Pharmacy Act

Original Language Title: Gesetz über das Apothekenwesen

Read the untranslated law here: http://www.gesetze-im-internet.de/apog/BJNR006970960.html

Pharmacy Act (Pharmacy Law - ApoG) Emin Ausfertigung date: 20.08.1960 full quotation: "Pharmacy act as amended by the notice of October 15, 1980 (BGBl. I S. 1993), most recently by article 1 of the law of 15 July 2013 (BGBl. I S. 2420) has been changed" stand: Neugefasst by BEK. v. 15.10.1980 I, 1993;
 
as last amended by article 1 G v. 15.7.2013 I 2420 for more information on the stand number found in the menu see remarks footnote (+++ text detection from validity: 9.8.1980 +++) (+++ changes due to EinigVtr cf. §§ 2 and 28 +++) heading: long heading of idF d. Article 20 No. 1 G v. 14.11.2003 I 2190 mWv January1, 2004; Short title & letter abbreviation eingef. by article 20 No. 1 G v. 14.11.2003 I 2190 mWv 1.1.2004 first section permission § 1 (1) the incumbent pharmacies to ensure a proper supply of medicines of the population provided in the public interest.
(2) a person who wants to operate a pharmacy and up to three presumed, requires the permission of the competent authority.
(3) the permission applies only to the pharmacist, it is issued and for the spaces referred to in the approval certificate.

Section 2 (1) permission is granted if the applicant 1 in the meaning of article 116 of the basic law, Member of one of the other Member States of the European Union or another Contracting State to the agreement on the European economic area or of a Contracting State, the Germany and the European Union contract have admitted a corresponding right, or wandering aliens within the meaning of the law on the legal status of homeless foreigners on request;
2. full legal capacity is.
3. the German licensure as a pharmacist has;
4. the reliability required for the operation of a pharmacy has; This is not the case, if there are facts, which demonstrate the unreliability of the applicant in relation to the operation of a pharmacy, especially if there are criminal or serious moral transgressions, that for the management of a pharmacy seem ill-suited him leave, or if he has proven by grossly trivialising or persistent breach of this law, the pharmacy operation order issued under this Act or for the manufacture of medicinal products and the marketing of these adopted legislation as unreliable;
4A. 5. the affidavit gives off that he has made no agreements which violate § 8 sentence 2, article 9, paragraph 1, article 10 or article 11, and other contracts related to the establishment and operation of the pharmacy in context, shall submit the purchase or lease on pharmacy, as well as at the request of the competent authority;
6. proves that he will; have the spaces prescribed after the pharmacy rules (sec. 21) in the event of the licence
7 is unsuitable not in health, properly to conduct a pharmacy;
8 tells whether and, where appropriate, in what place it in a Member State of the European Union or in another Contracting State to the agreement on the European economic area or in a Contracting State, the Germany and the European Union have granted a corresponding right contractually, operates one or more pharmacies.
(2) is an approved applicant who does not pass no. 4 of Federal Pharmacists order pharmaceutical testing in the area of application of this Act in accordance with article 4, paragraph 1, to grant permission if it is requested for a pharmacy which is operated for at least three years by way of derogation from paragraph 1.
(2a) (lapsed) (3) the pharmacist after his approval or granting more than two years continuously no pharmaceutical activity exercised one according to § 4 of paragraph 1a to 1 d, 2 or 3 the Federal Pharmacists order of the pharmaceutical inspection-equivalent diploma, certificate or other evidence of formal qualifications, the permission only to grant when he is in the last year before the application is him so such activity once again for at least six months in a in a Member State of the European Union or in another Contracting State the agreement on the European economic area or in a Contracting State which Germany and the European Union have granted a corresponding right contractually, remote pharmacy or hospital pharmacy has exercised.
(4) the permission to operate of several public pharmacies shall be granted if 1 the applicant meets the requirements according to the paragraphs 1 to 3 for each of the requested pharmacies and 2 neighbouring districts or county-level cities are the pharmacy of him-to-work and the presumed to be operated by him within the same group or same district-free city or into each other on request.
(5) for the operation of several public pharmacies apply according to the provisions of this Act with the following stipulations: 1 the operator has to lead one of the pharmacies (main pharmacy) personally.
2. for any other pharmacy (branch), the operator has to call a pharmacist in charge, which has to comply with the obligations, as laid down in this law and in the pharmacy manager pharmacy operating regulations in writing.
To the person of the responsible change 1 number 2 within the meaning of the sentence, the authority of the operator is two weeks prior to the change in writing. An unforeseen change of the person of the responsible must immediately be change displayed pursuant to sentence 2.

