Obtainment of licenses and permits in Ukraine

• we advise on passing the accreditation procedure by a medical institution and preparing the necessary documents / bringing the applicant in compliance;
• preparation of documents/provision of templates for the development of documents for submission to the Ministry of Health;
• support of exit expert appraisal;
• obtaining an accreditation certificate.

Cooperation is finished after getting a pharmacy license for a Client.

Drugstore license  -  Terms  -  Required documents  -  Requirements  -  Experience

• 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.

• 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).

• We check the enterprise for the compliance with the license regulations and eliminate nonconformities, if any;
• We prepare a comprehensive package of documents for inspection; 
• We advise the head of the enterprise on procedural aspects of the inspection; 
• We directly participate in the inspection.

• we consider the situation of the Client in terms of the chances of winning the case at the Expert and Appeal Board on licensing under the State Regulatory Service of Ukraine (hereinafter referred to as the Board of Appeal)

• prepare a complaint against the decision of the licensing authority to revoke the license and submit it to the Board of Appeal;

• we represent the interests of the Client in the Appeal Board, and if necessary, we carry out a judicial procedure for appealing of a decision to revoke a license (in most cases, a judicial procedure for appealing is not necessary).

• consult Clients;
• prepare and submit documents that are required for registration of medical equipment and medical products to the State Inspectorate for Quality Control of Medicines. 

• Advise on the procedure for obtaining an SES Certificate for the premises in the Client’s situation - the necessity, procedure, risks and timing;

• Conduct a preliminary study of the object of examination for compliance with the standards;

• If the inspection shows that the object complies with the law - we prepare a package of documents for submission to the authorities of the State Service of Ukraine on Food Safety and Consumer Protection;

• If, the inspection shows that there are contradictions with the requirements of the law - we consult with the sanitary and epidemiological authorities for the issuance of the Certificate without the need to make changes;

• Monitor the consideration of the application for the SES Certificate for the premises and answer, if necessary, the questions of the state authority;

• Obtain the SES Certificate for the premises.

In addition, our lawyers can accompany on-site inspections of regulatory agencies (for example, during the inspection of medical offices).

• help you to understand the stages of the registration procedure of your medication, the optimal term of registration, costs minimization of medicines registration;
• after signing the confidentiality (non-disclosure) agreement, we will review your case and prepare a detailed plan of further actions taking into consideration the following: necessary documentation, stages, registration budget, timeframes;
• provide legal support in the appointment of an authorized representative;
• hold preliminary consultations with the Center of Drug Evaluation and Research, analyze, revise or develop the dossier (fully or partially) in compliance with the requirements of the Ministry of Health of Ukraine and advisory committees;
• draw up: methods of quality control, instructions, identification mark;
• accompany the primary expert evaluation;
• accompany the specialized examination

• we help to determine whether the product is medical and, if so, which class it belongs to;
• identify devices, declaration  of which  can be carried out according to a simplified procedure (for example, self-declaration or recognition of certificates issued in EU countries);
• we help verify the compliance of medical devices with the Technical Regulations, including by means of an audit of the quality management (control) system.

• Assist with identification of the necessary actions and documents that will subsequently be necessary to license school infirmary;

• Assist with documents that our client cannot obtain on his own;

• Fill out all the applications/forms;

• Submit paperwork based on power of attorney (no need to come to Kyiv);

• Monitor decision of the Ministry of Health and prepare payment details of official license fee.

• Advise on the current legislation, on the procedure for registration of disinfectants (due to the lack of a developed legal framework of the Ministry of Health)
• Submit a package of documents to the State Service of Ukraine for Food Safety and Consumer Protection ( temporarily replacing the Ministry of Health) for the disinfectant registration, as well as represent and protect the Client’s interests, in case of any objections;
• Help to identify a particular disinfectant as such, which falls or does not fall under the definition of a disinfectant;
• Advise on all matters related to the registration (procedure, draft instructions, labels, technical specifications and other documents);
• Obtain paper confirmation of the registration from the relevant register of the State Service of Ukraine for Food Safety and Consumer Protection (temporarily replacing the Ministry of Health).

