Apply for an operating license for a pharmacy

Prerequisites

• Possession of the German license to practice as a pharmacist
• the availability of suitable operating rooms and equipment
• to submit a written application if you meet all the requirements of Section 2 of the Pharmacy Act.
• When a new pharmacy is founded, an acceptance inspection is carried out by the competent supervisory authority in Hamburg, the Authority for Justice and Consumer Protection, V4, before opening.

Documents required

Required documents result from § 2 Pharmacy Act.

You can find out more about the type and scope of the documents in the leaflet " Issuing a pharmacy operating license" or clarify them with the Office for Consumer Protection - V4 of the Authority for Justice and Consumer Protection (BJV).

Please note

With the amendment of the Pharmacy Act of August 12, 2002 and after its promulgation in the Federal Law Gazette on August 27, 2002, Section 12a ApoG came into force on August 28, 2003. According to this, the holder of a license to operate a community pharmacy is obliged to conclude a written contract with the institution responsible for the home for the supply of residents of homes within the meaning of Section 1 of the Homes Act with pharmaceuticals and pharmacy-only medical products. This must be approved by the authority for justice and consumer protection, department of pharmacy.

Deadlines

The application should be submitted at least two months before the planned opening of the pharmacy and be complete 2 weeks before the opening date.

Procedure

• You submit your written application for a pharmacy operating license and all the necessary documents to the competent authority.
• The authority may request additional documents.
• The operating permit is to be issued when the competent authority determines that the legal requirements have been met.
• In the case of a new opening, an appointment is made for the acceptance inspection of the operational pharmacy before the opening.

Processing time

4 – 8 weeks

Fees

• Variable depending on time


• State law fees

Legal remedies

Information on how to appeal will be provided with the decision on your application.

Legal basis

• § 1 (2) Pharmacy Act (ApoG)


• § 2 Pharmacy Act (ApoG)


• § 6 Pharmacy Act (ApoG)


• § 2a Pharmacy Operating Regulations (ApBetrO)


• § 4 Pharmacy Operating Regulations (ApBetrO)


• Section 4 (1) No. 4 of the Federal Pharmacist Regulations

With the documents to be submitted, you prove the German license to practice as a pharmacist. Furthermore, you prove that you have suitable business premises and declare or affirm in lieu of an oath that you will comply with the legal requirements in accordance with Section 2 of the Pharmacy Act.

It is advisable to contact the supervisory authority responsible for you before submitting your application in order to clarify the scope of the documents required for your application. The requirements can be found in the leaflet "Issuing a pharmacy operating license".