The state has approved distance trading in medicines
For the attention of representatives of pharmaceutical companies, pharmacy companies and manufacturers of medicines and distance trading organisations
Pepeliaev Group advises that a law has been adopted that allows distance trading in over-the-counter medicines, as well as in prescription medicines for the period of the pandemic/emergency.
On 3 April the Russian President signed Law No. 105-FZ “On amending article 151 of the Federal Law ‘On information, information technologies and on the protection of information’ and the Federal Law ‘On the circulation of medicines’”.
Items of subordinate legislation are expected to be adopted in the near future which will regulate the procedure for obtaining authorisations for distance trading in medicines.
The procedure for commencing distance trading in medicines
Distance trading in over-the-counter medicines will be allowed for pharmacy companies provided that such companies:(1) have a licence for pharmaceutical activity, and
(2) have an authorisation for distance trading issued by the Russian Federal Service on Surveillance in Healthcare (Roszdravnadzor).
The Russian Government will determine the procedure for issuing such authorisations, the requirements for pharmacy companies and the procedure for distance trading in medicines as well as the rules for delivery.
Information about the medicines sold and received will be entered into the system for monitoring the movement of medicines for medical purposes.
However, according to the general rule, there is a prohibition on distance trading in prescription medicines, narcotic and psychotropic medicines and medicines containing alcohol with over 25 per cent ethanol by volume.
The law being adopted during the pandemic contains a clause enabling the Russian Government to establish a temporary procedure for distance retail trading in medicines (including prescription medicines) for medical purposes as well as a temporary procedure for obtaining authorisations for such trading and for delivering the specified medicines to individuals.
The requirements for entities carrying out distance trading in medicines
In addition please note that the law provides for no requirements for pharmacy companies other than those established as licensing requirements. However, the Russian Government is now able to establish additional requirements.
Please note that the publishing on a website of information that contains a proposal for distance trading in medicines by entities that do not have a licence for pharmaceutical activity and an appropriate authorisation issued by Roszdravnadzor will result in such website being blocked and administrative liability being imposed.
What to think about and what to do
The additional requirements for the entities involved in the circulation of medicines that are planning to commence distance trading in them may cause difficulties. It is worth bearing in mind that, when regulation is changing rapidly, the new developments, some of which may be temporary, should be tracked.
Also, please note that once distance trading in medicines is introduced, the online advertising of the medicines may fall under the scrutiny of the regulatory authorities.