§ 3 the permission expires 1 death;
2. by waiver;
3. due to withdrawal or revocation of licensure as a pharmacist, because on the approval or withdrawal of permission according to § 2 para 2 of Federal Pharmacists order;
4. If for a year by the permission of no use; been made the competent authority may extend the time limit if there is an important reason.
5. (dropped out) section 4 (1) which is permission to take back, if one of the requirements not existed when they were granted pursuant to section 2.
(2) the permit shall be revoked, if subsequently one of the conditions has been removed pursuant to section 2 para 1 No. 1, 2, 4, 6, or 7. The permit may be revoked if the permit holder has subsequently taken agreements contrary to § 8 sentence 2 in connection with sentence 4, article 9, paragraph 1, section 10 or section 11.

§ 5 operated a pharmacy without a permit, the competent authority has to close the pharmacy.

§ 6 a pharmacy may be opened only after the competent authority has to certify that the pharmacy complies with the legal requirements (decrease).

Section 7 requires permission to the personal direction of the pharmacy in their own responsibility. In the case of § 2 para 4 No. 2 is whether according to § 2 paragraph 5 called pharmacist the obligations according to sentence 1. This shall not affect the obligations of the operator. The personal management of a hospital pharmacy is the employed pharmacists.

Several people together to operate a pharmacy only in the form of a company of civil law or a public trading company section 8; in these cases require all shareholders of the permission. Investments in a pharmacy in form of a Stille Gesellschaft and agreements where the remuneration for loans granted the permit holder or otherwise transferred assets sales or profits of the pharmacy is aligned, rental agreements in particular the turnover or profit-oriented are not permitted. Leases about pharmacies pursuant to § 9, where the lease of the turnover or profit depends, not considered as agreements within the meaning of sentence 2. Sentences 1 to 3 shall apply to pharmacies pursuant to § 2 para 4.
Footnote (+++ § 8 sentence 2: § 8 sentence 2 applies to investments and agreements, which passed on August 9, 1980 and were ineffective not because of circumvention of the objectives of the Act only from 1 January 1986 application (article 2 para 3 of the Act to amend the Pharmacy Law of August 4, 1980 - Federal Law Gazette I p. 1142). +++) § 9 (1) the lease of a pharmacy or pharmacy according to § 2 para 4 is allowed only in the following cases : 1. If and as long as the landlord in possession of the permit is and the pharmacy in his person this important reason can not even run or no. 7 revoked the permit due to the absence of one of the conditions laid down in article 2, paragraph 1 or revocation of approval due to the absence of one of the conditions laid down in article 4, paragraph 1, sentence 1, no. 3 of the federal order of pharmacists is extinguished;
2. after the death of a permit holder by his heir children up to the time in which the youngest of the children age of 23. One of the girls before the age of 23 years to take the pharmacy profession, so the deadline at the request can be extended until's can meet the conditions for the granting of the permit in his person
3. due to the surviving beneficiaries spouse or life partner up to the time of the marriage or establishing a partnership unless he receives not a permit referred to in paragraph 1.

The admissibility of the lease is not affected by, a pharmacy within the same place in cities within the same or in an adjacent district, adjourned after the occurrence of the cases referred to in sentence 1 or that their premises are changed. In the case of the installation or modification of premises is a pharmacy that is leased pursuant to sentence 1 No. 1, the lessor of any new permission needed. § 3 No. 5 remains unaffected.
(1a) the landlord before the expiry of the agreed rental period dies, as the competent authority may allow to avoid undue hardship to the tenant, that the lease between the tenants and the heirs for a period of not more than twelve months will continue.
(2) the lessee requires the permission referred to in § 1. The lease shall not interfere with the professional responsibility and freedom of choice of the pachtenden pharmacist.
(3) for the duration of the lease No. 4, section 4, paragraph 2, and section 7, sentence 1 shall not apply to the permission of the lessor article 3 insofar as that provision refers to no. 6 article 2, paragraph 1.
(4) the permission granted under paragraph 2 is to take back if one of the requirements not existed when they were granted pursuant to paragraph 1; She shall be revoked, if subsequently one of those conditions has been removed. § 4 shall remain unaffected.

§ 10 of the licence holder must not undertake only certain drugs or prefers to offer or to give or to restrict the range of medicinal products to be of him elsewhere on the supply of certain manufacturers or traders or groups of such.

