Activities subject to licensing

According to the Hungarian law, performing a certain range of activities is subject to licensing by National Authorities. These activities can only be performed if your company gets the necessary license for performing the activities. The activity can be indicated at the incorporation as your company’s activity before you get the license for it, but you can’t carry out the activity, until you get your license for it.

Please let us give you a brief introduction about the most commonly chosen licensed activities.

For performing pharmaceutical manufacturing activity necessary a pharmaceutical manufacturing license, issued by the National Pharmaceutical and Nutrition Institute, and a certificate of GMP (Good Manufacturing Practice) compliance.

The basic condition for issuing the license is a qualified person, who has the appropriate qualification and professional practice. The manufacturer is obliged to report the changes in connection with the qualified person to the National Pharmaceutical and Nutrition Institute in the form of manufacturing-license modification request.

The steps of the procedure:

1. The evaluation of the received application, and the warning the applicant for content supplementation if it is necessary,
2. In case of a complete application, which is formally and substantively appropriate, the official notification of the applicant about the time of the site inspection,
3. Site inspection at the specified time,
4. Warning the applicant about correcting improving the deficiencies, revealed at the inspection and detailed in the inspector’s report,
5. Evaluation of the documents submitted in the rectification,
6. Issuing the manufacturing license,
7. Recording the data in the EU database, operated by the European Medicines Agency (http://eudragmp.ema.europa.eu/inspections/displayWelcome.do)
8. Issuing the GMP certificate,
9. The refusal of the application, if the content supplementation, or the documents submitted in the rectification are not appropriate.

You can find all the information about applying for the license for manufacturing on this website: https://ec.europa.eu/health/documents/eudralex/vol-2_en

The uploading of the data into the EudraGMDP public database, and issuing an instance of a paper-based certificate is a part of the site inspection, and it is free of charge. Requesting additional original certificates is subject to charges.

The conditions of requesting a certificate of GMP compliance:

• The subject of the certificate is a Hungarian site,
• Less than 3 years has passed since the inspection,
• Submitting a complete application by post, in a traditional (paper-based) form, for the Institute, with the following data content:
  • Application identifier (applicant’s registration number), date,
  • Name and address of the applicant,
  • The name and address of the site, which is the subject of the certificate (based on the original certificate in the EudraGMDP),
  • Date of the inspection, National Pharmaceutical and Nutrition Institute case number,
  • Number of copies requested,
  • Comment (if any),
  • Naming appendices and number of pages (if any),
  • Proof of payment of the procedural fee, with the following information:
    • Number of copies requested,
    • Type of the requested certificate: ,,GMP’’,
    • Application identifier,
    • Name of the applicant (if it is someone else, than the payer),
    • Manufacturing site.

The National Pharmaceutical and Nutrition Institute inspect the companies, which are entitled to a pharmaceutical manufacturing license regularly, at least every 3-5 years.

To operate such an agency in Hungary, necessary a license, which can be obtained by the competent government office according to the registered address of the company. For obtaining the license necessary an adequate office, the applicant or the employee employed by him/her (in minimum 20 hours/week) must has the appropriate degree or professional qualification, practice according to the Hungarian laws, and the applicant has to deposit an appropriate amount of the financial collateral according to the Hungarian laws.

Performing these activities are also subject for an authority license, there are specified requirements for obtaining this license.

These requirements are the following:

• The managing director, the senior employee and the person responsible for the activity has to prove with a certificate that he/she does not have a criminal record, and he/she does not have a disqualification from employment in the scope of the named activities,
• The managing director, the senior employee and the person responsible for the activity has to declare that he/she was not an owner, managing director, senior employee, member or person responsible for the activity of such a tour operator or travel agency company, which was disqualified from performing tour operator or travel agency activity, because the breach of a legal provision, within 5 years prior to the commencement of the activity,
• The person responsible for the activity has to prove with a certificate that he/she has the required professional practice and qualifications.
• A certificate of that the person responsible for the activity has at least one C1 type state-approved language exam,
• A certificate that the managing director employs the person responsible for the activity at least 20 hours a week,
• In case of incorporating a tour operator company, necessary a specified amount of asset collateral.

In case if you are intend to establish a company operating with financial activities or an insurance company there are certain documents which you will need for obtaining the license, which can be obtained from the National Hungarian Bank.

Financial activities can only be performed as a share company or as a branch. In case of financial activities please note that (expect for the ’’Zártkörűen Működő Részvénytársaság’’) if you have chosen the production of the share in dematerialized form in the Deed of Foundation, you have to produce these shares in printed form before the license obligation, otherwise you won’t able to do that afterwards.

For performing financial activities you will need the following documents:

• An application for the license, with indicating that what type of financial activity the company would like to perform,
• The company’s Deed of Foundation,
• The document containing the designation of the planned operating area,
• The official certificate about the founders availability, and that they have paid the total amount of the start-up capital – which minimum amount is 166.750 EUR (except for financial holding companies and financial companies operating a payment system) – the start-up capital shall be paid in cash at a certain credit institution, which did not participated in the foundation, and none of the founders have ownership in it also please note that until during the licensing procedure, you won’t be able to use the start-up capital,
• The presentation of the Organizational and Operational Rules,
• The certificate of that the company has the necessary material and personal conditions for performing financial activities,
• A statement that the management of the financial company will be performed in the head office, which will be established in Hungary,
• A statement that the company has informed the Hungarian National Bank about every essential facts and data, in connection with obtaining the license.

