2021 LS&HC Horizons - Flipbook - Page 63
Life Sciences and Health Care Horizons 2021
63
Changes in regulatory landscapes in Russia
Simplified procedures for obtaining Marketing
Authorizations (MA)
A new simplified procedure for obtaining an
MA extends to 36 types of medical devices,
including medical masks and respirators. The
simplified procedure allows obtaining MA
without submitting results of any trials/tests. If
no request is issued by the regulator, MA will be
issued within five business days. The applicant
for MA must complete trials/tests after receipt
of MA.
The simplified procedure for obtaining MA for
medicines that are, for instance, intended for
prevention and treatment of diseases that pose a
danger to others, is also available.
Online sale of over-the-counter medicines
Online sale of over-the-counter medicines has
been legalized in Russia. There is also an initiative
to allow selling prescription drugs online.
Patent linkage
The Russian PTO promises a prompt launch
of the register of APIs protected by patents.
The procedure for obtaining MA also provides
the requirement to indicate in application
information on IP rights that are used in the
medicines and valid in Russia.
Softening restrictions of state procurement
of foreign medicines
Stimulation of local production of medicines
and medical devices remains high on the agenda
of the Russian regulator. In 2020, limits of the
approach focused on import substitution became
evident, which resulted in a new trend to soften
restrictions relating to state procurement of
foreign medicines. We see additional softening of
these restrictions in Russia in 2021.
Tightening liability for sale of counterfeit and
substandard medicines
More severe administrative and criminal liability
(including suspension of company’s activities
and imprisonment up to 12 years) has been
introduced to mitigate the risks caused by the
online sale of medicines.
Track & trace system
In July 2020, the track & trace marking of
medicines became obligatory in Russia.
Natalia Gulyaeva
Office Managing Partner, Moscow
natalia.gulyaeva@hoganlovells.com
Julia Gurieva
Senior Associate, Moscow
julia.gurieva@hoganlovells.com
