Pharmacy Act

Original Language Title: Gesetz über das Apothekenwesen

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Law on pharmacy (Pharmacy Law-ApoG)

Non-official table of contents

ApoG

Date of delivery: 20.08.1960

Full quote:

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

:Recaught by Bek. v. 15.10.1980 I 1993;
last modified by Art. 1 G v. 15.7.2013 I 2420

For details, see Notes

Footnote

(+ + + TextProof Validated: 9.8.1980 + + +)
(+ + +). Changes due to EinigVtr cf. § § 2 and 28 + + +)

Heading: Langüberschrift idF d. Art. 20 No. 1 G v. 14.11.2003 I 2190 mWv 1.1.2004; short transcript and Letter abbreviation inserted. by Art. 20 No. 1 G v. 14.11.2003 I 2190 mWv 1.1.2004

First Section
Permission

Non-official Table of Contents

§ 1

(1) The pharmacies are responsible for ensuring the proper supply of medicinal products to the population in the public interest.(2) If you want to run a pharmacy and up to three store pharmacies, you must have the permission of the competent authority.(3) The authorisation shall apply only to the pharmacist to whom it has been granted and to the rooms designated in the certificate of approval. Non-official table of contents

§ 2

(1) permission is to be granted on request if the applicant is
1.
German within the meaning of Article 116 of the Basic Law, a member of one of the other Member States of the The European Union or any other Contracting State of the Agreement on the European Economic Area or a Contracting State to which Germany and the European Union have contractually granted a corresponding legal claim, 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 required for the operation of a pharmacy reliability; this is not the case where there are facts which are the unreliability of the applicant with regard to the operation of a pharmacy, in particular where criminal or serious moral misconduct is available, which make him appear unfit for the management of a pharmacy, or if he or she is in breach of that law by means of a grossly or persistent infringement, the pharmacy operating order issued under this law, or the pharmacy operating order issued for the manufacture of such legislation, medicines and transport have proved to be unreliable;
4a.
5.
gives the affidavit insurance that it has not made any agreements which are contrary to § 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 related to the establishment and operation of the pharmacy, ;
6.
proves that in case of granting permission, he/she shall have the rooms prescribed by the pharmacy order (§ 21) ,
7.
is not unsuitable in health to properly guide a pharmacy;
8.
whether and where applicable in a Member State of the European Union or in another Contracting State of the Agreement on the European Economic Area or in a Contracting State to which Germany and the European Union have contracted an appropriate legal claim, one or more pharmacies shall operate.
(2) By way of derogation from paragraph 1, an approved applicant shall be: has not passed the pharmaceutical examination within the scope of this Act in accordance with Section 4 (1) No. 4 of the Federal Pharmacist Order, to grant permission only if it is requested for a pharmacy which has been operating for at least three years .(2a) (omitted) (3) If the pharmacist has a diploma, certificate or other equivalent in accordance with Section 4 (1a) to (1d), (2) or (3) of the Federal Pharmacists ' Regulations, the pharmacist shall have equivalent qualifications in the pharmaceutical form of the pharmaceutical examination. If there is no pharmaceutical activity for a continuous period of more than two years, the authorisation shall be granted only if, in the last year preceding the date of application, he or she shall return to such activity for a period of at least six months. 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 to which Germany and the European Union are contractually Have granted legal claim, have exercised a pharmacy or hospital pharmacy.(4) The permission to operate several public pharmacies shall be granted on request if
1.
of the The applicant shall comply with the conditions laid down in paragraphs 1 to 3 for each of the pharmacies applied for and
2.
the pharmacy to be operated by him and the pharmacies to be operated by him. (5) The rules of this Regulation shall apply to the operation of several public pharmacies.
(5) The rules of this Law with the following measures corresponding to:
1.
The operator has one of the pharmacies (main mortgage)
2.
2.
For each other pharmacy (store pharmacist), the operator has to nominate a pharmacist in writing as the person responsible for the obligations , as set out in this Act and in the Pharmacist Code of Operations for Pharmacists.
If the person responsible for the person responsible is to be changed within the meaning of the sentence 1, point 2, the operator shall be responsible for doing so by the operator. two weeks prior to the change in writing. 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 made immediately. unofficial table of contents