• Advise the Client on all matters related to the requirements for the pharmacy storage facilities, as well as for the qualification of personnel;
• Analyze available documents for the pharmacy storage facilities and personnel;
• Prepare an application, statements and other documents to be submitted to the State Service of Ukraine on Medicines and Drugs Control for obtaining a License to Wholesale Medicines;
• Submit the documents signed by the Client to the State Service of Ukraine on Medicines and Drugs Control; 
• Monitor the process of the documents review by the State Service of Ukraine on Medicines and Drugs Control.

• advise Client on all matters related to preparation of documents and help to prepare them;
• submit the documents to the licensing body;
• support consideration of application by the National Commission for the State Regulation of Communications and Informatization;
• obtain the license based on power of attorney granted by the Client.

• advise Client on all matters related to preparation of documents and help to prepare them;
• submit the documents to the the National Commission for the State Regulation of Communications and Informatization;
• support consideration of application by the National Commission for the State Regulation of Communications and Informatization.

• provide verbal advice concerning the requirements for telecommunication operators and providers and in connection with their inclusion in the appropriate register;
• prepare an application for inclusion in the Register of Telecommunications Operators and Providers;
• submit an application for inclusion in specified register to the NCSRCI (National Commission for the State Regulation of Communications and Informatization);
• support processing of application by NCSRCI

• consult on an issue of television/radio broadcasting licensing (requirements, terms, etc.); 
• prepare the package of documents that is necessary for obtaining a license;
• provide the submitting of documents to the National Council of Television and Radio Broadcasting of Ukraine;
• monitor the process of documents review by the National Council of Television and Radio Broadcasting of Ukraine and making of decision concerning license;
• provide details for the payment of license fee following the rendering of favorable decision concerning license issuance;
• after the payment of license fee, we receive a ready-made license form and deliver to you a license for television/radio broadcasting.

• Analyze the documents which are provided by a foreign party for their legal sufficiency;
• Provide project of an agreement with a foreign employer and agent and also provide an example of a labor agreement with potential employees;
• Translate foreign documents into Ukrainian and certify them notarially;
• Consult on matters related to the required list of documents for getting a foreign employment agency license in Ukraine;
• Prepare a model of certificate which confirms that collective agreement wasn’t signed;
• Prepare the full list of documents and submit it to the licensing authority;
• Accompany examination of the documents for getting the foreign employment agency license in Ukraine.

• advise Client on all matters related to preparation of documents that are required for obtainment of license for passenger transportation, taxi service etc.;
• develop the documents for submitting to the State Service of Ukraine for Transport Safety, prepare an application form and other required documents;
• submit the documents to the body of licensing on a power of attorney and obtain the license within agreed term.

• consult the Client on issues relating to obtaining veterinary practice license, in particular, in respect of documents preparation, staff qualification and the fineness of chosen premises and/or assist with the choosing;
• fill in all necessary documentation and submit an application per power of attorney, without personal attendance of the Client;
• escort obtaining a license in the licensing authority for the entirety of the period;
• take charge of solving of problem situations of the Client during the documents review in the state authorities;
• obtain confirmation of license issuance in a hard copy.

• consult a Client on matters of getting a license for operations with precursor chemicals in Ukraine;
• analyze documents which are given by a Client, if necessary we provide support on getting some of them. For example, no criminal certificate;
• consult a Client during the process of getting a police permission for premises;
• prepare and send a Client for signing documents which are necessary for getting this license – particularly, information about material and technical equipment etc;
• represent interests of a client in Kyiv by the power of attorney;
• after getting a decision on issuance license we find out correct bank details for paying an official license fee, help to pay it.

