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Russian Ministry of Healthcare has developed a draft regulation concerning remote retail of drug products


Russian Ministry of Healthcare has developed a draft Rules concerning remote retail of medical and veterinary drugs (excluding narcotic and psychoactive drugs) (hereinafter – the “Rules”).

The Rules have been developed in pursuance of the Instruction of Russian Government1 and scheduled for enactment by a separate governmental regulation. The text of the relevant regulation is available at http://regulation.gov.ru/projects#npa=60998 (in Russian only). The draft Rules as well as the relevant adopting regulation draft are currently at the stage of public discussion that shall continue until 27 March 2017.

According to the documents accompanying the regulation, the Rules have been developed in furtherance of the bill “Concerning amendment of certain laws of the Russian Federation with regard to remote retail of medical drug products” (hereinafter – the “Bill”). The purpose of the Bill is to reconcile the contradiction between current version of clause 24 Art. 5 of the Law 61-FZ2 (this clause allows for suspension of websites offering drug product for remote sale, delivery or transferring and does not require obtaining a special court decision ordering such suspension) and Art. 15.1 of the Law 149-FZ3 (this norm does not allow for inclusion of websites offering remote retail of drug products into a “black list”4 of suspended websites). In particular, the Bill establishes a list of cases where remote retail of drug products is permitted and provides for suspension (blacklisting) of the website non-complying with this legislation (that is, websites falling outside the list of cases where remote retail of drug products is permitted).

According to the Rules, in order to retail drug products remotely a company has to obtain a retail pharmaceutical license. The Rules are based on a principle of “one license for one website”.

Furthermore, the Rules set forth a number of requirements applicable to the content of the website used for remote retail of drug products.

There is no restriction concerning remote retail of prescription drug products as both prescription and non-prescription are allowed for such retail. The only restriction is imposed on remote retail of:

  • drug products subject to item recording requirement,
  • drug products with anabolic activity, and
  • drug products containing more than 30% of alcohol.

The Rules provide that a customer order (received by a company through its website or otherwise) shall be fulfilled by the company itself (including packaging and delivery of the ordered drug product). Hence, the company is not allowed to engage any third parties to fulfill the customer order.

In case of purchasing a prescription drug product by virtue of remote retail, a pharmacist of the company (that is, the person delivering the drug product) is obliged to review the original of the drug prescription whereas the customer is obliged to unpack the delivery packaging of the drug product and make sure that the list of the package contents corresponds to what has been ordered by the customer.

According to the expert opinion, expressed in the field-specific literature, the Bill had been initially scheduled for enactment in March 2017 but has been postponed later on. In any event, the draft regulation adopting the Rules has been developed based on the assumption that the Rules shall become effective as of the year 2018.

_____

1Instruction of the Government of the Russian Federation dated 19 September 2015 № ОГ-П12-6624
2Federal law dated 12 April 2010 № 61-FZ “On circulation of drugs”
3Federal law dated 27 July 2006 № 149-FZ “On information, information technology and protection of information”
4Unified register of domain names, webpage indexes of the Internet websites and network addresses allowing for identification of Internet websites containing information restricted from circulating in the Russian Federation



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