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

Registration of dossier of importer of drugs into Ukraine

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Terms and cost of the importer dossier obtainment

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 for the importer dossier obtainment

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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Drug importer's dossier: how can we help?

We have been working in the legal services market of Ukraine for more than 10 years, and during this time we have managed to study the main problems of our Clients.

The situation, which requires a legal solution to the issue, is associated with fear and stress in many people. The reason for this may be different factors:
  • Negative experience of communication with unqualified lawyers in the past. This is usually accompanied by default, delay or even direct deception.
  • Dissatisfaction with the quality of communications. When, for example, you try to call a lawyer for hours to ask a simple question or find out information about your case.
  • The need to deal with a bunch of legal issues on your own and to learn skills that will never come in handy again in life. Often this is a waste of personal time, because in practice, just little knowledge - you need experience of communication with government agencies and knowledge of the process itself.
Unfortunately, most of these fears give rise to experience of cooperation with low-skilled lawyers or their general negative reputation.
 
A visit to a lawyer is the same as a visit to a doctor. For a positive result, there is no need to trifle, otherwise you will have to pay twice.

Cooperating with us, you can always count on:
  • Reliability. If we take up the task, it will be solved. Without delays and unforeseen additional costs.
  • Availability. We are always in touch. We do not have to look for our Client manager. Reports will be provided on time and will contain all the information you need.
  • Simplicity. A simple solution and transparency during the process is our main goal. We appreciate your time and our time.
  • Target-oriented, not task-oriented. Our extensive experience allows us to assess the situation and identify the main needs of the client. It gives us an opportunity to calculate future risks and to offer the Client the most optimal variant of satisfaction of his needs.
If You want to know more about the drug importer dossier or order one - call us!

0 800 210 915
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