Department for Manufacture Licensing of Medicines, Blood and Certification

Опубліковано 30.10.2024 о 18:04

Manufacture Licensing of Medicines, Blood and Certification Department is an independent structural unit of the State Service of Ukraine on Medicines and Drugs Control.

 

The Department includes:

MANUFACTURE LICENSING OF MEDICINES, BLOOD AND CERTIFICATION FOR INTERNATIONAL TRADE

 

CONTROL OF LICENSING CONDITIONS COMPLIANCE OF MEDICINES AND BLOOD MANUFACTURE DIVISION

 

MEDICINES MANUFACTURE CERTIFICATION DIVISION

 

Main Department functions:

Ensuring the licensing of business activities for the medicines manufacture, including the issuance, renewal and revocation of licenses.

Ensuring the licensing of business activities related to the procurement and testing of donor blood and blood components regardless of their final destination, processing, storage, distribution and realization of donor blood and blood components intended for transfusion, including issuance, renewal and revocation of licenses.

Ensuring medicines quality certification for international trade and confirmation for exported active pharmaceutical ingredients.

Ensuring the implementation of work on confirming the compliance of the manufacturing conditions for medicines with the good manufacturing practice requirements.

Formation and maintenance of the license register of economic activities for the medicines manufacture and ensuring the data transfer to the Unified License Register.

Participation in the development of draft regulations on business licensing activities for the medicines manufacture.

Participation in the development of draft regulations on medicines quality certification for international trade and confirmation for exported active pharmaceutical ingredients.

Participation in the development of draft regulations on confirming the compliance of the manufacturing conditions for medicines with the requirements of good manufacturing practice.

Methodological support of activities on issues within the competence of the Department and ensuring unified methodological approaches to the performance of functions related to: licensing of economic activities for the medicines manufacture; licensing of economic activities for the procurement and testing of donor blood and blood components regardless of their final destination, processing, storage, distribution and realization of donor blood and blood components intended for transfusion; medicines quality certification for international trade and confirmation for exported active pharmaceutical ingredients; confirmation of compliance of the medicines manufacturing conditions with the requirements of good manufacturing practice.

Participation in the development of proposals to harmonize the legislation of Ukraine on: medicines manufacturing licensing; licensing of economic activities for the procurement and testing of donor blood and blood components regardless of their final destination, processing, storage, distribution and realization of donor blood and blood components intended for transfusion; medicines quality certification for international trade and confirmation for exported active pharmaceutical ingredients; confirmation of compliance of the conditions for the medicines manufacturing with the requirements of good manufacturing practice in accordance with EU legislation, PIC/S and WHO requirements.

Developing, approving and ensuring compliance of the SMDC’s quality management system documentation with the requirements of Ukrainian and EU legislation, PIC/S, WHO, ISO 9001, ISO 19011 international standards, and issues within the competence of the Department.

Ensuring the functioning of the defined processes of the SMDC quality management system and constant improvement of their effectiveness.

Ensuring interaction between the central office of the SMDC and its territorial authorities on issues within the competence of the Department.

Organization of work on the state supervision (control) of business entities engaged in the medicines manufacturing business; business activities on procurement and testing of donor blood and blood components regardless of their final destination, processing, storage, distribution and realization of donor blood and blood components intended for transfusion in order to ensure compliance with the License conditions for certain types of business activities.

Organizing inspections prior to license issuance or when opening new places of business activity or expanding types of activities and monitoring compliance with the requirements of the legislation on the implementation of the License conditions for conducting medicines manufacturing activities.

Ensuring the holding of the Working Group meetings on medicines manufacturing licensing, wholesale and retail trade of medicines of the State Service of Ukraine on Medicines and Drugs Control within the competence of the Department.

Preparation of draft decisions of the State Service of Ukraine on Medicines and Drugs Control based on the results of state supervision (control) over the licensees’ compliance with the License Requirements of certain types of economic activities within the competence of the Department.

Ensuring the expertise of the documents submitted for obtaining a license or when opening new places of business or expanding activities: for the medicines manufacturing; for the procurement and testing of donor blood and blood components regardless of their final destination; for the processing, storage, distribution and sale of donor blood and blood components intended for transfusion.

Ensuring organization of the Working Group meetings on the evaluation of the results of medicines manufacturing inspections for compliance with the requirements of good manufacturing practice of the State Service of Ukraine on Medicines and Drugs Control.

Ensuring consideration of letters, applications and complaints regarding violations of the law during the medicines manufacturing process.

Interaction with the Quality Management Sector of the State Service of Ukraine on Medicines and Drugs Control or the Authorized Person for Quality Management, if appointed, on the issues of compliance with the requirements of the State Service of Ukraine on Medicines and Drugs Control and continuous improvement of their effectiveness.

 

 

 

 

 

https://www.dls.gov.ua/%d1%83%d0%bf%d1%80%d0%b0%d0%b2%d0%bb%d1%96%d0%bd%d0%bd%d1%8f-%d0%bb%d1%96%d1%86%d0%b5%d0%bd%d0%b7%d1%83%d0%b2%d0%b0%d0%bd%d0%bd%d1%8f-%d0%b2%d0%b8%d1%80%d0%be%d0%b1%d0%bd%d0%b8%d1%86%d1%82%d0%b2-2/

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