Law on pharmacy (pharmacies law-ApoG)

Unofficial table of contents

ApoG

Date of completion: 20.08.1960

Full quote:

" Pharmacy Act in the version of the Notice of 15. October 1980 (BGBl. I p. 1993), most recently by Article 1 of the Law of 15 July 2013 (BGBl. I p. 2420).

Status:	New by Bek. v. 15.10.1980 I 1993;
	Last amended by Art. 1 G v. 15.7.2013 I 2420

For more details, please refer to the menu under Notes

Footnote

(+ + + Text proof applicable: 9.8.1980 + + +) 
(+ + + Changes due to EinigVtr cf.  § § 2 and  28 + + +) 

  

Heading: Cross-country headline idF d. Art. 20 No. 1 G v. 14.11.2003 I 2190 mWv 1.1.2004; short transcript. Letter abbreviation inserted. by Art. 20 No. 1 G v. 14.11.2003 I 2190 mWv 1.1.2004

First section
Permission

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§ 1

(1) The pharmacies shall be responsible for ensuring the proper supply of medicinal products to the general public in the public interest. (2) Those who wish to operate a pharmacy and up to three store pharmacies shall require the permission of the competent authorities to ensure that the pharmacies are properly supplied. Authority. (3) The permission shall only apply to the pharmacist to whom it has been granted and to the rooms designated in the certificate of approval. Unofficial table of contents

§ 2

(1) permission shall be granted upon request, if the applicant

1.

German within the meaning of Article 116 of the Basic Law, a member of one of the other Member States of the European Union or of another Contracting State of the Agreement on the European Economic Area or a Contracting State, to which Germany , and the European Union has granted a contractual right, or homeless foreigner within the meaning of the law on the legal status of homeless foreigners;

2.

is fully capable of business;

3.

the German Approbation as a pharmacist;

4.

the reliability required for the operation of a pharmacy; this is not the case where there are facts which constitute the unreliability of the applicant with regard to the operation of a pharmacy, in particular where: criminal or serious moral wrongful misconduct which may appear to be inappropriate for the management of a pharmacy, or if it is due to a serious or persistent infringement of this law, which is due to this law. Pharmacy operating rules or those for the manufacture of medicinal products and transport has proven to be unreliable with the legislation adopted;

4a.

5.

the oath-making insurance company provides that it has not made any agreements which violate § 8 sentence 2, § 9 para. 1, § 10 or § 11, and the purchase or lease contract via the pharmacy as well as at the request of the competent authority also other Contracts which relate to the establishment and operation of the pharmacy;

6.

proves that, in the case of the granting of permission, it will have the premises prescribed by the pharmacy operating order (§ 21);

7.

is not unsuitable in health terms to properly guide a pharmacy;

8.

, whether and, where applicable, where it is located in a Member State of the European Union or in another State Party to the Agreement on the European Economic Area or in a Contracting State, Germany and the European Union Have contractually granted a corresponding legal claim, operates one or more pharmacies.

(2) By way of derogation from paragraph 1, an approved applicant who has not passed the pharmaceutical examination within the scope of this Act in accordance with Article 4 (1) (4) of the Federal Pharmacist Order shall be granted the authorisation only if it has been approved for a Pharmacy is requested, which has been operated for at least three years. (2a) (omitted) (3) Has the pharmacist after his approval or after granting of a federal pharmacist order of the pharmaceutical examination according to § 4 (1a) to (1d), 2 or 3 of the Federal Pharmacists ' Regulations equivalent diplomas, certificate or other evidence of formal qualifications more in the absence of a pharmaceutical activity for a continuous period of two years, the authorisation shall be granted only if, in the last year preceding the date of application, he or she shall be authorised to carry out such activity for at least six months in one of the following: Member State of the European Union or in any other State Party to the Agreement on the European Economic Area or in a State Party to which Germany and the European Union are contractually entitled to a corresponding legal claim Have exercised a pharmacy or a hospital pharmacy. (4) permission to Operation of several public pharmacies shall be granted on request, if:

1.

the applicant fulfils the conditions laid down in paragraphs 1 to 3 for each of the pharmacies requested; and

2.

the pharmacy to be operated by him and the pharmacies to be operated by him within the same circle or town or in neighbouring counties or towns in a circle-free area.

(5) For the operation of several public pharmacies, the provisions of this Act shall apply in accordance with the following measures:

1.

The operator has one of the pharmacies (main mortgage) personally to lead.

2.

For each other pharmacy (filial pharmacy), the operator must designate a pharmacist in writing as the person responsible for fulfilling the obligations laid down in this law and in the pharmacy operating order for pharmacists. .

If the person in charge of the person responsible within the meaning of sentence 1 (2) is to be changed, the operator shall be notified in writing by the operator two weeks before the change. In the event of an unforeseen change of the person in charge of the person responsible, the change indication as set out in the second sentence shall be immediately. Unofficial table of contents

§ 3

The permission is granted

1.

by death;

2.

by waiving;

3.

by withdrawing or revocation of the Approbation as a pharmacist, by waiving the Approbation or by revocation of the permission in accordance with § 2 para. 2 of the Federal Pharmacists ' Regulation;

4.

where no use has been made for one year; the competent authority may extend the time limit if there is an important reason.

