Russia delivers Sputnik V papers to Croatia’s drug regulator Halmed


Croatian drugs regulator Halmed said on Monday that a "preliminary inspection of documentation" on the Russian-made Sputnik V coronavirus vaccine is currently underway, and that there would be no emergency imports of the vaccine "for the time being."

Halmed said they had received documentation about the vaccine from the Health Ministry, and that a team of ten experts are currently conducting a “preliminary inspection of the documentation” to determine if the delivered documents comply with what had been requested by Croatia.

Halmed said that so far there had been no requests for emergency imports of the Russian vaccine and that there would not be any procedures of that kind for the time being.

The Russian vaccine is currently also under evaluation by the European Medicines Agency (EMA), which had previously gave clearance to four Western-made vaccines, manufactured by Pfizer, AstraZeneca, Moderna, and Johnson & Johnson. EMA’s approval is valid across the 27-country bloc.

However, individual EU member states can independently study and approve other vaccines for use in their own markets, such as Russia’s Sputnik V or the Chinese-made Sinopharm.