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How to Register a Medicine Company



How to Register a Medicine Company


To register a medicine company in Hong Kong, you will need to:


1. Choose a business structure. You can choose to register your medicine company as a sole proprietorship, partnership, limited company, or unlimited company. The most common structure for medicine companies is a limited company.


2. Choose a business name. Your business name must be unique and cannot be similar to the name of any other existing company in Hong Kong. You can search for available company names on the Companies Registry website.


3. Apply for a business registration certificate. You can apply for a business registration certificate online or by mail. You will need to provide the following information:

  • Your business name

  • Your business structure

  • Your business address

  • The names and addresses of your directors and shareholders (if applicable)

4. Obtain a pharmaceutical license. You must obtain a pharmaceutical license from the Department of Health in order to operate a medicine company in Hong Kong. To apply for a pharmaceutical license, you will need to provide the following information:

  • The name and address of your company

  • The names and qualifications of your key personnel

  • The types of medicines that you will be dealing in

  • A detailed description of your quality assurance system

5. Comply with other applicable regulations. There are a number of other regulations that medicine companies must comply with in Hong Kong. These regulations cover areas such as product safety, advertising, and record keeping.


Here are some additional tips for registering a medicine company in Hong Kong:

  • Make sure that you have a good understanding of the Hong Kong regulatory environment for medicine companies.

  • Get advice from a qualified professional, such as a lawyer or accountant, to help you with the registration process.

  • Be prepared to provide all of the necessary documentation and information to the Department of Health.

  • Be patient, as the registration process can take several months.


Application for Licence for Listed Seller of Poisons to Conduct Retail Sale of Part 2 Poisons


Examples of Part 2 Poisons are cold and flu medication containing chlorpheniramine, hair-dye preparations containing phenylene diamines; toluene diamines; other alkylated-benzene diamines or their salt.


Upon receipt of the completed application, inspection will be conducted to assess whether the premises are suitable for conducting retail sale of Part 2 Poisons, for example, premises located in a residential address/unit is considered as not suitable to conduct the retail sale of Part 2 Poisons. All applications will be submitted to an Executive Committee of the Pharmacy and Poisons Board for consideration.


In general, factors that would be taken into account when evaluating an application include:

  • Results of pre-licensing inspection;

  • Previous drug-related conviction(s), in particular those have significant impact to the public interest, registered against the applicant or the key personnel; and

  • Previous disciplinary action(s) against the applicant or the key personnel.

Application form can be downloaded here.


The performance pledge of the Department of Health is that application will be approved within two months.


If approved, a Licence for Listed Sellers of Poisons under Section 25 will be issued with an expiry date of 31st December of that same year and sent to the applicant by mail.


Fee


The prescribed fee for application for entry on the list of Listed Sellers of Poisons is HK$455.


The annual retention fee on the List of Listed Sellers of Poisons is HK$430.


How Bestar can Help


Bestar can help you register a medicine company in Hong Kong by providing the following services:

  • Company name search and reservation

  • Business registration certificate application

  • Pharmaceutical license application

  • Advice on compliance with other applicable regulations

Bestar has a team of experienced professionals who can help you throughout the registration process, from choosing a business structure to applying for a pharmaceutical license. They can also help you to comply with all of the applicable regulations in Hong Kong.


Here are some of the benefits of using Bestar to help you register a medicine company in Hong Kong:

  • Save time and hassle: Bestar can handle all of the paperwork and formalities involved in the registration process, so you can focus on running your business.

  • Avoid mistakes: Bestar has the experience and knowledge to help you avoid any common mistakes that can be made during the registration process.

  • Get expert advice: Bestar can provide you with expert advice on all aspects of registering a medicine company in Hong Kong, from choosing a business structure to complying with applicable regulations.

If you are interested in using Bestar to help you register a medicine company in Hong Kong, you can contact us for a free consultation.

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