For obtaining the license you have to attach the following documents to the application:

• The business plan for the first three years,
• One or more business policy which contains the General Terms and Conditions also,
• A statement about when you are planning to start your activities,
• A statement about the company is ready to fulfil the data service defined by the Hungarian Law,
• The test run results of the computer programs used for the data service,
• A statement about joining Central Credit Information System, and
• The Complaint Management Policy.

For performing financial activities the following material and personal conditions are indispensable:

• Accounting and Registration Rules according to the Hungarian Law,
• Compliant internal rules,
• Adequate technical, IT, security equipment for performing the financial activity,
• Control procedures and system, and – expect for the financial enterprises which only operate with group finance – business insurance,
• Information and control system subject to decrease the operational risks, and a contingency plan, and
• A clear organizational structure.

In case if you are intend to establish a company operating with financial activities or an insurance company there are certain documents which you will need for obtaining the license, which can be obtained from the National Hungarian Bank.

For performing insurance activities you will need the following documents:

• An application for the license,
• The company’s Deed of Foundation,
• The preliminary calculations about the costs of setting up the organization for administrative services and business activities, and a certificate from the credit institution about the existence of funds to cover these costs (the minimum amount of these funds are 333.500 EUR in case of insurance or reinsurance joint stock company or third country insurance branch 166.700 EUR in case of insurance or reinsurance cooperative 3400 EUR in case of mutual insurance association),
• The identity data of the senior person(s), and the documents which certifies the existence of the personal conditions for him/her/them according to the Hungarian Law,
• In case of the founder is a foreign natural person or a foreign not natural person, the statement about his/her/its agent for service (the agent for service can be an attorney at law or a law firm registered in Hungary, or the applicant’s insurer, reinsurer or insurance intermediary registered in Hungary, and the employee of these),
• In case of insurance or reinsurance joint stock company the identity data and the rate of shares of the shareholders, furthermore information about the owner(s) with qualified influence, and the rate of the qualified influence,
• The data of the persons who are in close relationship with the insurer or the reinsurer,
• The proof of payment of the administrative service fee,
• A statement that the company has informed the Hungarian National Bank about every essential facts and data, in connection with obtaining the license.

In case of an insurance or reinsurance company, the senior person(s) must meet the following requirements:

• have a clean criminal record,
• have professional competence and business reliability,
• have managerial practice,
• have an advanced degree.
• the senior person can’t be acting as an auditor at another insurance or reinsurance company.

If there is a person between the founders, who are intend to get a qualified influence in the company, there can be other documents (this can be different in individual cases) required for obtaining the license.

In case of founding an insurance or reinsurance company which belongs to the group or the ancillary supervision, there can be other requirements (this can be different in individual cases) required for obtaining the license.

According to the Hungarian Laws performing freight transportation is also subject to license in Hungary. For carrying out this activity you have to submit an application to the Traffic Authority, for which application you have to attach the copy of the documents provided by your country’s competent authority, which certifies the good business reputation, the professional competence and the financial performance. The road passenger transportation by bus activity is also subject to licensing in Hungary, and the same conditions apply to them as for the road freight transportation.

In case of you want to obtain a community license you will need the following documents:

• Valid road transportation license,
• Statement about the vehicles and trailers,
• Copy of the certificate which certifies the professional competence,
• Training certificate.

For performing road passenger transportation by car, you also have to apply for a license at the Traffic Authority.

Apart from the application you will need the following documents to successfully obtain the license for performing the activity:

• The examination certificate, which certificates the successful acquisition of the appropriate skills,
• A public document issued no earlier than 30 days, which certifies that you are a public debt free taxpayer,
• According to the number of the transportable passengers, an amount of 170 EUR per vehicle as collateral asset, which is treated separately, and a guarantee or a liability insurance certificate corresponding to this, provided by a financial institution,
• A moral certificate,
• If the professional leader is an employee than his/her labour contract, and
• The traffic license.

This activity can only be performed in the framework of a company, which is entitled to perform one or more of the following activities:

• Accommodation utilization activities,
• Tourism activities,
• Tourist activities,
• Sport activities,
• Cultural activities,
• Educational activities,
• Passenger transportation in connection with rail-, air-, water passenger transport, or
• Event organization activities.

You have to certify with the Articles of Association, or with the Deed of Foundation that your company are performing at least one of the activities listed above.

There are certain activities like gambling or telecommunication activities, which require concession procedure for licensing. We do not recommend these activities, because getting the license for these activities are really complex, time-consuming and expensive procedures, and the success is hard to guarantee.

As you can see obtaining these licenses is a really elaborate process, but if you entrust us with your confidence we can help you to solve these matters in the most convenient, effective, and cost-effective way for you.