§ 11 may (1) permit holders and staff of pharmacies with physicians or other persons who deal with the treatment of diseases, carry out any legal transactions or make arrangements that have a preferred delivery of certain medicines, the feeding of patients, the assignment of notes or the manufacturing of medicinal products without full indication of the composition to the subject. section 140a of the fifth book of the social code shall remain unaffected.
(2) by way of derogation from paragraph 1 the holder of a permit to operate of a public pharmacy on the basis of an agreement may give immediately ready to use Zytostatikazubereitungen which are produced within the framework of the usual operation of the pharmacy, to the applying physician.
(3) the holder of a permit to operate of a hospital pharmacy must submit that on request of the holder of a permit to operate of a public pharmacy within the framework of its pharmacy of manufactured ready Zytostatikazubereitungen on this community pharmacy or at the request of the holder of a permit to operate of a different hospital pharmacy at this hospital pharmacy. This applies to the holder of a permit to operate of a public pharmacy for dispensing the drug referred to in sentence 1 at a hospital pharmacy or an other community pharmacy. A contract according to § 14 para 3 or 4 is not required.
(4) in case of a threatening communicable disease, whose spreading requires providing immediate and significantly exceeding the usual level of specific medicines, a) paragraph 1 shall not apply to medicinal products which by the health authorities of the Confederation or of countries or of these notified bodies according to § 47 para 1 sentence 1 No. 3 c of the German medicines Act on stock or number 1 c of the German medicines Act were made pursuant to article 21, paragraph 2 , b) applies to paragraph 3 sentence 1 and 2 according to preparations of active ingredients stocked by the health authorities of the Confederation or of countries or of these notified bodies.

§ 11a permission to dispatch of nonprescription medicines in accordance with section 43, paragraph 1, sentence 1 of the German medicines Act is to grant the holder of a permit pursuant to section 2 on application, if he in writing that in the case of the granting of the permit will meet the following requirements: 1 the shipping is from a public pharmacy in addition to the usual operation of the Pharmacy and be carried out according to the applicable regulations , if no separate rules for the shipping trade.
2. with a quality assurance system ensures that a) the to be shipped medicines so will be packed, transported and delivered that its quality and efficacy is maintained, b) sent drug of the person is delivered, which is communicated by the client of the order of the pharmacy. This determination may include in particular the handing over to a particular named natural person or a designated group of persons c) the patient or the patient is advised on the need to contact a doctor if problems occur on the medication and d) the consultation will be done through pharmaceutical personnel in German language.
3. es ensures that a) shipped within two working days after receipt of order ordered drug an other agreement is made, unless the drug is available in this time, unless it was with the person, ordered the drug. insofar as is evident, that the ordered medicines can not be sent within the period referred to in sentence 1, the Orderer in a suitable manner of them is to teach, b) all medicinal products ordered are delivered, as far as they are allowed within the scope of the German medicines Act in the traffic and are available c) in case of known risks of medicinal products an appropriate system to report such risks by customer , is to inform of the customer about such risks and internal defenses available, d) causes a free second delivery, e) maintained a system for tracking and f) transport insurance is completed.
Sentence 1 with the proviso that the pharmacy will also have the appropriate facilities and equipment shall apply in the case of e-commerce with nonprescription medicines.

§ 11b (1) permission according to § 11a is to take back if one of the conditions has been not their issuance according to § 11a.
(2) the permit shall be revoked, if subsequently one of the conditions has been removed according to § 11a. The permit may be revoked if the facts justify the assumption that the licence holder contrary to an enforceable order of competent authority operates the pharmacy not to meet the requirements of section 11a, sentence 1 No. 1-3, sentence 2 or a legal regulation according to § 21 according to.
(3) the shipping trade without permission, applies section 5 according to.

§ 12 legal transactions that violate fully or partially § 8 sentence 2, article 9, paragraph 1, article 10 or article 11, are null and void.

section 12a (1) the holder of a permit to operate of a public pharmacy is obliged to conclude a written contract to supply residents of homes within the meaning of article 1 of the law on home with pharmaceuticals and pharmacy-only medicine products with the support of the homes. The contract requires to its legal validity of the approval of the competent authority. The approval is granted if 1 to supplying the community pharmacy and the homes within the same group or same district-free city or in each other are neighboring districts or county-level cities, 2. the proper drug supply is guaranteed, in particular the type and scope of supply, the right of access to the home, as well as the requirements to the review of proper, residents-related storage of the products supplied by him by pharmaceutical personnel of the pharmacy, as well as the documentation of this supply are contractually fixed , 3. the duties of the pharmacist for the information and consultation of home residents and of the administration or application of the supplied products responsible are set as far as an information and advises on the safety of the residents or the employees of the home are needed, the contract pharmacy choice of home residents not restricts 4 and the contract contains no exclusivity commitment in favour of a pharmacy 5. and clearly delimits the responsibilities of several pharmacies involved in the supply.
Subsequent changes or amendments to the contract are notified to the competent authority.
(2) the supply is before recording the activity of the competent authority.
(3) as far as residents of homes provide themselves with medicines and pharmacy-only medicine products from community pharmacies, there are no contract referred to in paragraph 1.

