Actual - Real Estate

On March 9, Bulgarian Parliament allowed foreign citizens to buy land in Bulgaria. Now foreigners and

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

foreign legal persons may acquire land, plots, forests, forest stock land tracks and agricultural land

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

Examples of combination products may in

. This law also regards the adjoining land of apartments, flats, houses, etc. Now it can be bought as

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

easily as the building itself.

Foreigners, who are not permanently resident in Bulgaria will be able

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

o own land for a second home after the expiry of the terms set in Bulgaria's EU accession treaty.

Non

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

Combination pro

-Bulgarian citizens will also be allowed to have forests and land in preserved areas, unless these are

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

as are not exclusive state property. A buyer of a piece of land in Bulgaria should make sure whether t

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

e property he is about to buy is a part of a protected area or not, because if he buys a property in a

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

protected area he will have to follow the rules for using a land in a protected area.

Citizens of th

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

e EU who want to buy agricultural land in Bulgaria for farming and/or agriculture in Bulgaria are also

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

allowed to do so.

So far, foreign citizens who want to acquire land in Bulgaria had to establish a lo

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

Following aspects would a

cal company and buy the land on their company's behalf. This was a routine, legal procedure, used by t

dd to the challenges in developing combination products:

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

he thousands foreign buyers of Bulgarian properties. Now, after joining the European Union, Bulgria ha

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

rmonized this law with the EU legislation. And foreigners who want to have land in Bulgaria no longer

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

ave to settle a company to buy it. This made acquiring land from non-Bulgarian citizens a much easier

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

and less expensive procedure.

Land and plots attract the attention of foreign investors. Their price

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

Professional from academic institutions, pharmaceutical industries, health care indust

has been continuously increasing in the last years. The new coming obstacle for those investors is the

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

project "Natura 2000" declaring a number of plots in different parts of Bulgaria as preserved nature a

.

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

reas. This is a new project for Bulgaria, triggering a number of debates and discussions and if somebo

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

Companies that provide selfless information through particip

dy is about to buy a plot or agricultural land he should be sure that it's not a part of "Natura 2000"

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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