5.

(dropped)

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§ 4

(1) The permission shall be withdrawn if, in the case of its grant, one of the conditions pursuant to § 2 has not been provided. (2) The permission shall be revoked if any of the prerequisites pursuant to § 2 para. 1 no. 1, 2, 4, 6 or 7 have subsequently been omitted. The permission may be revoked if the holder of the permission has subsequently concluded agreements which violate § 8 sentence 2 also in connection with sentence 4, § 9 para. 1, § 10 or § 11. Unofficial table of contents

§ 5

If a pharmacy is operated without authorisation, the competent authority shall close the pharmacy. Unofficial table of contents

§ 6

A pharmacy may not be opened until after the competent authority certifies that the pharmacy complies with the legal requirements (acceptance). Unofficial table of contents

§ 7

Permission is required for the personal management of the pharmacy on its own responsibility. In the case of Section 2 (4), the pharmacist appointed by the operator pursuant to § 2 (5) No. 2 shall be subject to the obligations laid down in the first sentence; the obligations of the operator shall remain unaffected. The personal management of a hospital pharmacy is the responsibility of the appointed pharmacist. Unofficial table of contents

§ 8

Several persons together can only operate a pharmacy in the legal form of a civil law company or an open trading company; in such cases all members of the company require permission. participations in a pharmacy in the form of a breast-feeding company and agreements in which the remuneration of loans granted to the holder of the authorisation, or of any other non-profit-making assets, is aligned with the turnover or profit of the pharmacy, In particular, leases on sales or profit are inadmissible. Lease agreements concerning pharmacies according to § 9, in which the lease depends on the turnover or profit, shall not be considered as agreements within the meaning of sentence 2. The rates 1 to 3 shall apply to pharmacies in accordance with § 2 para. 4.

Footnote

(+ + + § 8, second sentence: § 8, second sentence, applies to participations and agreements which existed on 9 August 1980 and which were not ineffective because of the circumvention of the objectives of the Act, only from 1 January 1986 application (Article 2 (3) of the Law on Amendment to the law on pharmacy of 4 August 1980-BGBl. 1142). + + +) Unofficial table of contents

§ 9

(1) The leasing of a pharmacy or of pharmacies pursuant to § 2 para. 4 shall be permitted only in the following cases:

1.

if and as long as the lessee is in possession of the permission and the pharmacy cannot operate on its own for an important reason lying in his person or if the licence is revoked on the grounds of the removal of one of the conditions pursuant to section 2 (1) no. or by revocation of the Approbation due to the removal of one of the conditions pursuant to § 4 (1) sentence 1 no. 3 of the Federal Pharmacociation Order;

2.

after the death of a permit holder by his or her hereditary children up to the date in which the youngest of the children is 23. Year of life completed. Take one of these children before the completion of the 23. The period of life of the pharmacy profession may be extended upon application until such time as the person in question may fulfil the conditions for the grant of the licence;

3.

by the surviving spouse or life partner up to the date of marriage or the establishment of a life partnership, provided that he does not himself obtain a permit in accordance with § 1.

The admissibility of leasing shall not be affected by the fact that, after the occurrence of the cases referred to in the first sentence, a pharmacy shall be transferred within the same place, in cities within the same place or in an adjacent urban district, or that its Operating rooms are changed. If, in the event of a transfer or a change in the premises, a pharmacy which is leased in accordance with the first sentence of 1 (1), the lessor shall not require any new authorization. No 5 shall remain unaffected. (1a) Before the expiry of the agreed lease period, the lessor shall die, the competent authority may, in order to avoid unreasonable hardship for the tenant, allow the lease between the tenants and the heir to be paid for the (2) The tenants shall require the permission in accordance with § 1. The lease contract must not affect the professional responsibility and the freedom of choice of the pachtenden pharmacist. (3) For the duration of the lease, please refer to the permission of the publisher § 3 No. 4, § 4 para. 2, insofar as these (4) The permission granted in accordance with paragraph 2 shall be withdrawn if, in the case of its grant, one of the conditions laid down in paragraph 1 has not been fulfilled; it shall be revoked if: One of these conditions has subsequently been omitted. § 4 shall remain unaffected. Unofficial table of contents

§ 10

The holder of the authorisation may not undertake to offer or supply certain medicinal products exclusively or preferably, or otherwise to select the medicinal products to be donated by him, to the supply of certain manufacturers or distributors, or of groups of such groups. Unofficial table of contents