Article 13 (1) after the death of the permit holder's heirs must allow manage the pharmacy for a maximum of 12 months by a pharmacist.
(1a) the tenant of a pharmacy before the expiry of the agreed rental period dies, as the competent authority may allow to avoid undue hardship to the lessor, that manage the pharmacy for a period of not more than twelve months by a pharmacist can be.
(1B) the administrator requires the administrative of authorisation for the time. The authorisation shall be granted if it meets the requirements of section 2 para 1 No. 1 to 4, 7 and 8.
(2) the permit is void if the administrator no longer has the licensure as a pharmacist. § 4 shall apply accordingly.

(3) the administrator is responsible for the observance of the pharmacy operation rules and the rules on the manufacture of medicinal products and the marketing of these.
The institution of a hospital permission to operate of a hospital pharmacy is Bundeswehr pharmacies, branch pharmacies, second section of hospital pharmacies, emergency pharmacies section 14 (1) at the request of grant, if he 1 the appointment of a pharmacist who fulfils the conditions laid down in article 2, paragraph 1 No. 1 to 4, 7 and 8, paragraph 3, also in conjunction with subsection 2 or 2a, and 2. the rooms prescribed for hospital pharmacies after the pharmacy operation order proves.
The head of the hospital pharmacy or a pharmacist appointed by him has to inform the doctors of the hospital on orphan medicinal products and to advise, in particular with regard to a functional and economical drug therapy. This applies also to the extent as the ambulatory care is affected.
(2) that is to take back, if it is later known that when granting a permit the set 1 required prerequisites not has been referred to in paragraph 1. It shall be revoked if one of the conditions has been removed pursuant to paragraph 1, or if the licence holder or a person authorized by him grossly or persistently contravenes the provisions of this Act, the regulation adopted on the basis of article 21 or the for the manufacture of medicinal products or the marketing of these adopted legislation. According to sentences 1 and 3 must, with regard to the approval under paragraph 5 If the conditions under paragraph 5 sentence 2 have not been, or have disappeared.
(3) a person who intends as a holder of a permit to operate of a hospital pharmacy referred to in paragraph 1 to provide a further, not even registered hospital with medicines has to conclude a written contract with the carrier of this hospital.
(4) the hospital by the holder of a permit to operate of a pharmacy according to § 1 paragraph 2 or under the law of another Member State of the European Union or another Contracting State to the agreement on the European economic area provide a person who intends as a carrier of a hospital, has the holder of this permit to reach a written agreement. The place of performance of the contractual services is the seat of the hospital. Applicable law is German law.
(5) the agreement after paragraph 3 or 4 requires the approval of the competent authority to its legal validity. This authorisation shall be granted if it is ensured that the hospital signed a contract for the supply of medicines in the hospital by this pharmacy with a pharmacy according to paragraph 3 or 4, which meets the following requirements: 1. the proper drug supply is ensured, in particular, which are according to the operational rules of the pharmacy or pharmacies, which have their seat in another Member State of the European Union or another Contracting State to the agreement on the European economic area , available after the rooms required in that State regulations and the necessary staff and facilities;
2. the pharmacy provides the Hospital of this ordered medicines directly or in the case of dispatch in accordance with the requirements according to § 11a;
3. the pharmacy provides medicines particularly urgent need the hospital acute care, immediately and accurately available;
4. a personal consultation of the staff of the hospital by the head of the pharmacy according to paragraph 3 or 4 or the pharmacist of the supplying pharmacy authorised by him is carried out as needed and in an emergency without delay;
5. providing pharmacy ensures that the staff of the hospital in terms of a functional and economical drug therapy of her; continuously advise
