New changes to the current regime of remote sale of medicinal products

From September 1, 2021, amendments to the Rules¹ for issuing Permits for the Retail Sale of Medicines for Medical Use by remote Means, the Implementation of such sale and the delivery of medicines to Citizens, approved by the Decree of the Government of the Russian Federation dated 31.05.2021 N 827 (hereinafter – the Rules), came into force.

The main changes in the Rules are the following:

1. The cancelation of the mandatory requirement on availability of 10 retail locations in the pharmacy network. This amendment will allow non-chain pharmacies to participate in remote sale of medicines. In addition, the new edition of the Rules nullifies the requirement that a pharmacy must have a website for remote drug trading.
2. The feasibility of a contract between a pharmacy organization and an aggregator of information. The new edition of the Rules allows the conclusion of a contract with one or several owners of aggregators. When applying for a permit for remote trading through the website of the information aggregator of a pharmacy organization, it is necessary to specify the addresses of the website on the Internet or a mobile application (if available) belonging to the owner of the aggregator. It is also allowed to conclude a contract for the retail sale of medicines with the buyer with the possibility of pre-payment of the order by the owner of the aggregator on behalf of and at the expense of the pharmacy organization.
3. Price regulation. The retail price for a medicinal product specified in the purchase and sale agreement should not exceed the retail price of a medicinal product in a pharmacy chain. It is important to note that the cost of delivery of the medicine is not taken into account when calculating its price.
4. Responsibility of pharmacies. Pharmacies are responsible for the storage, quality and delivery of medicines to customers, even if the medicines were purchased on the partner's website and delivered by courier companies. Responsibility of pharmacies also occurs in the case of the sale of falsified, counterfeit, substandard and unregistered medicines in the Russian Federation.
5. The obligation for information aggregators to restrict users' access to information about an unregistered medicinal product. In particular, when placing an offer for the sale of a medicinal product that is not registered in the Russian Federation on the Internet, the owner of the aggregator is obliged to stop placing such an offer for sale (restrict access to it by users of the website and (or) mobile application) and notify the Federal Service for Surveillance in Healthcare of the fact of such placement.
6. The new concept of "Re-registration of a permit" for the remote purchase and sale of drugs. The procedure for reissuing a permit is applied to organizations that have changed the name of a legal entity, TIN, addresses of places of activity or an Internet site, etc. At the same time, the procedure for reissuing the permit takes 5 days, as well as the procedure for obtaining access to the e-com market.

Thus, the adoption of the new version of the Rules will expand the possibilities of remote sale in medicines by attracting information aggregators and non-network pharmacies to remote sale, as well as it will simplify the procedure for reissuing a permit for remote sale in medicines in case of changes in the data about a legal entity, engaged in remote trading.



¹Decree of the Government of the Russian Federation dated 31.05.2021 N 827 " On amendments to the Rules for Issuing Permits for the Retail Sale of Medicines for Medical Use by remote means, the Implementation of such sale and the delivery of Medicines to citizens"