To: Certificate holders of registered pharmaceutical products
New Regulatory Control of Products containing Vitamins and Glucosamine
|
On 4 December 2015, the Pharmacy and Poisons (Registration of Pharmaceutical Products and Substances: Certification of Clinical Trial/Medicinal Test) Committee (the Committee) considered the control of products containing vitamins and glucosamine in the US, EU, UK, Australia, Canada, Singapore and Taiwan together with scientific information related to the properties and effects of vitamins and glucosamine. After deliberation, the Committee decided that the following new regulatory control of products containing vitamins and glucosamine should be implemented in Hong Kong with immediate effect:
|
|
A. Vitamin products will not be considered as pharmaceutical products unless -
|
|
|
i. they are indicated for parenteral use;
ii. they have medicinal claims for treating or preventing disease; or
iii. they belong to the following categories:
|
|
|
|
a. pharmaceutical product containing vitamin A with not less than 10,000 I.U. daily dose;
b. pharmaceutical product containing vitamin B3 (nicotinic acid) with more than 200 mg daily dose;
c. pharmaceutical product containing vitamin D with more than 1,000 I.U. daily dose;
d. pharmaceutical product containing alfacalcidol;
e. pharmaceutical product containing calcitriol; and
f. pharmaceutical product containing vitamin K in oral dose form (except vitamins K1 or K2 with 120 mcg or less daily dose).
|
|
B. Glucosamine products will not be considered as pharmaceutical products unless -
|
|
|
i. they are indicated for parenteral use; or
ii. they have medicinal claims for treating or preventing disease.
|
|
In light of the above, please review the products containing vitamins or glucosamine registered by your company. If they are not considered as pharmaceutical products, please delete the registration numbers from the labels and return the registration certificates to Drug Office for cancellation. In addition, please observe other legislative requirements applicable to the products concerned for compliance.
|
For those considered as pharmaceutical products, they will need to comply with the Pharmaceutical Inspection Co-operation Scheme Good Manufacturing Practice standards in the applications for renewal of registration with effect from 1 January 2017.
|
Please visit the following Drug Office websites on:
|
|
Ends / Tuesday, January 05, 2016
|