Information - Services - Formalities by subjects - Preparations for business start-up - Erlaubnispflichtige und überwachungspflichtige Unternehmen - Hospital pharmacy; application for an operating licence - Dienstleistungsportal Bayern

Description

Anyone who wants to operate a hospital pharmacy as the responsible body of a hospital must apply for a permit according to § 14 Pharmacy Act (ApoG). This can be done informally by e-mail to the competent government.

The following are responsible for issuing an operating permit for a hospital pharmacy

• the Government of Upper Bavaria for the administrative districts of Upper Bavaria, Lower Bavaria and Swabia;
• the Government of Upper Franconia for the administrative districts of Upper, Middle and Lower Franconia and Upper Palatinate.

Prerequisites

Permission to operate a hospital pharmacy shall be granted to the responsible body of a hospital if it

1. the employment of a pharmacist who fulfils the requirements according to § 2 para. 1 nos. 1 to 4, 7 and 8 as well as para. 3, also in connection with para. 2 or 2a ApoG, and
2. provides evidence of the premises required for hospital pharmacies in accordance with the Pharmacy Operations Regulations.

Procedure

The informal application with the necessary documents must be sent to the competent government.

Processing time

Permission can only be granted after all required documents have been submitted and open questions have been clarified, as well as a successful inspection of the premises (no critical or serious defects/faults).

Required documents

• Evidence concerning the person of the pharmacy manager
• Proof of premises for the pharmacy

  (among others floor plan)

Forms

Please select a location in "Localization" so that the address of the responsible authority can be filled in.

• Prefillable Form, Bavaria-wide: Formloser Antrag (mit Unterschrift)

  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.

  Dieser Assistent unterstützt Sie bei der Erstellung eines formlosen Schreibens, wenn die zuständige Stelle kein Antragsformular zur Verfügung stellt.

Fees

• A fee of between € 250 and € 3,000 is set on the basis of the administrative effort and time involved and the importance of the matter for the applicant (according to the schedule of costs - tariff no. 7.IX.7/tariff item 2.12). The fee covers the costs of the acceptance inspection.

  The costs (fees and expenses) are to be borne by the applicant.

Legal bases

• § 14 Gesetz über das Apothekenwesen (Apothekengesetz - ApoG)
• Verordnung über die Zuständigkeiten der Arzneimittelüberwachungsbehörden und zum Vollzug des Samenspenderregistergesetzes sowie des Gendiagnostikgesetzes (Arzneimittelüberwachungszuständigkeitsverordnung - ZustVAMÜB)

Remedy

Administrative court action

Related issues

• Pharmacy; application for operating license.