Фото: Reform.by
The Council of Ministers of Belarus has amended the procedure for the state registration of biomedicinal cell products and several administrative procedures. The relevant resolution was signed by Prime Minister Aliaksandr Turchyn.
The document updates Regulation No. 1120 on the Procedure for the State Registration of Biomedicinal Cell Products. In particular, it specifies the circumstances under which changes may be made to the registration dossier of already registered products, including the addition of new indications for use, changes to the manufacturing site, or revisions to shelf life.
The resolution also establishes the procedure for creating and maintaining the State Register of Biomedicinal Cell Products and defines its structure.
In addition, the timeframes for administrative procedures for business entities have been shortened. The period for state registration, confirmation of registration, and amendments to the registration dossier has been reduced from 15 to 10 days. If requests need to be sent to other state bodies or organizations, the timeframe has been cut from one month to 20 days.
The government press service also reported that, taking into account the requirements set out in Good Pharmacy Practice for opening pharmacies, the excessive requirement to obtain approval from local executive authorities before opening a pharmacy has been abolished.