Information - Apotheke; Beantragung der Betriebserlaubnis - Dienstleistungsportal Bayern

Description

Anyone wishing to run a pharmacy, whether as owner, tenant or manager, requires a permit in accordance with the Pharmacy Act. This permit must be applied for at the locally responsible district administrative authority (district office, independent city).

The pharmacy may not be opened until it has been approved by the competent authority, which has certified that the pharmacy meets the legal requirements.

The permit may also be withdrawn or revoked by the competent authority under certain conditions.

Special notes

A permit to operate a hospital pharmacy must be applied for from the governments of Upper Bavaria and Upper Franconia (see under "Related Topics").

Required documents

• Application for a pharmacy operating licence

  with details of when you intend to operate which pharmacy in which capacity (owner, tenant, etc.)

• Deeds

  Licence to practise medicine (original or certified copy), if applicable, doctorate certificate (original or certified copy)

• Medical certificate

  This must explicitly state that you are physically and mentally fit to run a pharmacy, and that you are free of addictive disorders.

• Extract from the central business register
• official certificate of good conduct
• Identity card or passport
• Confirmation by the Chamber of Pharmacists of the activities reported to it and statement on reliability
• affidavit

  In doing so, you affirm that you have not entered into any agreement that violates § 8 Sentence 2, § 9 Paragraph 1, § 10 or § 11 ApoG and that you have submitted the purchase or lease agreement for the pharmacy as well as, at the request of the authorities, other contracts related to the establishment and operation of the pharmacy. The affidavit is best submitted in person to the district administration authority

• Declaration on the operation of other pharmacies

  You must state in writing whether and, if so, at what location you operate one or more pharmacies in another Member State of the European Union or in another State party to the Agreement on the European Economic Area or in a Contracting State to which Germany and the European Union have granted a corresponding legal right by treaty.

• Resume

  with details of training and previous professional activity, in particular proof of pharmaceutical activity for the last two years before the application is submitted

• Plans
  • Official site plan of the property with exact location (only necessary for new construction of a pharmacy)
  • Construction drawing of the intended premises
  • The intended use, as well as the respective size (sqm) of the rooms must be indicated. However, this is usually only required for newly built pharmacies.
  • Proof of space (original or certified copy)

• Proof of actual power of disposal over the pharmacy (original or certified copy)
  • as the owner of the pharmacy: purchase contract, donation contract, will
  • as a tenant of the pharmacy: lease agreement
  • Declaration of the lessor: The lessor must submit a written declaration to the district administrative authority on the reason for the lease (§ 9 Para. 1 No. 1 ApoG)
  • as administrator of the pharmacy: management contract

Legal bases

• Verordnung über die Zuständigkeiten der Arzneimittelüberwachungsbehörden und zum Vollzug des Samenspenderregistergesetzes sowie des Gendiagnostikgesetzes (Arzneimittelüberwachungszuständigkeitsverordnung - ZustVAMÜB)
• § 1 Abs. 2, 2 und 6 Gesetz über das Apothekenwesen (Apothekengesetz - ApoG)

Remedy

administrative claim

Related issues

• Hospital pharmacy; application for operating license.