Chemicals Act; application for the certificate of compliance with the principles of good laboratory practice

You may apply for a certificate of compliance with the principles of good laboratory practice (GLP) for facilities performing tests according to § 19 a para. 1 ChemG.

Description

Laboratories (testing facilities) that carry out non-clinical health and environmental safety tests on substances or mixtures must do so in compliance with the principles of Good Laboratory Practice (GLP) if the results of the safety tests are to enable an assessment of the possible hazards of the substances or mixtures for humans and the environment in an authorisation, licensing, registration, notification or notification procedure (Section 19a (1) Chemicals Act (ChemG)).

Prerequisites

The certificates are issued to those who prove that they comply with the principles of good laboratory practice (GLP) from Annex 1 (to Section 19a (1)), Section II ChemG.

Procedure

In Bavaria, applications are accepted by the Bavarian State Office for Health and Food Safety.

For the application, the form can be used which is available on the website of the Bavarian State Office for Health and Food Safety (LGL) in German.

Upon receipt of the complete application, the Bavarian State Office for Health and Food Safety notifies the test facility of an inspection by members of the Bavarian GLP Inspection Commission. The inspectors arrange an inspection date with the test facility.

If the inspection shows that the test facility or test site and the studies or phases of studies conducted there comply with the GLP principles, the LGL issues the GLP certificate and the associated notification. The GLP certificate shall indicate the categories of tests and the date of the inspection.

An application for a GLP certificate may also be made by a person who is not obliged to carry out GLP inspections but who can substantiate a legitimate interest (Section 19b (1) sentence 2 ChemG). A legitimate interest is regularly recognised if a governmental body in the importing country demands proof from the Bavarian exporter that the tests of his products have been carried out according to GLP principles, although these tests are not subject to GLP according to German law.

Deadlines

none

Forms

  • Form, Bavaria-wide: Antrag auf Erteilung einer GLP-Bescheinigung
    Please note

    This form has to be signed and sent to the responsible authority. You can sign the form manually and send it by email/fax or sign the form electronically with your qualified electronic signature an send it by (secure) email. If the responsible authority has set up a De-Mail account, you can also send the form by De-Mail using an sender-confirmed message.

Fees

  • The fees in connection with GLP certificates are laid down in the Ordinance on the Enactment of the Schedule of Costs to the Bavarian Cost Law (KG):

    • Issue of a GLP certificate: 1,500 to 15,000 EUR
    • Amendment or supplementation of a GLP certificate: EUR 125 to 10,000.

    The fees are determined on a case-by-case basis. The essential factor here is the size of the company and the scope of the various tests, on the basis of which the duration of the inspection and the number of inspectors are determined.

    In addition to the fees, there are expenses, e.g. for the travel costs of the inspectors.

    An advance payment of 90 % of the estimated costs is due after submission of the application. The final payment must be made before the certificate is delivered.

Remedy

Administrative court proceedings; information

administrative claim

Status: 10.11.2021

Responsible for editing: Bayerisches Staatsministerium für Umwelt und Verbraucherschutz

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  • Online transactions, Bavaria-wide
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  • Form, Bavaria-wide
  • Form, locally limited
  • Prefillable Form, Bavaria-wide
  • Legal bases, Bavaria-wide
  • Legal bases, locally limited
  • Fees, Bavaria-wide
  • Fees, locally limited
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