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Small and medium sized businesses throughout the UK are risking not being compliant

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

with the new fire prevention laws that came into effect on 1st October 2006.

Virtua

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

Examples of combination products may in

ly all non-domestic premises in England and Wales are affected by the Regulatory Ref

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

orm (Fire Safety) Order (RRO) 2005. The RRO states that anyone responsible for premi

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

es must carry out a fire safety risk assessment or face possible prosecution.

A sur

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

Combination pro

ey carried out by the Federation of Small Businesses in March highlighted the potent

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

ial problems. A spokesman for the FSB commented, “We carried out a survey in March 2

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

06 which showed 59% of firms in England and Wales were unaware of the new requiremen

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

s”.

So what can businesses do to make sure they are compliant?

1. New fire safety

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

guidance has been published by the department for communities and local government a

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

d can be downloaded from it's website at ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

s.gov.uk/" target="_blank">www.firesafetylaw.communities.gov.uk

2. If you are s

dd to the challenges in developing combination products:

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

till not sure if or how the new laws affect you contact your local fire safety offic

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

r

3. Contact your insurance broker. They maybe able to provide you with advice and

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

uidance when it comes to risk management for your business

Risk management and maki

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

ng sure you have the correct level of protection is vital for any business so these

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

Professional from academic institutions, pharmaceutical industries, health care indust

ew laws need action now.

Remember:

a. Old fire safety certificates will no longer

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

e valid

b. You risk prosecution from the fire and rescue service if you do not adhe

.

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

re to these new fire safety laws

c. Your insurance cover may also be affected by fa

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

Companies that provide selfless information through particip

ling to comply

Make sure your premises are protected from fire before it's too late

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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