The Russian Government has recently approved the Regulations on Licensing the Manufacture of Medicines (the Regulations), which replaces the previous set of rules for obtaining licences for manufacturing medicines. The Regulations were approved in furtherance of the new Law on Licensing and new approaches to the preparation of licensing regulations. These Regulations introduce a number of changes.
First, the Regulations list separate requirements to be satisfied by (i) licence applicants in order to obtain licences and (ii) licence holders in order to maintain their licences. This separation is, in our view, a positive development as it establishes a new level of clarity in this area compared to the previous system that used a unitary set of requirements, not all of which were obviously equally relevant for licence applicants and holders.
Secondly, the Regulations re-introduce a requirement for licence holders to raise the professional qualifications of certain of its employees at least once every 5 years.
Thirdly, the Regulations list the types of activities that constitute manufacturing of medicines. The effect of this provision is that, whenever a licence holder starts to perform new types of activities not indicated in its current licence, it must apply for reissue of its licence. The licence must also be reissued if the address where manufacturing is conducted changes.
Fourthly, the Regulations describe procedures for licence reissuance in the above cases. We note that since licences are now granted for an unlimited period of time, no reissuance in connection with expiration of its term is required.
Lastly, the Regulations uphold a long-standing practice and list what breaches of licensing terms and conditions qualify as "material" breaches. Having clearly defined instances of material breaches in this area is important, particularly because the licence may be suspended or even cancelled if a material breach occurs.
Thus, the Regulations set out a new clear framework of procedures to be followed by licence applicants wishing to obtain licences for the manufacturing of medicines and licence holders who wish to have them reissued.