License for import of drugs in Ukraine

License for import of drugs in Ukraine

What we do

  • 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).

OUR FEES

The cost of a medicines import license
negotiable

The cost of our services 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.

In addition, you pay an official payment to the state - one living wage for able-bodied persons (from January 1, 2019 - 1921 hryvnias, from July 1 - 2007 hryvnias, from December 1 - 2102 hryvnias).

For foreign manufacturers / sellers of medicines who are only planning to enter the Ukrainian market, our company can offer comprehensive services for:
  1. registration of medicines;
  2. filling in the files of the importer and obtaining an import license;
  3. obtaining a wholesale trade license for the further sale of medicines;
  4. 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.

Successfully rendered services

The license was obtained in March of 2013

License for import of medicines that was issued for a limited liability company.

WHY CHOOSE US

  • plus

    YEARS OF EXPERIENCE IN THE FIELD OF MEDICINE AND PHARMACEUTICALS

    Our company has experience working with medical institutions, pharmaceutical manufacturers and other representatives of this industry. Due to this, we understand the specifics of their work, as well as the practice of licensing bodies.
  • plus

    OPPORTUNITY OF FULL SUPPORT OF ENTERING THE MARKET

    An import license is far from the only document that needs to be obtained for the importation of medicines into Ukraine. In addition, you will need a license for the wholesale trade in medicines along with other permits that our company can also help you with.

ANY QUESTIONS LEFT?

Our lawyers will advise you!

Ask a lawyer

DOCUMENTS FOR OBTAINING A LICENSE OF IMPORTER OF MEDICINES

  • Importer’s EDRPOU code
  • Importer's files
  • Information on the absence of control

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:

  1. Extract from EDRPOU;
  2. Contact details;
  3. Bank account details;
  4. DUNS number;
  5. Passport and ID code of a sole trader (if the importer is a sole trader);
  6. Information about the place of economic activity;
  7. Information on persons authorized to conduct quality control of medicines;
  8. Information about medicines that will be imported ( hard and soft copies to be presented);
  9. Other documents / information.

Each of the above items may have its own subpoints, and additional documents / information will be required in that case.

REFERENCES FROM OUR CLIENTS

L. Chervonyuk, LLC "Vitalux"

Vitalux company highly appreciates results of cooperation with Law firm “Pravova dopomoga”, can characterize it as a reliable partner and based on personal experience is ready to recommend it to interested persons...... More information

Chief ophthalmologist of Ukraine, Oksana Vitovska, All-Ukrainian alliance of ophthalmologists

We would like to express sincere gratitute to the team of Law firm "Pravova dopomoga" and personally to Volodymyr Gurlov for professionalism and purposefulness in your work.... More information

Partner, Denis Y. Lysenko, Vasil Kisil & Partners

... we would like to express our respect and gratitude for the fruitful cooperation.
... our work on joint projects assured us of your high level of professionalism
... More information

General Manager Stashkevych I.Y., LLC “Trading company” Rud”

We would like to indicate that law firm "Pravova Dopomoga" has become a reliable partner for legal services provision and we can recommend it as a team of qualified professionals who are easy and pleasant to deal with... More information

General director Skibinskiy V., Yokogawa Electric Ukraine Ltd.

Yokogawa Electric Ukraine Ltd. recommends Vladimir Gurlov and his team of lawyers as a reliable legal partner and advisor for foreign businesses in Ukraine...... More information

General director I.Logvinenko , Bravo Airways

Bravo Airways company expresses its gratitude to law firm "Pravova Dopomoga" for high quality and timely provision of legal services.
... More information

President Tedeev E.S., Ukrainian wrestling association

Ukrainian wrestling association would like to express its sincere appreciation to the team of Law firm "Pravova Dopomoga" for mutually beneficial cooperation... More information

Important to know

  • 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 FAQs

Is an on-site inspection called for to obtain a license to bring (import) medicines into Ukraine?
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.
Does the license to import drugs give the right to carry out their further sale?
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.

SWIFT OBTAINMENT
AND BEST QUALITY PROVEN BY YEARS OF PRACTICE!

Volodymyr Gurlov, Managing partner

Volodymyr Gurlov, Managing partner

RELEVANT INFORMATION

1) Importation of medicines must be accompanied by existing certificates on the quality of a medicine (series) issued by the manufacturer;

 

2) 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.
3) It is forbidden to import low-quality medicines, which, among other things, include products whose expiration date is near the end (see clause 2 above) or expired or those that have been subject to mechanical, physical, chemical, biological treatment, etc. and which makes their use impossible.



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