Tag Archives: pharmaceuticals

Online sales of medicines are allowed

16 May 2020 the Russian Government enacted the rules on online sales and delivery of medicines (the Rules). According to the Rules, online sales of medicines are allowed. The exceptions are: RX medicines, narcotic and psychotropic medicines, and medicines containing more than 25% ethyl alcohol.

To receive authorization for online sales a pharmacy shall have a license for at least 1 year, minimum of 10 retail stores, an Internet website or a mobile app, a delivery service, or a contract with such service provider.

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IP Court restrained to sell and market a generic drug until the patent expiry

On 24 April 2018 the Intellectual Property Court published its Decision in case A41 85807/2016 between Swiss-based Novartis AG and local generic Nativa LLC.

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ILN Today Post

Neil P. Di Spirito Joins Epstein Becker Green, Further Strengthens Firm’s FDA Capabilities

Washington, DC (August 16, 2018) – Epstein Becker Green (EBG) is pleased to announce that Neil P. Di Spirito, an attorney with more than two decades of experience advising pharmaceutical, medical device, biologic, and life sciences clients on compliance with U.S. Food and Drug Administration (FDA) regulations, has joined as a Member of the Firm in the Health Care and Life Sciences practice in the District of Columbia and Florida.

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Lidings Demonstrates Outstanding Reputation Among Best Legal Advisors in Russia

Reflected by the Pravo.ru’s Sympathy Rating – 2017 identifying the most prominent legal advisors in Russia based on the feedback of peers Lidings recognized as a leading firm for its expertise in employment law and pharmaceuticals and healthcare industry practice area. Individual and moreover exclusive recognition as the only recommended lawyer in this sphere, for a remarkable work for advising pharmaceutical companies in Russia, is given to Lidings’ Managing Partner, Head of the firm’s Pharmaceuticals and Healthcare industry practice, Andrey Zelenin.

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ILN Today Post

Report from Russia: Strengthening Government Control or Striving for Compliance with International Standards?

The Russian pharmaceutical market has been extensively developing over the past decade, largely influenced by foreign investments in this area of the country’s economy. It is currently one of the top 10 largest pharmaceutical markets in the world. At the same time, the Russian pharma market has witnessed stricter state regulation of pharmaceutical activity, generally defined as a certain restraining measure over uncontrolled pharma market growth. The escalation of state control within the industry is especially noticeable during the past two years. More…

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Lidings becomes advisor of choice for the leading pharmaceutical companies

Lidings law firm, the leading legal advisor to foreign businesses in the Russian market, further strengthens its Pharmaceutical practice with the addition of key international clients, leaders in their field.

With Life Sciences being one of Lidings’ most rapidly developing practice areas the firm’s client list boasts industry leaders including pharmaceutical giants like Boehringer Ingelheim, Ferring Pharmaceuticals, Ipsen Pharma, MEDA Pharmaceuticals, Sanofi Aventis, Servier, and others.

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ILN Today Post

Bill on amendments to the Federal Law “On circulation of drugs”

The bill “On amendments to the Federal Law “On circulation of drugs” and to the article 333.32.1. of the second part of the Tax Code of the Russian Federation” (hereinafter referred to as the “Bill”) has been published on the web-site of the Ministry of Healthcare of the Russian Federation.

The Bill offers a number of major changes to the Federal Law # 61- FZ “On circulation of drugs” dated 12th of April 2010 (hereinafter referred to as the “Law- # 61-FZ”) primarily concerning the registration of new drug products. Thus, the Bill amends inter alia the article 4 of the Law- # 61-FZ by clarifying certain existing definitions (for instance, “generic drug”) as well as introducing the new ones: “comparison drug”, “biosimilar product”, “substitutable drug”. More…

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Intellectual Property Alert: Supreme Court Ruling will have significant impact on pharmaceutical industry

For nearly a decade, the U.S. Supreme Court has declined to consider the question of whether so-called “reverse payment” or “pay-for-delay” agreements between branded pharmaceutical manufacturers and prospective generic competitors to settle patent infringement lawsuits violate federal antitrust laws. On December 7, the court finally granted certiorari on a petition by the Federal Trade Commission (FTC) in order to resolve a dispute between several of the federal circuit courts of appeals as to whether reverse payment agreements are lawful per se, as several appellate courts have held, or are presumptively anticompetitive.

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Drug and Pharmacy Alert: Illinois appeals court upholds pharmacists’ right to refuse to dispense emergency contraception

An Illinois appeals court recently held that pharmacists are permitted to refrain from prescribing emergency contraceptives, finding that health care professionals are protected by an Illinois state law. The plaintiffs, both individual pharmacists and corporations that own pharmacies, had challenged an order by former Governor Rod Blagojevich that required pharmacists to dispense “Plan B,” a type of contraceptive also known as the “morning-after pill.” The appellate court’s decision to allow individual pharmacists to claim the protection is consistent with a plain reading of the Illinois statute. The statute’s overbroad wording reads as follows:

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U.S. Supreme Court Grants Review of the "Outside Sales" Exemption Found Applicable to Pharmaceutical Sales Representatives

By:      David Garland and Douglas Weiner

In February 2011, the U.S. Court of Appeals for the Ninth Circuit gave a resounding victory to employers in the pharmaceutical industry by finding that pharmaceutical sales representatives are covered by the outside sales exemption of the Fair Labor Standards Act (“FLSA”). Christopher v. SmithKline Beecham, No. 10-15257 (9th Cir. Feb. 14, 2011). Plaintiffs, and the U.S. Department of Labor (“DOL”) in an amicus brief, had argued the exemption did not apply because sales reps are prohibited from making the final sale. Prescription medicine in the heavily regulated pharmaceutical industry can only be sold to the ultimate consumer with the authorization of a licensed physician. Sales reps use their “selling skills” to persuade doctors to prescribe their employer’s products when the doctor’s patients have a medical need for them. Sales reps do not transfer title to the medicine themselves.

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