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

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.

Deadlines

none

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.

Remedy

Administrative court proceedings; information

Administrative court action

Status:27.10.2023

Responsible for editing:Bayerisches Staatsministerium für Gesundheit, Pflege und Prävention

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