§ 11

(1) The holder and the staff of pharmacies may not engage in legal transactions with doctors or other persons dealing with the treatment of diseases, or meet any agreements which may be a preferential delivery of certain medicinal products; the supply of patients, the allocation of prescriptions or the manufacture of medicinal products without the full details of the composition. § 140a of the Fifth Book of the Social Code remains unaffected. (2) By way of derogation from paragraph 1, the holder of a permit to operate a public pharmacy may, on the basis of an agreement, have ready-to-use cytostatic preparations within the scope of the (3) The holder of a permit to operate a hospital pharmacy may, at the request of the holder of a permit to operate a public health insurance company, Pharmacy The ready-made use of the pharmacy Cytostatic preparations to this public pharmacy or, at the request of the holder of a permit to operate another hospital pharmacy, submit to this hospital pharmacist. This shall apply accordingly to the holder of a permit to operate a public pharmacy for the supply of the medicinal products referred to in the first sentence to a hospital pharmacist or to another public pharmacist. There is no need for a contract pursuant to § 14 (3) or (4). (4) In the event of a threatening communicable disease, the spread of which requires an immediate and the usual measure of significantly overshooting of specific medicinal products ,

a)

Paragraph 1 shall not apply to medicinal products which are stored by the health authorities of the federal or state governments or by those notified bodies in accordance with Section 47 (1) sentence 1 (3c) of the Medicinal Products Act or in accordance with Article 21 (2) (c) of the drug law,

b)

shall apply, in accordance with the provisions of the first and second sentences of paragraph 3, to active substances which have been obtained from the health authorities of the Federal Republic of Germany or of the Länder or of those notified bodies.

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§ 11a

Permission to send pharmacy-based medicines pursuant to § 43 (1) sentence 1 of the German Medicines Act shall be granted to the holder of a licence pursuant to § 2 on request if he/she assures in writing that in the case of the grant of the Permission will meet the following requirements:

1.

The dispatch shall be made from a public pharmacy in addition to the usual pharmacy operation and in accordance with the applicable regulations, insofar as there are no separate regulations for the mail order.

2.

A quality assurance system shall ensure that:

a)

the medicinal product to be shipped is packaged, transported and delivered in such a way as to maintain its quality and effectiveness,

b)

the medicinal product dispatched shall be delivered to the person who is notified by the contracting authority of the order of the pharmacy. This definition may include, in particular, the handout to a named natural person or a designated group of persons,

c)

the patient is advised of the need to contact the treating physician if there are any problems with the medication; and

d)

the advice of pharmaceutical personnel in German will be provided.

3.

It shall ensure that:

a)

within two working days of receipt of the order, the medicinal product ordered shall be dispatched to the extent that the medicinal product is available at that time, unless otherwise agreed with the person who is the product of the medicinal product ; to the extent that it is clear that the medicinal product ordered cannot be dispatched within the time limit laid down in the first sentence, the purchaser shall be informed in an appropriate manner,

b)

all medicinal products ordered shall be delivered to the extent that they may be placed on the market within the scope of the Medicines Act and are available,

c)

in the case of known risks in the case of medicinal products, a suitable system is available for the reporting of such risks by customers, for the provision of information to customers on such risks and for internal defence measures,

d)

A free second delivery is initiated,

e)

a system of tracking is maintained, and

f)

a transport insurance is completed.

In the case of electronic commerce with medicinal products subject to pharmacotherapy, the provisions of the first sentence shall apply with the proviso that the pharmacy will also have the facilities and equipment suitable for this purpose. Unofficial table of contents

Section 11b

(1) The permission in accordance with § 11a shall be withdrawn if, in the case of its grant, one of the conditions pursuant to Section 11a has not been fulfilled. (2) The permission shall be revoked if any of the conditions pursuant to Section 11a have subsequently been omitted. Permission may be revoked if facts justify the assumption that, contrary to a enforceable order of the competent authority, the holder of the authorisation does not comply with the requirements of Article 11a, first sentence, no. 1 to 3, sentence 2 or of a (3) If the mail-order business is operated without permission, § 5 shall apply accordingly. Unofficial table of contents

§ 12

Legal transactions, which in whole or in part violate § 8 sentence 2, § 9 (1), § 10 or § 11, are void. Unofficial table of contents

§ 12a

(1) The holder of a permit to operate a public pharmacy shall be obliged to supply medicinal products and medical devices subject to pharmacies with the carrier of the home for the supply of home residents within the meaning of Section 1 of the Home Code. to conclude a written contract. The contract shall be subject to the legal validity of the authorisation of the competent authority. The authorisation shall be granted if:

1.

the public pharmacy and the homes to be supplied are situated within the same circle, or in the same circular city, or in neighbouring counties or towns and cities,

2.

the proper supply of medicinal products is guaranteed, in particular the nature and extent of the supply, the right of access to the home and the obligations to verify the correct, resident-related storage of the products supplied by him are laid down by pharmaceutical staff of the pharmacy, as well as the documentation of such care,

3.

the obligations of the pharmacist for the provision of information and advice to home residents and those responsible for the administration or application of the delivered products are laid down to the extent that information and advice on the safety of the home residents or the workers of the home are required,

4.

the contract does not restrict the free choice of pharmacies of home residents and

5.

the contract does not contain exclusivity in favour of a pharmacy and clearly defines the areas of competence of a number of pharmacies involved in the supply of supplies.

