105. Ordinance of the Federal Minister for Health on the delivery of medicinal products for human use by distance (distance-sales regulation)

On the basis of § § 59a (7), 62a and 94i (3) of the Medicines Act, BGBl. No. 185/1983, as last amended by the Federal Law BGBl. I n ° 162/2013, and Section 6a (1) Z 9 of the Health and Nutrition Security Act, BGBl. I No 63/2002, as last amended by the Federal Law Gazette (BGBl). I No 189/2013, shall be arranged:

Scope

§ 1. (1) This Regulation shall apply to public pharmacies (hereinafter referred to as pharmacies) which deliver medicinal products for human use by means of distance sales.

(2) Pharmacies have the requirements of the pharmacies operating order 2005-ABO 2005, BGBl in the submission of medicinal products for human use by distance sales. II No 65/2005, as amended, to the extent that this Regulation does not provide a different basis for the Regulation.

Definitions

§ 2. For the purposes of this Regulation:

1.		Distance sales: conclusion of a contract with the exclusive use of one or more means of distance communication;
2.		Means of distance communication: means of communication which may be used for the conclusion of a contract without the simultaneous physical presence of the parties, in particular printed matter with or without address, catalogues, press releases with order form, pre-manufactured standard letters, long-distance calls with persons or vending machines as interlocutors, radio, telephone, telecopia, teleshopping as well as publicly accessible electronic media, which allow individual communication, such as such as the Internet or the electronic mail;
3.		Pharmaceutical quality assurance: all the measures provided for in order to ensure that proprietary medicinal products are of the quality required for the intended use;
4.		Quality risk management: a systematic process for the evaluation, control, communication and monitoring of risks, which can influence the quality of the proprietary medicinal products.

General requirements

§ 3. (1) Pharmacy shall be allowed to deliver non-prescription medicinal products for human use only in Austria or registered in Austria, by distance sales.

(2) The levy referred to in paragraph 1 shall be made in the course of the dispatch of the medicinal products for human use from the pharmacy premises.

(3) The supply of medicinal products for human use by distance sales and all related processes shall be subject to constant quality standards in accordance with the state of science and technology.

(4) The delivery of medicinal products for human use by distance sales shall be carried out under the responsibility of the pharmacist's head of pharmacist; in particular, he/she shall ensure that:

1.		the medicinal product for human use is dispatched only in a quantity corresponding to the usual personal requirements and there is no minimum order quantity,
2.		the customer receives a confirmation of the receipt of the order and, upon acceptance of the order, a confirmation is sent to the customer,
3.		the medicinal product for human use, from the confirmation of acceptance of the order to the customer, will be sent without unnecessary delay, unless otherwise agreed,
4.		the customer shall be informed in an appropriate manner, if it is clear that the dispatch of the medicinal product for human use cannot be carried out in accordance with Z 3,
5.		the medicinal product for human use shall be dispatched in accordance with the particulars of the customer, unless § 5 (7) applies,
6.		the consignment is to be carried out to the customer or to a person notified to the pharmacy, which may include a named natural person or a designated circle of natural persons,
7.		the consignment is not followed by an acknowledgement of receipt; and
8.		the medicinal product for human use, which has been returned to the pharmacy, will not be placed on the market again.

Pharmaceutical quality assurance

§ 4. (1) Any pharmacy supplying medicinal products for human use by means of distance marketing must operate an effective and functional system of pharmaceutical quality assurance in accordance with the scope of the activities carried out.

(2) The pharmaceutical quality assurance system shall, in particular, ensure that:

1.		the medicinal product for human use is suitable for consignment,
2.		the medicinal product for human use to be sent is packaged, transported and delivered in such a way as to demonstrate that its quality and efficacy are not compromised;
3.		in the case of complaints which have become known, these are systematically recorded and reviewed,
4.		there is a system for tracking the shipment, and
5.		a transport insurance is completed.

(3) Any pharmacy supplying medicinal products for human use through distance sales must have a quality risk management system. The effects of the results from this process, which can influence the quality of the proprietary medicinal products, must be monitored. Subsequently, corrective or preventive measures should be taken, where appropriate. In the context of the quality risk management, appropriate records must be kept and kept in the pharmacy.

