License for import of drugs in Ukraine
Cost of services
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What we offer
- We are preparing an application on the basis of the documents provided for submission to the authority that issues the license (State Service Of Ukraine On Medicines And Drugs Control);
- We advise on the requirements that must be met in order to successfully complete the licensing process;
- We participate in the field inspection of the State Service of Ukraine On Medicines And Drugs Control (if necessary);
- We monitor the decision making to issue a license, we form the details for the payment of state duties
- We get the license and the application for it.
In addition, our lawyers can support:
- preparation of the importer files;
- obtaining a license for the wholesale (sale to pharmacies) trade in medicines;
- making changes to the importer’s existing license;
- drug registration in Ukraine
- obtaining a license for precursors (for medicines where precursors / other drugs are present).
Documents for obtaining a license to import medicines
The list of necessary documents depends on whether our company will initially complete the application for a license, or the Client will provide a pre-filled application.
Along with the application, it will be necessary to submit a copy of the files of the importer. Along with the application, it is necessary to provide data on the imported medicines on a CD.
Although the list of documents for submission is short (the application, the files of the importer and a description of the documents) for the preparation of the first two, you will have to provide a significant amount of documents / data, namely:
- Extract from EDRPOU;
- Contact details;
- Bank account details;
- DUNS number;
- Passport and ID code of a sole trader (if the importer is a sole trader);
- Information about the place of economic activity;
- Information on persons authorized to conduct quality control of medicines;
- Information about medicines that will be imported ( hard and soft copies to be presented);
- Other documents / information.
Each of the above items may have its own subpoints, and additional documents / information will be required in that case.
The cost of drug license obtainmentIt depends on:
- Whether our company takes up full support of obtaining a license or represents interests in the licensing authority;
- Whether the Client needs other licenses.
A one-time fee in the amount of one living wage for able-bodied persons is charged for the issuance of a license. The amount of this payment changes several times a year. You need to pay exactly the amount that was established on the day the license was issued. You can not worry about this, we will provide you with the payment details and indicate the current amount.For foreign manufacturers / sellers of medicines who are only planning to enter the Ukrainian market, our company can offer comprehensive services for:
- registration of medicines;
- filling in the files of the importer and obtaining an import license;
- obtaining a wholesale trade license for the further sale of medicines;
- obtaining a license for ingredients of narcotic nature, if any, are included in the composition of medicines.
The term for obtaining an import license for medicines is 10 working days (business days) from the date of submission of documents.
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What to know about obtaining a license to import medicines
- A license to import medicines has no statute of limitations (is unlimited);
- To obtain a license for the import of medicines, an enterprise or entrepreneur acting as an importer must obtain a license to trade (wholesale) in medicines;
- The license is issued by the State Service Of Ukraine On Medicines And Drugs Control;
- Licensing conditions are approved by the resolution of the Cabinet of Ministers of Ukraine under number 929, which is dated November 30, 2016;
- A license to import medicines in Ukraine allows you to bring (import) into our country only a list of medicines specified in the appendix to the main license;
- In the case of operations with narcotic drugs or precursors, it is necessary to have a respective license;
- The licensee’s staff must have an “authorized person” who must have a pharmaceutical, biotechnological or biological education degree and at least 2 years of work experience, which is in line with the requirements.
Answers to frequently asked questions
Yes, it is. First, the applicant provides data on paper and electronic media, and then the reliability of the data is verified by employees of the State Service Of Ukraine On Medicines And Drugs Control with a visit to the place of economic activity.
No, it does not. An import license gives the right only to import drugs into the territory of Ukraine to importers, who must already have a license for a pharmacy warehouse, which essentially allows wholesale trading.
Additional information on drug importer licenseImportation of medicines must be accompanied by existing certificates on the quality of a medicine (series) issued by the manufacturer.
The shelf life of the medicines imported into Ukraine must be:
- at least half of the period that was indicated by the manufacturer on the packaging as the expiration date, if the period is less than 1 year;
- at least 6 months if the shelf life is more than 1 year.
If You wish to obtain grug importer license fast and simple - call us!