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E-Articles - Thinking of Using St. Vincent and Grenadines as an Offshore Jurisdiction?
This is another example of a good jurisdiction gone bad. Until 2002,
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
SVG called for strict privacy under the Confidential Relationship P
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
reservation (International Finance) Act, 1996, but this was repealed
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 replaced by the Exchange of Information Act in 2002. This new A
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ct calls for the exchange or disclosure of information between local
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
regulators and foreign regulatory/government officials. Not good, q
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
uite bad actually since this will alow for wholesale fishing expedit
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
ons to see if there perhaps some sort of tax violation and all priva
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
cy is gone.
A Financial Intelligence Unit (FIU) was established in
A Financial Intelligence Unit (FIU) was established in
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
Saint Vincent and the Grenadines in May 2002, as called for in the t
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
erms of the Financial Intelligence Unit Act 2001. The FIU works read
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ily with other national government agencies to ensure that SVG has a
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
n effective anti-money laundering system (think privacy invading and
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
funds at risk of seizure during an investigation and of actually be
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ng forfeited if they see fit to do so). The FIU was allowed to join
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
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
the Egmont Group of Financial Intelligence Units in July, 2003. The
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
Group acts as a worldwide interface for Financial Intelligence Units
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
; more than 80 countries are involved. This means goodbye privacy.
.
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
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
SVG does not have anonymous bearer share corporations.
We can think
We can think
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
of no good reason to use SVG for anything when privacy is a concern
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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