The re-registration term for marginal selling prices of vital and essential medicines will expire on February 18, 2020.
The corresponding decree was adopted by the Russian Government in December 2019.
In 2019, a new obligation for marketing authorization holders was introduced: in certain cases, they have to submit the prices for vital and essential medicines in certain cases, particularly if the price for an imported medicine in Russia is lower than in the country where it was produced. Provided that marginal selling prices had been registered before June 7, 2019, pharmaceutical companies have to go through a re-registration process in 2019-2020. If the manufacturer fails to re-register prices for vital and essential medicines, their sale will be illegal after January 1, 2021.
In order to re-register the maximum sale price for vital and essential medicines , the following documents must be submitted to the Ministry of Health:
- Application for obligatory re-registration in 2019 – 2020 of the manufacturer’s registered marginal selling price for a reference medicine included in the list of vital and essential medicines.
- Information about the pharmaceutical manufacturing license
- Information on the marketing authorization of the medicine
- Calculation of the manufacturer’s marginal selling price for a reference medicine, submitted for mandatory re-registration in 2019-2020
- Information on minimum sale prices for medicines in foreign countries
- Information confirming the manufacturer’s selling prices for the medicine in foreign countries specified in Annex No. 3 (Czech Republic, France, Greece, Hungary, Belgium, Netherlands, Poland, Romania, Slovakia, Spain, Turkey) according to the Regulations on obligatory re-registration in 2019-2020 of registered marginal selling prices for manufacturers producing medicines included in the list of vital and essential medicines (2 copies with translation into Russian).
- Document certifying the credentials of the authorized person.