• we calculate different options of the set of construction works, based on the Designation nomenclature of types of works in construction;
• we help to get the maximum possible amount of works in the cost of works that is agreed with a Client;
• we help to find the missing specialists, and to comply with other requirements raised for a construction license applicant at the stage of getting a license for construction;
• we prepare the full package of documents for application for building license – reports, an application, and other;
• we support consideration of Client’s application at the State Architectural and Construction Inspectorate, after the application was submitted;
• we control the readiness of the building license, the entering of official payment, we take the license form and appendix thereto – the list of types of construction works, by power of attorney.

High risk works are nowadays performed based on the Permit or on the Declaration. Having become familiarized with the list of works performed based on the Permit, and with the list of those performed based on the Declaration, you will understand clearly which document is necessary for you.

When needed, we shall help you deal with this subject.

If your company needs the Permit, here is what we do:

• prepare papers for getting the expert opinion at the appropriate authority;
• get the expert opinion at the appropriate authority;
• submit documents to the State Service of Ukraine on Labor;
• get the high risk works permit.

• Advise the Client on all issues related to the preparation of documents for the successful start of construction and commissioning;
• Analyze the Client’s situation and develop an optimal action plan;
• Prepare a complete package of documents for the successful start of construction and its further commissioning;
• Submit documents to the relevant state authorities;
• Support the consideration of documents and solve all issues related to their consideration;
• Obtain the Permission for construction works and the Construction and Commissioning Permit, and transfer it to the Client.

• Help the Clients to decide whether they need to obtain a Hazardous Waste Management License. If their activities are not subject to licensing, or if obtaining a license is not mandatory, we propose the best possible plan of actions;
• If it is necessary to obtain the License, we advise the Client on procedural issues and necessary documents;
• Fill in all the necessary documents and submit them to the licensing authority under the power of attorney granted by the Clients; the Client’s personal presence is not required;
• Provide legal support and assistance during the consideration of the documents by the licensing authority;
• If any problems arise during the documents consideration, we are committed to address any of them.

• Make an emission inventory, the results of which are necessary for further drafting of documents;
• Develop documents that substantiate the volume of air pollutant emissions;
• Prepare and submit documents for obtaining a permit on emission of harmful substances in atmospheric air;
• Communicate with representatives of the state authorities issuing the permit, representing your interests;
• Obtain the ready-made permit and hand it over to you.

• advise on all matters of collecting and preparing necessary documents for obtaining a license, as well as a full list of requirements that a lessor must meet;
• draft internal rules for a provision of financial leasing services, a standard financial leasing agreement;
• help with an organization of pre-license audit;
• draft and submit to the National Bank of Ukraine (hereinafter - the NBU) the necessary package of documents for obtaining a license.

• consult on all aspects related to preparation of documents for obtaining a tour operator license;
• prepare the necessary document package for submission to the licensing authority;
• submit documents to the licensing authority;
• supervise the process of documents review from the moment of submission to the decision about issuance of tour operator’s license.

We also help with:

• registration of legal entity, for which you will obtain a tour operator’s license;
• obtaining a bank guarantee;
• creation of web-site for your company, which is needed for obtaining a tour operator’s license.

• help to determine the right type of subsurface use depending on the Client's wishes and needs;
• provide a full list of documents to suit the Client's specific situation;
• study the Client's needs in terms of the need to participate in an auction and the possibility of not participating in it;
• accompany the Client throughout all stages of obtaining a permit for the use of subsoil;
• accompany the entire process of permit issuance by the State Geology and Subsoil Service of Ukraine;
• consulting on renewal of subsoil use permits in Ukraine;
• accompany the Client through the process of interaction with local authorities and environmental inspections.

• We provide legal support and assistance in obtaining an International Business License (hereinafter - the License);
• We analyze the documents provided by the Client, including the information on the situation and find the best solutions;
• We represent the Client’s interests in other private and state structures on issues related to obtaining and successful use of the License;
• We help collect and prepare the appropriate set of documents required to obtain the International Business License;
• We assist with the calculation and payment of the state fee;
• We advise the Client throughout the licensing procedure and the collection of documents;
• We help with the development of various foreign economic agreements, letters, conclusions, etc., if necessary;
• We submit a package of documents to the state authority, obtain the License and hand it over to the Client; 

• register copyright, verify its compliance with requirements of the law;
• help to determine how to register the object of copyright in the best possible way (as code, picture or audio file);
• determine the uniqueness of your work, computer program, song etc.;
• fill out and prepare all necessary documents for registration;
• consult in the process of work being created by the author;
• obtain and send a registration certificate.

