Drugs; Application for Certification under Good Manufacturing Practices or Good Distribution Practices

Certification in accordance with Good Manufacturing Practice or Good Distribution Practice is required following the inspections mandated by Section 64 of the German Medicines Act, for example, when companies wish to manufacture or market medicinal products on a professional or commercial basis.

For contact details of the responsible authoritiy and local valid information select under "Select location" a location.

Within 90 days of an inspection to verify compliance with Good Manufacturing Practices or Good Distribution Practices, a certificate shall be issued to the inspected establishments, facilities, or individuals if the inspection has determined that the relevant principles and guidelines are being followed.

The GMP/GDP certificate is issued if the inspection did not reveal any critical or serious deficiencies or errors.

The inspections were planned and carried out by the relevant government agency. Other agencies may be involved ex officio as necessary.

Fee for issuing a certificate: 100 EUR (according to the schedule of fees—Tariff No. 7.IX.8 / Tariff Item 2.4)

Expenses (e.g., inspection costs, travel expenses) depend primarily on the time required.

These expenses are to be borne by the institution or company seeking certification.

none

The certificate will be issued within the statutory period of 90 days following the inspection, provided there are no critical or serious defects or errors.