Russian Business Forum

[Markus]

Import of the medicinal product and its medical application in Azerbaijan are allowed only after carrying out of the state registration procedure. If the registration procedure has been successfully completed you get the registration certificate which is valid within 5 years.

We are a private independent professional agency that assists foreign and local companies in state registration of their products in Azerbaijan.
We have a many years of practical experience that allows us to achieve great success as in dossier preparation process, as in communication with state authorities.

The counsels of our consultants will help you to overcome with the least wastes the bureaucratic barriers at the way of the state registration or re-registration procedure of the medicinal product.

Service of registration and re-registration of the medicinal (medical) product in Azerbaijan:
http://russia-agency.eligne.com/13e-reg ... aijan.html

[Markus]

"Until today the registration of medicinal products in Azerbaijan was a mere formality and its procedure was reduced to the bare minimum. The new procedure of registration has been worked out by the Centre’s specialists and the representatives of the World Health Organization (WHO) whom also established which standards to meet....."

The regulation of the pharmaceutical market in Azerbaijan.

[Markus]

LEGALIZATION AND TRANSPARENCY OF THE PHARMACEUTICAL BUSINESS

- Let’s touch upon a subject of the pricing policy of medicines registration. As far as we know, formerly, a businessperson paid officially 500 US dollars for the registration of a medicine and plus 1000 US dollars besides - in order to oil an official’s hand. How do matters stand today?
- In order to determine the price guidepost concerning the registration of medicines, we got through a lot of work, studying the experience of CIS-countries and other foreign states. For example, in USA, the registration comes to 220 thousand dollars, in Russia - 16 500 dollars. As of the population and the market volume, our country is similar to Belarus, where the price of medicines registration is about 4000 dollars. After continuous discussions, we decided to determine the registration price in amount up to 1300 dollars for brand generics (such preparations represent 95% of Azerbaijan pharmaceutical market). The similar price is applicable in Tbilisi and Turkmenistan. As regards illegal “bonuses” - these old methods fell into oblivion.

- In fact, there was the legalization of “shady” cash flows directed into pockets of officials of the Ministry of Health...
- Above all, it resulted in the transparency of the rapports between the pharmaceutical business representatives and controlling authority (in this case - the Center of Innovations) and it is very important. After all, only in this case, we may demand the observance of all rules by a businessperson. Therefore, some persons are pleased at this fact other ones are aggrieved. The latter ones will have to change their methods of work to civilized ones.

- What counterfeited products did you “catch” from the flow of medicines of our laboratory?
- There is always a certain “yield”, since, as we already said, Azerbaijan pharmaceutical market is very far from perfect today. Literally one of these days, our specialists prevented the importation to the territory of Azerbaijan of the large lot of widely used drug – “TheraFlu”. One of supplying companies discussed above attempted to bring in to the territory of the country. It should be immediately noted that it was a counterfeited preparation faked-up in order to resemble the registered trademark of world-famous manufacturer - TheraFlu. This counterfeit was not corresponding with original according to all eleven parameters, with which the expert examination of a medicine is realized. The composition of this “medicine” did not include even the principle active agent.
In the upshot, such counterfeits imported to the country by intermediary firms cause harm, first of all, to the image of a world-famous manufacturer, secondly, to official distributor, who cares about the reputation of the represented company. The fact of no small importance is that it adversely affects the volume of sale of the original high-quality medicine with the same name. Of course, a certain share of pharmaceutical counterfeits presents everywhere, where the pharmaceutical market exists; but the matter is that every country should minimize this share and protect its consumers from off-grade products.

[Sophie]

- As we know, in Azerbaijan, the medicines’ price includes the value added tax (VAT) at the rate of 18%. The similar drugs are cheaper in Georgia, where such tax is absent. This advantage, during many years, allowed Georgian businesspersons (including distributors) to increase their volume of medicines sales owing to Azerbaijan consumers, thus, their funds were used for the development of Georgian economy. As a consequence of it, analogous Azerbaijan pharmaceutical companies bore considerable losses and could not struggle against such situation. What measures do you foresee in this respect?
- It is a problem of parallel import. This problem is quite serious. But there is a positive change: for the first time, in the pharmaceutical market (in accordance with the internal order of the Center of Innovations), since September 1, 2006, the importation of medicines to the territory of Azerbaijan will be realized par two parameters - through the distributors of manufacturing companies (and, respectively, per registered trade package intended exactly for our country - the packages of the same manufacturers may be different, if they intended for different countries). Thus, only that package, which is registered in the territory of Azerbaijan, may be imported to the country. In other words, if formerly we could prohibit the importation only on the sole ground (quality index), now, we have a real legal field, permitting to forbid the import of the preparations in packages intended for other countries. It may solve the problem of parallel import and, thus, we will protect the rights of national pharmaceutical companies, distributors, and their consumers.

Nigyar Medzhidova, Zerkalo Newspaper