Approbationsordnung für Apotheker (AAppO)

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AAppO

Date of completion: 19.07.1989

Full quote:

" Approbationsordnung für Apotheker vom 19. Juli 1989 (BGBl. 1489), as last amended by Article 1 of the Regulation of 2 August 2013 (BGBl I). 3005) has been amended "

Status:

Last amended by Art. 1 V v. 2.8.2013 I 3005

For more details, please refer to the menu under Notes

Footnote

(+ + + Text evidence from: 1.10.1989 + + +) 
(+ + + Changes due to EinigVtr cf.  § 23 + + +) 

  

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Input formula

On the basis of § 5 of the Federal Pharmacists ' Order of 5 June 1968 (BGBl. 601), paragraph 1 of which is Article 1 (2) of the Law of 19 June 1989 (BGBl I). 1106), and paragraph 2 thereof, by Article 1 (2) (b) of the Law of 23 July 1988 (BGBl I). 1077), as well as Section 14 (3) of the Federal Pharmacists ' Order, which is provided by Article 23 of the Law of 25 June 1969 (BGBl). 645) has been amended to:

First section
The pharmaceutical training

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§ 1 Structure of training

(1) The pharmaceutical training comprises:

1.

a study of pharmacy of four years at a university;

2.

a family of eight weeks;

3.

a practical training period of twelve months;

4.

the Pharmaceutical Review, which is to be deposited in three stages.

(2) The examination sections of the Pharmaceutical Examination shall be filed:

1.

the first section after a study of pharmacy of at least two years,

2.

the Second Section after the existence of the First Section of the Pharmaceutical Examination and a Study of Pharmacy of at least four years,

3.

the third section after the existence of the second section and after completion of the subsequent practical training referred to in paragraph 1 (3).

(3) The standard period of study within the meaning of § 10 (2) of the Higher Education Framework Act is four years. Unofficial table of contents

§ 2 University education

(1) The aim of the university education is to provide students with the necessary knowledge, skills and methods, taking into account the requirements and the changes in the professional world, in such a way that they are working on scientific work, critical classification of scientific knowledge and the responsible pursuit of the profession of pharmacy. (2) The university education includes an education for the fields listed in Appendix 1 and one Elective subject, which is in the form of lectures, seminars and practical Courses with the specified number of regular hours and certificates are to be taught. Unofficial table of contents

§ 3 Famulatur

(1) The trainee is to be familiared with the pharmaceutical activities by the family according to § 1 para. 1 no. 2. In addition, it will be given an insight into the organisation and operational procedures as well as in the legislation for pharmacies and in the specialist language. (2) The Famulatur is during the course-free periods of the studies before the notification to the first Section of the Pharmaceutical Examination under the supervision of a pharmacist all day. At least four weeks of the Famulatur are to be paid in a public pharmacy which is not a two-gaded pharmacy; the rest of the time may also be available in

1.

a hospital or federal mortgage,

2.

the pharmaceutical industry, or

3.

a medical examination body or a comparable institution, including the Bundeswehr

shall be completed. The period referred to in the last sentence of the last sentence may also be used in comparable institutions in one of the other Member States of the European Union or in another State Party to the Agreement on the European Economic Area or in a Member State of the European Union. The Contracting State to which Germany and the European Union have contractually granted an appropriate legal claim shall be made. A payment in sections of at least four weeks is permitted. The trainee receives a certificate according to the model of Appendix 7. (3) For pharmacists, pharmacy engineers, pharmaceutical and technical assistants and pharmacy assistants, the family is no longer required. Unofficial table of contents

§ 4 Practical training

(1) The practical training in accordance with § 1 (1) no. 3 shall take place after the existence of the second part of the Pharmaceutical Examination. It is divided into an education of

1.

six months in a public pharmacy that is not a two-gag pharmacy, and

2.

six months, which may be available in

a)

a pharmacy in accordance with point 1,

b)

a hospital or federal mortgage,

c)

the pharmaceutical industry,

d)

a university institute or other appropriate scientific institutions, including those of the Bundeswehr,

e)

a medical examination body or a comparable institution, including the Bundeswehr

are to be paid. Three months of training pursuant to sentence 2 (2) (b) may also be completed at the ward of a hospital or a Bundeswehr hospital. (2) During the full-day practical training, the students acquired during the previous course of study should Pharmaceutical knowledge is deepened, extended and applied in practice. Training shall include, in particular, the development, production, testing, evaluation and delivery of medicinal products, the collection, evaluation and dissemination of information, in particular on the risk of medicinal products, and advice on medicinal products. The training also includes medical devices that are placed on the market in pharmacies. The training must be managed by a pharmacist who is a principal professional in the training centre, provided that it is carried out at a university institution, and that it includes a pharmacoscientific activity under the supervision of a Professors, university or private lecturers. (3) The trainee has to make available his/her work force on a regular basis and prepare for the third section of the Pharmaceutical Examination. It may only be used for activities which promote its training. The trainee receives a certificate in accordance with the model of Appendix 5. (4) During the practical training, the trainee has to take part in accompanying educational events in which the apprentis in Appendix 8 take part. shall be mediated. The competent authority shall carry out the accompanying teaching events or appoint one or more appropriate bodies to carry out such training events. The trainee receives a certificate in accordance with the model of Appendix 6. (5) The training referred to in paragraph 1 shall be subject to interruptions up to the level of the training provided for by the German Federal Framework Agreement. Holiday periods counted.

Second section
General examination regulations

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§ 5 State Examination Office

(1) The examination sections provided for in this Regulation shall be filed before the competent authority of the State Examination Office. (2) The examination sections shall be deposited in front of the State Examination Office of the country in which the examination subject at the time of the examination is completed. who has studied pharmacy or has recently studied pharmacy. Repeat exams must be submitted before the State Examination Office, where the examination section has not been passed. Exceptions to the first and second sentences may be allowed for important reasons. The decision shall be taken by the State Examination Office, where admission is requested, in consultation with the State Examination Office in accordance with the sentence 1 or 2. (3) In the case of examination applicants, during which periods of a related study or outside the The scope of this Regulation may be credited to a pharmacy study or a related course of study and, where appropriate, to the examinations in accordance with § 22 of such studies, unless a competence in the case of the first sentence is not applicable , Section 22 (5) accordingly. Unofficial table of contents

§ 6 Notification for Examination

(1) The State Examination Office decides on the admission to the individual examination sections. (2) The application for admission to a section of examination must be made in writing in the form prescribed by the State Examination Office and must be submitted for the first time. Section of the Marketing Authorisation Examination by 10 January or by 10 June the State Examination Office. The application for admission to the second and third sections of the pharmaceutical examination must have been received by the State Examination Office up to the date announced by the State Examination Office. (3) The application for admission to the first section of the pharmaceutical industry The test shall be accompanied by

1.

the birth certificate, in the case of married couples also the marriage certificate,

2.

proof of university entrance qualification, in the case of certificates acquired outside the scope of this Regulation, also the notification of recognition of the competent authority,

3.

proof of the family nature (Annex 7), or in the cases of § 3 (3), the corresponding evidence,

4.

the proof of a two-year pharmacy study,

5.

the certificates relating to the regular and successful participation in the events relating to the areas referred to in Appendix 1 to points A to D, in accordance with the model of Appendix 2.

6.

(dropped)

(4) To be attached to the application for admission to the second part of the Pharmaceutical Review

1.

the certificate of the existence of the First Section of the Pharmaceutical Examination (Annex 10),

2.

proof of a degree of pharmacy of at least four years,

3.

the certificates relating to the regular and successful participation in the events relating to the areas referred to in Annex 1 to points E to I, in accordance with the model of Appendix 2;

4.

the certificate relating to the compulsory elective in Appendix 1 (K), in accordance with the model of Appendix 3.

5.

(dropped)

(5) The application for admission to the Third Section of the Pharmaceutical Examination shall be accompanied by:

1.

the evidence on the existence of the First and Second Section of the Pharmaceutical Examination (Annex 10),

2.

proof of practical training (Annex 5),

3.

