Our company produces medicines and medical devices. Is it possible to export medical products without market authorization or any registration procedure abroad?

Yes, it is possible. Many countries have their own classification of medical products that differs from country of manufacturer. Often, medical devices 1st and 2nd classes, personal hygiene products and cosmetics do not require obtaining a market authorization and could be imported after a simple procedure for obtaining an import permit. The main thing is to pass the classification procedure in the country of export and get a conclusion about which class your product belongs to.

Our company plans to produce a generic drug. What can prevent us from entering the market from a legal point of view?

From a legal point of view, it is necessary to protect yourself from violation of the rights of third parties, because if a patent violation is established, you will have to pay compensation in the form of twice the cost of the released batch of pharmaceutical products. Therefore, it is necessary to check whether the patents of the originator and other companies are violated, since the original drug may be protected by more than one patent, including patents on the substance and its forms, the composition of the pharmaceutical, the use for a specific purpose, and possible combinations. It is very important to find all the patents that may interfere with the release, and to identify ways to circumvent them from a legal and technological point of view.

Is it possible to bring a product to export markets with the same tradename as on the local market?

In case of entering new markets, it is necessary to check whether there is already a registered identical (or confusingly similar) trademark in the pharmaceutical category in the regions of export. If there is, then the release of the drug is possible only under another name.

However, even if there is no patent for the original tradename in these regions, it is important to think about linguistic and cultural characteristics of each country. If it turns out that your name is not acceptable for any of the countries, it is important to choose a different name. In this case, a synergy of efforts between the marketing department and patent attorneys is necessary. Choosing a suitable name will allow you to effectively bring the product to a new market and not lose sales.

What form of payment is applicable in the Russian pharmaceutical market?

The most often way is post payment. For all biggest distributors period of payment is 120 days. It is suitable as for wholesalers as for huge pharmacy chains. Meanwhile, sometimes it is necessary to use consignation, especially if your brand is new and unknown. Also, important to know, that one of popular payment way in a lot of countries “letter of credit” is not suitable in Russia, because Russian bank system is different from international banking system.

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