On 15 June 2018, Federal Law No. 140-FZ “On Amendments to the Federal Law ‘On the Circulation of Medicines’”* (the “Law”) came into force. It simplifies the registration of foreign medicines, enhances the opportunities for contract manufacturing in Russia and introduces new grounds for suspending the use of medicines.
The adoption of the Law is aimed at making the process of state registration of medicines in Russia less bureaucratic. It is also an additional measure aimed at developing contractual production and promoting localised production of foreign medicines in Russia.
At the same time, the Law provides grounds for state authorities to suspend the circulation of medicines, which will encourage manufacturers to maintain strict compliance with medicine production requirements.
Registration of foreign medicines simplified
When registering medicines produced outside Russia, pharmaceutical companies can now submit a decision on the carrying out of inspections from the Russian Ministry of Industry and Trade instead of providing a report that the manufacturers met the requirements of good manufacturing practices (GMP). Previously, it was impossible to submit documents for registration before the completion of inspections for GMP compliance.
Thus, the processes of registration and inspection of production can now run in parallel. As a result, launching medicines into the Russian market will be quicker than in the past.
Previously, the legislation prohibited a pharmaceutical company from producing the same medicine with the same international non-proprietary name, but with a different trade name. This meant that a local manufacturer could produce a branded medicine with a given active ingredient for only one customer. If the company produced the medicine for its own distribution in Russia, it could not produce the same medicine under a contract production agreement for a foreign manufacturer.
The Law now lifts this prohibition, provided that different entities own the registration certificates for the medicines to be produced. This, therefore, opens up new opportunities for contract production of medicines in Russia. From now on, a Russian manufacturer, which provides contract production services, can produce the same drug for two or more foreign customers, or carry out its own production of this medicine.
Suspension of the use of medicines
The Law introduces new grounds for suspending the use of medicines.
If during an inspection it is revealed that the manufacturer is not complying with GMP or licensing requirements, and the violations can endanger or harm the health of patients, the authorised body can suspend the use of the medicines. This decision will be made when:
- the composition or production process of the drug does not conform to the registration dossier;
- the medicine is manufactured on a production site that is not specified in the registration dossier;
- there are no documents confirming the quality of the medicine; or
- violations of GMP or licensing requirements have not been remedied.
These measures have been introduced to prevent the circulation of drugs of inadequate quality in Russia.