Public ID: PID-JGYRWB
Process for clinical trials affecting UK pharmaceuticals exporters/investors in Russia
Trade barrier summary
The approvals process for conducting clinical trials in Russia more complicated than those of other countries. There is a lengthy approval process from the Russian Ministry of Health, and the Ethics Committee, to be able to commence a clinical trial. The pharmaceutical business also needs to apply for an import licence and a biomedical sample export licence. The Ministry of Health calculates the amount of pharmaceuticals that the business can export to the market, which is stated in the import licence. If the pharmaceutical product expires, requiring a new batch to be exported, or if there is more demand from patients than anticipated – then the business has to reapply to the Ministry of Health, to change the import licence. Clinical trial equipment cannot be exported to Russia, unless the equipment is registered in market.
12 December 2019
18 December 2020