Top Adding - Legal

Energy Safe Victoria the regulator for electrical and gas safety in Victoria, has not placed any specific regulations o

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

n electrical test and tagging. However, that under the Victorian Occupational Health and Safety Act (2004) employers ha

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ve a legal liability to provide and sustain a safe working environment which is without risks to employees’ health. Thi

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

s means identifying any dangers related with electrical equipment in a workplace.

In the CDROM Managing Safety in Your

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

Workplace distributed by Worksafe Victoria, it is advised that all electrical testing and tagging for all portable non

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

hard wired appliances, leads and power boards is completed to uphold the employers duty of care under Section 21(2)(a)o

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

f the Victorian Occupational Health and Safety Act. To receive a free CD ROM Contact WorkSafe on 03 9641 1333

AS/NZS37

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

0 In-Service Safety Inspection and Testing of Electrical Equipment is acknowledged all over the country as the minimum

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

safety obligation for the workplaces. Worksafe Victoria has advised the Victoria Trades Hall Council that they are now

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

"actively enforcing the standard and inspecting all types of premises to confirm introduction of minimum safety testing

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

programs consistent with AS3760." This standard applies to all types of electrical appliance including leads and power

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

boards in offices, factories and so on (ie computers, microwaves, kettles, tools and even mobile phone chagres).

If th

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

e workplace is a construction site, then the Industry Standard for Electrical Installations on Construction Sites must

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

apply. Section 4.3 states all portable electrical equipment and flexible electrical cords, must be tested in accordance

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

with AS/NZS 3760 “prior to its first use, and every 3 calendar months thereafter, while being used on the site.” result

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

s must be recorded and made available for an audit.

Testing and tagging of electrical appliances can be done either by

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

a qualified electrician or a competent person (someone who has successfully completed an approved course at a TAFE col

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ege)

Advice to Employees

Testing and tagging of all portable appliances as per AS3760 should now be the norm in all w

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

orkplaces. If this is not the case in your workplace, you as an employee, you should approach your employer and request

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

that this be done as soon as possible. If it is not done, then the employer is breaching his/her duty under Section 21

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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