§ 3

permission is issued
1.
by death;
2.
by renunciation;
3.
by revocation or revocation of the Approbation as a pharmacist, by waiving the Approbation or by revocation of the permission pursuant to § 2 para. 2 of the Federal pharmacy order;
4.
if no use has been made for one year; the competent authority may extend the time limit if an important Reason is present.
5.
(omitted)
unofficial table of contents

§ 4

(1) The permission shall be withdrawn if, in the case of its grant, one of the conditions pursuant to § 2 has not been fulfilled.(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. Non-official table of contents

§ 5

If a pharmacy is operated without permission, the competent authority has to close the pharmacy. Unofficial table of contents

§ 6

A pharmacy may not be opened until after the competent authority certifies that the pharmacy is legal requirements (acceptance). Non-official table of contents

§ 7

The 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. Non-official table of contents

§ 8

Several people together can only have a pharmacy in the legal form of a civil law company, or of an open trading company; in such cases, all members shall be required to be authorised. participations in a pharmacy in the form of a breast-feeding company and agreements in which the remuneration for the holder of the authorisation holder 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 the sentence 2. The rates 1 to 3 apply to pharmacies in accordance with § 2 para. 4.

Footnote

(+ + + § 8 sentence 2: § 8 sentence 2 shall apply to participations and agreements which are held on 9 November 2008). It was only from 1 August 1980 that it had not been effective because of the circumvention of the objectives of the Act. January 1986 (Article 2 (3) of the Law amending the Law on pharmacy of 4 January 1986). August 1980-BGBl. 1142). + + +) Non-official table of contents

§ 9

(1) The leasing of a pharmacy or of pharmacies pursuant to § 2 para. 4 is only permitted in the following cases:
1.
if and as long as the lessor is in possession of the permission and the pharmacy from one person in his/her person may not operate on its own or may revoke permission for the removal of one of the conditions pursuant to § 2 (1) No. 7 or by revocation of the Approbation due to the ominant of one of the conditions pursuant to § 4 (1) sentence 1 No. 3 of the federal pharmacy order;
2.
after the death of a permission holder by his or her hereditary children until the date in which the youngest of the Children's 23. Year of life completed. Takes one of these children before the completion of the 23. The period of life of the pharmacy profession may be extended upon application until it can fulfil the conditions for the grant of the licence;
3.
by the surviving spouse or life partner up to the time of marriage or the justification of a life partnership, unless he himself has a permit in accordance with § 1.
The admissibility of the lease shall not be affected by the fact that after the occurrence of the cases referred to in the first sentence, a pharmacy within the same place, in cities within the same place or in an adjacent city district, shall be subject to the following conditions: or that their premises shall be 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. § 3 No. 5 shall remain unaffected.(1a) In order to avoid unreasonable hardship, the responsible authority may allow the tenant to die before the expiry of the agreed lease period, so that the lease between the tenant and the heir for a maximum period of 12 months may be will continue.(2) The tenants shall require the permission in accordance with § 1. The lease contract must not affect the professional responsibility and freedom of choice of the pachtenden pharmacist.(3) For the duration of the lease, the permission of the publisher § 3 No. 4, § 4 para. 2, insofar as this provision relates to § 2 para. 1 no. 6, as well as § 7 sentence 1, shall not apply.(4) The permit 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 any of these conditions have subsequently been omitted. § 4 shall remain unaffected. Non-official table of contents

§ 10

The permission holder must not commit to offering certain medicines exclusively or preferably or to give or otherwise restrict the selection of the medicinal products to be supplied by him to the supply of certain manufacturers or distributors or groups of such products. Non-official table of contents