6. the Director of the supplying pharmacy according to paragraph 3 or 4 or the pharmacist appointed by him is a member of the drug Commission of the hospital.
Approval of the competent authority is required for the supply of other hospital by a hospital pharmacy under same ownership. Rate applies for the granting of authorisation 2 according to.
(6) the head of the hospital pharmacy under paragraph 1 or a pharmacy pursuant to paragraph 4 or a pharmacist representative he has to check the drug supplies of the hospital to be supplied in accordance with the pharmacy operational rules and in particular to ensure the perfect condition and proper storage of drugs. He has to set a reasonable time limit and to show their non-compliance with the authority responsible for the pharmacy supervision to eliminate identified shortcomings.
(7) the Director of the hospital pharmacy pursuant to paragraph 1 or a pharmacist appointed by him, or the head of a pharmacy pursuant to paragraph 4 may provide only such hospitals with medicines, which are legally binding contracts or for whose care a set of 3 has been approved under paragraph 5. The persons referred to in sentence 1 may emit drugs only on the individual stations and other units of the hospital to the care of patients who fully stationary, stationary part, forward or to stationary treatment (section 115a of the fifth book of the social code), outpatient surgery in the hospital or in the context of other station-replacement surgery (§ 115 b of the fifth book of the social code) are supplied for immediate use in patients at approved clinics of the hospital , especially at university clinics (section 117 of the fifth book of the social code), Psychiatric Institute clinics (section 118 of the fifth book of the social code), social-paediatric centres (section 119 of the fifth book of the social code), and authorized hospital doctors (section 116 of the fifth book of the social code), as well as on patients in outpatient treatment at the hospital when the hospital, entitled or authorised (section 116a of the fifth book of the social code) (§§ 116 b and 140 b para 4 sentence 3 of the fifth book of the social code) is. For the release of patients after inpatient or outpatient treatment at the hospital the amount of medicines needed to bridge may be placed on these only, when in the aftermath of the treatment follows a weekend or a holiday. Without prejudice to the set of 3, the medicines needed to bridge the gap for no longer than three days can be dispensed to patients for the regulation of domestic nursing is no. 3 of the fifth book of the social code according to section 92, paragraph 7, sentence 1. Medicinal products only for their own needs may be placed on employees of the hospital.
(8) hospitals in the meaning of this law are facilities according to § 2 No. 1 of the hospital financing Act. These are equal with regard to the supply of medicines: 1 national law certain carriers and operators of the ambulance service, 2 Spa and special facilities which serve the health care or medical or vocational rehabilitation, unless they a) treatment or care, as well as provide Board and lodging, b) under permanent full-time medical management and c) at least 40 per cent of annual benefits for patients of public service providers or for self-pay account , no higher than the public service providers pay calculated charges.
Certain carriers and operators of the ambulance service national law as well as spa and special facilities are to be regarded as a station for the purposes of paragraph 7 sentence 2, unless they are subdivided in stations or other units with different supply purpose. A permit may not be granted for these the institution of an institution referred to in sentence 2 referred to in paragraph 1.
(9) paragraphs 3, sentence 1 to 3 no application insofar as medicines to treat of a dangerous communicable disease, whose spreading significantly higher provision of specific medicines requires an immediate and the usual level, and by the health authorities of the Federation or of the countries find 4, 5 set of 3 and paragraph 7 or stocks of these notified bodies according to § 47 para 1 sentence 1 No. 3 c or pursuant to article 21, paragraph 2, 1 c of the medicinal products Act made number were.