Proof of participation in the accompanying course events (Appendix 6).

(6) Insofar as the evidence referred to in paragraph 3 (4) and (5) and the evidence referred to in paragraph 4 (2) to (4) cannot yet be annexed to the application, they shall be submitted in a period to be determined by the State Examination Office. If the applicant has not yet completed the practical training referred to in Article 4 (1) when reporting to the third section of the Pharmaceutical Examination, he shall submit a provisional certificate from the person responsible for the training, which indicates that it will complete the training up to the expected date of the examination. The final certificate in accordance with the model of Appendix 5 must be returned immediately after receipt; it must be submitted to the State Examination Office at the latest at the beginning of the third section of the Marketing Authorisation Examination. (7) There are indications that: The State Examination Office may submit the submission to the Examiner for a reason which would lead to the failure of the Approbation as a pharmacist due to a lack of one of the conditions of § 4 (1) sentence 1 No. 2 or 3 of the Federal Pharmacist Order. other documents, in particular medical certificates or Guidance certificate, request. The special interests of disabled examinees must be taken into account in order to ensure equal opportunities when carrying out the tests. Unofficial table of contents

Section 7 Admission of authorisation

(1) The admission to an examination section shall be refused if:

1.

until the date referred to in Article 6 (2), the applicant does not submit the application or does not submit the required evidence or does not submit the required evidence, unless he makes an important reason for doing so credibly, the state of the the examination procedure still allows the examination applicant to participate and the missed action is to be obtained no later than four weeks before the examination date,

2.

in the case of § 6 (6), the applicants do not submit the missing evidence on time,

3.

the examination section concerned must not be repeated.

(2) The admission to an examination section shall be refused if there is a reason that would lead to the failure of the Approbation as a pharmacist due to a lack of one of the requirements of § 4 para. 1 sentence 1 No. 2 or 3 of the federal pharmacist order. Unofficial table of contents

§ 8 Type of examination

(1) In the first part of the Marketing Authorisation Examination, written, second and third parts of the Marketing Authorisation Examination shall be examined orally. (2) By way of derogation from paragraph 1, the competent authority in accordance with the national law may, instead of: in writing, the knowledge and skills required in the first part of the pharmaceutical examination can be demonstrated in a different way (alternative examination procedure). (3) Admission as an alternative examination procedure requires: that

1.

the reform target will be described and the qualitative improvements expected for pharmaceutical training will be identified by this examination procedure,

2.

there is a special study order to be issued by the university,

3.

ensure that the knowledge and skills to be identified in the first section of the Pharmaceutical Review will be examined in a similar manner in a written examination in this examination procedure,

4.

an appropriate accompanying and final evaluation of this examination procedure is ensured,

5.

the minimum and maximum duration of the duration of this examination procedure and the justification for renewal applications on the basis of evaluation results;

6.

access to a course of study with an examination procedure corresponding to the regulation in the first section of the pharmaceutical examination or to a course of study with an alternative examination procedure is exempted,

7.

the conditions under which the university may terminate this examination procedure,

8.

, as in the case of a transition to another course of study in pharmacy with regard to further studies, the calculation of study periods and study achievements, and

9.

, as the requirements described in Annexes 1, 2, 12 and 13, are met in this procedure.

(4) If the alternative examination procedure provides that the first section of the Marketing Authorisation Examination does not have to be filed, the documents referred to in § 6 (3) (1) to (4) shall be included in the notification of the second section of the Pharmaceutical Examination ; the time requirements of § 15 (5) do not apply in this case. A certificate shall be issued in accordance with the model of Appendix 10, which shall show separately the results of the verification of tests carried out in accordance with paragraph 3, point 3, and equivalent to the first section of the pharmaceutical examination. Unofficial table of contents

Section 9 Evaluation of examinations

(1) The following notes shall be used for the evaluation of the performance of the test item:

"very good" (1)	=	an excellent performance,
"good" (2)	=	a performance that is significantly higher than the average requirements,
"satisfactory" (3)	=	a performance that meets average requirements in every respect,
"sufficient" (4)	=	a performance which, in spite of its shortcomings, still meets the requirements,
"Not sufficient" (5)	=	A performance that is no longer sufficient due to significant defects.

(2) The grade of an examination section shall be calculated from the average of the individual grades of the examination subjects. (3) For the evaluation of the pharmaceutical examination, account shall be taken of the notes (numerical value referred to in paragraph 2 in conjunction with paragraph 4, sentence). 1) of the First, Second and Third Section of the Pharmaceutical Examination to form an overall grade. The overall grade for the pharmaceutical test shall be determined as follows:

a)

The note (numerical value) for the first section is multiplied by two, the note (numerical value) for the second section with three, and the note (numerical value) for the third section with two.

b)

The sum of the figures obtained in accordance with point (a) shall be divided by seven.

(4) The grades of the examination sections and the overall grade for the pharmaceutical examination shall be calculated up to the second place after the comma. The numerical value determined in this way shall be indicated in the certificates referred to in Annexes 10 and 11. The grades of the individual examination sections as well as the overall grade of the Marketing Authorisation Examination shall be assessed as follows:

"very good"	at a numerical value of up to 1.5,
"good"	at a numerical value of more than 1.5 to 2.5,
"satisfactory"	at a numerical value of more than 2.5 to 3.5,
"sufficient"	at a numerical value over 3.5 to 4.0.

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§ 10 Written examinations

(1) In the written examination, the examinee has to answer written questions in the supervisory work. It must indicate which of the answers provided by the questions it considers appropriate. (2) The examination questions must be based on the knowledge generally required for the pharmacist and enable reliable test results. (3) In the written examination, the same examination questions must be asked in each case for all examinees. In determining the examination questions, the State Examination Offices are to serve in accordance with an agreement between the countries of a body which has the task of establishing examination questions for the first stage of the pharmaceutical examination. When the examination questions and answers are drawn up, it is necessary to determine which response will be recognised as appropriate. The State Examination Offices may make public the items to which the examination questions relate. (4) The examination tasks shall be checked by the State Examination Offices prior to the determination of the results of the examination to determine whether they, in accordance with the requirements of paragraph 2, which are manifestly defective. The second and third sentences of paragraph 3 shall apply accordingly. If this verification reveals that individual examination tasks are manifestly flawed, they shall be deemed not to have been filed. The prescribed number of questions for the individual examinations (Section 17 (2)) is diminished accordingly. The assessment of the written examination referred to in paragraphs 5 and 6 shall be based on the reduced number of examination questions. The reduction in the number of examination questions must not have an effect on the disadvantage of a test item. (5) A subject that has been checked in writing has been passed if the proportion of questions correctly answered by the examinee is no more than 18 from the hundred under the average examination performance of the examinees of the respective examination date is located in the entire Federal territory or if the examinee has correctly answered at least 50 of the hundred of the questions. (6) The services in the written examination are to be evaluated as follows:
If the examinee has reached the minimum number of appropriate questions to be answered for the existence of the examination referred to in paragraph 5, the note shall be:

"very good",	if at least 75 of the hundred,
"good",	if it's at least 50, but less than 75 of the hundred,
"satisfactory",	if it's at least 25, but less than 50 per hundred,
"sufficient",	if it is the minimum number, but less than 25 per cent

in addition to the examination questions which have been made. If the examinee did not reach the minimum number of questions which were correctly answered for the passing of the examination, the grade "shall not be sufficient". (7) The result of the written examination is determined by the State Examination Office and shall be notified immediately to the examiner. The note for the examination section and the grades for each subject, the number of questions correctly answered by the examinee in the individual subjects, and the average examination performance shall be indicated. Unofficial table of contents

