Chemicals Act; application for the certificate of compliance with the principles of good laboratory practice.
You can 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.
Laboratories (testing facilities) that perform non-clinical health and environmental safety testing of substances or mixtures must do so in compliance with the principles of Good Laboratory Practice (GLP) if the results of the safety testing are to enable an assessment of the potential hazards of the substances or mixtures to humans and the environment in an authorization, licensing, registration, notification or notification procedure (Section 19a (1) Chemicals Act (ChemG).
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, Paragraph 1), Section II ChemG.
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 language.
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 GLP principles, the LGL issues the GLP certificate and the associated notice. The GLP certificate shall specify the categories of tests and the date of the inspection.
An application for a GLP certificate can also be made by anyone who is not obliged to carry out inspections subject to GLP, but who can credibly demonstrate a justified interest (Section 19b (1) sentence 2 ChemG). A legitimate interest is regularly recognized if a governmental body in the importing country requires the Bavarian exporter to prove 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.
Antrag auf Erteilung einer GLP-Bescheinigung
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.
The fees in connection with GLP certificates are set out 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: 125 to 10,000 EUR
The fees are set on a case-by-case basis. The essential factor here is the size of the company and the scope of the various inspections, on the basis of which the duration of the inspection and the number of inspectors are determined.
Expenses are added to the fees, e.g. for the inspectors' travel expenses.
An advance payment of 90% of the anticipated costs is due after the application has been submitted. The final payment is to be settled before delivery of the certificate.
Links to more information
Responsible for editing: Bayerisches Staatsministerium für Umwelt und Verbraucherschutz
- Online transactions, Bavaria-wide
- Online transactions, locally limited
- Prefillable Form, Bavaria-wide
- Legal bases, Bavaria-wide
- Legal bases, locally limited
- Fees, Bavaria-wide
- Fees, locally limited