Any subsequent alterations or additions to the contract must be reported to the competent authority without delay. (2) The supply must be reported prior to the activity of the competent authority. (3) As far as the inhabitants of the home are concerned, even with medicinal products and to provide medical devices with pharmacies from public pharmacies, there is no need for a contract in accordance with paragraph 1. Unofficial table of contents

§ 13

(1) After the death of the holder of the authorisation, the heirs may have the pharmacy administered by a pharmacist for a maximum of 12 months. (1a) When the tenant of a pharmacy dies before the end of the agreed lease period, the competent authority may be required to: To avoid unreasonable hardship for the lessee, allow the pharmacy to be managed by a pharmacist for a maximum period of 12 months. (1b) The liquidator is required to administer a permit for the period of time. The authorisation shall be granted if it fulfils the conditions set out in § 2 (1) no. 1 to 4, 7 and 8. (2) The authorisation shall be issued if the liquidator no longer has the Approbation as a pharmacist. § 4 shall apply accordingly. (3) The liquidator shall be responsible for the observance of the pharmacy operating order and the rules governing the manufacture of medicinal products and the traffic with them.

Second section
Hospital pharmacy, Bundeswehrapotheken, Zweigapotheken, Notapotheken

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§ 14

(1) The institution of a hospital shall, upon request, be granted permission to operate a hospital pharmacy if he/she

1.

the position of a pharmacist who satisfies the conditions laid down in Article 2 (1) (1) to (4), (7) and (8) and (3), including in conjunction with paragraph 2 or 2 (a), and

2.

the rooms prescribed for hospital pharmacies in accordance with the pharmacies operating regulations.

The head of the hospital pharmacist or a pharmacist appointed by him has to inform and advise the doctors of the hospital on medicinal products, in particular with regard to appropriate and cost-effective drug therapy. This shall also apply in so far as the outpatient care is affected. (2) The permission shall be withdrawn if it becomes known subsequently that a condition required by the first sentence of the first sentence of paragraph 1 has not been provided for the grant. It shall be revoked if any of the conditions referred to in paragraph 1 have been omitted or if the holder of the authorisation or a person appointed by him is subject to the provisions of this Act, to the legal regulation adopted pursuant to Section 21 or to the provisions of this Law, or to the provisions of this Act. The manufacture of medicinal products or the marketing of such medicinal products shall be contrary to the law of the Member State concerned or to the right to be taken into account. Accordingly, in respect of the authorization referred to in the first and third sentences of paragraph 5, if the conditions laid down in the second sentence of paragraph 5 have not been or have not been fulfilled. (3) Who, as the holder of a permit to operate a hospital pharmacy, has not been granted the right to in accordance with paragraph 1, it is intended that a further hospital, not to be supplied by itself, with medicinal products, has to conclude a written contract with the institution of that hospital. (4) Who, as the institution of a hospital, is responsible for: , the hospital of the holder of a permit to operate a pharmacy pursuant to § 1 para. 2 or to have the laws of another of the Member States of the European Union or of another State Party to the Agreement on the European Economic Area provide for a written contract with the holder of that permit shall: close. The place of performance for the contractual services shall be the seat of the hospital. The applicable law is German law. (5) The contract concluded in accordance with paragraph 3 or 4 shall require the approval of the competent authority for its legal validity. This authorisation shall be granted if it is ensured that the hospital, with a pharmacy referred to in paragraph 3 or 4, has concluded a contract for the supply of medicinal products to the hospital by this pharmacy, the following conditions: meets:

1.

the proper supply of medicinal products is guaranteed, and in particular those according to the pharmacies operating rules or pharmacies established in another Member State of the European Union or of another State Party to the Agreement on the European Economic Area, in accordance with the rules in force in that State, and the necessary staff, as well as the necessary staff;

2.

the pharmacy supplies the hospital with the medicinal products ordered by the hospital, directly or in the case of the hospital in accordance with the requirements laid down in § 11a;

3.

the pharmacy makes medicines available to the hospital for acute medical care particularly urgently, without delay and in accordance with the requirements of the hospital;

4.

a personal consultation of the staff of the hospital by the head of the pharmacy in accordance with paragraph 3 or 4, or the pharmacist responsible for the supplying pharmacy, shall be carried out on demand and without delay in the event of an emergency;

5.

the supplying pharmacy ensures that the staff of the hospital are continuously advised with regard to appropriate and cost-effective pharmacotherapy;

6.

the head of the supplying pharmacy referred to in paragraph 3 or 4, or the pharmacist he is responsible for, is a member of the hospital's Medicines Committee.

