Licensing of Pharmaceutical FAQ

Licensing of Pharmaceutical

FAQ 1. What license should I apply for when dealing with pharmaceutical trade?

Depending on the nature of your business and the application that you submitted, various licenses stipulated under the Pharmacy and Poisons Ordinance (Cap. 138), Antibiotics Ordinance (Cap. 137) and Dangerous Drugs Ordinance (Cap. 134) will be issued upon application and the decision of the relevant regulatory authorities:

Wholesale Dealer License*: for person dealing in wholesale and/or import/export of poisons and/or pharmaceutical products

License for Manufacturer: for person dealing in the manufacture of pharmaceutical products

Certificate for Registration of Premises of an Authorized Seller of Poisons: for premises of an authorized seller of poisons where poisons are kept for retail purposes

License for Listed Sellers of Poisons: for person dealing in retail sale of Part 2 poisons

Antibiotics Permit: for person dealing in and/or to possess antibiotics

License to Manufacture Dangerous Drug: for person dealing in the manufacture of dangerous drugs

Wholesale Dealer’s License to Supply Dangerous Drug: for person dealing in wholesale of dangerous drugs

(* From 6 February 2015, holders of valid Wholesale Poisons License or Certificate of Registration of Importers and Exporters will be regarded as Wholesale Dealer License holders until the expiry of their license or certificate.)

 

FAQ 2.  How can I apply for the various licenses?

You may fill in the relevant application forms and provide the supporting documents as listed in the checklists for application. For application guidelines and forms, please refer to the website of our office below:

http://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/
lic_guide_main.html

 

FAQ 3.  How long does it take to receive my license in general?

The issue of licenses is subject to the approval of relevant regulatory authorities. If the applicant can satisfy the requirements, it normally takes about one to two months from the date of application to obtain the license.  

 

FAQ 4. If there are changes in my business after I have received the license, what should I do?

You should notify any changes of the business, e.g. name of company, address, personnel, etc., of a license to our Licensing and Compliance Division as soon as possible. Some changes, e.g. person-in-charge of poisons, may require approval.  

 

FAQ 5.  How can I renew my license?

A notice for renewal of license/demand notes will be sent to the licensee one to two months before the expiry date of each license. The licensee should follow the instructions for payment and collection of each license.  

 

FAQ 6.  How can I apply for the Free Sale Certificate of pharmaceutical products?

Local Manufacturer of pharmaceutical products with a license for manufacturer may fill in the application form for a Free Sale Certificate of its own pharmaceutical products, subject to the payment of a fee prescribed in the Pharmacy & Poisons Regulation. The current fee is HK$180. For the guidance on application and the application form, please refer to the website of our office below: 

http://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/useful_guidelines_forms.html

 

FAQ 7.  Do I need any license to sell medicines via the Internet?

The same licenses mentioned in A.1 will be applicable to the sale of poisons, dangerous drugs and antibiotics via the Internet.  

 

비즈니스 / 컨설팅 문의하기

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