§ 11

(1) The holder and the staff of pharmacies may contact doctors or other persons who are receiving treatment of diseases, do not engage in legal transactions or meet agreements that include a preferential supply of certain medicinal products, the supply of patients, the allocation of prescriptions or the manufacture of medicinal products without full Indicate the composition of the item. § 140a of the Fifth Book of the Social Code remains untouched.(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, directly apply ready-to-use cytostatic preparations produced within the framework of the usual pharmacy operation. the practitioner.(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 pharmacy, make use of the ready-to-use cytostatic preparations produced in the context of his pharmacy. a public pharmacy or, at the request of the holder, a permit to operate another hospital pharmacy on the hospital's mortgage. 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. A contract pursuant to section 14 (3) or (4) shall not be required.(4) In the event of a menacing communicable disease, the spread of which requires an immediate and normal level of delivery of specific medicinal products,
a)
paragraph 1 does not apply to medicines used by the health authorities of the federal government or the federal government. Countries or bodies designated by them pursuant to Section 47 (1) sentence 1 no. 3c of the Medicines Act or manufactured in accordance with Section 21 (2) (1c) of the Medicines Act,
b)
the first and second sentences of paragraph 3 are applicable to preparations from active substances that have been designated by the federal or state health authorities or bodies designated by these bodies.
Non-official table of contents

§ 11a

The permission to send pharmacy-based medicines in accordance with § 43 (1) sentence 1 of the Medicines Act shall be granted upon request to the holder of a permit pursuant to § 2, if he has been assured in writing that, in the case of the granting of the permit, he shall comply with the following requirements: style="font-weight:normal; font-style:normal; text-decoration:none; ">
1.
The dispatch will be made from a public pharmacy in addition to the usual pharmacy operation and after the shall be subject to applicable rules unless separate rules exist for the mail order.
2.
A quality assurance system ensures that: that
a)
the medicine to be shipped is packaged, transported and delivered in such a way that its
b)
the consigned medicinal product 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 or the person who is responsible for the The patient should be advised to contact the treating physician if there are any problems with the medication and
d)
the advice of the doctor. Pharmaceutical personnel in German language will be performed.
3.
It will be ensured that
a)
will be sent the ordered medicine within two working days of receipt of the order, where the medicinal product is available during this period, unless otherwise agreed with the person who has ordered the medicinal product; to the extent that it is apparent that the medicinal product ordered does not within the said sentence 1
b)
all medicinal products ordered shall be delivered to the extent that they are supplied in the the scope of the Medicines Act may be placed on the market and available,
c)
in the case of known risks for medicinal products; appropriate system for reporting such risks by customers, for informing customers of such risks and for internal defence measures is available,
d)
a free second delivery is caused,
e)
a system for tracking tracking is maintained and
f)
a transport insurance is completed.
the case of electronic commerce in pharmacies subject to pharmacies, the first sentence shall apply to: The pharmacy will also have the facilities and equipment suitable for this purpose. Non-official table of contents

§ 11b

(1) The permission in accordance with § 11a is to be withdrawn if, in the case of its grant, one of the conditions pursuant to Section 11a is not .(2) The permission shall be revoked if any of the prerequisites pursuant to Section 11a have subsequently been omitted. Permission may be revoked if facts justify the assumption that the holder of the authorisation, contrary to a enforceable order of the competent authority, does not comply with the requirements of Article 11a, first sentence, no. 1 to 3, sentence 2 or of a Ordinance pursuant to § 21 operates accordingly.(3) If the mail order is operated without permission, § 5 shall apply accordingly. Non-official table of contents

§ 12

Legal transactions that are in whole or in part breach of § 8 sentence 2, § 9 para. 1, § 10 or § 11 are void. Non-official table of contents

§ 12a

(1) The holder of a permit to operate a public pharmacy is obliged to supply Residents of homes within the meaning of § 1 of the Home Act with medicinal products and medical devices subject to pharmacies with the institution of the home shall conclude a written contract. The contract shall be subject to the legal validity of the authorisation of the competent authority. Approval is to be granted if
1.
is the public pharmacy and the home to be supplied of the same circle or circle-free city, or in neighbouring circles or circular 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 by the pharmaceutical staff of the Pharmacy as well as the documentation of this supply are contractually determined,
3.
the obligations of the pharmacist for the information and advice of home residents and of the the administration or use of the delivered products is determined in so far as 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 pharmacy choice of home residents and
5.
the contract does not Exclusive binding in favour of a pharmacy and clearly demarcates the areas of competence of several pharmacies involved in the supply.
Night-time changes or supplements to the contract are the competent authority without delay.(2) The supply is to be reported before the activity of the competent authority is received.(3) In so far as the residents of Heimen supply themselves with medicinal products and medical devices subject to pharmacies from public pharmacies, no contract shall be required under paragraph 1. Non-official table of contents

