Cases

REGULATORY

VARIATIONS TO ARTWORK

We all know what can happen when a formal defect on the Russian version of the artwork (leaflet or carton box) can oblige the foreign manufacturer to re-import the finished products, re-pack and ship them back again, with consequences in higher logistic cost and lost revenues, as well as technical requirements such as the Cold Chain.

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TRANSFER OF MARKETING AUTHORIZATION WITHOUT
SALES DISRUPTION

Company A (abroad) buys a portfolio of medicines from Company B (abroad, also), with existing sales in Russia. Inpharma has managed to transfer the license successfully, helping registering the new products at Russian Ministry of Health, without disrupting sales.

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BUREAUCRATIC ISSUES

Due to the poor communication between an Expert organization and the Russian Ministry of Health, it was almost impossible for a European manufacturer to submit samples to the experts. Inpharma submitted official letters on time, leveraging in favor of the manufacturer, and finally solving the issue.

LOCAL STRICT REQUIREMENTS

Very often, foreign companies do not understand which part of the Russian documentation they are required to fill – with a consequent formal rejection. Inpharma is able to align the request of the Russian Ministry of Health with the technical explanation given by the manufacturer, in Russian language.

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ORPHAN DRUG

A manufacturer willing to register an Orphan drug – medicinal products- intended for pathogenic treatment.

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LACK OF TIME

Any manufacturers in Russia are given only 15 days (upon communication that the decision has been received) to manage submission of the samples of APIs for the future expertise, and it was almost impossible for a European manufacturer. In several occasions Inpharma assisted companies to be able to submit its documentation just before closing date of application.

 

 

SALES/RETAIL

“IN-HOUSE” VS. “RENT-A-REP” (PHYSICIANS CALLS)

A commercial director of a Western European company looking at deciding whether to set up a structure of representatives versus renting them. Inpharma has made deep research into the various options of commercial reach, clusters and costs, and provided the manager with a clear understanding of the possibilities available.

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FEES ANALYSIS FOR BABY MILK (PHARMACY RETAIL CHANNEL)

Inpharma has realized a project to understand the average market fee for a manufacturer looking at entering the Russian market of baby milk (infant formula).

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SALES BUDGET FOR COSMECEUTICS (PHARMACY RETAIL CHANNEL)

A South European manufacturer of high end creams and ointments looking to enter the Russian market had no idea of the process of registration fees as well as the promotional budget needed. Inpharma has prepared a full report followed by a budget and an action plan.

 

LOGISTICS & DISTRIBUTION

 COLD CHAIN REQUIREMENTS

A Western European manufacturer was looking at a new Logistic provider with a strong reputation for managing the complex Cold Chain requirements. Inpharma has worked out a solution in conjunction with ORFE AO. Today this manufacturer ships daily its products all across Russia.

 
 

VAT AND TAX

PERMANENT ESTABLISHMENT RISK

A manufacturer looking at decreasing its risk of permanent establishment in Russia without having a legal entity, avoiding problems related to its VAT and TAX.

 
 

MARKET ACCESS

PRICE INCREASE

A manufacturer looking to increase the price of its reimbursed products by several times. This has been possible by having a full understanding of the Russian Law and its counterparts in Europe, due to the typical price-reference system.