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Regulatory Reform (Fire Safety) Order 2005

Current fire safety Laws detail employers and others' with responsibilities for people's safety if there is an out break of fire. At present there are various pi

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

eces of legislation that contain fire safety provisions, which makes it difficult for people to know what is applicable to them and their business in respect of complying with the Law.

As part of the Governments

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

Examples of combination products may in

' commitment to reduce death, injury and damage caused by fire, the Office of the Deputy Prime Minister (ODPM) has now implemented changes in fire safety Law. Existing fire safety Law will be repealed or revoked

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

and be replaced with the Regulatory Reform (Fire Safety) Order 2005 (RRFSO), which has now received Parliamentary Approval (7 June 2005) and will come into force in April 2006.

The RRFSO will be a fire risk asse

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

ssment based approach where the responsible person(s) for the premises must decide how to address the risks identified, while meeting certain requirements.

By adopting a fire risk assessment, the responsible per

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

Combination pro

son(s) will need to look at how to prevent fire from occurring in the first place, by removing or reducing hazards and risks (ignition sources) and then at the precautions to ensure that people are adequately pro

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

tected if a fire were still to occur. Therefore the main emphasis of the changes will be to move towards fire prevention.

The fire risk assessment must also take into consideration the effect a fire may have on

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

anyone in or around your premises plus neighbouring property. The building fire risk assessment will also need to be kept under regular review.

The RRFSO will apply to virtually all non-domestic properties, incl

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

uding voluntary organisations and will be subject to monitoring and where appropriate enforcement by the Local Authority Fire Service (LAFS).

Overall the RRFSO is intended to be less burdensome and clearer.

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

Summary of RRFSO

All existing fire legislation will be repealed or revoked, which includes the Fire Precautions Act 1971, the amended 1997 Fire Precautions (Workplace) Regulations plus 100 other pieces of fi

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

re related legislation.

Fire certificates will be abolished and no longer issued.

Responsible person(s) will be responsible for fire safety. They must conduct a fire risk assessment regardless of the size of th

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

Following aspects would a

e risk.

The identified responsible person(s) would take full corporate liability.

Extended scope of consideration now to include property safety, fire fighter safety and the environment around the site. The res

dd to the challenges in developing combination products:

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

ponsible person would have a duty to protect all risks.

Unlike the amended 1997 Fire Precautions (Workplace) Regulations, the RRFSO places emphasis on business continuity and containing and preventing the spread

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

of small fires.

Protection is explicitly extended to all occupants, which would include employees, visitors, contractors and passers-by who would all have to be considered in the fire risk assessment.

What

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

are the implications for business?

When the RRFSO comes into force, building fire safety will be solely risk assessment led, therefore all businesses regardless of size will have to conduct a comprehensive f

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

ire risk assessment to enusre;

The elimination or reduction of risks (ignition sources),

There are suitable means of detecting & raising the alarm in the event of fire,

There are adequate emergency escape rout

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

Professional from academic institutions, pharmaceutical industries, health care indust

es & exits, There are appropriate type & sufficient quantities of fire extinguishers,

There are the correct type & sufficient quantities of fire signs & notices,

There are provisions for the correct maintenanc

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

e of installed fire equipment,

Suitable provisions for the protection of Fire Service personnel,

That occupants receive the appropriate instruction / training in, e.g. actions to be taken in the event of fire a

.

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

nd fire evacuation drills,

Who is the responsible person(s)?

Employer with control of a workplace,

Failing that or in addition;

Person with overall management of a building,
Occupier of premises,

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

Companies that provide selfless information through particip

Owner of premises (i.e. empty buildings),
Landlords (multi occupied buildings).

Where can I get help?

The Government intend to have guidance documents available in support of the RRFSO by early 2006.

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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