§ 13

(1) After the death of the permission holder, the heirs are allowed to use the pharmacy for a maximum of 12 months by a pharmacist can be managed.(1a) In order to avoid unreasonable hardship, the tenant of a pharmacy dies before the expiry of the agreed lease period, the competent authority may allow the pharmacist to have a pharmacy for a maximum period of 12 months by a Pharmacist can be administered.(1b) The liquidator shall be required for the period of administration of a permit. The authorisation shall be granted if it satisfies the conditions set out in Article 2 (1) (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 regulations and the rules governing the manufacture of medicinal products and the traffic with them.

Second section
Hospital pharmacies, Bundeswehrapotheken, Zweigapotheken, Notapotheken

Non-official table of contents

§ 14

(1) The institution of a Hospital is to be granted permission to operate a hospital pharmacy upon request if it is
1.
the position of a pharmacist who meets the requirements of § 2 para. 1 no. 1 to 4, 7 and 8 as well as paragraph 3, also in connection with para. 2 or 2a, and
2.
the rooms prescribed for hospital pharmacies according to the pharmacy operating regulations.
The head of the hospital pharmacy 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 insofar as the outpatient care is affected.(2) The permission shall be withdrawn if it is subsequently known that the grant has not been subject to any of the conditions required by the first sentence of paragraph 1. 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 Act, 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. In accordance with the authorization referred to in the first and third sentences of paragraph 5, the authorization shall be subject to procedures where the conditions laid down in the second sentence of paragraph 5 have not been fulfilled or have not been fulfilled.(3) Anyone who, as the holder of a licence to operate a hospital pharmacist pursuant to paragraph 1, intends to supply a further hospital not carried by him/herself with medicinal products, has written to the institution of that hospital a written record of To close the contract.(4) Those who intend to be the institution of a hospital, the hospital shall be the holder of a permit to operate a pharmacy in accordance with Section 1 (2) or the laws of another Member State of the European Union or of another Contracting State to the Agreement on the European Economic Area shall conclude a written contract with the holder of that agreement. The place of performance for the contractual services shall be the seat of the hospital. The law applicable is German law.(5) The contract concluded in accordance with paragraph 3 or 4 shall be subject to the legal validity of the authorisation of the competent authority. 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: satisfies:
1.
The proper supply of medicines is guaranteed, and in particular, the Pharmacies or pharmacies which have their registered office 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 necessary rooms and facilities as well as the necessary staff;
2.
The pharmacy provides the hospital with the medicinal products ordered by the hospital. or in the case of the sanctising in accordance with the requirements of § 11a;
3.
the pharmacy presents medicinal products that are the hospital for acute medical care necessary, immediately and in accordance with requirements;
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, as required and without delay in case of emergency;
5.
the supplying pharmacy ensure that hospital staff are continuously advised with regard to appropriate and cost-effective medicinal products therapy;
6.
Head of the supplying pharmacy referred to in paragraph 3 or 4, or the pharmacist he is responsible for, shall be a member of the hospital ' s Medicinal Products Commission.
A permit issued by the competent authority shall also be granted for the supply of another person. Hospital required by a hospital pharmacy under the same sponsorship. For the granting of the authorisation, the second sentence shall apply mutatily.(6) 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 check the stocks of medicinal products of the hospital to be supplied in accordance with the pharmacies ' operating rules and in so doing in particular to ensure the proper quality and proper storage of the medicinal products. In order to remedy the shortcomings identified, it must set a reasonable period of time and indicate that the competent authority responsible for the supervision of pharmacies is not respected.(7) The head of the hospital pharmacist referred to in paragraph 1, or a pharmacist appointed by him or the head of a pharmacy referred to in paragraph 4, may supply only those hospitals with medicinal products with which there are legal contracts or for which: A supply authorisation referred to in the third sentence of paragraph 5 has been granted. 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 approved ambulances of the hospital, in particular in university outpatients (§ 117 of the Fifth Book of the Social Code), psychiatric institute bullets (§ 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 Social Code) as well as 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 (§ § § 116b and 140b (4) sentence 3 of the Fifth Book of the 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 a weekend or a week of treatment is followed immediately after treatment. Holiday follows. 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. . Medicinal products may only be delivered to employees of the hospital for their immediate needs.(8) Hospitals within the meaning of this Act are institutions according to § 2 No. 1 of the Hospital Finance Act. These are the same with regard to the supply of medicinal products:
1.
the carriers according to national law. and lead-through of the rescue service,
2.
Cure and specialist facilities that serve the purpose of health care or medical or professional rehabilitation, if you grant
a)
treatment or care as well as lodging and food,
b)
under constant main professional medical guidance, and
c)
at least 40 of the hundred of the annual benefits for patients with public service providers or for self-paying persons who do not pay higher charges than those charged to the public service providers.
the competent authorities and officers of the rescue service, as well as special facilities and facilities, shall be regarded as a station within the meaning of the second sentence of paragraph 7, unless they are located in stations or other subunits with different Supply purpose is divided. The institution of a body referred to in the second sentence shall not be granted a permit referred to in paragraph 1.(9) Paragraphs 3, 4, 5 sentence 3 and 7, sentences 1 to 3, shall not apply in so far as they are medicinal products for the treatment of a menacable communicable disease, the spread of which is an immediate and the usual measure the provision of specific medicinal products is required, and the health authorities of the federal or state authorities or the bodies designated by these authorities pursuant to § 47 (1) sentence 1 no. 3c or § 21 (2) (1c) of the Medicines Act. Non-official table of contents