§ 15 (1) in the Division of the Ministry of defence is whether the Bundeswehr pharmacies drug supply.
(2) the Federal Ministry of defence taking into account the special military circumstances in regulations regulates the establishment of the Bundeswehr pharmacies and their establishment and operation. He ensures that the members of the German armed forces with regard to the supply of medicines and drug safety are not unlike as civilians.
(3) (dropped out) a State of emergency in the drug supply occurs due to lack of a pharmacy section 16 (1), as the competent authority may grant permission to operate of a branch pharmacy the holder of a nearby pharmacy on request, if this proves the rooms prescribed for it.
(2) branch pharmacies must be maintained. Article 13 shall apply mutatis mutandis.
(3) the permission should be granted a pharmacist not for more than a branch pharmacy referred to in paragraph 1.

(4) permission is granted for a period of five years; She may be granted again.

§ 17 results six months after public announcement of a State of emergency in the medicine supply of the population, that neither an application for operating a pharmacy of still a branch pharmacy has been made, so can the competent authority a municipality or a municipal Association permission to operate of a pharmacy under direction of a pharmacist to be by her grant, if they prove the spaces prescribed by this law and institutions. The pharmacist must meet the requirements of section 2 para 1 No. 1 to 4 and 7.
Third section emergency service fee, pharmacy regulations and exemptions for federal police and riot police section 18 (1) in the register of associations of the Amtsgericht Frankfurt am Main under registration number 4485 registered Deutsche Apothekerverband E.v. built and manages a Fund for promoting ensure the emergency service pharmacies. He performs the functions relating to the Fund as well as the appropriation and distribution of funds, including the adoption and enforcement of the necessary administrative acts as Beliehener in accordance with §§ 19 and 20. The Deutsche Apothekerverband E.v. is issuing authority within the meaning of § 7 of the administrative enforcement Act in the meaning of § 3 of the administrative law of of enforcement of and law enforcement agencies.
(2) the Deutsche Apothekerverband E.v. has to build set 1 the Fund separately from the other assets of the Association referred to in paragraph 1 and to manage. That him incurred expenditure in the establishment and management of the Fund will be from the revenues of the Fund covered. The funds are to apply in the Federal Republic of Germany finance agency. The Fund has to provide resources adequate to ensure its solvency in the current quarter, which are to make from the proceeds of the Fund. For the initial application of resources loans can be recorded in an appropriate level to repay up to no later than December 31 2013 from the revenue of the Fund are.
(3) the legal and technical supervision over the Deutsche Apothekerverband E.v. in carrying out the tasks referred to in paragraph 1 results in the Federal Ministry of health. The Deutsche Apothekerverband E.v. has the supervisory authority on request to disclose the accounting of the Fund.

Section 19 (1) which are pharmacies obliged, after the end of each quarter within ten days of notification of the decision referred to in paragraph 2 sentence 1 for all in the quarter given packs of prescription drugs for use in people the proportion of the fixed payment is the promoting ensure the emergency service pharmacies according to § 3 paragraph 1 sentence 1 of the medicine pricing regulation, to dissipate according to § 18 paragraph 1 sentence 1 of established funds to the. As far as the pharmacies for the settlement with health insurers take data centers claim, they have to be that on the settled and the shares attributable to the other given medicinal pursuant to sentence 1 of the data centers.
(2) the Deutsche Apothekerverband E.v. shall determine the payable amounts compared to the pharmacy for each quarter. Contradiction and lawsuit against the setting have no suspensive effect. The Beliehene appeal authority is number 2 of the administrative court procedure within the meaning of article 73 (1) sentence 2. Fees and expenses are charged for a preliminary proceedings. For the complete or partial rejection of a conflict, a fee is charged up to 500 euros. Withdrawal of a conflict after the start of its substantive editing, but before its completion, the fee is pursuant to sentence 5 in proportion to rise. The opposition has no success only because the breach of a procedural or formality is irrelevant to article 45 of the Administrative Procedure Act, no fee is charged. According to the rates of 5 and 6, the opposition authority decides on the charges in its reasonable discretion. The Administrative Court is locally responsible for complaints against the Nr.1B,c, in whose territory he is established.
(3) the data centers submit the Deutsche Apothekerverband E.v. in means of electronic data transfer or machine readable on disks full information on the number of packs of prescription medicinal for use in people given in the respective quarter of the individual pharmacies at the expense of the statutory health insurance referred to in paragraph 1 sentence 2. The pharmacies have to inform the Deutsche Apothekerverband E.v. with the total number of packs of prescription medicinal for use in people who are not at the expense of the statutory health insurance, prescribed or not in kind were made by way of a declaration given by them in the respective quarter. Form and content of the declaration pursuant to sentence 2 are set by the Deutsche Apothekerverband E.v. and disclosed on its Web site. The transmission of data has to be made within four weeks after the end of the quarter. The data may be processed only for the purposes referred to in paragraph 2 sentence 1, and it can be used.
(4) the Deutsche Apothekerverband E.v. refunded from the revenue of the Fund data centers necessary costs for the provision of information pursuant to paragraph 3 sentence 1 in proven height. Notwithstanding sentence 1, the Deutsche Apothekerverband E.v. with the data centers can agree a lump-sum refund.
(5) as far as pharmacies make no claim data centers, the transfer of all shares according to 1 sentence 1 paragraph immediately through the pharmacy on the basis of a declaration. Paragraph 3 set to 5 apply 2 and paragraph 3.
(6) the Deutsche Apothekerverband E.v. ensures that the pharmacies comply with paragraphs 1, 3 and 5 their obligations after. Failure or suspicion of an incomplete removal of the shares referred to in paragraph 1 he can make the necessary for determining the amounts to be deducted checks of pharmacies, as well as the data centers under-utilized. The persons responsible for carrying out the verification may enter in particular the operating and business premises during normal business hours, require the necessary information, and in justified cases business documents, including electronic files, view and make copies thereof or copies. The obligated party to the information the information on such questions, may refuse the answers himself or one of his number 1 to 3 of the code of civil procedure referred to members of the danger of criminal prosecution or proceedings would expose in § 383 paragraph 1 according to the law of administrative offences. The pharmacies and the data centers have to support the representative of German Pharmacists Association e. V. in the review.
(7) a pharmacy of their commitment to the self declaration does not comply pursuant to paragraph 3 sentence 2 or actual evidence of the inaccuracy of the information of the self statement, the Deutsche Apothekerverband E.v. can appreciate the number of packs of prescription drugs that were made not at the expense of the statutory health insurance or not in kind, given in the respective pharmacy. These are all circumstances into account, which are for the estimation of importance. The estimate will be charged up to 500 euros. Paragraph 2 sentence 3 to 9 shall apply accordingly.

