Versand von apothekenpflichtigen Arzneimitteln Erlaubnis
Begriffe im Kontext
- Erlangung von Lizenzen, Genehmigungen oder Zulassungen im Hinblick auf die Gründung und Führung eines Unternehmens
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If you want to send pharmacy-only medicines as a pharmacy, you need a permit to do so. You can find out more here.
The mail order of pharmacy-only medicines is subject to authorization. For each public pharmacy through which you, as the pharmacy owner, wish to send pharmacy-only medicines, you need your own mail-order permit.
In order to obtain the permit, your mail-order pharmacy must meet certain quality requirements.
For example:
- Your mail-order business is carried out from a public pharmacy in addition to the usual pharmacy operations
-
a quality assurance system is in place, which means, among other things
- the medicine is packaged, transported and delivered in such a way that quality and efficacy are maintained
- delivery is made to the person named in the order; this may be a named person or a named group of persons
- the advice provided by the pharmaceutical staff is given in German
- You generally send the available medicine within 2 working days of receiving the order
- You use a shipment tracking system
- the second delivery is free of charge
- You have taken out transport insurance for the shipment
- Proof of the operating license for the pharmacy
- Assurance from the applicant that they meet the requirements for quality management and the mail-order process and that they will provide mail-order services in addition to the usual pharmacy operations
If you wish to use premises outside the approved pharmacy premises for the mail-order business, you must provide the following information and proof of the additional premises:
- Size
- Nature
- Furnishings
- Function
- Floor plans to scale
- rental agreement
- Dispatches may only be made from a public pharmacy in addition to the usual pharmacy operations.
- Your public pharmacy has an operating license.
- A quality assurance system for the dispatch process is in place.
- If the medicinal products are distributed via e-commerce, i.e. via the Internet, appropriate facilities and equipment must be available.
Mail-order sales of pharmacy-only medicines may only commence after a license has been granted.
If the competent authority grants the mail-order authorization, it forwards this information to the Federal Institute for Drugs and Medical Devices (BfArM). The BfArM publishes information on authorized mail-order pharmacies in a national register. As a mail-order pharmacy, you are obliged to display the specified EU safety logo on your website. A click on the logo leads to the details of the webshop operator in the register. This serves to inform consumers about authorized mail-order pharmacies in the European Union (EU).
- Dispatch of pharmacy-only medicines is subject to authorization
- a public pharmacy requires a license for every mail-order sale of medicines
-
Permit possible if certain quality requirements are met, for example
- mail order business is carried out from a public pharmacy in addition to the usual pharmacy business
-
a quality assurance system is in place, which means, among other things
- Medicines are packaged, transported and delivered in such a way that quality and efficacy are maintained
- Delivery is made to the person specified in the order; this may be a named person or a named group of persons
- Advice is provided by the pharmaceutical staff in German
- Dispatch of available medicines generally within 2 working days of receipt of the order
- System for shipment tracking available
- Second delivery is free of charge
- Transport insurance taken out