• analysing the documents which are submitting  to the National Bank of Ukraine, giving the conclusion about its self-sufficiency and legal correctness;
• developing the internal rules about the transfer of funds;
• helping with the business plan and with auditing organisation;
• preparing and applying a set of documents for obtaining a license;
• giving a consultation about questions, which are connected to the collecting and preparing of documents, what are needed for obtaining a license and about the full list of requirements, which the financial institution and its owners must met.

• We consult market entities on the matters of the licensing of operations with oil products, including analysis of documents the entity has (for example, documents of property, designated use, etc.);
• We consult on situations when it is possible not to get a license for fuel sale;
• We get permission for hazardous works (or operation of machines) for any business connected with production or storage of combustive and lubricating materials;
• We assist oil product manufacturers with search and registration of relations with the accredited testing laboratories (for defining the fuel quality factors);
• We perform the search of organizations for development and/or develop independently the technical conditions and technical documentation for fuel manufacturers;
• We help oil product manufacturers to find and formalize relationships with accredited testing laboratories (to determine fuel quality indicators)
• We help fuel producers to develop technical specifications and technical documentation;
• We organize cooperation with organizations to develop and/or personally develop technical specifications and technical documentation for fuel producers.

• We define with the Client which kind of subsurface resources use he will be engaged in, and we make him familiar with the list of documents that he should have for that;
• After the prepayment is made by the Client, we assess the documents available, and in case some of them are missing, we consult and assist in getting such documents;
• After a power of attorney is signed by the Client, our lawyers prepare the package of documents and submit it to the corresponding authority that issues a permit for subsurface resources use;
• If required, we assist in re-registration of the permit or with changes in the permit for subsurface resources use thereafter for extra pay.

• advise on peculiarities of the licensing of fire protection works (services);
• analyze provided documents from the perspective of their conformity with the regulatory requirements;
• assist in preparation of the documents that you do not have or are unable to acquire yourself (if necessary);
• form final list of documents and approve it with the licensing authority;
• submit the the documents with the bodies of the State Emergency Service of Ukraine (hereinafter - SESU);
• monitor the decision publication on license issuance and provide you with details for payment of the official state fee;
• receive notification from the SESU (in paperform) regarding license issuance.

• provide consulting concerning compliance of financial institution, its head (Director General, General etc.) and the chief accountant with legal requirements;
• assess documents that are planned to be submitted to the National Bank of Ukraine, and we make a conclusion concerning their legal correctness and compliance of persons with conditions;
• assist in writing a business plan, a questionnaire of financial institution, and other documents, if required;
• analyze the financial and auditing reports before they are signed at an auditing company;
• prepare the package of documents and provide it at the National Bank of Ukraine for consideration and for getting a currency exchange license;
• control passing of documents in consideration at the National Bank of Ukraine.

• we provide readiness of all documents required for registration of the license;
• we develop completely the information for the Client’s website or (if so agreed) prepare independently the website for the license;
• we pass the documents for the meeting of the licensing authority, and we control getting a positive decision about issue of license;
• after the decision is taken by the licensing authority about issue of license, we provide for you the actual banking details for payment of license fee;
• we get a copy of resolution about issue of license and pass it to the Client (if so agreed);
• we perform the consulting in the matters of getting a license for resale of electric power (trading activity).