Ordering, pharmaceutical consulting

§ 5. (1) Any pharmacy supplying medicinal products for human use by means of distance sales shall indicate on its website name, address, telephone number, e-mail address and, where appropriate, a fax number, in order to ensure that the customer with the pharmacy is at any time in Contact can occur.

(2) On the website of the pharmacy the customer is to be informed that before the first order, it has to register with name, address, date of birth, telephone number and-if available-e-mail address.

(3) The customer has the right to a consumer protection act according to § 6b of the German Consumer Protection Act (Consumer Protection Act), BGBl. No 140/1979, as amended, free telephone advice by a pharmacist/pharmacist of the pharmacy sending the medicinal product for human use; he/she is entitled to this right and the periods of use of the pharmacy Please note the website.

(4) The website of the pharmacy shall contain a short and clear information required for the proper application of the medicinal product on offer to the customer, in particular on the area of application of the product, the Application and dosage instructions and their composition, as well as the contraindications and any interactions contained in the leaflet. The website also has an indication to consult, where appropriate, the pharmacy for clarification of questions concerning the medicinal product for human use.

(5) Without prejudice to para. 3, 4 and 7, prior to dispatch of a medicinal product for human use, advice to the customer by a pharmacist/pharmacist of the sending pharmacy shall be made if this is due to the safety of medicinal products. is necessary or where the supply of the medicinal product for human use requires advice.

(6) If a telephone consultation or a consultation of the customer by e-mail has been made in the course of the ordering process, this must be documented.

(7) The order shall be examined by a pharmacist, in particular with a view to the clear identification of the medicinal product for human use. In the event of any ambiguity or concern, the customer is to be contacted; if no clarification is possible in this respect, a dispatch is not permitted.

Quality control

§ 6. (1) Before dispatch of the medicinal product for human use, the sending pharmacy shall be subject to a final inspection, under the supervision of a pharmacist/pharmacist, in particular whether the delivery is in accordance with the order.

(2) The pharmacist, as referred to in paragraph 1, has to release the medicinal product for human use for dispatch; this must be documented.

Transport and delivery

§ 7. (1) Where the pharmacy supplying medicinal products for human use by distance sales is entrusted with the transport and supply of the medicinal product for human use to be sent, a logistics company shall ensure that it has a view to: its activities to be carried out have the necessary expertise and experience, as well as a system of tracking.

(2) A written contract between the sending pharmacy as the contracting authority and the logistics company shall be the order taker as a contractor for the order in accordance with paragraph 1, who shall be permanently in the pharmacy in the original or in the form of a copy. must be submitted to the Federal Office for Health and Safety at the request of the Federal Office for Health. In such a contract, the responsibilities of each side must be clearly defined.

(3) The sending pharmacy has to provide the responsible logistics company with the information necessary for the proper transport and delivery of the consignment.

§ 8. (1) Medicinal products for human use which are dispatched shall be transported in such a way as to ensure that:

1.		the labelling is not lost,
2.		they do not contaminate or contaminate other products or materials,
3.		adequate precautions against leeway, damage and theft,
4.		they are not exposed to any undue heat, cold, light, humidity or any other harmful influence, or to microbial infestation or infestation,
5.		they are protected from weather conditions during loading and unloading, and
6.		they are safe from access by unauthorised persons.

(2) The transport packaging shall be qualified, the transport process, in particular the transport duration and transport temperature, shall be validated on the basis of the quality risk management.

(3) The transport packaging must not contain any indication that the products sent are medicinal products for human use. Transport packaging must be selected in such a way that it is easy to check whether the packaging has been opened or otherwise damaged, or whether the contents of the pack have been removed or damaged.

§ 9. (1) The sending pharmacy shall have every delivery of a medicinal product for human use in addition to its obligation to provide information and confirmation in accordance with § 7 Fern-und Auswärts-Gesetz-FAGG, BGBl. I No 33/2014, to be accompanied by a dossier containing at least the following information:

1.		name, address, telephone number, e-mail address and, where appropriate, a fax number of the pharmacy,
2.		date of dispatch,
3.		the name and pharmaceutical form of the medicinal product for human use,
4.		quantity delivered,
5.		the name and address of the customer and, where applicable, of a person pursuant to § 3 (4) (6) (6), which is to be followed by the consignment;
6.		where applicable, the name and address of the logistics company responsible for transport and delivery; and
7.		Note, if necessary, to consult the pharmacy in order to clarify matters.

