Answers - Legal

A franchising company must always be a Stickler for details when it comes to

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

government licensing and compliance with Law of their franchises and franchis

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

Examples of combination products may in

ed outlets. If a franchisee fails to comply with Law or secure the proper go

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

ernment licenses to operate their business it could become a public relations

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

nightmare.

Not only must franchising companies monitor their franchises, th

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

Combination pro

y should also address this issue prior to the commencement of the franchise i

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

n the franchising company’s franchise disclosure documents and franchise agre

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

ments. It is for this reason that I added a clause into all of my franchisin

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

g companies franchise agreements. Below you'll find a clause;

3.24 Complianc

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

with Law

3.24.1 Government Licensing

Franchisee will comply with all natio

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

nal, federal, state, regional and local laws and regulations pertaining to th

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

Following aspects would a

e operation of the Franchised Business and will timely obtain and maintain an

dd to the challenges in developing combination products:

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

and all permits, certificates, registrations, insurance or licenses necessar

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

y for the full and proper conduct of the Franchised Business. Franchisee will

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

pay promptly, as they become due, all national, state, city and county licens

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

ing, registration and permit fees and charges in connection with the operatio

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

Professional from academic institutions, pharmaceutical industries, health care indust

of the Franchised Business.

-- -- -- -- -- -- -- --

Now then, you must con

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

sult your own franchise attorney to determine how best to address this issue

.

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

or your company and to make sure that you are protected as a franchisor to in

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

Companies that provide selfless information through particip

sure the integrity of your brand-name. I hope you will consider this in 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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Answers - Franchisee Compliance With Law and Government Licensing Issues

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