guidance notes on classification of products as ......nutritional supplements in powder or liquid...

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Guidance Notes on

Classification of Products as

“Pharmaceutical Products” under the

Pharmacy and Poisons Ordinance

(Cap. 138)

Pharmacy and Poisons Ordinance:

“Pharmaceutical products” must firstbe registered before sale

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Registration Criteria:

safety efficacy quality

Question:

What is a “pharmaceutical product” ?

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Pharmacy and Poisons Ordinance:

“Pharmaceutical product" and "medicine" mean any substance or mixture of substances manufactured, sold, supplied or offered for sale or supply for use in -

the diagnosis, treatment, mitigation, alleviation or prevention of disease or any symptom thereof;

the diagnosis, treatment, mitigation, alleviation of any abnormal physical or physiological state or any symptom thereof; or

altering, modifying, correcting or restoring any organic function

in human beings or in animals.

(a)

(b)

(c)

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Summary:

Products for the: diagnosis, treatment, mitigation, or prevention ……

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……. of

a disease, or a disease symptom

are “pharmaceutical products”

Two Deciding Factors:

(a) The usage claims made in relation to the product; and

The composition of the product. (b)

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Are the usage claims “medicinal”?

Claims related to : diagnosis, treatment, mitigation, or prevention of any diseases or their symptoms

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Examples of “medicinal” claims

Prevention of heart diseases Relieves diarrhoea/constipation Soothes inflammation Sore throat treatment Eases heartburn and indigestion Stops coughs Lowers blood sugar

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Examples of usage claims which are not considered as “medicinal”

Improves general health Improves immunity Improves skin conditions Conditions the skin and relieve dryness Anti-dandruff (provided that the product does not

contains climbazole, coal tar, pine tar, selenium, etc.)

Destroys odors Anti-plaque

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Anti-acne skin products Products for the treatment or management of

drug abuse Nicotine replacement therapies for smoking

cessation

Examples of products which are classified as “pharmaceutical products”:

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Examples of products which are not “pharmaceutical products”:

Contraceptive devices, e.g. intrauterine devices, vaginal sponge, foams and creams; condoms with or without spermicides

Contact lens care products Cosmetics and toiletries Deodorants and antiperspirants Diagnostic agents used outside the human body Toothpastes, including those containing fluorides and/or

potassium nitrate (except those containing medications like tranexamic acid)

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Examples of products which are not “pharmaceutical products” (cont.):

Insect repellents

Nutritional supplements in powder or liquid form used as meal

replacements and products presented and sold as food. Household disinfectants that are not used on human or animal

bodies Sunscreen products

Products that are not used in human or animals

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Antiseptic/Disinfectant Products

A list of antiseptic ingredients, with maximum concentrations, specified in the appendix.

Products containing these ingredients at or below the specified

concentrations and NOT for use on broken skin or wounds are not considered as pharmaceutical products. Claims such as ‘antiseptic’, ‘anti-bacterial’ and ‘kills germs’ on these products are not considered as ‘medicinal claims’.

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Certain products for which registration is not required:

Medical Devices bone cements (including bone cements with antibiotics) catheters (including heparin-coated catheters) contact lens care products drug eluting stents haemodialysis concentrates intra-uterine devices for contraceptive use surgical dressings surgical sutures

Proprietary Chinese Medicines

General Guide

Substances listed in the Poisons List Regulations (Cap. 138B), Antibiotics Regulations (Cap. 137A) and Dangerous Drugs Ordinance (Cap. 134) and ingredients found in registered pharmaceutical products are good indications as pharmaceutical products/ substances.

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Relevant Websites

Drug Office www.drugoffice.gov.hk Chinese Medicine Council of Hong Kong www.cmchk.org.hk Medical Device Control Office www.mdco.gov.hk Department of Justice Bilingual Laws Information System www.legislation.gov.hk

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Thank you!