Regulatory law

Regulatory law

rutland & partners specializes in Czech regulatory law in the below described sectors.

Key contacts

Aviation

If you want to be active in the aviation market in the Czech Republic, you have to meet the conditions set by the Civil Aviation Authority (CAA). rutland & partners team has extensive experience with working with the CAA.

 

The basic requirement is to register an aircraft in the Aircraft Register of the Czech Aviation Authority.

 

The Aircraft Register is the register where every aircraft operated by an individual with a permanent residence in the Czech Republic or a legal entity based in the Czech Republic must be registered. The Aircraft Register is a publicly accessible document and anyone may inspect the Czech Aircraft Register and request a copy or extract of the entered data or confirmation that the data is not entered in the Aircraft Register from the CAA.

 

The following aircraft data supposed to be entered in the Czech Aircraft Register:

  • owner
  • operator
  • registration mark
  • aircraft type and serial number
  • other basic technical data
  • establishment of a lien on the aircraft, aircraft components and spare parts for the aircraft and its components
  • aircraft address, if assigned
  • the date of registration and deletion of the aircraft from the Aircraft Register

 

By registering the aircraft in the Czech Aircraft Register, the aircraft acquires the nationality of the Czech Republic. Once the aircraft is registered, the CAA will assign an aircraft registration mark and an aircraft registration certificate to it.

 

Export and import permits for airplanes.

The CAA makes the import and export of aircrafts quite difficult. In fact the CAA requires more than 30 documents for obtaining the permit. The CAA divides countries into 2 groups:

 

EASA member states

  • all 28 members of the EU + Iceland, Norway, Switzerland and Liechtenstein

 

Non-EASA member states

  • every other state
  • 2 more documents required
  • Type Certificate – Confirmation of compliance with the applicable certification standard
  • Recommendations for ARC issue – Must be processed by an authorized CAMO (Continuing Airworthiness Management Organizations)

The Arms industry - Export and import license for arms products and material. Radars, drones and parts of arms products

 

Since 1930s´, the Czech Republic (formerly Czechoslovakia) has been a major player in the field of the arms industry. And these days, it still is. Nowadays, the Czech Republic has a huge advantage, as it is a member of the EU, which is makes us a part of a market with more than 500 million people.

 

General License

 

This is a simplified type of license, which is created on the basis of registration with the Ministry of Industry and Trade – License Administration. On the basis of this license, military material may be exported within the territory of another EU Member State if:

 

  • the recipient is part of an EU Member State’s armed forces or is a contracting authority which carries out purchases exclusively for the armed forces of a Member State
  • the beneficiary is a legal entity or an individual certified under the relevant legislation of the Member State (exporting country)
  • export is carried out for the purpose of demonstrating samples of goods, assessments or exhibitions
  • export is carried out for the purpose of maintenance or repair of military equipment

 

Other obligations of the exporter in particular include the requirement to prepare accompanying documents for each export case, and the obligation to deliver the documents prescribed by Czech law and the related information to the Ministry of Industry and Trade – License Administration

 

Summary License

This is the second type of export license for arms trade within EU Member States based on which military equipment may be exported to multiple recipients in one or more EU Member States.

 

Individual licenses

Through this type of license, the exporter is authorized to export military equipment to one specific recipient in another EU Member State

Sale of Electrical Energy

Electricity business in the Czech Republic is directed by ERO – Energy Regulatory Office (ERÚ – Energetický regulační úřad). rutland & partners specialists have extensive experience with dealing with the ERO. Sale of electricity is strictly regulated by law as a lucrative field where the main share of the market is take up by state firm ČEZ.

 

Among regulations of electricity business, ERO also provides:

  • Price controls
  • Support for the use of renewable and secondary energy sources, combined heat and power generation, biomethane, decentralized energy production and protection of customers´and consumers’ interests
  • Protection of licence holders’ vested interests, legitimate customers´and consumers’ interests in the energy industries.

 

We can help you with obtaining a license for:

 

  • Production of electricity
  1. With Installed power of the production plant below 200 kW
  2. With Installed power of the production plant higher than 200 kW
  • distribution of electricity
  • transmission of electricity
  • trade with electricity

Medical devices

When entering the EU market dozens of requirements must be fulfilled especially when you want to be in the medical device market. The regulation of this field is extremely strict in the EU.

                                                          

Council Directive 93/42/EEC applies to medical devices and their accessories. This Directive defines medical devices as instruments, apparatuses, appliances, software, materials or any other article, whether used by itself or in some combination, including software which is intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes, and is intended by the manufacturer to be used on human beings for the purpose of:

  • the diagnosis, prevention, monitoring, treatment or alleviation of disease
  • the diagnosis, monitoring, treatment, allevation of or compensation for an injury or a handicap
  • the replacement or modification of the anatomy or of a physiological process,

control of conception

 

To get on the EU market, your products must first be inspected and certified by the relevant approval authority. The notified body makes sure everything is up to EU standards. There are two approval authorities in the Czech Republic for medical devices. One being ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p. and the other INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s.

