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Although relatively quiet in comparison to its more commercialised neighbour, the Republic of Cyprus, Northern Cyprus has long been home to a thriving, British ex-pat

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

community. In recent years the north has seen a marked increase in property purchase by overseas investors, keen to take advantage of the relatively low prices. As wit

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

Examples of combination products may in

h any overseas purchase, there are potential pitfalls for the unwary, but buying in Northern Cyprus need not be the potential nightmare it is made out to be by some.

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

Following a military coup by Greek Cypriots, the island was invaded by Turkish troops in the mid 1970s, following which the island was effectively divided into two par

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

ts; the south governed by Greek Cypriots and the North by Turkish Cypriots with a border between, controlled by the UN and which for years could not be crossed. Recent

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

Combination pro

easing of the political gap between the two parts has seen the border effectively opened, and EC citizens, as well as Cypriot nationals, can freely cross and stay unr

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

estricted in either country. Currently the government in the south remains the only one generally internationally recognised and as both Turkish and Green Cypriots ‘lo

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

st’ land in the 70s, this remains a point of contention.

There have been many attempts at finalising the political situation in Cyprus, the most recent and comprehens

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

ive being the Anan plan. Proposed by the UN, this would have involved a complex scheme of land restitution and compensation, followed by a constitutional settlement. T

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

he plan was put to a vote in both parts of the island, but whilst accepted by the Turkish Cypriot population, it was rejected by their Greek counterparts.

Currently t

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

erefore, land in Northern Cyprus falls into different categories. Land which was held in Turkish Cypriot title prior to the 70s is under no dispute. Though comparative

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

Following aspects would a

ly costly, there is effectively no fear of loss in the future. The vast majority of property and development, however, is built on land granted title after 1974. Turki

dd to the challenges in developing combination products:

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

sh Cypriots who had lost property in the south and who fled to the North, were allocated land under a points system. Such land and property was formally Greek Cypriot

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

owned and title was granted by the Turkish Cypriot authorities. Be cautious of land that has buildings on it which existed prior to 1974. But most properties have been

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

built on formally undeveloped land. It is unlikely in the extreme that any final plan would include an element of restitution of such land, and neither the Anan plan,

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

nor any other, has proposed such an idea. There may be a possibility that in the event of a final resolution of the ‘Cyprus Problem’ a degree of compensation might be

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

Professional from academic institutions, pharmaceutical industries, health care indust

payable. In all truth, this would be most unlikely to be substantial and is anyway reflected in relatively lower purchase prices today.

Any prospective purchasers wi

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

ll find the legal system in Northern Cyprus bears strong resemblance to that in Britain. Any decent solicitor will be able to give proper advice and it goes without sa

.

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

ying that this is essential. More importantly for prospective buyers, the recent rush of buying has tailed off, so this may be a good time to bag a bargain. As for bui

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

Companies that provide selfless information through particip

lding and renovating, that’s a different story, and be warned that the biggest problem of all in Northern Cyprus is the relatively laid-back attitude of the work force

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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