Versand von apothekenpflichtigen Arzneimitteln Erlaubnis
Nordrhein-Westfalen
•
99005002005000, 99005002005000
•
Typ 2/3
Inhalt
Begriffe im Kontext
nicht vorhanden
- Erlangung von Lizenzen, Genehmigungen oder Zulassungen im Hinblick auf die Gründung und Führung eines Unternehmens
Fachlich freigegeben am
02.11.2023
Fachlich freigegeben durch
Ministry of Labor, Health and Social Affairs of the State of North Rhine-Westphalia
- § Section 11a of the Pharmacy Act (ApoG)
- § Section 43 (1) of the German Medicinal Products Act (AMG)
- § Section 17 (2a) and (2b) of the Pharmacy Operating Regulations (ApBetrO)
If you want to send pharmacy-only medicines, you need a permit to do so. You can find out more here.
The mail order of pharmacy-only medicines is subject to authorization. A separate mail order permit must be applied for for each public pharmacy through which pharmacy-only medicines are to be dispatched.
The mail-order business may only commence after a permit has been issued.
- Proof of the pharmacy's operating license
- If rooms outside the approved pharmacy premises are to be used for the mail-order business: Details of the size, nature, furnishings and function of the additional operating premises, submitting floor plans to scale and the rental agreement)
- Assurance by the applicant that the requirements of the Pharmacy Act regarding quality management and the mail-order process will be met and that the mail-order business will be provided in addition to the usual pharmacy operations
- Dispatch may only take place from a public pharmacy for which an operating license has been issued, in addition to normal pharmacy operations
- The legal regulations for pharmacy operations apply
- A quality assurance system for the dispatch process must be in place
The costs are based on the General Administrative Fee Regulations for the State of North Rhine-Westphalia (Allgemeine Verwaltungsgebührenordnung NRW - AVwGebO NRW), see tariff item 12.1.4.11
- You submit your application
- The competent authority checks the requirements
- If necessary, the competent authority requests documents
- If necessary, the premises are inspected
- The competent authority issues the corresponding permit if the requirements are met
Mail-order sales of pharmacy-only medicines may only commence after a license has been granted.
- Dispatch of pharmacy-only medicinal products Permission
- Dispatch may only take place from a public pharmacy for which an operating license has been issued, in addition to normal pharmacy operations
- Mail-order pharmacies must meet certain quality requirements
- Responsible: Districts and independent cities