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Title: Olivenol: Food or Health Supplement
Date: 30-Nov-2012
Category: Pharmacy Legislations and Issues

ANNOUNCEMENT ON RECENT ACTIVITY IN COMMUNITY PHARMACY CONCERNING PRODUCTS CLASSIFY AS FOOD OR HEALTH SUPPLEMENTS.

There has been a recent  activity concerning community pharmacy in that some have been visited by Enforcement officers of the Pharmaceutical Services Division and a certain product, Olivenol was confiscated as it was deem not a registered product.

The issue seems to be that there is an ambiguity as to whether that product is categorized as a food, or a supplement.  Community pharmacy usually depend on the supplier on such registration matter.  

There are various opinions on this issue.  However  in order not to have excessive speculation on this, the opinions are not published here.  Nevertheless MPS is concern over this and has taken note of them.  To resolve this, it is hope that the MPS would be able to seek  an appointment with the relevant authorities for a dialogue. However it is confident that the authorities will manage this in a fair and just manner. (Update: see the report on the meeting)

Meanwhile the advise to community pharmacy is to remove the relevant products from the shelves.

If it is of any help one of the council members extracted this information from the BPFK website on Guidance on Product Classification Oct 2011 as follows:

FOOD-DRUG BASED
A) FOOD
 
v A product is considered as food if the active ingredient is less than 20%
 
v The food based ingredient is more than 80%
 
v It is not in pharmaceutical dosage form such as capsule, softgel, swallowed whole tablet.
 
Note : It is advisable that the company change the dosage form to classify a product as food if the food ingredient is more than 80% (e.g liquid, powder etc)
If a product categorised as food, please refer to:
Food Safety & Quality (FSQ) Division, Ministry of Health
Aras 4, Bangunan Plot 3C4, No. 26, Jalan Persiaran Perdana,Presint 3, 62675 Putrajaya.
NOTE: Criteria for Food-Drug Based Classification is subject to change in accordance to decision made in Food Drug Interphase (FDI) meeting held at least twice annually.
B) DRUG/ MEDICINE
 
v A product is considered as drug/medicine if the active ingredient is more than 20%.
 
v It is in pharmaceutical dosage form (e.g capsule, softgel, swallowed whole tablet).
 
Note : If the product is considered as drug/medicines, the applicant/ MAH are responsible to fulfill all requirements of registration in Drug Registration Guidance Document (DRGD). Please refer to www.bpfk.gov.my Regulatory Information Drug Registration Guidance Document (DRGD).
TRADITIONAL
 
v A product falls under category of traditional if it fulfills the definition of traditional product (please refer, 5. Product Classification Medicine, F)
 
HEALTH SUPPLEMENT (HS)
 
v A product falls under category of Health Supplement if it contains ingredients listed in Appendix 9 (please refer, 5. Product Classification Medicine, D)
 
v If a product is a combination of traditional and health supplement ingredients, the product is considered HS.


Note : Please be informed that products contain active ingredient listed in ‘Drug Registration Guidance Document’ Appendix 9 List A & B are under control of Health Supplement Unit. It is advisable for you to provide acceptable safety profile, clinical study or justification to support the combination of ingredients that are NOT listed in List B upon registration. Failure to do so may result in REJECTION of product registration application.

>> Related article:  Olivenol and Unregistered Products



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