Q366 · Our medicine label or package insert needs…

Q366 · Category H: Licensed operations and routine regulatory oversight (Q351–Q400)

Yes, medicine labels and package inserts (also known as “leaflets”) are important parts of a medicine's registration dossier, and any change to their content must be approved by the Department of Health. Whether adding a new warning, updating indications, changing directions for use or dosage, or simply making an artwork change, each is a “change to the particulars of registration” and must go through the formal change application procedure. You will need to submit to the Department of Health an “Application for Change of Particulars of Registered Pharmaceutical Product/Ingredient”, together with a comparison of the old and new labels/leaflets, scientific data or documents supporting the change (for example, the latest clinical study data supporting the addition of a warning), and the reason for the change. You may use the new label or leaflet only after receiving the Department of Health's approval letter.

📘 Regulatory basis

Under section 36 of the Pharmacy and Poisons Regulations (Cap. 138A), a certificate holder wishing to change any registration particulars of a pharmaceutical product covered by the certificate must apply to the Pharmacy and Poisons Board.

📗 Drew Tang's recommendations

We recommend that clients classify and consolidate all planned changes to labels and package inserts. For example, several minor administrative changes (such as a change of telephone number) could be combined in one application to improve efficiency. Major safety-related changes (such as adding a boxed warning) should be treated as a top priority and applied for separately without delay. Clearly highlighting all changes and providing adequate justification in the application will help expedite the approval process.

📕 Risk notice

Unilaterally changing a label or package insert without approval means that the medicines you sell on the market do not match their registration particulars. Legally, this is equivalent to selling unregistered medicines. If this is discovered, the Department of Health may require you to recall all products already on the market and may suspend or cancel their registration. This would not only cause substantial financial losses but also seriously damage the company’s reputation.

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang

Business Manager Tang Shangyong (Drew Tang) will review your products, operating model, licence type and preparation requirements with you one-to-one. The precise service scope is confirmed in writing; pharmaceutical duties are carried out by legally qualified personnel, and approvals are determined by the competent authorities.

Our medicine label or package insert needs updating (for example, to add a warning). Does this change need to be reported to the Department of Health?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang