Under the Pharmacy and Poisons Regulations, pharmaceutical products must be registered with the Pharmacy and Poisons Board before they can be sold, offered for sale, distributed or possessed for the purposes of sale, distribution or other use.
Criteria for registration
Your pharmaceutical product will only be approved for registration if it meets
the criteria of safety, efficacy and quality relevant to it.
Who should apply?
If your pharmaceutical product is manufactured in Hong Kong, the person responsible for obtaining registration of the product is the licensed manufacturer, or the licensed wholesale dealer contracting with the licensed manufacturer.
If your pharmaceutical product is manufactured outside Hong Kong, the person responsible for obtaining registration is the licensed wholesale dealer who imported the pharmaceutical product, or the Hong Kong branch, subsidiary, representative, agent or distributor of the overseas manufacturer.
Pharmaceutical products not subject to registration
Products which fall under the following categories are not required to be registered with the Pharmacy and Poisons Board:
(A) products containing only proprietary Chinese medicines or Chinese herbal medicines as defined in the Chinese Medicine Ordinance (Cap. 549);
(B) drug substances imported by licensed manufacturers solely for the purpose of manufacturing their own pharmaceutical products;
(C) products possessed or used under the direction of a registered medical practitioner or a registered dentist for the treatment of a particular patient, or of a registered veterinary surgeon for the treatment of a particular animal;
(D) products imported for re-export only;
(E) products manufactured in Hong Kong for export by the licensed manufacturer only;
(F) products administered for the purposes of a clinical trial/medicinal test in accordance with a clinical trial/medicinal test certificate issued under the Pharmacy and Poisons Regulations.
The following particulars:
1、Soft copy of the business registration certificate of the applicant;
2、An authorized person for the application, contact telephone and facsimile numbers and content of the submission dossier. Please declare in the PRS 2.0 system that the applicant “agrees to submit additional or updated supporting documents when required”;
3、Soft copy and certified true copy of the manufacturer’s licence; For products manufactured outside Hong Kong: Information on the manufacturing facilities and practices of the manufacturer;
4、Soft copy and certified true copy (Please see sub-paragraph D below) of Good Manufacturing Practices (GMP) certificate of the manufacturer;
5、One set of prototype sales pack (e.g. outer carton, container label, and other component(s) comprising the sales pack) for each pack size of the product, complying with the labelling requirements;
6、For products containing a new chemical or biological entity:
1) official evidence of registration approval of the product (e.g. soft copy and original or certified true copies of free sale certificates) in two or more of the following countries: Australia, Austria, Belgium, Bulgaria, Canada, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Holland, Hungary, Ireland, Italy, Japan, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, UK and USA;
2) expert evaluation reports on the safety, efficacy and quality of the product. Curriculum vitae of the expert and the expert’s signature on the corresponding reports are required;
3) European Union Risk Management Plan (EU-RMP) and/or US Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategy (REMS) required for the product, if applicable. Information on whether any of the risk management plan activities and mitigation strategies will be implemented in Hong Kong;
4) Proposed package insert of the product. Where the package insert is in the form of a patient information leaflet, a prescribing information leaflet for healthcare professionals for use in Hong Kong should also be submitted;
7、 Clinical and scientific documentation substantiating the safety and
efficacy of the product:
8、Document(s) to support the proposed indication(s), dosage, route of administration and other contents of the package insert (if any)；
9、In the case of applications for registration of pharmaceutical substances: Sample of the pharmaceutical substance as it will be sold to the purchaser.:
10、Detailed and complete qualitative and quantitative composition of the finished product issued by the manufacturer.
11、Specifications of the product issued by the manufacturer. Document(s) showing compliance with one or more of the following pharmacopoeias must be provided unless otherwise justified: Pharmacopoeia of the People’s Republic of China, British Pharmacopoeia, European Pharmacopoeia, International Pharmacopoeia, Japanese Pharmacopoeia and/or United States Pharmacopoeia.
12、Detailed method of analysis of the product for all tests stated in the finished product specifications. Certificate of analysis of a representative batch of the finished product, issued by the manufacturer or the company performing the analysis;
13、Stability test data of the product;
14、Bioequivalence (BE) data: for anti-epileptic drugs and for critical dose drugs / narrow therapeutic range drugs;
15、Special exemptions are provided for the quality analysis of products containing vitamins, minerals, etc.
16、If materials of animal origin are used in the manufacturing of the product, you should also provide documentary evidence obtained from the manufacturer on the source of the animals, the nature of the animal tissues used in the manufacturing and the production processes, showing compliance with one or more of the safety measures taken to minimize the risk of communicable diseases that can be transmitted to human, including but not limited to Transmissible Spongiform Encephalopathy (TSE) transmission promulgated by the European Medicines Agency, USA or Australia.
Contact us
If you have further enquire, please feel free to contact Tannet at anytime, anywhere by simply visiting Tannet’s website www.tannet-group.net, or calling Hong Kong hotline at 852-27826888 or China hotline at 86-755-82143422, or emailing to tannetgroup@gmail.com / tannet-solution@hotmail.com.
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