§ 15

(1) In the Division of the Federal Ministry of Defence, the pharmaceutical supply is responsible for the Bundeswehrapotheken.(2) The Federal Ministry of Defence, taking into account the special military circumstances in service regulations, regulates the establishment of the Bundeswehrapotheken as well as its establishment and operation. In doing so, he ensures that the members of the Bundeswehr are not in a different position with regard to the supply of medicinal products and to 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 as a result of a lack of a pharmacy, it may be possible to: the competent authority shall give the holder of a nearby pharmacy, upon request, permission to operate a two-gapher counter if the latter proves the rooms prescribed for that purpose.(2) Two-way mortgages must be managed. § 13 shall apply accordingly.(3) The authorisation referred to in paragraph 1 shall not be granted to a pharmacist for more than one two-gas pharmacy.(4) The permit shall be granted for a period of five years; it may be granted again. Non-official table of contents

§ 17

Is issued six months after public notice of a state of emergency in the pharmaceutical supply of the Population that neither an application for the operation of a pharmacy nor a two-gade pharmacy has been lodged, the competent authority of a municipality or association of congregations may permit the establishment of a pharmacy under the direction of one of the pharmacies to the pharmacists to be established if they demonstrate the premises and facilities prescribed by this Act. The pharmacist must meet the requirements of § 2 (1) no. 1 to 4 and 7.

Third section
Emergency service flat rate, pharmacy operating regulations and exceptions for federal police and Standby Police

Non-official table of contents

§ 18

(1) The one in the Register of Associations of the Local Court of Frankfurt am Main under the Registration number 4485 registered Deutsche Apothekerverband e. 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 (Deutsche Apothekerverband e. V., in accordance with the first sentence of paragraph 1, the Fund shall be set up and managed separately from the other assets of the Association. 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 able to reserve operating resources at an appropriate level, which shall be made up of revenue from the Fund. For the initial application of the resources, loans may be received at an appropriate level, which shall be at the latest by 31 December 2008. The Fund shall be repaid from the Fund's revenue in December 2013.(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. Non-official table of contents

