A change of applicant was declared, according to Appendix 28. The dossier materials were also submitted to the Pharmacovigilance Department. A remark was made to additionally provide a registration form for variations, since the qualified person for pharmacovigilance had changed. It was decided to submit a registration form for variation B.I.8. (a). Question: Is this change consequential to the change of applicant? – State Expert Center of the Ministry of Health of Ukraine