§ 11 Oral examinations

(1) For the Second and Third Section of the Pharmaceutical Examination, examination commissions are appointed by the State Examination Office. They consist of the Chairperson of the Examination Committee, other members and the members of the Beisitzern. For the Chairman and the other members, alternate members shall be appointed. The Chairperson is responsible for maintaining order. (2) For the second part of the Pharmaceutical Examination, an examination committee is formed at each university. The chairperson, the members and their deputies shall be professors or high school or private lecturers of the subjects covered by the examination, persons who shall at least determine the subjects to be determined by the examination or have equivalent qualifications. For examiners of the subject mentioned in § 18 (1) (v), others at the university in this subject can also be appointed independently lecturers. The examination in the individual subjects shall be carried out by the member of the examination board appointed for the subject in question in the presence of another member or a co-sitter. The chairman or his deputy may participate in the examinations in which he is not a examiner himself, and ask for examination questions. In the case of repeat exams, the chairperson or a member of the examination board appointed by the examiner must be present in addition to the examiner, who may also ask for examination questions. The examiner decides on the evaluation of the examination achievements; the other members of the Examination Committee present during the examination must be heard beforehand. (3) The Examination Committee for the Third Section of the Pharmaceutical Examination consists of: the chairman and at least two, at most four other members. Members are professors and university or private lecturers of the university, as well as pharmacists who do not belong to the faculty of a university, to order. In addition, other suitable examiners can be ordered. The chairman is responsible for the audit; he is himself an auditor. It must ensure that the test specimens are interviewed in a suitable manner. The examination board shall be present throughout the examination. The examination committee shall take its decision with a majority of votes. In the event of a tie, the Chairperson's vote shall be the same. (4) The examinees shall be examined individually or in groups of up to four persons. (5) The competent authority may send observers to the oral examinations. In the second section of the Pharmaceutical Examination, the examiner, in the third section of the Pharmaceutical Examination, may be the Chairman of the Examination Commission for up to five persons, who shall refer to the same section of the Marketing Authorisation Examination , as well as allow a representative of the competent pharmacist's chamber, with the approval of the test specimen, to be present at the examinations. For important reasons or at the request of the test specimen as well as in the case of repeat tests, the public can be excluded. When the examination result is announced, the persons referred to in the second sentence may not be present. (6) On the course of the examination of each test item, the examiner or one of the examiners or the chairman of the examination committee may not be present. Protocol guide, which may itself be a member of the examination board, to produce a record according to the model of Appendix 9. The subject-matter of the examination, the evaluation of the overall performance and any serious irregularities must be considered. The minutes are to be signed by all present members of the examination board as well as the protocol guide. (7) The performance of an oral examination must be assessed in accordance with § 9 (1). An oral examination has been passed if the examinee has received at least the grade "sufficient". The examination subject shall be notified to the examination subject for the individual examination subjects on the day of examination. The State Examination Office shall inform the examinee of the result in writing. Unofficial table of contents

§ 12 Examination dates

(1) The State Examination Offices shall establish the dates for the written examination in a uniform manner for the scope of this Regulation. The oral exams of the second part of the Pharmaceutical Examination usually take place during the lecture-free period. The dates for the oral examinations of the Second and Third Section of the Pharmaceutical Examination are determined by the State Examination Office in consultation with the Examination Committee. (2) The repetition of a written examination is within the scope of the the next of the dates referred to in the first sentence of paragraph 1 shall be carried out. The date for the repetition of an oral examination or an oral examination section shall be determined by the State Examination Office in consultation with the Examination Committee. In order to participate in the repetition of a written examination, the examinee shall be the next examination date, for the repetition of an oral examination as a rule, to a date of examination, which shall be carried out within three months of the date of the unsuccessful examination. The Federal State Examination Office is responsible for loading the exam. § 13 shall apply. (3) The charge for testing shall be delivered to the examinee at the latest seven calendar days prior to the date of the examination. Unofficial table of contents

Section 13 Resignation and failure

(1) After admission to an examination section, a resignation from an examination is only permissible with the approval of the State Examination Office. The examinee must immediately inform the State Examination Office of the reasons for his resignation. If the State Examination Office approves the resignation of the entire examination section, of several technical examinations or of a technical examination, the examinations shall be deemed not to have been undertaken in that regard. The authorisation shall only be granted if there is an important reason. In the case of the illness, the State Examination Office may require the submission of a medical certificate or a medical certificate. If it does not approve the resignation of the entire examination section, of several subject examinations or of a review, the examination shall be deemed to have not been passed. (2) Paragraph 1 shall apply accordingly if the examiner fails to meet a test date, (3) For the filing of the examination in a test section or examination subject which is not in force pursuant to paragraph 1 or paragraph 2, § 12 paragraph shall apply. 2 accordingly. Unofficial table of contents

§ 14 Disrupt or deception

If a examiner disturbs the proper conduct of an examination to a considerable extent or if he undertakes a deception, the State Examination Office, in the course of oral examinations in consultation with the Examination Commission, may the examination or the examination subject to the examination. the entire examination section for "fail to pass". Unofficial table of contents

§ 15 existence and repetition of examinations

(1) A section of the examination has been passed if the examinations in all subjects have been passed. The pharmaceutical examination has been passed if the three examination sections have been passed. (2) A passed examination must not be repeated. (3) Any unpassed examination in one subject can be repeated twice. If the second repeat examination is not passed in one subject, the entire examination section has not been passed. (4) If a section of the examination has not been finally passed, the pharmaceutical examination as a whole has not been passed definitively. A repetition of the examination even after a renewed study of pharmacy is not allowed. (5) The evidence required for admission to the second part of the pharmaceutical examination may be repeated before the first part of the examination is completed. Pharmaceutical examination is only available in the semester following the first examination for the first part of the examination. (6) If a technical examination of the third section of the pharmaceutical examination has not been passed, the decision will be taken by the Examination board immediately, whether and how long the examinee will again participate in an education according to § 4 . The period of participation shall not exceed three months. The State Examination Office shall inform the examinee in writing of the decision. Unofficial table of contents

§ 16 certificates and communications

(1) Following the existence of the First, Second and Third Section of the Pharmaceutical Examination, the State Examination Office shall issue a certificate according to the model of Appendix 10, after the existence of the three sections of the Marketing Authorisation Examination, a certificate issued by the State Examination Office. Specimen of Appendix 11. (2) The State Examination Office shall inform the examinee and the other State Examination Offices if the Pharmaceutical Examination has not been passed definitively.

Third Section
The Pharmaceutical Review

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Section 17 First section of the Pharmaceutical Review

(1) The first section of the Marketing Authorisation Examination shall cover the following subjects:

I.

General, inorganic and organic chemistry,

II.

Basic principles of pharmaceutical biology and human biology,

III.

Fundamentals of physics, physical chemistry and drug formation,

IV.

Fundamentals of pharmaceutical analysis.

(2) The tests shall take place on four days in the order in paragraph 1. The examination shall take two and a half hours for the first two days and two hours in each of the following two days. The number of questions to be answered in the supervisory work and their distribution to the individual subjects is the result of Annex 12. (3) The questions must be placed on the test substance set out in Annex 13. Unofficial table of contents

Section 18 Second section of the Pharmaceutical Examination

(1) The second part of the Marketing Authorisation Examination shall cover the following subjects:

I.

Pharmaceutical/Medical Chemistry,

II.

Pharmaceutical Biology,

III.

Pharmaceutical technology/biopharmaceuticals,

IV.

Pharmacology and Toxicology,

V.

Clinical Pharmacy.

(2) The examinations in the individual subjects shall generally be filed immediately in succession, with interruptions up to a maximum of eight days. Each test shall take at least 20 minutes for a test specimen, not more than 40 minutes. (3) The questions must be placed on the test material specified in Appendix 14. Unofficial table of contents

§ 19 Third section of the Pharmaceutical Examination

(1) The third section of the Pharmaceutical Examination shall cover the following subjects:

I.

Pharmaceutical practice,

II.

Special legal areas for pharmacists.

(2) The test shall take at least half an hour and not more than one hour for a test specimen. (3) The examination questions must be placed on the test substance specified in Appendix 15. The examination shall determine whether the examinee possesses the knowledge required to exercise the profession of pharmacist.

