Registration of Proprietary Chinese Medicines > Labelling and package inserts of proprietary Chinese medicines

Under the Chinese Medicine Ordinance, all proprietary Chinese medicines should be properly labelled and attached with package inserts.

 

Labelling of proprietary Chinese medicines

The label on a package of proprietary Chinese medicine shall usually include the following particulars:

  1. the name of the medicine;
  2. the name of each active ingredients used (if the proprietary Chinese medicine is composed of 3 or more kinds of active ingredients, the names of more than half of the active ingredients are required);
  3. the name of the country or territory in which the medicine is produced;
  4. the registration number on the certificate of registration;
  5. the name of the holder of the certificate of registration or the manufacturer (if the package is the outermost one, the name of the holder of the certificate of registration is necessary);
  6. packing specification;
  7. dosage and method of usage;
  8. expiry date; and
  9. batch number.

 

Package inserts of proprietary Chinese medicines

The package inserts of proprietary Chinese medicines shall usually include the following particulars:

  1. the name of the medicine;
  2. the name and quantity of each active ingredient used (if the proprietary Chinese medicine is composed of 3 or more kinds of active ingredients, the names and quantity of more than half of the active ingredients are required);
  3. the name of the holder of the certificate of registration or the manufacturer producing the medicine;
  4. dosage and method of usage;
  5. functions or pharmacological action;
  6. storage instructions, and
  7. packing specification.

As for the indications, contra-indications, side effects, toxic effects and precautions, they shall also be included on the package insert as far as practicable.

The content of the labels and package inserts of proprietary Chinese medicines enable the public to obtain the basic information and precautions of the medicines. Pursuant to the protection of the public on safe use of medicines and to facilitate the trade to show relevant content on the labels and package inserts, the Chinese Medicines Board has formulated "Guidelines on labels of proprietary Chinese medicines" and "Guidelines on package inserts of proprietary Chinese medicines".

The Chinese Medicines Board has also formulated "Q&A for labelling and package inserts of proprietary Chinese medicines (Chinese version only)" for reference.

For detailed requirements of the legal provisions on labelling and insert packages of proprietary Chinese medicines, please refer to the Application handbook for registration of proprietary Chinese medicines or Chapter 549, Laws of Hong Kong, the Chinese Medicine Ordinance and Chinese Medicines Regulation.

 

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