC/N/2/HKG/6

  
  

  Pharmaceuticals Licence Application and Movement Monitoring System (PLAMMS)

  
  

  Non-automatic import licensing procedure is applicable to all pharmaceutical products and medicines. In order to achieve the purposes stated in (f), an automatic licensing system, namely PLAMMS was implemented on 7 January 2015. The system provides an additional means for making application for importing unregistered pharmaceutical products and medicines for re-export purpose. If an applicant wants to use PLAMMS, the company is required to become a registered user of PLAMMS and to apply for enlisting the unregistered pharmaceutical products and medicines in the system before making applications. When an application for importing enlisted products is made, the application details will go through a built-in automatic evaluation check, including the validity of the applicant’s trader licence, to ascertain the fulfilment of the legal requirements for the issue of the import licence. Once the application is approved, the applicant can print out the licence in his/her own computer.

  
  

  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 licences 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.

  
  

  The import licensing procedures for pharmaceutical products and medicines aims to establish a mechanism to regulate importations of such products into the Hong Kong Special Administrative Region. The applicant is required to hold appropriate trader’s licence(s) issued by the Pharmacy and Poisons Board of Hong Kong prior to the application for an import licence. Unless otherwise stated, an import licence is valid for six months.

  
  

• 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.

  
  

  Pharmaceutical products and medicines as defined by section 2 of the Pharmacy and Poisons Ordinance.

  
  

  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.

  
  

  Since 30 June 2016, changes to the automatic licensing system and procedures have been published and made available in the following Department of Health Drug Office websites:

  
  

  
  
  • 
    http://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/Trade-app-ie.pdf?v=ggn6filaoa9lw2ec7syvi;
  
  
  • 
    http://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/ie-guidance-notes-e.pdf?v=zg60wp0o40mj3qevobt9;
    
  
  
  • 
    http://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/Form3_(EN).pdf?v=kholhfp01hs17jznz5mi;
  
  
  • 
    http://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/Form6_(EN).pdf?v=7l7varq9t8chgxeis5rk9;
  
  
  • 
    http://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/Guidance_Notes_application_of_IE_for_UPP(re-export)-Annex_4.pdf?v=bj8vtbtvvnbg68vvx6r; and
  
  
  • 
    http://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/PLAMMS_User_Guide.pdf?v=5duo381.
  
  

  
  

  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.

  
  

  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.

  
  

• 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