Fourth Section
The approbation

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§ 20 Application for Approbation

(1) The application for the application of the Approbation as a pharmacist shall be addressed to the competent authority of the country in which the applicant has passed the third section of the Marketing Authorisation Examination. The application shall be accompanied by

1.

a short-term curriculum vitae,

2.

the birth certificate, in the case of married couples also the marriage certificate,

3.

proof of identity,

4.

an official certificate of good conduct, which may not be issued earlier than one month before the date of submission,

5.

a declaration by the applicant as to whether proceedings are pending against him or her by a judicial criminal procedure or by a criminal investigation procedure,

6.

a medical certificate which may not be older than one month from which the applicant is not unsuitable for the exercise of his or her profession in the health and safety of the profession; and

7.

the certificate of the existence of the pharmacist examination.

(2) Insofar as the evidence is not issued in German, they must also be presented in certified translation. The competent authority may request the presentation of further evidence, in particular on the authenticity of the documents submitted and on the activity to date. Sentence 2 does not apply to the pharmaceutical diplomas, certificates and other evidence of formal qualifications listed in the Appendix to § 4 (1a) sentence 1 of the Federal Pharmacociation Code. (3) The applicant has already provided the pharmacy profession in the home state. , the competent authority of the competent authority of the Member State of origin may provide information on penalties or other professional or criminal measures imposed on the applicant for the purposes of issuing the licence to a pharmacist in the home Member State because of serious and precisely determined anti-steadings, or criminal acts concerning the exercise of the profession in the country of origin. If the authority responsible for issuing the Approbation as a pharmacist has knowledge in the case of the first sentence of the facts which have occurred outside the scope of the Federal Pharmacist Code and in respect of the conditions of § 4 The first sentence of the first sentence of paragraph 1 of the Federal Pharmacy Code may be relevant, it shall inform the competent body of the State of origin and ask them to review these facts and to ask the competent authority of the State of origin of the facts and the consequences which they may have in respect of the certificates and evidence which it has issued, to be notified. (4) (5) The application in accordance with § 4 paragraph 1 of the Federal Pharmacist Order shall be decided no later than three months after the submission of the documents to be submitted by the applicant pursuant to paragraphs 1 and 2 and § 4 (6) of the Federal Pharmacist Order. The competent authority shall confirm to the applicant in accordance with § 4 (1) to (3) of the Federal Pharmacist Order, within one month of receipt of the application, the receipt of the application and the receipt of the documents and shall inform him of the absence of any documents. The competent authority shall, within one month of receipt of the application, confirm to the applicant or the applicant the receipt of the application and the receipt of the dossier and inform him or her of the absence of documents. Unofficial table of contents

§ 21 Approbationsurkunde

The approbation certificate shall be issued in accordance with the model of Appendix 16. It shall be handed over to the applicant for receipt of the receiving commitment or to be awarded with the certificate of delivery.

Fifth Section
Supplementary provisions, permit, transitional and final provisions

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Section 22 Invoice of training periods and examinations

(1) The body responsible under national law shall, in so far as equivalence is given, count on the training provided for in this Regulation, in whole or in part

1.

Periods of related studies carried out within the scope of this Regulation,

2.

Periods of study of pharmacy or related studies carried out outside the scope of this Regulation,

3.

Periods of practical training completed outside the scope of this Regulation on the training referred to in Article 4 (1) (2).

(2) Under the conditions laid down in paragraph 1, the State Examination Office shall recognise exams which have been filed in the course of studies in accordance with paragraphs 1 and 2 of paragraph 1. This does not apply to the examination of the Third Section of the Pharmaceutical Examination. (3) In the case of recognition of an examination in the course of studies referred to in paragraph 1 (1), the grade of the examination section in question shall be the grade of the examination section concerned. to use the approved test. In the case of recognition of an examination in the course of studies referred to in paragraph 1 (2), a grade of the examination section and an overall grade of the pharmacist examination shall not be formed. The offsetting of exams must be noted, where appropriate, on the certificates of the examination sections and the certificate of the pharmaceutical examination in accordance with Annexes 10 and 11. (4) (omitted) (5) Invoice or recognition shall be made on request. The competent authority for the decisions referred to in paragraphs 1, 2 and 4 shall be the State Examination Office of the country in which the applicant for the study of pharmacy is registered or approved. In the case of students who have not yet obtained enrollment or admission to the pharmacy course at a university within the scope of this Regulation, the State Examination Office of the country in which the applicant is born shall be responsible. If this does not result in any jurisdiction, the State Examination Office of the State of Hessen is responsible. Unofficial table of contents

§ 22a Permission pursuant to Section 11 (1) of the Federal Pharmacist Order

(1) The application for the grant of a permit for the temporary exercise of the pharmacy profession in accordance with § 11 paragraph 1 of the Federal Pharmacist Code shall be addressed to the competent authority of the country in accordance with Section 12 (3) of the Federal Pharmacotic Code. If the applicant requests, for the first time, the granting of authorisation, he shall attach the following documents to the application:

1.

proof of identity,

2.

a tabular list of the training courses and the activities carried out,

3.

an officially certified copy of the certificate of completed training for the profession of pharmacist and, where appropriate, of the certificate of professional experience acquired by the applicant,

4.

a statement of where and in what way the applicant wishes to exercise the profession of pharmacy in the territory of the country,

5.

if available, the communication pursuant to § 4 (3) sentence 2 of the Federal Pharmacy Order and the minutes of the state proficiency test in accordance with § 22d (5),

6.

the following documents:

a)

an official domestic certificate,

b)

the documents issued by the competent authorities of the Member State of origin and which show that the applicant has not found himself guilty of conduct on which his or her unworthiness or unreliability is concerned with the exercise of the a pharmacist's profession, or,

c)

where the documents referred to in point (b) are not issued in the country of origin, an affidavit or in the States in which there is no affidavit, a solemn declaration made by the person concerned in the State of origin or domesticly before a competent judicial or administrative authority or, where appropriate, in front of a notary or a suitably authorised professional organisation, which certify a declaration confirming that affirmative or solemn declaration , has issued,

7.

a medical certificate issued in the national territory stating that the applicant is not unsuitable for the performance of the profession in respect of health; in so far as the residence of the applicant is not in the territory of the country, a recognised in the Member State of origin, or, where such proof is not required in the Member State of origin, a certificate issued by a competent authority in the home Member State,

8.

where available, evidence of the knowledge of the German language, which shall enable the competent authority to assess the extent to which the applicant has the language skills required to pursue the profession of pharmacist.

The documents referred to in points 6 and 7 of the second sentence may not be older than three months in the case of their submission. If the applicant requests the extension of the permit, he has the last permission granted, if the latter was issued by another authority, and an official domestic certificate and a domestically issued licence. shall be accompanied by a medical certificate which may not be older than three months on presentation. Where the competent authorities have reasonable doubts as to the authenticity of the certificates and evidence of formal qualifications issued in the country of origin, they may, by the competent authorities of the home Member State, confirm the The authenticity of these certificates and evidence is required. § 20 (2) and (3) shall apply mutagentily. (2) The application shall be decided in the short term, not later than three months after the submission of the documents to be submitted by the applicant, in accordance with paragraph 1. The competent authority shall, within one month of receipt of the application, confirm to the applicant the receipt of the application and the receipt of the dossier, and shall inform him of the absence of documents. In order to assess whether the documents submitted by the applicant in accordance with the second sentence of the second sentence of paragraph 1 prove that the training is completed in the country of origin, information from the Central Office for Foreign Education or from comparable facilities, the Authority shall also inform the applicant accordingly. In the cases of the third sentence, the expiry of the period referred to in the first sentence shall be inhibited until the reply to the authority of the Authority has been fulfilled. The same shall apply until confirmation of authenticity by the authority of the Member State of origin referred to in the fifth sentence of paragraph 1. (3) The competent authority shall have the applicant ' s level of training, including the documented relevant to take account of professional experience in deciding on the granting of permission and on this basis it shall examine its professional competence for the intended pharmaceutical activity. To the extent that the applicant has already submitted an application for the grant of the Approbation, the competent authority shall draw up the findings of the certificate pursuant to Article 4 (2) sentence 8 of the Federal Pharmacist Order and, where available, the minutes of the state proficiency test in accordance with § 22d (5). An approbation procedure which has already been granted or not yet completed in accordance with § 4 (3) of the Federal Office of Pharmacists does not preclude the grant of the licence. (4) The competent authority shall grant permission to the competent authority to: Restrictions and secondary provisions necessary to endanger the applicant, his knowledge of the German language and his/her health suitability, taking into account the level of training of the applicant as assessed in accordance with paragraph 3 of this Article. to exclude public health. If the danger to public health cannot be ruled out by restrictions and by-laws, permission to fail is to be refused. Permission is also to be refused if the requirements of § 4 (1) (2) of the Federal Pharmacist Code are not available. (5) The permit may be limited to less than two years on its initial grant only if in the case of the (6) In so far as the validity of the permit is restricted to a country and the activity is used in the following fields, the following shall be considered: requires more than one country, the competent authority shall have the permission (7) The permit for the temporary exercise of the profession of pharmacist shall be issued in accordance with the model of Appendix 17 to this Regulation. Unofficial table of contents