(2) The consignment shall be the subject of an acknowledgement of receipt to the customer or, where appropriate, to a person pursuant to § 3 (4) (6) (6).

Documentation

§ 10. (1) Any pharmacy supplying medicinal products for human use through distance marketing shall have a documentation system, including a system for the preparation, revision and approval of documents, in accordance with its scope of activity.

(2) Without prejudice to the documentation requirements provided for in Sections 4 (3), 5 (6) and 6 (2) of this Directive, records shall be kept of any medicinal product for human use issued in distance sales, which shall contain the following minimum particulars:

1.		the date of dispatch,
2.		the name and pharmaceutical form of the medicinal product for human use,
3.		the quantity delivered;
4.		the name and address of the customer and, where applicable, of a person pursuant to § 3 (4) (6) (6), which has been followed by the consignment,
5.		the date of the conclusion or, where appropriate, an endorsement if the consignment could not be definitively followed, and
6.		where appropriate, the name and address of the logistics company responsible for transport and delivery.

(3) If the records are kept with the help of electronic data processing, the records shall be kept in accordance with the provisions of the Signature Act, BGBl. I n ° 190/1999, in the current version, digitally signed. The data stored with such systems must be able to be made available in a legible form at any time during their storage period and must be submitted to the Federal Office for Health Security at the request of the Federal Office for Health.

(4) All records shall be kept for at least five years from the last dated signature.

Secrecy

§ 11. (1) Any pharmacy that delivers medicinal products for human use through distance sales shall have data security measures in accordance with § § 14 ff Data Protection Act 2000, Federal Law Gazette (BGBl). I n ° 165/1999, as amended, to be adopted.

(2) Any person entrusted with the distance sales of medicinal products for human use or related activities shall have personal data which has been entrusted to them solely on the basis of their activities in this regard; or , without prejudice to any other existing confidentiality obligations, to keep secret both during and after the end of their activities, in so far as no legally permitted reason for the transmission of the confidential or accessible information is available data that have become available.

Monitoring

§ 12. (1) The Federal Office for Health and Safety (Bundesamt für Sicherheit im healthcare) has periodically, at least once in five years ' time, for pharmacies to deliver medicinal products for human use by distance, in respect of compliance with the obligations of this Regulation. check.

(2) The frequency has to be based on the results of the previous reviews. In the event of a suspicion of breach of the provisions of this Regulation, which may endanger the life or health of human beings, a review shall be carried out as soon as possible.

(3) verifications are, except in the case of risk in default, or if there is reason to believe that the effectiveness of the act would be adversely affected by the prior announcement. The verifications shall be carried out, except in the case of risk in default, during the operating hours.

(4) Each inspection shall include a minutes according to § § 14f AVG, the contents of which are to be brought to the attention of the Federal Office for Safety in the Health Care of the Pharmacist's Head Office/the Head of Pharmacies.

(5) If it is found during the examination that the requirements of this Regulation are not complied with, the Federal Office for Safety in Health shall have the opinion of the pharmacy manager/supervisor after obtaining the opinion of the pharmacist. To remedy the deficiencies identified. If the defect is not complied with, the Federal Office for Safety in Health has to have measures which prevent or restrict the delivery of proprietary medicinal products by distance marketing.

Publication and entry into force pursuant to Section 94i (3) of the German Drug

§ 13. (1) Implementing Regulation (EU) No 699/2014 on the design of the common logo for the identification of persons offering medicinal products for sale in distance selling, and on the technical, electronic and electronic components of the logo. Cryptographic requirements for verifying the authenticity of the same, OJ C 327, 30.4.2004 No. 5., as amended by the corrigendum OJ L 184, 17.7.2014, p. No. OJ L 297, 15.10.2014 p.41, was published in the Official Journal of the European Union on 25.06.2014.

(2) According to Article 94i (3) of the German Medicines Act (Medicinal Products Act), § § 59 (10) Z 1 and 59a (1) to (4) of the Medicines Act, BGBl. No. 185/1983, in the version of the Federal Law BGBl. I n ° 48/2013, in force on 25 June 2015.

entry into force

§ 14. This Regulation shall enter into force on 25 June 2015.

Oberhauser