• obtaining ЕІС code necessary for the further work on the electricity market;
• preparation and submission to Ukrenergo NPC SE a package of documents for execution of agreement for the transfer of electricity;
• obtaining and delivering to you the signed agreement for the transfer of electricity;
• preparation and submission to Ukrenergo NPC SE a package of documents for accession to the imbalance settlement agreement;
• preparation and submission to Ukrenergo NPC SE a package of documents for registration of your company as a market participant;
• supervision of imbalance settlement agreement acceptance and inclusion of your company to the Register of market participants.

• we get an electricity license;
• we carry out an analysis of the documents provided;
• we develop completely the information for the licensee’s website and consult concerning its correct posting;
• we prepare documents to be submitted for the licensing authority;
• we support Client’s case at the National Energy and Utilities Regulatory Commission from the beginning of submission of documents until the electricity distribution licence is obtained;
• if necessary, we get a certified copy of the Resolution about license issuing;
• we pay official payments (if so agreed).

• Receive any license from the National Bank of Ukraine (hereinafter - the NBU);
• Develop and consult on the package of documents required for obtaining a license and carrying out further business activity;
• Ensure the company’s inclusion in the the State Register of Financial Institutions of Ukraine (if necessary);
• Assist in drafting additional documents (rules and regulations, agreements);
• Help to obtain an audit report and to successfully undergo the audit, we can offer our partner auditors;
• Analyze a set of the documents provided by the Client, and assist in collecting missing documents;
• Advise on the requirements for business activity depending on the type of license (factoring, leasing, guarantee, lending services, etc.).

• we advise the Client on the issues relating to the obtainment a license for veterinary drugs manufacturing, including issues related to the personnel qualification and the compliance of the premises with the license conditions;
• we assist with the choosing of premises for the implementation of activities on veterinary drugs manufacturing;
• we provide assistance with the development of dossier of the manufacturer’s division;
• we fill out all the necessary documents and submit them to the licensing authority under power of attorney on behalf of the Client without his personal presence;
• we accompany documents review in the licensing authority;
• in case of problem situations during the documents review we take charge of their solving.

• we analyze the documents of the Client: are they suitable for obtaining a license for manufacture, repair and sale of weapons;
• we provide verbal advice concerning obtainment of license, as well as regarding permitting documents required for license acquisition;
• if it should be necessary, we can obtain some of the documents necessary for acquisition of specified license, including Permit for opening and operation of the licensing system objects;
• we prepare an application, form a package of documents and submit it to the Ministry of Internal Affairs of Ukraine;
• we monitor documents review and provide details for the payment of state duty;
• we send to the Ministry of Internal Affairs of Ukraine a copy of payment receipt for license issuance.

• consult on due order and procedure for setting the “green tariff”;
• obtain an electricity generation license;
• prepare and submit a package of documents to the SE Guaranteed Buyer for signing of electricity sale and purchase agreement according to “green” tariff (where required);
• prepare and submit a package of documents for setting the “green tariff” to the NCSREPU (the National Commission for State Regulation of Energy and Public Utilities);
• receive and deliver to you a copy of resolution on setting for you (your enterprise) the “green tariff” on electricity sales.

• Obtain the Gas Supply License in Ukraine;
• Analyze the documents and information provided by the Client to obtain the license;
• Develop the licensee’s website, as well as consult on what, how and why should be specified on your website;
• Prepare a full package of documents required for obtaining the Gas Supply License;
• Monitor the progress of your case at the National Energy and Utilities Regulatory Commission (NEURC) and support your case until a successful decision is made;
• Provide the Client with the details to pay the license fee or pay official fees (at the Client’s request);
• Obtain and hand over to the Client a certified copy of the Gas Supply License Issuance Order.

• Help you choose the most suitable type of the license for your business;
• Prepare and review all the necessary documents to obtain a Gambling License;
• File and support the license file at the authorized authority for obtaining the Gambling License;
• Advise on gambling activities, offer the best plan of work;
• Analyze the documents provided by the Client;
• Advise on the avoidance of obtaining a Gambling License, when allowed by law;
• Organize the payment of the official license fee;
• Advise on further activities of the firm (by agreement);
• Provide assistance with certification of equipment needed for gambling;
• Help with connection to online monitoring system;
• Provide assistance in obtaining a domain name and registration of the corresponding trademark.