§ 22b Permission in accordance with § 11 paragraph 1a of the Federal Pharmacist Order

(1) The application for the temporary exercise of the pharmacy profession in accordance with Section 11 (1a) of the Federal Pharmacist Order must be addressed to the competent authority of the country in accordance with Section 12 (3) of the Federal Pharmacotic Code. If the applicant for the first time requests the grant of the permit, he shall attach the following documents to the application:

1.

the documents referred to in Article 4 (6), first sentence, points 1, 1a, 2 and 3 to 7 of the Federal Pharmacist Order; and

2.

a declaration, where and in what way the applicant wishes to exercise the profession of pharmacist domestiy and to what extent a particular interest in the granting of the permit is obtained.

The proofs according to § 4 (6) sentence 1 (3) and (4) of the federal pharmacist order may not be older than three months in the case of their submission. If the applicant requests the extension of the licence, he has the last permission granted, if the latter has been issued by another authority, and the documents in accordance with § 4 (6) sentence 1 (3) and (4) of the federal pharmacist order, which may not be more than three months in the case of their submission. Where the competent authorities have reasonable doubts as to the authenticity of the certificates and evidence of formal qualifications issued in the country of origin, they may, by the competent authorities of the home Member State, confirm the Authenticity and confirmation that the applicant complies with the minimum training requirements laid down in Article 44 of Directive 2005 /36/EC of the European Parliament and of the Council of 7 September 2005 on the Recognition of professional qualifications 22, L 271 of 16.10.2007, p. 18), as last amended by Regulation (EU) No 623/2012 (OJ L 327, 22.12.2012, p. 9), as amended by Regulation (EU) No 189/2012, as amended by Regulation (EU) No 127 § 20 (2) and (3) shall apply accordingly. (2) A special interest within the meaning of Article 11 (1a) of the Federal Pharmacists ' Regulations shall be in particular if the applicant

1.

the conditions laid down in § 4 (1) or (2) of the Federal Pharmacy Order are fulfilled and § 11a of the Federal Pharmacist Order cannot be applied or

2.

the pharmaceutical activity sought in accordance with the second sentence of paragraph 1, second sentence, may be carried out even though it does not fulfil the conditions laid down in Article 4 (1), first sentence, point 3 or point 5, of the Federal Pharmacists ' Regulations.

(3) The applicant does not fill the condition of § 4 (1) sentence 1 (4) of the Federal Pharmacist Order and the applicant does not fall under § 4 (1a) or § 4 (1d) of the Federal Pharmacist Order, § 22a (3) sentence 1 (4) The competent authority shall provide for the authorisation, with the restrictions and by-provisions necessary, in order to take account of the applicant's knowledge of the applicant's knowledge of the German language Language and its fitness for health a risk to public health to exclude. Articles 22a (2), 4 (2) and (3), (5) to (7) shall apply accordingly. Unofficial table of contents

§ 22c aptitude test in accordance with § 4 paragraph 2 sentence 7 of the federal pharmacist order

(1) The aptitude test in accordance with § 4 (2) sentence 7 of the Federal Pharmacist Order refers to the subjects in which the competent authority has established substantial differences in accordance with § 4, paragraph 2, sentence 8 of the Federal Pharmacist Order. In the aptitude test, the applicant has to prove that he has knowledge and skills in these subjects, including in the pharmacist's interview, which are necessary for the profession of pharmacist. (2) Aptitude test is an oral exam that takes place in one day. The examination is usually carried out as an individual examination. To the extent that the subjects to be tested permit, up to four applicants can be examined simultaneously. The duration of the test shall be based on the extent of the significant differences observed. It takes at least 30 minutes for each applicant, not more than 60 minutes. (3) The Länder can use the regular examination dates of the state examinations in accordance with § 12 (1) sentence 3 for carrying out the examinations. The competent authority of the country in accordance with Section 12 (2) of the Federal Pharmacist Code shall provide the applicant with the charge for the aptitude test not later than seven days before the date of the examination. § 13 applies accordingly. (4) The aptitude test is filed in the form of a state examination before a state examination commission in German. The Examination Committee is appointed by the competent authority of the country pursuant to Section 12 (2) of the Federal Pharmacist Order. The Examination Board shall consist of the Chairperson and at least two, at most four other members. For the Chairman and the other members, alternate members shall be appointed. As chairperson, other members and deputiors, professors or other teachers of the subjects who are the subject of the examination shall be appointed. Instead, the members of the Examination Committee may also be appointed to the faculty of a non-university pharmacist. The Chairman of the Examination Commission is in charge of the examination and must also consider itself. § 11 (3), 5 sentence 1 and paragraph 6 as well as § 14 apply accordingly. (5) The aptitude test is completed successfully if the examination board evaluates the performances in the subjects mentioned in paragraph 1 as passed. The existence of the test requires at least that the performance, in spite of its defects, still meets the requirements. § 11 Paragraph 3 applies accordingly. (6) The aptitude test is to be offered at least twice a year. It can be repeated twice in each compartment. A record to be signed by all the members of the Examination Commission shall be drawn up in accordance with the model of Appendix 18 to this Regulation on the course of the examination of each applicant, from which the subject-matter of the examination, the existence of: or non-existence of the test, the reasons for this, as well as the serious irregularities occurring. The Chairperson of the Examination Commission shall forward the minutes of the competent authority of the country in accordance with Section 12 (2) of the Federal Pharmacists ' Order. Unofficial table of contents

§ 22d Examination of knowledge pursuant to § 4 (3) sentence 3 of the Federal Pharmacists ' Order

(1) The examination of knowledge refers to the subjects of pharmaceutical practice and special areas of law for pharmacists and to one of the subjects in which the competent authority differs substantially in accordance with § 4, paragraph 2, sentence 8 of the Federal Pharmacists ' Order , and which shall be determined by the competent authority of the country in accordance with Section 12 (3) of the Federal Pharmacists ' Order. In the examination, the applicant has to show that he has knowledge and skills, including in the pharmacy course, which are necessary for the exercise of the pharmacist's profession. (2) The proficiency test is an oral examination which takes place in one day. The examination is usually carried out as an individual examination. To the extent that the subjects to be tested permit, up to four applicants can be examined simultaneously. The duration of the test shall be based on the extent of the significant differences observed. It takes at least 30 minutes for each applicant, not more than 60 minutes. (3) The Länder can use the regular examination dates of the state examinations in accordance with § 12 (1) sentence 3 for carrying out the examinations. The competent authority of the country in accordance with Section 12 (2) of the Federal Pharmacist Order shall provide the applicant with the charge for the examination of knowledge not later than seven days before the date of the examination. § 13 applies accordingly. (4) The proficiency examination is filed in the form of a state examination before a state examination commission in German. The Examination Committee is appointed by the competent authority of the country according to § 12 (3) of the Federal Pharmacist Order. The Examination Board shall consist of the Chairperson and at least two, at most four other members. For the Chairman and the other members, alternate members shall be appointed. As chairperson, other members and deputiors, professors or other teachers of the subjects who are the subject of the examination shall be appointed. Instead, the members of the Examination Committee may also be appointed to the faculty of a non-university pharmacist. The Chairman of the Examination Commission is in charge of the examination and has to examine it himself. § 11 (3), 5 sentence 1 and paragraph 6 and § 14 shall apply accordingly. (5) The proficiency test shall be completed successfully if the examination board in an overall consideration evaluates the benefits in the subjects mentioned in paragraph 1 as passed. The existence of the test requires at least that the performance, in spite of its defects, still meets the requirements. Section 11 (3) shall apply. (6) The proficiency test shall be offered at least twice a year. It can be repeated twice. A record to be signed by all the members of the Examination Commission shall be drawn up on the basis of the model of Appendix 19 to this Regulation on the course of the examination of each applicant, from which the subject-matter of the examination, the existence of: or non-existence of the test, the reasons for this, as well as the serious irregularities occurring. The Chairperson of the Examination Commission shall forward the minutes of the competent authority of the country in accordance with Section 12 (2) of the Federal Pharmacists ' Order. Unofficial table of contents