An authorisation from the competent authority is also required for the supply of another hospital by a hospital pharmacy under the same sponsorship. The head of the hospital pharmacist referred to in paragraph 1, or a pharmacy referred to in paragraph 4, or a pharmacist appointed by him, shall have the stocks of medicinal products in the hospital to be supplied, after the date of the grant of the authorisation. To check the conditions of the pharmacy establishment and, in particular, to ensure that the medicinal products are properly stored and stored properly. In order to remedy the deficiencies identified, it shall have to set a reasonable period of time and indicate the failure to comply with the competent authority responsible for the supervision of pharmacies. (7) The head of the hospital pharmacist referred to in paragraph 1 or a representative appointed by him Pharmacists or the head of a pharmacy referred to in paragraph 4 may supply only those hospitals with medicinal products with which legally effective contracts exist or which have been granted an authorisation under the third sentence of paragraph 5. The persons referred to in the first sentence may submit medicinal products only to the individual stations and other sub-units of the hospital for the care of patients who are fully stationary, part-time, pre-hospital or post-hospital in the hospital (§ 115a of the Fifth Book of the Social Code), operated on an outpatient basis or in the context of other station-setting interventions (§ 115b of the Fifth Book of the Social Code), as well as for immediate use in patients with authorised outpatient clinics of the hospital, in particular in university outpatient services (§ 117 of the Fifth (§ 118 of the Fifth Book of the Social Code), Social Paediatric Centres (§ 119 of the Fifth Book of the Social Code) and authorized hospital doctors (§ 116 of the Fifth Book of the Social Security Code) , as well as to patients in the context of outpatient treatment in hospital, if the hospital is authorized to do so (§ 116a of the Fifth Book of Social Code) or is entitled to do so (§ § 116b and 140b paragraph 4 sentence 3 of the Fifth Book of Social Code). In the case of the dismissal of patients after hospitalisation or outpatient treatment in hospital, the amount of medicinal products required for bridging may be given only if, in the immediate connection to the treatment, a weekend or follows a holiday. Without prejudice to sentence 3, patients for which the Regulation of Domestic Nursing is entitled under Article 92 (7), first sentence, No. 3 of the Fifth Book of Social Code, may release the medicinal products needed to bridge the sentence for a maximum of three days. . To employees of the hospital, medicinal products may only be made for their immediate needs. (8) Hospitals within the meaning of this law are institutions according to § 2 No. 1 of the Hospital Finance Act. These are the same with regard to the supply of medicines:

1.

the national authorities and the rescue service providers,

2.

Health care and specialist facilities which are used for health care or for medical or vocational rehabilitation, provided that:

a)

Provide treatment or care as well as accommodation and catering,

b)

are under permanent professional medical guidance, and

c)

a total of at least 40 per cent of the annual benefits for patients under public service providers or for self-payers who do not pay higher than the charges charged to the public service providers.

The carriers and officers of the rescue service, as well as special facilities and facilities, determined by national law, shall be regarded as a station within the meaning of the second sentence of paragraph 7, unless they are carried out in stations or other sub-units are divided into different purposes. The institution of a body referred to in the second sentence of paragraph 1 may not be granted a permit pursuant to paragraph 1. (9) Paragraphs 3, 4, 5 sentence 3 and 7 sentence 1 to 3 shall not apply in so far as they are medicinal products for the treatment of a threatening communicable disease, the spread of which requires an immediate and normal level of delivery of specific medicinal products, and which is provided by the health authorities of the federal or state governments or by these notified bodies pursuant to § 47 (1) sentence 1 no. 3c or in accordance with section 21 (2) number 1c of the Medicines Act. Unofficial table of contents

§ 15

(1) In the division of the Federal Ministry of Defence, the supply of medicinal products is the responsibility of the Bundeswehrapotheken. (2) The Federal Ministry of Defence regulates in the light of the special military circumstances in The establishment of the Bundeswehrapotheken as well as its establishment and operation. In doing so, he shall ensure that the members of the Bundeswehr are not in any way different with regard to the supply of medicinal products and the safety of medicinal products than civilians. (3) (omitted) Unofficial table of contents

§ 16

(1) If there is a state of emergency in the supply of medicinal products due to the absence of a pharmacy, the competent authority may, upon request, give the holder of a nearby pharmacy the authorisation to operate a two-gas pharmacy if the latter has the right to do so. (2) Two-gas mortgages must be managed. (3) The permission referred to in paragraph 1 shall not be granted to a pharmacist for more than one two-gamortgage. (4) permission shall be granted for a period of five years; it may be granted anew. Unofficial table of contents

§ 17

If, six months after the public notice of a state of emergency in the supply of medicinal products to the population, there is no application for the holding of a pharmacy or a two-person pharmacy, the competent authority of a Member State shall be required to: A congregation or community association shall grant permission to operate a pharmacy under the direction of a pharmacist to be established by the pharmacy if they demonstrate the premises and facilities prescribed by this law. The pharmacist must fulfil the conditions laid down in § 2 (1) no. 1 to 4 and 7.