• Support the process of obtaining an EIC code needed to operate in the gas market;
• Support the signing of the agreement with the GTS Operator needed to obtain gas transportation services;
• Provide assistance in obtaining access to the І-platform;
• Advise on obtaining the shipper code;
• Advise and sign the agreement for gas storage in the “customs warehouse” regime;
• Prepare and submit all necessary documents for the company’s inclusion in the gas market.
• Support the process of accreditation at the Exchange, which is necessary for gas trading.
• Advise on issues related to the registration as a gas market participant.

• Advise the Client on all issues related to the preparation of documents for obtaining a license for cargo transportation, dangerous goods, etc.;
• Develop a package of documents to be submitted to the State Service of Ukraine for Transport Safety, prepare an application and statements;
• Submit documents to the licensing authority by proxy, and get the license within the agreed time.
• In addition, our lawyers can help you:
• Prepare draft agreements with the road transport industry for medical and technical examination, parking, etc.;
• Find counterparties to sign the above agreements;
• License your employee to conduct pre- and post-trip medical examinations of drivers (in this case, you need to get a separate Medical License of the Ministry of Health).

• develop a "roadmap" for the process of veterinary drug registration;
• help with preparation of registration dossier for a veterinary drug;
• submit a package of documents to the appropriate agency;
• monitor the review of documents by the agency, always in touch in case you need to intervene;
• obtain a veterinary drug registration certificate for the Client, on his behalf.

• we advise on obtaining a license to carry out online education;
• we analyze the documents available to the Client, including whether the premises are suitable for opening a school in it;
• we help in the development of an educational program for the school online;
• if necessary, we help in obtaining permits for the premises (act from firefighters, withdrawal of the State Consumer Service);
• we prepare and send documents to the Client for signature, submit them to the Ministry of Education and Science of Ukraine;
• we monitor the status of consideration of the case by the Ministry and keep the Client informed of the situation.

• Identify the real need of the CLIENT in obtaining the SES Certificate for the product (whether it is necessary to obtain this certificate in your specific case);
• Consult on the whole procedure of obtaining the SES Certificate for a product;
• Analyze your available documents on the products, make a list of what may be missing for the successful receipt of the SES Certificate;
• Prepare a package of documents for their further submission to the State Service of Ukraine for Food Safety and Consumer Protection (formerly the Sanitary and Epidemiological Service), eliminate, in some cases, challenge the objections of the state authority; 
• Represent the Client’s interests at each stage of obtaining a hygienic certificate for the product;
• Obtain an official conclusion / survey report on the product and technical specifications of the presented products (if necessary).

• Obtain a permit for special water use in Ukraine;

• Analyze documents and information provided by the Client to obtain a permit for special water use;

• Develop a scheme of water withdrawal and wastewater discharge points;

• Advise on standards of maximum permissible discharge (MPD) of pollutants with waste water into water bodies;

• Develop a full package of documents for obtaining a permit for special water use;

• Monitor the Client’s documents at the State Water Resources Agency and State Service of Geology and Subsoil of Ukraine;

• Keep a check on obtaining a permit on the official website of the State Water Resources Agency;

• Accompany the Client when obtaining a permit at the Administrative Service Centre.

• Advise the Client on all issues related to the preparation of documents for obtaining the International Transportation License in Ukraine;

• Develop a package of documents for submission to the State Service of Ukraine for Transport Safety (Ukrtransbezpeka), prepare an application and statements;

• Submit the documents to the licensing authority by proxy and receive the International Transportation License within the stipulated period of time.

In addition, our lawyers can help with:

• Preparation of draft agreements with the road transport operators for medical and technical inspection, parking, etc;

• Search for counterparties to sign the above agreements for international transportations;

• Licensing of its own employee to conduct pre- and post-trip medical examinations of drivers (in this case we get a separate Medical License of the Ministry of Health).