§ 22e notification in accordance with § 4 (2) sentence 8 and paragraph 3 sentence 2 of the federal pharmacist order

The communication pursuant to § 4 (2) sentence 8 and (3) sentence 2 of the Federal Pharmacist Order contains the following information:

1.

the level of qualification required in Germany and the level of qualification submitted by the applicants in accordance with the classification provided for in Article 11 of Directive 2005 /36/EC, as amended,

2.

the subjects in which significant differences have been identified,

3.

an explanation of the substance of the main differences as well as the reasons why they result in the applicant not being sufficiently informed about the knowledge and skills required in Germany to pursue the profession of pharmacist , and

4.

an explanation as to why the main differences cannot be compensated for by the knowledge and skills acquired by the applicant as a pharmacist in the course of his professional practice.

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Section 23 Transitional provisions

(1) Persons who are studying pharmacy before 1. In accordance with the rules laid down in this Regulation, and in accordance with the provisions of this Regulation, have been submitted in October 2001 and the application for admission to the first section of the Pharmaceutical Review for a review taking place before 1 July 2004 shall be submitted in the the version in force on 30 September 2001. If they pass this section after 30 September 2003, they will continue their studies in accordance with the provisions of this Regulation in the version valid after 30 September 2001. (2) Persons who are studying pharmacy before 1. In accordance with the rules laid down in this Regulation, October 2001, and the application for admission to the second stage of the Marketing Authorisation Examination for a test taking place before 1 January 2006, shall be submitted in the following by 30 September 2001. (3) Persons who are studying pharmacy before 1. In accordance with the rules laid down in this Regulation, October 2001, including the application for admission to the Third Section of the Marketing Authorisation Examination for a review taking place before 1 July 2007, shall be submitted in accordance with the provisions of this Regulation, until the date of the examination of the as of 30 September 2001. (4) In the case of admission to the first or second section of the Marketing Authorisation Examination, the prescribed evidence is in § 6 (3) (5) and (6) and (4) (3) and (4) of this Regulation in the up to 30 years of age. Article 6 (3) (5) and (4) (3) of this Regulation in force in the following years: shall be deemed to be equivalent to the version in force after 30 September 2001. (5) Repeal checks after not passing the examination laid down in accordance with the provisions of this Regulation in the version in force until 30 September 2001 shall be: in the first part of the Pharmaceutical Review until 31 December 2005, in the Second Section of the Pharmaceutical Review until 31 December 2006 and in the Third Section of the Pharmaceutical Review by 30 June 2008 in accordance with those provisions , this Regulation shall apply in accordance with the provisions of this Regulation in force after 30 September 2001. (6) The State Examination Office may, by way of an examination of the subject referred to in § 18 (1) (v) before 1 January 2011, by way of derogation from § 11 (2) sentence 3, another member of the Order the examination board for the second section of the Pharmaceutical Review. Unofficial table of contents

§ 24

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Section 25 Entry into force of the Regulation and repeal of force

This Regulation shall enter into force on 1 January October 1989, in force. Unofficial table of contents

Final formula

The Federal Council has agreed.

The Federal Minister for Youth, Family, Women and Health Unofficial table of contents

Appendix 1 (to § 2 para. 2)
Fields of study of pharmacy

Source of the original text: BGBl. I 2000, 1716-1718 It is possible to shift lessons between the various areas of the fabric in the range of up to 42 hours per area. The total amount of practical exercises and seminars, including lectures with exercises or with seminars, may not be affected by this. In addition to the certificates indicated for the areas A to I, the body responsible under national law may require a total of up to four additional certificates.
In the practical exercises, 20 per cent practical seminars are included. Substance Area A
General chemistry of medicinal products, excipients and pollutants
Lectures, seminars and practical exercises with events:
Chemistry for pharmacists
Stereochemistry
Chemical nomenclature
General and analytical chemistry of the inorganic drugs, excipients and pollutants (including pharmacopoeial methods)
Chemistry including the analysis of the organic drugs, excipients and pollutants
Toxicology of excipients and pollutants
Total volume: 462 lessons with a share of 336 lessons practical exercises and 56 lessons
Three certificates of successful and regular participation substance area B
Pharmaceutical analytics
Lectures, seminars and practical exercises with events:
Pharmaceutical/Medical Chemistry
Quantitative determination of medicinal products, auxiliary substances and pollutants (including pharmacopoeia methods)
Introduction to instrumental analytics
Instrumental analytics
Total volume: 392 lessons with a share of 308 lessons practical exercises
Two certificates of successful and regular participation substance area C
Scientific Principles, Mathematics and Proprietary Medicinal Products
Lectures, seminars and practical exercises with events:
Physics for pharmacists
Fundamentals of Physical Chemistry
Physical exercises for pharmacists
Physico-chemical exercises for pharmacists
Mathematical and statistical methods for pharmacists
Basic principles of drug form
Doctrine
Pharmaceutical and medical terminology
History of the natural sciences with special consideration of pharmacy
Total: 280 teaching hours with a share of 140 lessons practical exercises and 14 lessons
Three certificates of successful and regular participation substance area D
Fundamentals of Biology and Human Biology
Lectures, seminars and practical exercises with events:
General biology for pharmacists
Systematic classification and physiology of pathogenic and drug-producing organisms
Pharmaceutical Biology I (Investigations of Substance Producing Organisms)
Medicinal plant excursions, determinations
Microbiology
Pharmaceutical Biology II (planting drugs)
Cytological and histological fundamentals of biology
Fundamentals of anatomy and physiology
Cursus of Physiology
Fundamentals of Biochemistry
Basics of nutrition
Total: 392 lessons with a share of 210 hours of practical exercises
Four certificates of successful and regular participation in the field E
Biochemistry and Pathobiochemistry
Lectures, seminars and practical exercises with events:
Biochemistry and Molecular Biology
Fundamentals of Clinical Chemistry and Pathobiochemistry
Biochemical investigation methods including clinical chemistry
Pathophysiology/Pathobiochemistry
Total volume: 196 lessons with a share of 98 hours of practical exercises
A certificate of successful and regular participation in the field of materials F
Pharmaceutical technology and biopharmaceuticals
Lectures, seminars and practical exercises with events:
Pharmaceutical technology including medical devices
Quality assurance in the manufacture and testing of medicinal products
Biopharmaceuticals including drug-related pharmacokinetics
Total amount: 364 lessons with a share of 196 hours of practical exercises and 42 courses of instruction
Two certificates of successful and regular participation substance area G
Biogenic medicinal products
Lectures, seminars and practical exercises with events:
Pharmaceutical biology; medicinal plants, biogenic drugs, biotechnology
Biogenic medicinal products (phytopharmaceuticals, antibiotics, genetically engineered products)
Pharmaceutical Biology III (Biological and phytochemical investigations)
Immunology, vaccines and sera
Total volume: 238 lessons with a share of 84 lessons practical exercises and 42 lessons
A certificate of successful and regular participation in the field of substance H
Medical chemistry and drug analysis
Lectures, seminars and practical exercises with events:
Pharmaceutical/Medical Chemistry
Drug analysis (drug monitoring, toxicological and environmental studies)
Analysis of medicinal products with special regard to pharmacopoeias (quality control and safety of medicinal products) and the relevant standards for medical devices
Total volume: 420 lessons with a share of 280 lessons practical exercises
Two certificates of successful and regular participation substance area I
Pharmacology and Clinical Pharmacy
Lectures, seminars and practical exercises with events:
Pharmacology and Toxicology
Clinical Pharmacy
Disease
Pharmacotherapy
Pharmacological-toxicological demonstration course
Pharmacoepidemiology and Pharmacoeconomics
Special legal areas for pharmacists
Total volume: 406 lessons with 112 lessons practical exercises and 98 seminars
Three certificates on the successful and regular participation in the field of materials K
Elective Box
Seminars and practical exercises in an elective subject that is part of the pharmaceutical sciences
Total: 112 lessons
A certificate of successful and regular participation; seminar events in the block K take the form of main seminars. Unofficial table of contents

Annex 2 (to § 6 (3) (5) and (4) (3))
Certificate

(Fundstelle des Originaltextes: BGBl. I 2000, 1719)

on the participation in the event ............................. 
of the substance area .............................................................. 
The Students of Pharmacy .............................................................. 
in ........................ of ....................................... 
to ....................................... at the above event 
regularly and successfully. 
  
 Siegel .........., the ....................... 
  
 ....................................... 
 (Signature of the responsible person 
 Professor/Lecturer)   

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Appendix 3 (to § 6 para. 4 no. 4)
Certificate

(Fundstelle des Originaltextes: BGBl. I 2000, 1719)

on the participation in the event ............................. 
of the elective subject ......................................................... 
The Students of Pharmacy .............................................................. 
in ........................ of ....................................... 
to ....................................... at the above event 
regularly and successfully. 
  
 Siegel .........., the ....................... 
  
 ....................................... 
 (Signature of the responsible person 
 Professor/Lecturer)   

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Appendix 4

(dropped) Unofficial table of contents

Annex 5 (to § 4 (3) sentence 3, § 6 (5) No. 2 and (6) sentence 3)
Certificate of practical training

(Fundstelle des Originaltextes: BGBl. I 1989, 1500)

Mr./wife ........................... is in the time of the ............... 
to ..................... according to § 4 of the Approbationsordnung für Apotheker 
practically trained. 
He/she has worked all day in this period and who is in § 4 paragraph 2 
carried out by the Commission.  Training 
is of the .............................................................. 
up to ......................... interrupted/not interrupted words. *) 
  
 ................, den ............... 
 Seal or stamp 
 ..................................... 
 (name of the training centre) 
  
 ..................................... 
 (Signature of the training 
 Responsible) 
---------- 
*) Delete as appropriate.   

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Annex 6 (to § 4 (4) sentence 3 and § 6 (5) no. 3)

Certificate of participation in the accompanying course events according to § 4 (4) of the Approbationsordnung für Apotheker

(Fundstelle des Originaltextes: BGBl. I 1989, 1500)

Mr/wife .............................................................. 
shall be at the level of ........................ 
Accompanying educational events in .............. 
. 
  
 ................, den ............... 
 Seal/stamp 
 ..................................... 
 (Signature)   

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Annex 7 (to § 3 para. 2 sentence 4 and § 6 para. 3 no. 3)

Certificate of activity as Famulus

(Fundstelle des Originaltextes: BGBl. I 1989, 1501)

Mr/wife .............................................................. 
is in the period from ......................... to .......................... 
in accordance with § 3 of the Approbationsordnung für Apotheker in der unten 
Set up under my supervision and management as Famulus. 
  
He/she has been working all day in this time.  The training is 
from .................................................................... 
until ......................... interrupted/not interrupted.  *) 
  
.............................................................., den ............. 
(designation of the training centre) 
  
 ................................... 
 (Signature of the responsible person 
 Pharmacists) 
-------- 
*) Delete as appropriate.   

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Appendix 8 (to § 4 para. 4 sentence 1)
Material areas taught during practical training

Source of the original text: BGBl. I 2000, 1720 Basic principles of formulation and defect, including the assessment of manufacturing requirements and procedures; development, authorisation and manufacture of ready-to-use products;
Planning, monitoring and dislocation of the goods, technical procedures and storage problems; influencing the durability of medicinal products and medical devices placed on the market in pharmacies, by transport and storage;
Procurement, evaluation, evaluation and dissemination of information on medicinal products and medical devices, including safety aspects;
Information and advice to patients, doctors and other health professionals about medicinal products and medical devices placed on the market in pharmacies, in particular on the proper storage, use, Incompatibilities and interactions, as well as the risks of permanent smoking and abuse of medicinal products;
communication techniques for dealing with healthy patients, patients and their relatives, physicians and other health professionals;
Aspects of quality assurance and quality control;
Applied pharmacotherapy; drug selection in self-medication; special treatment exposures; limits of self-medication; interpretation of medical, dental and veterinary prescriptions, as well as their terminology; pharmaceutical care; pharmacocustomary services;
blood and blood products;
Hospital hygiene;
Economic aspects of the use of medicinal products and medical devices;
Comparative assessment of products for infant and child nutrition; comparative assessment of nutritional measures including dietary supplements; comparative evaluation of products for enteral nutrition and parenteral nutrition;
Comparative assessment of products and objects for personal care, medical devices used in pharmacies, and pesticides;
Special features of veterinary medicinal products;
Specific aspects of health promotion;
accident prevention in the pharmacy and in pharmaceutical companies, including the appropriate handling of hazardous substances, cytostatics, radiopharmaceuticals and radioactive diagnostic agents; general measures in the event of accidents and poisoning (first aid);
Business administration for pharmacists, taking account of commercial law, tax law and commercial accounting;
Tasks and fields of activity of the pharmacist;
General legal and professional rights; legislation on pharmacy operations, marketing of medicinal products, narcotics, medical devices, dietetic foodstuffs, body care products, hazardous substances and plant protection products; Medicinal products for medicinal products;
Characteristics of the national and international pharmaceutical market;
Tasks and organisation of the health administration at federal, state and local level as well as at international level;
Pharmaceutical organizations and agencies;
Introduction to social legislation and social security. Unofficial table of contents

Annex 9 (to section 11 (6) sentence 1)
Transcript of the oral examination in the Second/Third *) Section of the Pharmaceutical Examination in the subject .......................

(Fundstelle des Originaltextes: BGBl. I 1989, 1503;
with regard to of the individual amendments. Footnote)

Mr./wife ............................, born on ..................... 
in ................, has been examined on ............ in ............ 
Subject of the examination ................................................... 
........................................................................ 
  
 Remarks + +) 
........................................................................ 
........................................................................ 
He/She has the oral exam with the grade .................... 
passed/did not pass.  *) 
  
................................ ................, den .............. 
  
................................ 
 (Signature of the Chairperson of the 
.................................  Audit Commission + + +)) 
 (Signature (s) of the 
 Examiner (s) *)) 
  
................................ 
(Signature of the co-chair) (signature of the protocol guide) 
--------   

*)

Delete as appropriate.

+ +)

In this case, it should also be noted whether, and if necessary, the number of repeat tests which have been carried out, or, if necessary, the reasons for which the examination has not been passed.

+ + +)

This applies to the third section of the examination and in the event that the Chairman participates in an examination of the Second Examination Section.

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Appendix 10 (to § 6 para. 4 No. 1, para. 5 no. 1, § 9 para. 4 sentence 2, § 16 para. 1 first half sentence and § 22 para. 3 sentence 3)

(Fundstelle des Originaltextes: BGBl. I 1989, 1504)

Issuing authority 
to ................................ 
  
