Advice You - Finance

This is a jurisdiction that may have a few small features regarding taxation but when it comes to privacy it is most defi

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

cient.

One disadvantage of Hong Kong companies is that annual financial statements must be prepared, audited and present

; 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 to the Government to prove that the company did no business in Hong Kong and therefore owes no taxes. Such statements

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

ust be presented within 18 months of the date of incorporation. This is our opinion is grounds for finding a friendlier j

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

urisdiction.

One has no idea where this information that you file is going to wind up. More trouble follows:

Directors

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

Combination pro

nd Shareholders are in both the Government and Public record, note we said shareholders. No privacy here. There is no req

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

uirement to report the Beneficial Owner to the Government, if nominees are used but if he or she wants to be a shareholde

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

as one should, then the privacy is gone out the window. No bearer share companies here.

Another negative is that the co

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

mpany must have a Secretary resident in Hong Kong, think more expense unnecessarily.

There are no anonymous bearer share

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

corporations in Hong Kong.

Banking is not encouraging in Hong Kong.

In order to reduce the possibility of money launder

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

ing , the Hong Kong Monetary Authority ordered banks to record whether Yuan deposits are made in cash, or via the convers

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

Following aspects would a

ion of other currencies. So they are watching and recording the inflow of foreign currencies, not good.

It also urged th

dd to the challenges in developing combination products:

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

financial institutions to keep track of multiple accounts opened by the same customer, and to ensure that the 20,000 Yua

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

n per day exchange limit is not breached by spreading the transactions across several accounts.

Note this exchange limit

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

is about $2500.00 dollars, fairly small and privacy invading.

Hong Kong is in Mutual Legal Assistance Treaties read one

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

with the USA right here:

http://hongkong.usconsulate.gov/ushk/treaties/1997/0415.pdf

Hong Kong authorities can freely o

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

Professional from academic institutions, pharmaceutical industries, health care indust

der financial institutions to report customer identities, etc.

The Joint Financial Intelligence Unit can release informa

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

tion to foreign governments freely with the understanding that the information will only be used for investigations not 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

evidence which would require additional requests for permission. This is just red tape and will be approved. This is not

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

Companies that provide selfless information through particip

a privacy jurisdiction and we see no advantages to using Hong Kong. For more information go to: http://www.panamalaw.or

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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