Laboratory operations under the law on protecting public health – authorization step by step
1. 5. 2014 | Source: Point of Single Contact (PSC) Czech Republic
Laboratory activities under the law on protecting public health means carrying out measurements/testing according to the requirements of this law and related regulations to ensure a proper professional standard of record-keeping for assessing the protection and support of public health and for the effective performance of state health supervision.
Those interested in laboratory operations must obtain a certificate of authorization from the National Institute of Public Health. Prior to making the application, it is necessary for the applicant to become closely acquainted with the requirements of the authorizing body.
The basic documents are:
- Conditions for granting authorization pursuant to Act No. 258/2000 Coll., on protecting public health, as amended
- Authorization instructions
Procedure for obtaining authorisation:
- Application for a certificate of authorization for laboratory operations
- Application to renew the certificate of authorization
- The application is given to the National Institute of Health.
The application shall be supplemented with:
- List of sets provided for assessment
- List of laboratory documentation
- Survey of participation in MPZ, PT
- Statement of quality policy
Once the documents are assessed and the material meets all the requirements, a contract for control measures between the authorizing body and the applicant is signed (in duplicate) and the applicant is sent an invoice for the payment of fees according to the tariffs of the authorizing body.
An audit will take place at the applicant
The authority shall grant authorization for a period of 2 years
During the period of validity of the certificate, the authorizing body is authorized to carry out inspections to see whether the applicant is fulfilling the conditions of authorization. These controls are paid for by the holder of the certificate of authorization in accordance with the tariffs of the authorizing body.
The person issued the certificate of authorization must give the application for renewing the certificate of authorization to the National Institute of Health at least 6 months before the expiration of the certificate. The costs associated with renewing the certificate of authorization shall be borne by the applicant. The application for renewing the authorization is the same as the application for the certificate of authorization.
For an easier and faster application process, and primarily for reasons of inspection, the authorizing body always requires the same range of documents, such as when applying for a certificate of authorization for laboratory operations. In place of standard paperwork, copies of at least one actual record for each provided set are required.
The certificate of authorization is renewed for 5 years
The business may be conducted after fulfilling all the above stated requirements.
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Forms referred to in the guideline: