GMP confirmation, certification, re-registration, changes, full life cycle support of medicinal products
There are two ways to confirm the compliance of manufacturing of medicinal products with GMP requirements: by recognizing the GMP certificate issued by a competent authority of EU countries (EUDRA), UK, FDA (USA) or by inspecting the manufacturing conditions by Ukrainian inspectorate.
Recognition is only applicable to those manufacturers who already have the GMP certificate issued by a competent authority of EU countries (EUDRA), UK, FDA (USA). For all other countries, there will be on site audit by Ukrainian authority.
Terms: 1,5 – 2,5 months. These terms include a primary expertise, a specialized examination, taking a decision on the issuance of a resolution on the approval of working conditions according to the demands of Good Manufacturing Practice (GMP) and signing a GMP conclusion.
Terms: 4-6 months.
These terms include primary and specialized expertise, the inspection of the manufacture, generation of reports about the results of the inspection, taking a decision on the issuance of a certificate of compliance with Good Manufacturing Practice (GMP) requirements by an authorized body;
Registration of medicines, dietary supplements and cosmetics in Ukraine
According to the legislation, submission of the Application for state re-registration of the finished medicine
Please fill out the contact form and you will be contacted
Send request and we response asap.
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