Section 20 (1) pharmacies, which by the competent authority to the service in the emergency services continuously in the time by no later than 8: 00 until at least 6: 00 of the following day were determined and have completely rendered the emergency service, a lump-sum grant for this purpose.
(2) the authority in charge of the Division to the service in the emergency services tells the pharmacies the Deutsche Apothekerverband E.v. for their area of responsibility after the end of each quarter no later than the end of the following month, have provided emergency services in the respective quarter referred to in paragraph 1, as well as each emergency services provided the number of.
(3) the Deutsche Apothekerverband E.v. sets the flat-rate aid referred to in paragraph 1 to the pharmacy for each quarter and pay him for each emergency service provided for in paragraph 2 to the pharmacies of the Fund according to § 18 paragraph 1 sentence 1 after the end of every quarter no later than the end of the following quarter. § 19 paragraph 2 sentence 3 to 9 shall apply mutatis mutandis. The grant is calculated as a quotient of the expenditure according to § 18 paragraph 2 sentence 2, including the costs to be reimbursed according to § 19 paragraph 4, and the amounts of formation of resources according to § 18 paragraph 2 sentence 4 and to fulfil the obligations arising from loan according to § 18 paragraph 2 sentence 5 adjusted total shares in existing in the Fund according to article 19, paragraph 1, and the number of emergency services notified under paragraph 2.

The Deutsche Apothekerverband E.v. has section 20a to replace the damage which the Federal Republic of Germany resulting in unlawful and intentional or negligent violation of his obligations in the exercise of the functions and powers according to sections 18 to 20.

Article 21 


(1) the Federal Ministry of health is authorized to adopt a pharmacy operational rules by decree with the consent of the Federal Council, to ensure proper operation of pharmacies, ensuring branch pharmacies and hospitals and to the quality of there to be produced and to be medicinal. Here are the ground rules established by the World Health Organization for the manufacture of medicinal products and the assurance of their quality, to take into account the provisions of the pharmacopoeia and the generally accepted rules of pharmaceutical science. With the consent of the Federal Council, 1 rules governing the Organization, facilities and participation of pharmacies in the conduct of supply forms agreed after the fifth book of the social code can be adopted to set by the pharmacy operation order. Still, the Federal Ministry is empowered to make arrangements in particular to the design including the operation and quality assurance of information in electronic media, which are used in connection with electronic trade in medicines, by decree with the consent of the Federal Council.
(2) in the pharmacy operation order pursuant to paragraph 1 sentence 1 regulations can hit developing, manufacture, acquire, test,- and decanting, packaging and packing, camps, offering for sale, submitting and labelling of medicinal products as well as the isolation or destruction not capable to transport medicines and on other operations, 1a will be about 1.
the requirements for shipping, on e-commerce including shipping, to the advice and information in connection with the drug trade and ensure the proper delivery of these drugs to the final consumer, on documentation requirements, as well as for the determination of pharmaceuticals or drugs groups, their dispensing through mail order of medicines safety or consumer protection reasons is not allowed, as far as not having adequate resources the medicines safety and consumer protection can be guaranteed and the assumption of risks is justified and the risks are disproportionate, 2. the management and storage of evidence about the operations referred to in point 1, 3. the special test conditions and control of the animals used in the development, manufacture and testing of medicinal products as well as management and storage of evidence about; affect the rules of the animal welfare act and the regulations adopted according to the animal welfare act, 4 the requirements for the Pharmacy staff and its usage, 5 representing the pharmacy manager, 6 the size, composition, facilities and equipment the pharmacy operating room and other spaces, affecting the shipping and e-commerce including shipping with medicines as well as the advice and information in connection with this trade , 7 the composition and labelling of containers at the pharmacy, 8 common pharmacy goods, the Nebengeschäfte, the service and the warehouse of pharmacies and the drug delivery within and outside of the pharmacy operation room, 9 the conditions of licensing for the construction of recipe collection and the procedure to be observed as well as the conditions of the closure of recipe collection and the requirements of their operating , 10 the naming and the responsibility of control parents in pharmacies, 11 reset by batch samples as well as the extent and duration of storage, 12 the requirements for hygiene in the pharmacies and 13 the review of pharmaceutical supplies in hospitals as well as the management and storage of evidence about.
(3) in the regulation referred to in paragraph 1, in particular the following regulations to the design including the operation can set 4 and quality assurance of information in electronic media met that are used in connection with electronic trade in medicinal products: 1 performance and application security, 2nd order form and there listed information, 3. questionnaire to information relevant to the drug therapy, as far as these may be required for reasons of drug safety , 4. information about drug safety, 5. method of transfer and quality of information, 6 quality assurance, quality control and quality confirmation, 7 target group orientation, 8 transparency, 9 authorship of the Web site and the information, 10 confidentiality and data protection, 11 update information, 12 accountability and contact for feedback, 13 accessibility to health or drug-related data or content, 14 linking to other Web sites and other information carriers, 15 facilities to detect and check the status of the audit or review of Pharmacy and the Web page, as well as their bases.
(4) where pharmacies have a permit for the manufacture of medicinal products according to the regulations of the medicines Act, the corresponding regulations of the pharmaceutical legislation apply to pharmacy operating the pharmacy operation order for the manufacturing plant.

