- no location -
Select your location for location specific information:
Medicinal products; application for certification according to good manufacturing practice or good distribution practice
Certification in accordance with Good Manufacturing Practice or Good Distribution Practice is necessary following the inspections required under Section 64 of the German Medicinal Products Act, for example if companies wish to manufacture or market medicinal products on a professional/commercial basis.
Responsible for you
For contact details of the responsible authoritiy and local valid information select under "Select location" a location.
Procedure details
Description
Within 90 days of an inspection to verify good manufacturing practice or good distribution practice, a certificate is issued to the inspected companies, facilities or persons if the inspection has led to the conclusion that the relevant principles and guidelines are being complied with.
Requirements
The GMP/GDP certificate is issued if the inspection has not revealed any critical or serious defects/errors.
Proceedings
The inspections were planned and carried out by the responsible government. Other authorities may be involved ex officio.
Fees
Costs for issuing a certificate: EUR 100 (according to the list of costs - tariff no. 7.IX.8 / tariff item 2.4)
Expenses (e.g. inspection costs, travel expenses) depend in particular on the time required.
They are to be borne by the facility/company to be certified.
Deadlines
none
Processing time
The certificate is issued within the statutory period of 90 days after the inspection if there are no critical or serious defects/errors.
Legal bases
Appeal
Administrative court action
Status: 17.04.2025
Editorially responsible for prodecure description: Bayerisches Staatsministerium für Gesundheit, Pflege und Prävention
Contains machine translated content.
Show the original content