Third Section
Emergency service package, pharmacy operating regulations and exemptions for federal police and riot police

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§ 18

(1) The Deutsche Apothekerverband e. registered in the Register of Associations of the Local Court of Frankfurt am Main under the registration number 4485. V. establishes and manages a fund to promote the provision of emergency services to pharmacies. It shall carry out the tasks in connection with the establishment of the Fund and the appropriation and distribution of the funds, including the decree and the execution of the administrative acts required for this purpose, as a Beliehener in accordance with § § 19 and 20 of the German Act. true. The Deutsche Apothekerverband e. V. is the issuing authority within the meaning of Section 3 of the Administrative Enforcement Act and the executing authority within the meaning of Section 7 of the Administrative Enforcement Act. (2) The German Pharmacists ' Association e. V., in accordance with the first sentence of paragraph 1, the Fund shall be established and managed separately from the other assets of the Association. The expenditure arising from the establishment and management of the Fund shall be covered by the Fund's revenue. The financial resources shall be invested with the Federal Republic of Germany Finance Agency. In order to ensure its ability to pay in the current quarter, the Fund shall be required to keep operating resources at an appropriate level, which shall be made up of revenue from the Fund. For the initial application of the operating funds, loans can be received at an appropriate level, which are to be repaid from the Fund's revenue by 31 December 2013 at the latest. (3) The legal and professional supervision of the German Pharmacists ' Association e. V. the Federal Ministry of Health shall carry out the tasks referred to in paragraph 1. The Deutsche Apothekerverband e. V., the Supervisory Authority shall, upon request, disclose the accounts of the Fund. Unofficial table of contents

§ 19

(1) The pharmacies shall be obliged to apply, after each end of the quarter, within ten days of the notification of the date of notification referred to in the first sentence of paragraph 2, for all the packs of ready-to-use medicinal products for use in the case of human beings, which are subject to medical prescription in the quarter the proportion of the fixed surcharge in accordance with Article 3 (1), first sentence, of the Regulation on the price of medicinal products, which serves to promote the freezing of the emergency services of pharmacies, to be deducted from the fund established in accordance with Article 18 (1) sentence 1. To the extent that the pharmacies are entitled to the settlement with the health insurance data centers, they shall have the shares in the data centers, as well as the shares of the other medicinal products which have been transferred to the other pharmaceutical products. (2) The German Pharmacists ' Association (Deutsche Apothekerverband e. V. shall fix the amounts to be deducted from the pharmacy for each quarter. Objection and action against the fixing shall not have suspensive effect. The Beliehene is an opposition authority within the meaning of Section 73 (1), second sentence, point 2 of the Administrative Court order. Fees and levies are levied for a preliminary procedure. A fee of up to 500 euros will be charged for the complete or partial rejection of an objection. In the event of withdrawal of an objection after the commencement of its factual processing, but before termination thereof, the fee shall be charged in accordance with the provisions of the 5-sentence sentence. If the contradiction is not successful only because the infringement of a procedural or formal provision according to § 45 of the Administrative Procedure Law is insignificant, no fee will be charged. The opposition authority shall decide on the fees referred to in sentences 5 and 6 at its reasonable discretion. The administrative court in whose district it has its registered office is the administrative court in whose district it has its registered office. (3) The data centers referred to in the second sentence of paragraph 1 shall be transmitted to the German Pharmacists ' Association (Deutsches Apothekerverband e. V. information on the number of packages supplied by individual pharmacies in each quarter at the expense of statutory health insurance by means of electronic data transmission or machine-readable data on data carriers Medicinal product for use in human beings subject to medical prescription. Pharmacies have the German Pharmacists ' Association (Deutsches Apothekerverband e. V. the total number of packages which they have issued in the respective quarter of the packages of ready-to-use medicinal products for use in the case of people who are not prescribed by statutory health insurance or are not given in kind were to be communicated through a self-declaration. The form and content of the declaration in accordance with the second sentence shall be published by the German Pharmacists ' Association. V.) and published on its website. The transmission of the data shall take place within four weeks after the end of the quarter. The data may only be processed and used for the purposes referred to in the first sentence of paragraph 2. (4) The German Pharmacists ' Association e. V. from the revenue of the Fund, the data centres shall be reimbursed the necessary costs for the transmission of the information referred to in the first sentence of paragraph 3 in a proven amount. By way of derogation from the first sentence, the Deutsche Apothekerverband e. (5) As far as pharmacies do not use data centers, all the shares referred to in the first sentence of paragraph 1 shall be carried out directly by the pharmacy on the basis of a self-declaration. Paragraphs 2 and 3, sentences 3 to 5 shall apply accordingly. (6) The German Pharmacists ' Association (Deutsche Apothekerverband e. V. shall ensure that pharmacies comply with their obligations under paragraphs 1, 3 and 5. In the case of an underclass or in the case of evidence of incomplete removal of the shares referred to in paragraph 1, it may carry out the necessary checks on the pharmacies and the data centres used to determine the amounts to be deducted. The persons responsible for the inspection may, in particular, enter the operating and business premises at the usual business hours, request the necessary information and, in justified cases, business documents, including: electronic files, view and make copies or copies thereof. The person who is required to provide information may refuse to answer any such questions, the answers to which he or she himself or one of his relatives, referred to in § 383 (1) (1) to (3) of the Code of Civil Procedure, of the risk of criminal prosecution, or of a procedure under the Law on Administrative Offences. The pharmacies and the data centers have the agents of the German Pharmacists ' Association e. (7) If a pharmacy does not comply with its obligation to give a self-declaration pursuant to the second sentence of paragraph 3, or if there are actual indications of the inaccuracy of the information provided for the self-declaration, the Commission may German pharmacists ' association e. V. the number of packs of medicinal products subject to medical prescription issued in the pharmacy in question, which have not been delivered at the expense of statutory health insurance or not as a material benefit. Account shall be taken of all the circumstances which are of importance for the estimation. A fee of up to 500 Euros will be charged for the estimate. The provisions of the third sentence of paragraph 2 shall apply accordingly. Unofficial table of contents

