EAEU may allow to register empty primary packages as medical devices

The Russian Ministry of Industry and Trade insists on mandatory registration of primary drug packages (vials, ampoules, etc.) as medical devices, but only if they are imported empty into Eurasian Economic Union (EAEU).

There will be no need to register package, if it already contains active substance, i. e., in case of importing the medicinal product in primary package.

Currently, the Russian manufacturers register packages as medical devices, only if they want to obtain VAT preferences, as the tax rate for medical devices stands at 10% instead of the usual 18%.

In EAEU member states, the common market of drugs and medical devices exists since May 2017. The transitional period, when the manufacturers select, on their own, whether to make registration under the national or common rules, will continue until 2021.

All this indicates that the Ministry of Industry and Trade supports the position of Belarus in the dispute between EAEU member states on whether to make mandatory the registration of primary drug packages. This issue is currently being discussed in the Eurasian Economic Commission (EEC). Russia is just elaborating its common position due to the differences in the approaches of relevant agencies and pharmaceutical manufacturers.