MainStandardized proceduresObtainment of licenses and permits in UkraineRegistration dossier of importer of drugs into Ukraine

Registration dossier of importer of drugs into Ukraine

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TERM AND COST

The service doesn't have a fixed price.

Drafting of a dossier for an importer usually takes us 2-4 weeks.

We can provide sample of the importer dossier that has been already successfully registered  by the State Administration of Ukraine on Medicinal Products. Cost equals to 1000 USD.

What we do
  • agree on the amount, cost and term of service provision with the Client;
  • sign legal services agreement and confidentiality agreement (while providing the service we will need to receive a significant amount of information that is not public);
  • together with an authorized representative of the Client we draft dossier based on information about the particular importer (it should be noted that the dossier includes a significant amount of importer's data that may vary from importer to importer so we require obligatory participation of at least one representative of the importer);
  • organize signing of the dossier by the importer, sign act of acceptance.

REQUIRED DOCUMENTS

Licensing terms also provide mandatory presence of licensees documents and protocols: 
  • Specifications or quality control methods;
  • Test instructions; 
  • Written procedures (methods);
  • Rules for making and logging operations;
  • Agreements between customers and performers;
  • Documentation on how to perform various actions;
  • Certificates series;
  • Reports on tasks, projects and research.
Important to know
  • Requirement about obligatory dossier existence is provided by p. 2.8. of License requirements that are approved by the order № 143 February 20, 2013 (available under the link - http://zakon2.rada.gov.ua/laws/show/z0307-13/print1382602773135957);
  • An importer dossier should meet the provisions of a) State Pharmacopoeia of Ukraine and / or the European Pharmacopoeia, in case of absence these requirements in pharmacopoeia - other leading pharmacopoeia (UK, USA, Japan) b) other normative-technical documents and legal acts, which set requirements for drugs, packaging conditions and shelf-life and quality control methods drugs;
  • There is an approved by Ministry of Health form of a dossier. It describes structure and content of the document.
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