§ 20

(1) Pharmacy which has been determined by the competent authority for service in the emergency service throughout the period from 8 p.m. to at least 6 a.m. of the following day and has provided the emergency service in full, shall be provided with a flat-rate subsidy. (2) The authority responsible for the classification for service readiness in the emergency service shall communicate to the German Pharmacists ' Association e. V. for their area of responsibility after each quarter ended at the latest by the end of the following month, the pharmacies which provided emergency services in accordance with paragraph 1 in each quarter, and the number of emergency services provided. (3) The German pharmacists ' association e. V. shall fix the flat-rate subsidy referred to in paragraph 1 with regard to pharmacies for each quarter and shall pay it for each emergency service notified in accordance with paragraph 2 to pharmacies from the fund in accordance with Article 18 (1), first sentence, after each quarter ended at the latest by the date of the end of the period of Expiration of the following quarter. Section 19 (2) sentences 3 to 9 shall apply accordingly. The grant shall be calculated as the quotient of the expenditure to be paid in accordance with Article 18 (2), second sentence, including the costs to be reimburse pursuant to section 19 (4), and the amounts to be paid for the formation of resources pursuant to Article 18 (2) sentence 4 and to the performance of the Obligations arising out of loans pursuant to Article 18 (2) sentence 5 of the sum of the shares in the Fund in accordance with Article 19 (1) and the number of emergency services notified under paragraph 2. Unofficial table of contents

§ 20a

The Deutsche Apothekerverband e. V. has to replace the damage caused to the Federal Republic of Germany by unlawful and deliberate or negligent breach of its duties in the performance of the duties and powers in accordance with § § 18 to 20. Unofficial table of contents

Section 21

(1) The Federal Ministry of Health is authorized to issue a pharmacy order with the consent of the Federal Council, with the consent of the Federal Council, in order to ensure the proper operation of pharmacies, two-gas pharmacies and hospital pharmacies. in order to ensure the quality of the medicinal products to be produced and delivered there. In this context, the basic rules laid down by the World Health Organisation for the manufacture of medicinal products and the assurance of their quality, the provisions of the Pharmacopoeia and the generally accepted rules of the pharmaceutical industry are: To take science into account. With the consent of the Federal Council, regulations on the organisation, equipping and participation of pharmacies in the implementation of supply forms agreed in accordance with the Fifth Book of Social Code may be regulated by the pharmacy operating order in accordance with the first sentence of sentence 1. be adopted. In addition, the Federal Ministry is empowered, with the consent of the Federal Council, to regulate in particular the design, including the operating and quality assurance of information in electronic media, by means of a legal regulation, which in (2) In the pharmacies operating rules referred to in the first sentence of paragraph 1, provisions may be made available on:

1.

the development, manufacture, acquisition, testing, refilling, packaging and packaging, storage, holding, disposal and labelling of medicinal products, as well as the removal or destruction of non-marketable medicinal products and other medicinal products operations,

1a.

the requirements for dispatch, electronic commerce, including dispatch, advice and information in connection with this trade in medicinal products, and ensuring that these medicinal products are properly handed over to the End-users, documentation requirements and the determination of medicinal products or groups of medicinal products which are not allowed to be delivered by mail order for reasons of safety or consumer protection, except where: , with appropriate means of safety and consumer protection , and the acceptance of the risks is justified and the risks are disproportionate,

2.

the management and retention of evidence of the operations referred to in point 1;

3.

the special experimental conditions and the control of the animals used in the development, production and testing of medicinal products and the management and storage of evidence thereof; the provisions of the Animal Protection Act and of the grounds on which they are based; of the Animal Protection Act shall remain unaffected,

4.

requirements for pharmacy staff and their use,

5.

the representation of the pharmacist,

6.

The size, nature, equipment and installation of the pharmacy premises and other rooms, which are responsible for the dispatch and electronic commerce, including dispatch of medicinal products, as well as advice and information in connection with this trade,

7.

the nature and labelling of the containers in the pharmacy,

8.

the goods customary in the pharmacy, the ancemials, the willingness to work and the warehouse of pharmacies, as well as the distribution of medicinal products within and outside the premises of pharmacies,

9.

the conditions for the granting of licences for the establishment of reception centres and the procedures to be followed, as well as the conditions for the closure of reception centres and the requirements for their operation,

10.

the designation and the responsibility of inspectors in pharmacies;

11.

the deferring of batch samples and their duration and duration of storage,

12.

the requirements for hygiene in pharmacies and

13.

the review of pharmaceutical stocks in hospitals, as well as the management and retention of evidence about it.