§ 19

(1) The pharmacies are obligated, after each quarter of the quarter, within ten days of the date of the announcement of the notice of the decision in accordance with the first sentence of paragraph 2, for all packages of ready-made medicinal products for use in the quarter, for use in the case of humans, the proportion of the fixed surcharge referred to in the first sentence of Article 3 (1) of the Regulation on the price of medicinal products, which is the promotion of the To ensure the emergency service of pharmacies, it shall be used for the disposal of the funds established pursuant to Article 18 (1), first sentence. To the extent that the pharmacies take advantage of data centers for settlement with the health insurance companies, they have to depart from the data centers according to the first sentence of the first sentence, as well as the shares of the other medicinal products which have been transferred to the other medicinal 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 he has its head office is responsible for proceedings against the Beliehenan.(3) The data centres referred to in the second sentence of paragraph 1 shall be transmitted to the German Pharmacists ' Association. 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 subject to medical prescription for use in people who are not prescribable to the detriment of statutory health insurance or are not 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 (Deutsche Apothekerverband 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 level. By way of derogation from the first sentence, the Deutsche Apothekerverband e. V. agree on a flat-rate reimbursement of costs with the data centers.(5) As far as pharmacies do not use data centers, the disposal of 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. Paragraph 2 and the third sentence of the third sentence of paragraph 3 shall apply by analogy.(6) The 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. V. to assist in the review process.(7) If a pharmacy does not comply with its obligation to clarify the self-declaration referred to in the second sentence of paragraph 3, or if there is actual evidence of the inaccuracy of the statements of the self-declaration issued, the German Pharmacists ' Association (Deutsche Apothekerverband 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 non-cash benefits. 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 mutatily. Non-official table of contents

§ 20

(1) Pharmacy, which is the competent authority for service in the emergency service throughout the period of no later than 8 p.m. until at least 6 o'clock on the following day, and the emergency service has been provided in full, a flat-rate subsidy is provided for this purpose.(2) The competent authority responsible for the classification of duty in the emergency service shall communicate to the German Pharmacists ' Association e. V. at the latest by the end of the following month at the latest, for their area of responsibility, the pharmacies which have provided emergency services in accordance with paragraph 1 in each quarter and the number of emergency services provided.(3) The German Pharmacists ' Association (Deutsche Apothekerverband 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) sentence 1 after each quarter end at the latest by 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), fifth sentence, 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 German Pharmacists ' Association (Deutsches 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. Non-official table of contents

§ 21

(1) The Federal Ministry of Health is authorized to enter into force by means of a legal regulation with the consent of the Federal Council To ensure the proper functioning of pharmacies, two-gas pharmacy and hospital pharmacies, and to ensure the quality of the medicinal products to be produced and to be dispensed. These are the basic rules laid down by the World Health Organisation for the manufacture of medicinal products and the safeguarding of their quality, the provisions of the Pharmacopoeia and the generally accepted rules of pharmaceutical science. shall be considered. 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 the first sentence. 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 connection with the electronic trade in medicinal products is to be used.(2) Regulations may be made in the pharmacy operating order referred to in the first sentence of paragraph 1 by means of
1.
Developing, manufacturing, purchasing, testing, refilling, packaging and packaging, storing, holding, giving 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 shipment, electronic commerce including shipping, advice and information in connection with this Trade in medicinal products and ensuring the proper discharge of these medicinal products to the final consumer, to documentation requirements and to the determination of medicinal products or groups of medicinal products whose delivery by means of mail order trade Whereas it is not permissible to establish the safety of medicinal products or to protect consumers, provided that it is not possible to guarantee the safety of medicinal products and consumer protection by appropriate means, and where the adoption of the risks is justified; and Risks are disproportionate,
2.
The management and retention of evidence over 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, as well as the management and storage of evidence The provisions of the Animal Protection Act and the legal regulations adopted pursuant to the Animal Protection Act shall remain unaffected,
4.
the requirements for the Pharmacy staff and their use,
5.
the representation of the pharmacist,
6.
The size, nature, equipment and furnishings of the pharmacy premises and other spaces for dispatch and electronic commerce, including dispatch with medicinal products, as well as advice and information in connection with this trading,
7.
the nature and labelling of the containers in the pharmacy,
8.
the pharmacies ' common goods, ancesuits, service and warehouse of pharmacies, as well as the drug delivery inside and outside the Pharmacy premises,
9.
The requirements of the granting of authorisation 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 return of batch samples as well as their extent and storage duration,
12.
the hygiene requirements in the pharmacies and
13.
the review of the drug stores in Hospitals, as well as the management and storage of evidence thereof.
(3) In the legal regulation referred to in the fourth sentence of paragraph 1, the following provisions may in particular be provided for the design, including the operator, and the quality assurance of Information shall be provided in electronic media used in connection with electronic commerce in medicinal products:
1.
Performances and Application Security,
2.
Order form and details listed there,
3.
Questionnaire about the information relevant to the drug therapy, insofar as these may be required for drug safety reasons,
4.
Information on Drug Safety,
5.
Mediation type and quality of the Information,
6.
Quality Assurance, Quality Control, and Quality Confirmation,
7.
target_group orientation,
8.
transparency,
9.
Copyright of the Web page and the information,
10.
Secrecy and Privacy,
11.
update information,
12.
Responsibility and contact for Feedback,
13.
Accessibility to health or drug-related data or content,
14.
Link to other web pages and other information carriers,
15.
Discovery and discovery facilities Verification of the status of the supervision or verification of the pharmacy and the website and its basic principles.
(4) Where pharmacies have permission to manufacture medicinal products in accordance with the provisions of the Medicines Act, the following shall apply: the pharmacy establishment, the pharmacy operating order, for the manufacturing plant the corresponding provisions of the pharmaceutical law. Non-official table of contents

