How are the materials of the registration dossier submitted under the registration/re-registration procedure and under the procedure for amending registration materials for APIs of biological origin that are not products of recombinant technologies (for example, of plant or animal origin)?

According to the requirements of Order of the Ministry of Health of Ukraine dated 26.08.2005 No. 426 as amended (hereinafter – the Order), for state registration of APIs, documents are submitted according to the list specified in Annex 12 to the Order, taking into account the requirements regarding APIs set out in Annex 6 to the Order. As regards the procedure for making changes to registration materials, registration dossier materials are submitted according to the requirements set out in Annex 17 to the Order.

At the same time, we draw your attention to the need for the applicant to take into account the requirements of guideline EMA/CHMP/BWP/429241/2013 "Guideline on the use of starting materials and intermediates collected from different sources in the manufacturing of non-recombinant biological medicinal products" when preparing registration dossier materials for the above-mentioned APIs.