(3) The legal regulation referred to in the fourth sentence of paragraph 1 may, in particular, provide for the following arrangements for the design, including the operation and quality assurance of information in electronic media, which shall be in connection with the electronic trade in medicinal products shall be used:

1.

presentation and application security,

2.

Order form and information listed there,

3.

Questionnaire on information relevant to the therapy of medicinal products, where these may be necessary for the safety of medicinal products,

4.

Information on the safety of medicinal products,

5.

the nature of the information and the quality of information;

6.

Quality assurance, quality control and quality assurance,

7.

Target group orientation,

8.

transparency,

9.

the copyright of the website and of the information,

10.

secrecy and data protection,

11.

updating information,

12.

Responsibility and contact person for feedback,

13.

Access to health or drug-related data or content,

14.

Links to other websites and other information carriers,

15.

Facilities for the detection and verification of the status of the monitoring or checking of the pharmacy and the website, as well as the bases thereof.

(4) In so far as pharmacies have permission to manufacture medicinal products in accordance with the provisions of the Medicines Act, the pharmacy establishment shall apply to the pharmacy establishment, and the production plant shall be subject to the relevant provisions of the provisions of the Pharmacies Act. Pharmaceutical law. Unofficial table of contents

Section 22

The provisions of this law are not subject to the provision of medicines to the members of the Federal Police and to the riot police of the countries within the framework of the free treatment of medicinal products and their animal populations.

Fourth Section
Rules on penalties and penalties

Unofficial table of contents

Section 23

Anyone who intentionally or negligently operates or administers a pharmacy, hospital pharmacy or a two-gapotheke without the necessary permission or authorisation, shall be punishable by imprisonment for up to six months or with a fine of up to one hundred and eighty months. Daily sentences punished. Unofficial table of contents

§ 24

(dropped) Unofficial table of contents

Section 25

(1) Contrary to the law, those who intentionally or negligently act

1.

Contrary to Section 2 (5) no. 2, a person responsible shall not be appointed, not correctly or not in good time,

2.

, pursuant to § 8 sentence 2, section 9 (1), § 10 or § 11 (1) of the Unlawful Agreement, provides or accepts benefits or otherwise executes such an agreement,

3.

allows a pharmacy to be administered by a person who has not been granted an authorization pursuant to § 13 para. 1b sentence 1,

4.

, contrary to § 14 (7) sentence 1, a hospital is provided with medicinal products

5.

Article 14, paragraph 7, sentence 2, 3 or 4 of the medicinal product.

(2) The offence also acts as a person who, intentionally or negligently, is contrary to a legal regulation adopted pursuant to § 21, insofar as it refers to this fine for a certain amount of facts. (3) The administrative offence can be found in the cases of the Paragraph 1 (2), with a fine of up to twenty thousand euros, in the cases referred to in paragraph 1 (1), (3) and (4) and in paragraph 2, shall be punishable by a fine of up to five thousand euros.

Fifth Section
Closure and transitional provisions

Unofficial table of contents

Section 26

(1) Staff concessions, real concessions and other personal operating licences granted prior to the entry into force of this Act shall be deemed to be a permit within the meaning of § 1. This also applies to authorities whose owners are local authorities; the pharmacies can be leased; § 9 does not apply. (2) The permission granted under the previous law to operate a hospital pharmacy shall apply in its to date. The permission granted under the previous law to operate a two-gapotheke shall be deemed to be a permission within the meaning of § 16. Unofficial table of contents

§ 27

(1) Holder of pharmacies other than those referred to in § 26 require a licence to operate the pharmacy in accordance with § 1. Insofar as they operate a pharmacy upon the entry into force of such a law, the authorization shall be deemed to have been granted. (2) Insofar as such authorization shall be granted in accordance with the award certificate and the date until the date of entry into force of this law Law applicable to the law of a person who did not fulfil one of the requirements of § 2 para. 1 no. 3, it remains in the process. The use shall be effected by leasing; § 9 shall not apply; § 13 shall remain unaffected. (3) holders of such authorization shall be granted a permit to operate another pharmacy, which is not a two-gapotheke, only if it is applicable to the have not been granted until now Unofficial table of contents

§ 28

(1) In the case of leased pharmacies, the type-approval granted to the tenant or the confirmation as a tenant is valid as a permission in accordance with § 1. (2) On 1 May 1960, existing contracts for the leasing or administration of a pharmacy, which do not comply with § § 9 and 13 shall remain in force until the agreed contract period expires if they do not lose their validity at an earlier date. Unofficial table of contents

Section 28a

(dropped) Unofficial table of contents

§ 29

(dropped) Unofficial table of contents

§ 30

The provisions of this law shall not apply to medical and veterinary dispensaries for medicinal products (skin pharmacies). Unofficial table of contents

§ 31 (external force)

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Section 32

(dropped) Unofficial table of contents

Section 33 (Entry into force)

- Unofficial table of contents

Annex

(dropped)