Pharmaceuticals; application for certification according to Good Manufacturing Practice or Good Distribution Practice.
Certification according to Good Manufacturing Practice or Good Distribution Practice is necessary following the inspections required under Section 64 of the German Medicines Act if, for example, companies wish to manufacture or market medicines on a professional/commercial basis.
Description
Within 90 days of a Good Manufacturing Practice or Good Distribution Practice inspection, a certificate shall be issued to the inspected establishments, facilities or persons if the inspection has resulted in a finding of compliance with the relevant principles and guidelines.
Prerequisites
The GMP/GDP certificate is issued if the inspection did not reveal any critical or serious defects/errors.
Procedure
The inspections were planned and carried out by the responsible government. Other authorities are involved ex officio if necessary.
Processing time
The certificate is issued within the legal period of 90 days after the inspection, if there are no critical or serious defects/faults.
Fees
Costs for issuing a certificate: 100 EUR (according to cost schedule - 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.
Status: 13.10.2022
Responsible for editing: Bayerisches Staatsministerium für Gesundheit und Pflege
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