 

There are a couple of kinds of certificates, for example:

  • Medical Device Regulation (MDR)
  • In Vitro Device Regulation (IVDR)
  • Medical Devices Directive (MDD)
  • Active Implantable Medical Devices Directive (AIMDD)

 

We can assist you with preparing all of the needed documents and getting you on the market, as soon and as easily as possible.

Medical marijuanna

As the Czech Republic became one of the medical cannabis planting and production countries, rutland & partners have been representing medical marihuana growing companies intending to do busines in the Czech Republic. Due to this fact we have acquired a thorough knowledge of the Czech legislation regulating the hemp and cannabis planting and processing. We advice cannabis companies on growth, manufacturing and import/export of medical cannabis plants and products (including CBD cosmetic products) from and to the Czech Republic. Such advice comprises both Czech CBD and THC products. We have also represented foreign businesses in the goverment tenders for growing cannabis plants with higher than 0,3 THC levels. In the Czech Republic only govermental body can purchase medical marijuana with the higher level of THC and distribute it to pharmacies. However, import of cannabis plants is allowed based on an import license. CBD production is less controled in the Czech Republic, but still is subject to regulation which must observed, both by the Ministry of Agriculture and the Czech custom offices.

 

In addition, we are involved at the moment in the lobbying with Czech parliament for the clarification of the Czech Act on Dependency Producing Substances and hope that we will succeed to provide our clients with easier access to the Czech medical marihuana market.

Import/export of farm and wild animals

Farm animals

In regards to moving live farm animals across borders, the EU clearly dictates the difference between intra-Union trade and non EU importation/exportation. Intra-Union trade refers to the movement of animals across borders in the EU, while importation/exportation refers to the movement of animals across EU borders.

 

To ensure the safety of animals during transportation and to avoid the transmission of disease to humans or to other animals, the EU has put in place a wide range of regulations and various animal health requirements. General animal health requirements are applicable to both intra-Union trade and importation/exportation are specified in Council Directives.

 

Intra-Union trade

Conditions for intra-Union trade a harmonized throughout the EU. All live animals must travel with a health certificate validated by an official veterinarian, which confirms that the animals fulfill all basic health requirements set by the Council Directives. There may also be checks carried out at the final destination. In the event of a serious disease outbreak, special requirements may be implement to prevent the spread of said disease.

 

Importation/exportation

For importation, special requirements are specified by Commission Decisions. Commission Decisions define health certificates for all animal imports. These certificates must be verified by an official veterinarian who is a competent authority of the exporting non-EU country. After arrival in the EU, The animals and their certificates must be verified by EU veterinarians at a designated Border Inspection Post. Further checks may be carried out at the final destination.

Export of protected animals under The Convention on International Trade of Endangered Species

CITES is an international agreement signed by more than 180 countries. Its calls for international control of the trade of endangered species and the protection of wildlife. Czech Republic is member of CITES.

 

We are here to help with:

 

  • Import or export permits

Including dealing with Czech authorities, mainly with the Czech Ministry of Environment

  • Traveling Exhibition confirmation

The organization of a wildlife exhibition is not only hard in preparing a specific climate for species of fauna and flora. It is also complicated in regard to permits. rutland & partners will help you with obtaining all of the necessary documents

  • Sample Set Confirmation

Science research permits are also required for the trading of endangered species for scientific purposes.

CITES is an international agreement signed by more than 180 countries. Its calls for international control of the trade of endangered species and the protection of wildlife. Czech Republic is member of CITES.

 

We are here to help with:

 

  • Import or export permits

Including dealing with Czech authorities, mainly with the Czech Ministry of Environment

  • Traveling Exhibition confirmation

The organization of a wildlife exhibition is not only hard in preparing a specific climate for species of fauna and flora. It is also complicated in regard to permits. rutland & partners will help you with obtaining all of the necessary documents

  • Sample Set Confirmation

Science research permits are also required for the trading of endangered species for scientific purposes.

 

Certification of Non EU products

Nowadays hundreds of entrepreneurs are trying to get on the EU market because the area with more than 500 milion potential clients is a big advantage for every product regardless it is a food or some medical device. rutland & partners team is there for you and ready to help you with obtaining a Certification of a non EU product.

 

The free movement of goods is secured through the elimination of customs duties and quantitative restrictions, and the prohibition of measures having an equivalent effect. The principles of mutual recognition, elimination of physical and technical barriers, and promotion of standardisation were added in order to continue the completion of the internal market. The adoption of the New Legislative Framework (NLF) in 2008 strengthened the free movement of goods, the EU’s market surveillance system and the CE mark. Recent research indicates that the benefits arising from the principle of free movement of goods and related legislation amount to 386 billion euros annually.

 

e.g. toys, electrical equipment, machinery, medical devices, lifts, personal protective equipment, fertilizers etc.