Ukraine. Drug manufacturing: Licensing
Pursuant to Article 10 of the Law of Ukraine «On Medicinal Products» dd. 04.04.1996 #123/96-VR medicinal products shall be manufactured by business entities under a license. License is a document which permits economic activity on drug manufacturing on the whole territory of Ukraine. Licensing conditions for exercise of economic activity on drug manufacturing, wholesale, retail are approved by the Decree of the State Committee of Ukraine on Regulatory Policy and Entrepreneurship, the State Drug Inspectorate dd. 03.03.2009 #44/27 (hereinafter – the Licensing conditions).
Pursuant to the Resolution of the CMU "On approval of list of documents which shall be attached to a license application on a specific economic activity type» dd. 04.07.2001 #756 in order to obtain a license for drug manufacturing the applicant submits in form approved by the MHC of Ukraine information on availability and conformity of material and technical resources and staff qualification to Licensing conditions signed by the head of the business entity or attested by it certificates of the good manufacturing practice for all manufacture sites issued according to procedure stipulated by the MHC of Ukraine.
The license for drug manufacturing is issued if there are respective material and technical resources, qualified personnel (qualification of a single person in case of individual manufacturing) as well as conditions as to drug quality control.
The State Drug Inspectorate (licensing authority) shall decide within 10 business days as of receipt of the license application and accompanying documents on issuance of or refusal in issuance of the license.
Notification on decision as to issuance of or refusal in issuance of the license shall be sent (provided) to the applicant in writing within 3 business days after respective decision making. The license shall be handed over personally to the applicant or its authorized person within 3 business days after receipt of a document confirming payment of the license fee. If within 30 calendar days as of receipt of the notification on decision making as to license issuance the applicant fails to submit a document confirming payment of the license fee or to come to the State Drug Inspectorate to receive the license, the State Drug Inspectorate which has issued the license is entitled to withdraw its decision on license issuance or to declare such license as void.
Pursuant to the Resolution of the CMU "On approval of list of documents which shall be attached to a license application on a specific economic activity type» dd. 04.07.2001 #756 in order to obtain a license for drug manufacturing the applicant submits in form approved by the MHC of Ukraine information on availability and conformity of material and technical resources and staff qualification to Licensing conditions signed by the head of the business entity or attested by it certificates of the good manufacturing practice for all manufacture sites issued according to procedure stipulated by the MHC of Ukraine.
The license for drug manufacturing is issued if there are respective material and technical resources, qualified personnel (qualification of a single person in case of individual manufacturing) as well as conditions as to drug quality control.
The State Drug Inspectorate (licensing authority) shall decide within 10 business days as of receipt of the license application and accompanying documents on issuance of or refusal in issuance of the license.
Notification on decision as to issuance of or refusal in issuance of the license shall be sent (provided) to the applicant in writing within 3 business days after respective decision making. The license shall be handed over personally to the applicant or its authorized person within 3 business days after receipt of a document confirming payment of the license fee. If within 30 calendar days as of receipt of the notification on decision making as to license issuance the applicant fails to submit a document confirming payment of the license fee or to come to the State Drug Inspectorate to receive the license, the State Drug Inspectorate which has issued the license is entitled to withdraw its decision on license issuance or to declare such license as void.
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