The Q&As given below should be considered carefully in relation to individual circumstances. They must not be treated as a complete or authoritative statement of the law on any particular case.
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| Q1: What is regarded as “manufacture”? |
| A1. Under the Pharmacy and Poisons Ordinance, “manufacture” —
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| (a) | means— |
| (i) | the preparation of pharmaceutical products, from purchase or acquisition of materials, through processing and packaging, to their completion as finished products for clinical trial, sale or distribution; or |
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| (ii) | the repackaging of pharmaceutical products as finished products for clinical trial, sale or distribution; but |
| (b) | does not include the individual dispensing on a prescription or otherwise of the product if the product— |
| (i) | is not an advanced therapy product; or |
| (ii) | is an advanced therapy product the dispensing of which does not involve substantial manipulation of cells or tissues. |
| “Manufacturer”, in relation to a pharmaceutical product, means a person who manufacturers the product. |
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| Q2. What is considered a “pharmaceutical product”? |
| A2. Under the Pharmacy and Poisons Ordinance, “pharmaceutical product” — |
| (a) | means a substance or combination of substances that— |
| (i) | is presented as having properties for treating or preventing disease in human beings or animals; or |
| (ii) | may be used in or administered to human beings or animals with a view to— |
| | (A) | restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action; or |
| | (B) | making a medical diagnosis; and |
| (b) | includes an advanced therapy product. |
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| Q3: How can I apply for a Licence for Manufacturer under Cap. 138? |
A3. Applications shall be made to the Manufacturers Regulatory Unit at Room 2550, 25/F, Wu Chung House, 213 Queen’s Road East, Wan Chai, Hong Kong (Tel: 2961 8162, Fax: 3904 1225). Please refer to the "Guidance on Application for Licence for Manufacturer of Pharmaceutical Products".
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| Q4. Which is the licensing authority for a Licence for Manufacturer? |
A4. The licensing authority is the Pharmacy & Poisons (Manufacturers Licensing) Committee, an Executive Committee established under the Pharmacy and Poisons Board empowered by the Pharmacy and Poisons Ordinance, Cap. 138 of the Laws of Hong Kong.
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| Q5. What is “GMP”? |
A5. Good Manufacturing Practice (“GMP”) is that part of quality assurance which ensures that pharmaceutical products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization or the product specification.
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| Q6. Where can I get a copy of the GMP Guide? |
A6. The GMP Guide is available free of charge at the office of the Manufacturers Regulatory Unit at Room 2550, 25/F, Wu Chung House, 213 Queen’s Road East, Wan Chai, Hong Kong [Office hour: 09:00-18:00 (Mon); 09:00 – 17:45 (Tue to Fri); Saturdays, Sundays and Public Holidays: Off] and can also be downloaded from the Pharmacy and Poisons Board website ( http://www.ppbhk.org.hk/eng/index_content5.html
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| Q7. How long does it take for an application for Licence for Manufacturer to be approved? |
A7. Applications will be approved within two months upon full compliance with the legal and licensing requirements.
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| Q8. What is the application fee and the licensing fee for Licence for Manufacturer? |
A8. There is no fee at the time of application. On granting a Licence for Manufacturer or a Licence to Manufacture Preparations of Dangerous Drugs, a prescribed fee of $2,680 or $1,540 is payable respectively.
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| Q9. How long is the validity of a Licence for Manufacturer and a Licence to Manufacture Dangerous Drug? |
A9. A Licence for Manufacturer is valid for one year and is renewable annually. A Licence to Manufacture Dangerous Drug is valid until 1st January every year.
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| Q10. If there are changes in my business after I have received the licence, what should I do? |
A10. You should notify the Manufacturers Regulatory Unit at the aforementioned address any changes of the business, e.g. name of company, address, personnel, premises and etc. Some changes, e.g. Authorized Person, Head of Production, Head of Quality Control, or, for Secondary Packaging Manufacturers, the Quality Assurance Office and the Person-in-charge of Secondary Packaging, and manufacturing premises, may require prior approval from the licensing authority. Please refer to the "Guidance on Application for Change of Key Personnel and Manufacturing Premises of Pharmaceutical Manufacturers".
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| Q11. Where can I get copies of the Pharmacy and Poisons Ordinance and its Regulations? |
A11. The above Ordinance and Regulations can be viewed and downloaded at the Hong Kong e-Legislation website ( http://www.elegislation.gov.hk ).
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