SE «UPQI»’s experts are involved to conduction of expertise of documents submitted to State Service Of Ukraine On Medicines And Drugs Control on following issues:
- expertise of the application for issuance of the conclusion in purpose of compliance of the manufacturing conditions with the Good Manufacturing Practice requirements
- expertise of the application for issuance of the certificate in purpose of compliance of the manufacturing conditions with the Good Manufacturing Practice requirements
- making amendments to list of products' nomenclature, which is added as an annex to conclusion or certificate of compliance with the Good Manufacturing Practice requirements, concerning expanding or narrowing products' nomenclature
- reissuance of the conclusion or certificate of compliance with the Good Manufacturing Practice requirements
- making amendments to list of products' nomenclature, which is added as an annex to conclusion or certificate of compliance with the Good Manufacturing Practice requirements, concerning numbers of registration certificates, names of medicines, dosage etc.
Expertise can be conducted by SE «UPQI»’s experts on the basis of signed agreement with an applicant.
Prices for expertise are mentioned at the link below.
Вартість експертизи заяви та комплекту документів
tel. +38 (050) 440-40-62
mail: orgexpert@gmpcenter.org.ua