Laboratory operations under the law on protecting public health - conditions

1. 5. 2014 | Source: Point of Single Contact (PSC) Czech Republic

This document refers to the conditions for issuing a license to operate laboratories in accordance with the law on protecting public health and other information about the licensing procedure.

Back to the document “Laboratory operations under the law on protecting public health – authorization step by step”

Conditions for granting a licence

The conditions for granting authorization are:

  1. Professional level in relation to the proposed area of authorization under the conditions stipulated by the Ministry of Health
  2. Equipment for technical and administrative activities and access to equipment for special assessments
  3. The required number of staff with special training, knowledge and skills
  4. The obligation among staff members to maintain confidentiality on matters which the persons performing the authorization learn about
  5. The absence of financial or other interests that could affect the results of the activities of the person performing the authorization – affidavit
  6. The good character of the applicant for authorization – a person who has been convicted of a criminal offence, the matter of which is related to the business in question, shall not be deemed to have good character

Specification of meeting the conditions:

  1. Conditions for granting authorization pursuant to Act No. 258/2000 Coll., on protecting public health, as amended
  2. Authorization instructions

In order to demonstrate the good character of the applicant (natural or legal persons), the authorizing body requires an extract from the Crime Register. The request for an extract from the Crime Register and the extract from the Crime Register shall be transmitted in electronic form, in a manner allowing remote access. A natural person shall furthermore demonstrate his good character with similar documents, such as an extract from the Crime Register, issued by the countries where he resided continuously for more than 3 months during the last 3 years. These documents must not be more than 3 months old; the proof of good character can be replaced by proof of qualifications to perform the profession or activity if it demonstrates the fulfilment of the requirements of good character. The good character of a legal person shall be demonstrated for all members of the statutory body; for an organizational unit of the country, county or municipality by the supervisor. Recognizing proof of good character issued by a competent authority of another Member State of the European Union is governed by a special law.

Requirements connected to the provision of services by a provider from a different Member State

A certificate of authorization is not required for a natural person who is established in another Member State of the European Union if he can prove that:

  1. he is a citizen of a Member State of the European Union
  2. he holds a license to conduct the same activities under the legislation of another Member State of the European Union, where such authorization is required in this country
  3. he has a clean record

This natural person is required to submit a list of the methods, sampling procedures and sample preparations for measurement or investigation, including the final analytical methods and procedures to be used, to the Ministry of Health.

Further information on the licence proceedings

Type of licence

  • Validation

Respective authority

  • National Institute of Health

Control and supervisory bodies

  • National Institute of Health

Procedure for granting a licence

  • The applicant shall send the applications in electronic form to PSC or use the official forms of the authorizing body on the website www.szu.cz/authorization. An assessment of the qualifications of the laboratory will be assessed and the certificate of authorization issued based on this application.

Fees

  • According to the tariff

Validity period of the licence

  • 2 years, renewable for up to 5 years

Legal Regulation

  • Act No. 258/2000 Coll.

Related legal regulations

  • Act No. 95 and 96/2004 Coll.

Back to the document “Laboratory operations under the law on protecting public health – authorization step by step”