Actual - Real Estate

When buying property in Bulgaria, the first law you will encounter as a foreigner is that you cannot. That is scheduled to change in 2013 after EU accession, but investors looking to ge

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

t a piece of the lucrative land boom in that country, popular as it is with tourists from Britain and elsewhere, need to go in with their eyes open to the growing pains of the Balkan le

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

Examples of combination products may in

al system that surrounds land or property purchases.

The law stipulates that foreigners may not purchase land or any property that comes with land. The popular way around this is for f

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

reign nationals to register a company in Bulgaria when purchasing the equivalent to an ‘English freehold.’ A foreigner may own a company in Bulgaria and that company owns the property.

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

his is a straightforward procedure, but shop around for a reliable lawyer to knit it all together. I have heard reports of people paying as high as ?5000 for such a service. At least Di

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

Combination pro

k Turpin wore a mask.

For those seeking a cleaner transaction, buying an apartment, especially new construction in the capital city of Sofia, is not only less complicated, but more lik

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

ely a sounder investment. The law against foreign ownership is irrelevant when buying an apartment with no land belonging to it outright. In addition to this it is usually correct to us

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

property values in the capital city as the fair marker of where the market really stands. Whilst many sun seekers may be transfixed by the idea of a coastal apartment on the Black Sea

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

oast or a rural cottage, prudent investors tend to invest in the capital, looking for a steadier and long term market growth. As you can lunchtime ski from Sofia, this is not so stupid

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

Another issue buyers must keep their eye on is the difficulty of establishing title. The previous rule of the communists has left many question marks hanging over ownership. Property

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

as been reclaimed after 45 years, families have changed since the communist government interrupted ownership and rights of succession remain unclear, especially when the long lost love

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

Following aspects would a

child appears on the horizon.

Recently I was winding up research on a property for a client in the Rodopi Mountains, was about to buy, only to discover the land on which it was built w

dd to the challenges in developing combination products:

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

s actually still state owned. Such information is not on a national database and must be researched the old fashioned way. This is not a cause for abstinence, assuming you have the righ

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

agent and legal help acting prudently on your behalf.

When purchasing a property, standard procedure is to make a preliminary contract with the seller. This should include a number of

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

factors including an initial down payment and a final payment date. There must be a clause stating that, to the knowledge of the seller, there are no debts on the property and should an

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

be found after the transfer of the property these should remain the duty of the seller to deal with. Any penalties for failure to realize the preliminary contract should be reasonable,

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

Professional from academic institutions, pharmaceutical industries, health care indust

fair and equal to both parties. For this reason I always recommend having your own lawyer, experienced in Bulgarian property law and fluent in both Bulgarian and English. Without this

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

afeguard a contract can be so one-sided as to verge on being criminal.

There are hurdles to jump but they should not be a serious impediment to purchasers. Buyers need to be aware tha

.

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

the bountiful opportunities for bargains that exist in Bulgaria come with a parallel lack of maturity in the market. There are opportunities to pick up cheap properties as the estate b

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

Companies that provide selfless information through particip

siness is so underdeveloped with no information sharing, obtaining the right assistance will be the key to success. Jump in, but with both eyes open and with the right help by your side

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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