Main Subject - Business

As of the 8th November 2006, all HSMP applications shall we considered under a new en

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

hanced points criteria system. Work Experience, Significant Achievement, Skilled Part

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

Examples of combination products may in

er and GP provisions have been withdrawn from the scheme altogether. They have been r

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

placed by more stringent criteria in relation to academic qualifications, previous ea

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

nings, age and previous work and study in the UK.

Applicants may be outside the UK a

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

Combination pro

d may make an application to enter on this basis. Alternatively, applicants may alrea

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

y be working in the UK - usually on the basis of a Work permit - and may apply to swi

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

ch their status under the HSMP for the benefit of the far greater flexibility it offe

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

s. A number of clients switch to HSMP from a student visa or from a Working Holiday M

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

ker.

Individuals already in the UK may apply to switch into HSMP without leaving the

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

UK provided they have leave as a:

* Work permit holder; or

* Student who has succes

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

Following aspects would a

fully obtained a degree level qualification on a recognised degree course at either a

dd to the challenges in developing combination products:

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

UK publicly funded further or higher education institution or a bona fide UK private

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

ducation institution which maintains satisfactory records of enrolment and attendance

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

or

* Postgraduate doctor or a postgraduate dentist or trainee general practitioner;

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

or

* Working holidaymaker; or

* Science and Engineering Graduates Scheme participan

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

Professional from academic institutions, pharmaceutical industries, health care indust

; or

* Innovator; or

* Fresh Talent: Working in Scotland scheme participant.

There

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

are a number of calculators online that calculate your eligibility: www.international

.

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

orkpermits.com/hsmp-calculator.html

NB: As of 2008 the immigration process in the UK

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

Companies that provide selfless information through particip

will change and all UK visas / work permits will be on a skilled points based system.

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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Main Subject - The Highly Skilled Migrant Programme [HSMP] - Employment Without Boundaries

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