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E-Folder - BVI - New Memorandum & Articles of Association for Old
On 1 January 2007 all BVI companies formed under the Old Act (Internati
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
onal Business Companies Act (Cap 291)) will be automatically re-registe
; 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
ed under the New Act (BVI Business Companies Act 2004). There is an op
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
portunity to re-register under the New Act during 2007. This means tha
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
it will be necessary to consider adopting new Memorandum and Articles
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
f Association….more
On 1 January 2007 all BVI companies formed under t
On 1 January 2007 all BVI companies formed under t
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
he Old Act (International Business Companies Act (Cap 291)) will be aut
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
matically re-registered under the New Act (BVI Business Companies Act 2
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
004). There is an opportunity to re-register under the New Act during
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
007. This means that it will be necessary to consider adopting new Mem
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
randum and Articles of Association relevant to the applicable laws. It
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
’s important not just for good housekeeping reasons but the M&AAs will
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
eed to be up to date under the new legislation when an institution such
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
as a bank requires sight of them.
Whilst reviewing the M&AAs there
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
s also the opportunity to remove bearer share provisions if they are no
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
required, a move which will ultimately save US$750 in annual Governmen
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
t Tax.
We recommend the above action so that every BVI company’s M&AA
We recommend the above action so that every BVI company’s M&AA
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
oes not contradict and is fully consistent with the law that now applie
.
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
s. ILS can effect these changes efficiently and cost effectively.
Vis
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
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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