Dienstleistungsportal Bayern

Description

Prerequisites

Mail order may only be made from a public pharmacy for which an operating license has been issued, in addition to the usual pharmacy operations. Pure mail order pharmacies are not permitted. The statutory regulations for pharmacy operations apply.

Mail-order rooms from which mail-order operations are to be conducted must be located in reasonable proximity to the pharmacy's other operating rooms.

A quality assurance system for the mail order operation must be in place. This ensures that

• the medicinal product to be shipped is packaged, transported and delivered in such a way that its quality and efficacy are maintained; in particular, the temperature requirements applicable to the medicinal product must be complied with during transport until it is delivered to the recipient,
• the dispatched medicinal product is delivered to the person indicated to the pharmacy by the person placing the order. This determination may include, in particular, delivery to a named natural person or a named group of persons,
• the patient is informed of the requirement to contact the attending physician if problems arise with the medication, and
• the advice will be given by pharmaceutical personnel in German.

The holder of the pharmacy operating license must also ensure that

• the ordered medicinal product is dispatched within two working days of receipt of the order, insofar as the medicinal product is available within this period, unless another arrangement has been made with the person who ordered the medicinal product; insofar as it is apparent that the ordered medicinal product cannot be dispatched within the period specified in the order, the orderer must be informed of this in an appropriate manner,
• all ordered medicinal products will be delivered, as far as they are allowed to be marketed in the area of application of the Medicinal Products Act and are available,
• in the event of risks becoming known with regard to medicinal products, a suitable system is available for reporting such risks by customers, for informing customers of such risks and for internal defensive measures,
• the treated person is informed that, as a prerequisite for the supply of medicinal products, he/she must indicate with his/her order a telephone number at which he/she will be advised by pharmaceutical personnel of the pharmacy, also by means of telecommunication facilities, without additional charges; the possibilities and times of the advice shall be communicated to him/her,
• a second delivery is arranged free of charge,
• a tracking and tracing system is maintained, and
• transport insurance is taken out.

If the planned mail-order pharmacy is to be an "Internet pharmacy" - as is generally the case - the pharmacy must also have the facilities and equipment suitable for electronic commerce.

Procedure

• You submit your informal application for a mail order permit pursuant to Section 11 a ApoG and all required documents to the district administrative authority responsible for the location of the main pharmacy.
• The authority may request additional documents.
• The mail order permit is issued when the competent authority determines that the legal requirements have been met.
• As a rule, an inspection of the pharmacy by the responsible honorary pharmacist of the Government of Upper Bavaria or the Government of Upper Franconia takes place for which a fee is charged.

Special notes

The mail-order register of the German Federal Institute for Drugs and Medical Devices (BfArM) lists pharmacies and other dealers who are officially allowed to sell human medicines over the Internet. Since October 2015, all registered dealers must display the EU safety logo on their websites, in each case with the flag of the Member State of the company's registered office.

Deadlines

• The permit must be applied for before starting the activity. The application should be submitted at least 4 weeks before the pharmacy plans to start its mail order activity.
• The processing time depends on the completeness and scope of the submitted documents. It can therefore vary individually.
• The permit can only be issued after all required documents have been submitted and open questions have been clarified.
• The mail-order activity may only be commenced after permission has been granted.

Required documents

• Informal application for a mail order permit according to § 11 a ApoG with information on the planned scope of the mail order business

• Written or electronic assurance of compliance with the requirements of Section 11a ApoG and Section 17 (2) ApoBetrO Information on the planned scope of mail order business

• If premises outside the approved pharmacy premises are to be used for the mail order business: Site plan on a scale of 1:100 and, if applicable, rental agreement.

Legal bases

• § 11a Gesetz über das Apothekenwesen (Apothekengesetz - ApoG)
• § 4 Abs. 4 Verordnung über den Betrieb von Apotheken (Apothekenbetriebsordnung - ApBetrO)
• § 17 Abs. 2 Verordnung über den Betrieb von Apotheken (Apothekenbetriebsordnung - ApBetrO)
• § 43 Abs. 1 Satz 1 Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz - AMG)
• § 3 Abs. 1 Verordnung über die Zuständigkeiten der Arzneimittelüberwachungsbehörden und zum Vollzug des Samenspenderregistergesetzes sowie des Gendiagnostikgesetzes (Arzneimittelüberwachungszuständigkeitsverordnung – ZustVAMÜB)

Remedy

Administrative court action

Links to more information

• Versandhandels-Register

  Im Versandhandels-Register sind Apotheken und sonstige Händler aufgeführt, die offiziell Humanarzneimittel über das Internet vertreiben dürfen.