Section 22 facilities that serve the pharmaceutical supply of the members of the federal police and the willingness to police forces of the countries within the framework of the free medical care, as well as their livestock, subject to the provisions of this Act.
Fourth who intentionally or negligently operates a pharmacy, hospital pharmacy or pharmacy branch section of criminal law and penalty provisions article 23 without the required permission or authorization, or manages, is punishable by up to six months or punished with fines up to one hundred eighty daily rates.

section 24 (dropped out) section 25 (1) any person who intentionally or negligently 1 is violates article 2 par. 5 No. 2 do not, not properly or in a timely manner shall designate a responsible, 2. on the basis of one according to § 8 sentence 2, article 9, paragraph 1, article 10 or article 11 par. 1 invalid agreement provides services or accepts or executes such an agreement in any other manner, 3. manage a pharmacy by a person can , of a not has been approved 1 b set according to § 13 ABS. 1, 4. contrary to article 14, paragraph 7, sentence 1 provides a hospital with medicines or 5 contrary to § 14 paragraph 7 sentence 2, 3 or 4 medicines are off.
(2) any person is also, who intentionally or negligently contravenes an Ordinance adopted pursuant to section 21, where it references this penalty provision for a specific offence.
(3) the offence can no. 2 with a fine in the cases of paragraph 1 up to twenty thousand euros, in cases of paragraph 1 No. 1, 3 and 4 and paragraph 2 with a fine are punishable up to five thousand euros.
Fifth section final and transitional provisions article 26 (1) are considered personal concessions, real concessions and other personal operating permits that had been issued prior to the entry into force of this Act, permits within the meaning of § 1. The same applies to permissions, owned by local and regional authorities; the pharmacies can be leased; section 9 does not apply.
(2) the authorisations granted under existing law to operate of a hospital pharmacy continue to apply its previous extent. The previous law granted licences for the operation of a branch pharmacy considered permits within the meaning of section 16.

§ 27 require to operate the pharmacy of a permit pursuant to section 1 (1) holders of other than the pharmacy operating authorizations referred to in section 26. Insofar as they operate a pharmacy on the basis of such permission for the entry into force of this Act, permission is deemed granted.
(2) to the extent such permission in accordance with the certificate and the applicable up to the entry into force of this act according to the national provisions of a person, that not one of the requirements of section 2 para 1 No. 3, was used, it remains there. Has the use of leasing to be carried out; section 9 does not apply; § 13 shall remain unaffected.
(3) a permit to operate of other pharmacy that is not branch pharmacy, is granted holders of such permission only if they live without the previous permission.

Section 28 (1) when rented pharmacies is the approval granted the licensee or existing certification as tenant permit according to § 1 (2) on 1 May 1960 agreements the letting or management of a pharmacy, which do not comply with the articles 9 and 13, are up to the expiration of the agreed contract period in force if they not at an earlier date will expire.

section 28a (dropped out) section 29 (dropped out) section 30 on medical and veterinary drop-off points for medicines (pharmacies of House) the provisions of this Act do not apply.

§ 31 (except entry into force) - § 32 (dropped out) section 33 (entry into force) - plant (dropped out)