Information - Services - Formalities by subjects - Business start-up preparations - Certificates of competence and expertise - Chemicals Act; application for the certificate of compliance with the principles of good laboratory practice. - Dienstleistungsportal Bayern

Description

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, Paragraph 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 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.

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 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.

Legal bases

• §§ 19 a-d Gesetz zum Schutz vor gefährlichen Stoffen (Chemikaliengesetz - ChemG)
• Anhang 1 (zu § 19a Abs. 1) Gesetz zum Schutz vor gefährlichen Stoffen (Chemikaliengesetz - ChemG)

  Grundsätze der Guten Laborpraxis (GLP)

Remedy

administrative claim

Links to more information

• Gute Laborpraxis ( GLP): Informationen für Laboratorien (Prüfeinrichtungen)
• Verbraucherinformationssystem: Gute Laborpraxis