§ 22

Institutions that provide the medical care of the members of the Federal Police and of the riot police of the Countries within the framework of free health care and their animal populations are not subject to the provisions of this law.

Fourth Section
Criminal and Penal Regulations

Non-official Table of Contents

§ 23

Who intentionally or negligently without the required permission or permission a pharmacy, hospital pharmacy be punished with imprisonment of up to six months, or with a fine of up to one hundred and eighty daily rates. unofficial table of contents

§ 24

(omitted) unofficial Contents

§ 25

(1) acts contrary to the order, who intentionally or negligently
1.
contrary to § 2 para. 5 no. 2, a controller not named right or not in time,
2.
based on an agreement inadmissible pursuant to § 8 sentence 2, § 9 para. 1, § 10 or § 11 para. 1 inadmissible agreement provides or accepts such an agreement in any other way
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 para. 7 sentence 1 a hospital with medicinal products or
5.
contrary to § 14 para. 7 sentence 2, 3 or 4 medicinal products.
(2) The offence also acts as a person who, intentionally or negligently, is contrary to a legal regulation adopted pursuant to Section 21 of this Regulation, insofar as it refers to this fine for a certain amount of facts.(3) In the cases referred to in paragraph 1 (2), the administrative offence may be punishable by a fine of up to twenty thousand euros, in the cases referred to in paragraph 1 (1), (3) and (4), and in paragraph 2, with a fine of up to five thousand euros. name="BJNR006970960BJNG000500319 " />

Fifth Section
End-and Transitional Provisions

Non-Official Table of Contents

§ 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 permission within the meaning of § 1. This also applies to authorities whose owners are local authorities; the pharmacies may be leased; § 9 shall not apply.(2) The permission granted under the previous law to operate a hospital pharmacy shall continue to apply to the extent to which it has so far been granted. The permission granted under the previous law to operate a two-gapotheke shall be deemed to be a permission within the meaning of § 16. Non-official table of contents

§ 27

(1) Holder of pharmacies other than those referred to in § 26 must be subject to the operation of the Pharmacy of a permit according to § 1. Insofar as they operate a pharmacy on the basis of such authorization when this law enters into force, the authorization shall be deemed to have been granted.(2) Insofar as such entitlement is used by a person who does not fulfil one of the requirements of § 2 (1) No. 3, in accordance with the award certificate and the provisions of the law applicable until the entry into force of this law. was allowed to remain in the process. The use shall be effected by leasing; § 9 shall not apply; § 13 shall remain unaffected.(3) holders of such a right shall be granted a permit to operate another pharmacy which is not a two-gapotheke only if they do not have the previous entitlement. Non-official table of contents

§ 28

(1) In case of leased pharmacies, the type approval or confirmation as a tenant is granted to the tenant. as a permit 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 remain in force until the expiry of the agreed contract period if they do not lose their validity at an earlier date. unofficial table of contents

§ 28a

(omitted) unofficial Table of Contents

§ 29

(omitted) Non-official table of contents

§ 30

On medical and veterinary delivery points for medicines (Hausapotheken) the provisions of this law are not applicable. unofficial table of contents

§ 31 (external force step)

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§ 32

(omitted) unofficial table of contents

§ 33 (Entry Into Force)

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asset

(omitted)