Encyclopedia
Grounds for refusal to make changes
The grounds for refusing to make changes are the conclusion of an authorized federal executive authority regarding the possibility of reducing the safety, quality, or efficacy of the medicinal product in the event of making such changes1.
Federal Law No. 61-FZ dated April 12, 2010 "On Circulation of Medicinal Products", as amended on April 12, 2010, Article 30 // RSFSR. 2010. No. 16. Art. 1815. ↩