Is it possible to manufacture batches of finished medicinal products for Ukraine at an industrial site in accordance with the updated materials submitted for the procedure of introducing type IA or IAin changes before their approval by MoH order, if this change is not considered significant and is guaranteed not to affect the quality, safety or efficacy of the medicinal product?

In accordance with paragraph 10 of Section VI "Procedure for conducting expert evaluation of materials on amendments to the materials of the registration dossier for a medicinal product" of the Procedure for conducting expert evaluation of materials on medicinal products submitted for state registration (re-registration), as well as expert evaluation of materials on amendments to registration materials during the validity period of the registration certificate, approved by order of the Ministry of Health of Ukraine of 26.08.2005 No. 426 as amended, if the applicant makes type IA amendments to the materials of the registration dossier, the applicant may, at its discretion, notify in accordance with the legislation of the introduction of such amendments no later than 12 months after the applicant implements these amendments. This does not apply to type IAin amendments (type IA amendments with immediate notification). For these amendments, the applicant must notify in accordance with the legislation of the introduction of such amendments immediately after their implementation, indicating the date.