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.
"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....."
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Pharma Membre
Joined: Feb 13, 2007
Posts: 5
Posted:
Tue Feb 13, 2007 3:51 pm
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.
Pharma Membre
Joined: Feb 13, 2007
Posts: 5
Posted:
Tue Feb 13, 2007 3:52 pm
- What methods of the control over the counterfeited medicines imported to the country do you use?
- Under the Center of Innovations, we established the Inspectorate engaging in the control over the activity of pharmaceutical institutions and over the quality of medicinal preparations. In the Laboratory of Quality Control (of medicines), a “Hot Line” is organized. Any consumer, when he/she doubts the quality of a purchased drug, may dial the number of the Hot Line, and, in accordance with the name of this drug and its series, get to know if this drug passed the quality control. If it did not, then the customer may address in writing to the Inspectorate of Medicines Quality Control, and if this customer presents a check attesting the purchase of such drug, a complaint about the pharmacy sold such drug may be lodged. At that, we ought not to forget that in the tandem “customer - pharmacist” we must also protect the rights of the pharmacist in order to prevent the cases of blackmail from the direction of some customers; unfortunately, such cases are not excluded. By the way, formerly, the infringers being representatives of companies or pharmacies may be called to account only in the court of justice, but such process was delayed for many months and the pharmacies continued their business, neglecting consumers’ rights. Today, a new Provision is approved; it permits to us to apply penalty measures for the infringers - both for pharmaceutical institutions or pharmaceutical company.
Pharma Membre
Joined: Feb 13, 2007
Posts: 5
Posted:
Tue Feb 13, 2007 3:54 pm
- 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
ricky Membre
Joined: Aug 08, 2007
Posts: 1
Posted:
Thu Aug 09, 2007 7:04 am
Dear Sir /Madam
I want to know about the registration of medical products in azerbaijan
1)Required documents
2)Official charges per product
3)Official charges per dose
4)contact person in baku
5)your charges
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.
Quote:
Sophie Membre
Joined: Jan 26, 2006
Posts: 18
Location: France
Posted:
Sun Aug 26, 2007 9:03 pm
Hello ricky
Follow the link and ask your questions directly to company....
And don't forget to mention which company you represent....
Here is only discussion board....... !
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advisor52 Membre
Joined: Sep 09, 2007
Posts: 2
Location: Malta
Posted:
Mon Sep 10, 2007 2:58 pm
Our client is a major global pharma which employs several thousand employees world- wide within its various subsidiaries. The intentions of the company is to make a significant investment - minimum 51% of shares - in a pharmaceutical company In Russia, Ukraine and any other CIS countries with the following characteristics :
Good financials
Hospital presence
Therapeutic Areas : Oncology, Critical care, Neurology
Ideal size : (minimum) Turnover 10 million Euro
Infrastructure : Marketing and Sales reps in key markets particularly witha hospital presence
If you are connected with a company falls within the above general profile then we would be happy to persue further dialogue with you.
Edward Porter
INTERNATIONAL FINANCE ASSOCIATES
St Joseph Triq il-Gjacinti
Santa Lucia SLC 1171
Malta
Tel (+356) 9986 1192 Fax ( +356) 21 665928
http://www.ifa-consultants.com
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