We have made some changes that we would like to inform you about. PJSC “FITOFARM” received an extension of the license to carry out economic activities for the production of medicinal products (the decision was approved by order No. 1174 dated 10.19.2023, based on the results of the inspection by the State Health Service).
Address of the new place of implementation of the activity:
08303, Kyiv region, Boryspil city, Chumatska Street, house 17.
At this address, PJSC “FITOFARM” will carry out batch production (certification) and storage of medicinal products. Before the start of the war in Ukraine, PJSC “FITOFARM” had one site for the production of medicinal products and the release of batches, at the address: 84500, Donetsk region, Bakhmut city, street Sibirtseva, 2. After the war came to Bakhmut, “FITOFARM” transferred the production of its products to contract sites. Currently, contract production sites are responsible for the production, packaging and quality control of medicines, and «FITOPHARM» is responsible for the production of batches, that is it allows their sale and is responsible for the effectiveness, safety and quality of medicines for the entire period of their circulation on the market.
Why is the address of the production in Bakhmut still indicated on the packages of medicines? In accordance with the requirements for the Instructions for the medical use of the medicinal product and the requirements for the marking of the packaging of the finished medicinal product, the Procedure for the examination of registration materials for medicinal products submitted for state registration, as well as the examination of materials on making changes to the registration materials during the validity of the registration certificate, approved by the order of the Ministry of Health dated 26.08.2005 No. 426, the manufacturer’s information regarding the location is indicated in the Instructions and packaging:
– The name and location of the manufacturer and the address of the place of his activity (the manufacturer responsible for the production of series is indicated).
Taking into account the above, in the Instructions for medical use and on the primary and secondary packaging, the address of the manufacturer, which is responsible for the release of batches of the medicinal product, is indicated, that is, the address of PJSC “FITOFARM”, which is included in the License for the production of PJSC “FITOFARM”. Currently, after the expansion of the Production License of PJSC “FITOFARM”, changes will be made to the materials of the registration file, and, accordingly, the new address of the production activity will be indicated on the packaging materials, according to Appendix No. 2 to the License.