 Certificate 
 over the First/Second/Third *) Section of the 
 Pharmaceutical Review 
  
Mr./wife ............................, born on ....................... 
in ......................... in ................ in ................ 
First/second/third *) Section of the Pharmaceutical Review after 
The Approbationsordnung für Apotheker mit der Note ..................... 
(..............). 
 Number Value 
  
 ........................, the ............ 
 Seal 
 the issuing authority 
 ..................................... 
 (Signature) 
  
-------- 
*) Delete as appropriate.   

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Appendix 11 (to § 9 para. 4 sentence 2, § 16 para. 1 second half-sentence and § 22 para. 3 sentence 3)

(Fundstelle des Originaltextes: BGBl. I 1989, 1504)

Issuing authority 
to ................................ 
  
 Certificate 
 on the Pharmaceutical Review 
  
Mr./wife .........................., born on ....................... 
to ...................., has 
  
 The Pharmaceutical Review 
  
with the overall grade of ............... (..............). 
 Number Value 
  
 ........................, the ............ 
 Seal 
 the issuing authority 
 ..................................... 
 (Signature)   

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Appendix 12 (to § 17 para. 2 sentence 3)
Number and distribution of examination questions in the individual subjects of the first examination section

Source of the original text: BGBl. I 2000, 1721

I.	General, inorganic and organic chemistry	100 questions
II.	Basic principles of pharmaceutical biology and human biology	100 questions
III.	Fundamentals of physics, physical chemistry and drug-form teaching	80 Questions
IV.	Fundamentals of pharmaceutical analytics	80 Questions

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Annex 13 (to section 17 (3))
Test substance of the first section of the pharmaceutical review

Source of the original text: BGBl. I 2000, 1721

I.

General, inorganic and organic chemistry basic concepts and laws of chemistry; atomic and periodic table of elements; chemical bonding, intermolecular binding forces, solutions and heterogeneous systems; thermodynamics of chemical reactions as well as Reaction kinetics; chemical equilibrium; acid/base and redox systems; stoichiometry of chemical reactions; occurrence, recovery, properties and reactivity of elements of the periodic table and their compounds and their production; general the chemistry of medicinal products, excipients and pollutants; Summation formulae and geometry of important compounds; nomenclature; binding species and their theoretical bases; reaction equations and mechanisms; fundamentals of stereochemistry; chemistry of functional groups and classes of substances and their production and Properties; sum, structure and stereotypes; properties and reactivity of syntheses and natural materials; chemical bases of synthetic polymers and biopolymers; nomenclature.

II.

Fundamentals of the pharmaceutical biology and the humanbiology fundamentals of cytology and histology; fundamental principles and molecular principles of metabolism and genetics; characteristics, systematic classification and physiology of plants and Micro-organisms with special consideration of pharmaceutically and medically important organisms; Vieren; fundamentals of the anatomy and morphology of plants; ecological basic terms; drug and microbiological terms and conditions; and Techniques; important medicinal and poisonous plants; common plants in common Drugs; macroscopic and microscopic structure of the human body, its organs and tissues; function of organs and organ systems, including regulation mechanisms and cell biological aspects; basic principles of the immune system; Reproductive organs and their function, pregnancy; composition and extent of normal diet.

III.

Fundamentals of physics, physical chemistry and drug-formic basic concepts and measurement systems of physics; basic laws of the mechanics of solid bodies, liquids and gases; aggregate states and their changes; phase systems; Boundary surface phenomena; fundamentals of thermodynamics and kinetics; kinetics of diffusion and distribution; fundamentals of electricity theory including electrochemistry; fundamentals of optics, vibration and wave teaching; structure and properties of the atoms and molecules; fundamentals of radioactivity and isotope application; the physical basis of measurement methods, taking into account the requirements of pharmacy; general requirements for the manufacture of pharmaceuticals; basic operations; medicinal products for prescription; homeopathic preparations.

IV.

Fundamentals of the pharmaceutical analysis The basic methods used in the pharmaceutical analysis, the basis, the working methods and the application of classical qualitative and quantitative methods for the analysis of drugs, excipients and pollutants (cations, anions and neutral substances) including the pharmacopoeia method; analysis of functional groups of organic compounds; instrumental pharmaceutical analytical methods including trace analysis methods: Fundamentals, working methods and applications of electrochemical, Thermoanalytical, radiochemical, chromatographic, optical and spectroscopic methods for qualitative (identification and structural analysis) and quantitative analysis; validation of analytical methods; quality assurance.

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Annex 14 (to section 18 (3))
Examination substance of the second section of the pharmaceutical review

Source of the original text: BGBl. I 2000, 1722-1723

I.

Pharmaceutical/Medical chemical structure, stereochemistry, common representation or extraction, development (in particular rational drug development), properties, stability and analysis (identity, purity, content) of synthetic, partial-synthetic and natural active substances, narcotic substances, drugs, excipients and pollutants, as well as biocides and other xenobiotics; radiopharmaceuticals, synthesis and quality control of sterically uniform optically active medicinal substances; Bioreactivity and biotransformation of the active substances and Xenobiotics; qualitative and quantitative relationships between structure and pharmacokinetic and pharmacodynamic properties of the active substances, including stereochemical influences; chemical, physical-chemical, physical, the radiochemical and biochemical methods of pharmacopoeias and the corresponding harmonised standards for medical devices, structure and function of important reagents; other physical, physical-chemical, chemical, radiochemical and Biochemical methods for the investigation of substances used in the manufacture of use of medicinal products; application and validation of procedures for the quality control of active substances and adjuvants; quality assurance measures in the analytical laboratory; chemical toxicology and handling of hazardous substances and other substances Active substances; environmental analysis (water, soil, air); fundamentals of biochemistry (including the pharmaceutical and chemical aspects of gene and biotechnology) as well as physiologic, clinical and ecological chemistry; methods for the investigation of Body fluids and interpretation of results; medicinal products and Metabolic analysis, including in biological materials; pharmaceutically-chemical aspects of sera, vaccines and immunology; pharmaceutical-chemical investigations of pre-processed pharmaceutical products, such as separation and isolation of active substances and auxiliary substances , as well as their analysis; the pharmaceutical and chemical aspects of the main, secondary and interdependencies and incompatibilities of finished pharmaceuticals; nomenclature and terminology of active substances and adjuvants, including stereochemical aspects;

II.

Pharmaceutical biologics, drugs and phytopharmaceuticals; their extraction, ingredients, effect, therapeutic application and their pharmaceutical and clinical evaluation; detection, purity and quality testing of drugs; analytical methods for the investigation and standardisation of plant starting materials and prepared preparations; isolation processes of natural substances; abusive antibiotics and biogenic cytostatics; their recovery, mechanisms of action and therapeutic Application; mechanisms of resistance development; basic principles of biosynthesis of plant and microbial natural substances; biochemistry and clinical chemistry; principles of immunology; use of immunological and enzymatic methods in analytics and diagnostics; production, Testing and use of vaccines, immunoglobulins and immunoglobulins; blood products; molecular biological working techniques, genetic engineering methods for the production of drugs; gene therapeutics; medicinal products of the special therapeutic treatment.

III.

Pharmaceutical technology/biopharmaceutical development, production, properties, testing and biopharmaceutical evaluation of drug forms; modern drug delivery systems; tissue and organ-specific application forms, special features of Medicinal products containing bio-and genetically engineered medicinal products and of cytostatic preparations; principle, composition, handling and use properties of ready-to-use medicinal products; special dosing systems; requirements of pharmacopoeias Medicinal preparations; Medicinal forms of homeopathic Pharmacopoeia; properties, testing and assessment of the basic and adjuvant substances necessary for the manufacture of medicinal products, as well as common active substances and packaging materials; pharmaceutical-technological basic operations, process engineering, machinery, Control technology; biopharmaceuticals, application routes and resorption sites, pharmacokinetic bases for the development and testing of medicinal products, bioavailability, bioequivalence testing and assessment, in-vitro/in-vivo correlation; quality assurance in the manufacture and testing of medicinal products including statistical methods; legal bases of quality assurance, validation, inprocess and final controls; stability and stabilisation of medicinal products; incompatibilities and interactions; blood substitutes and blood and its Preparations, sera and vaccines; medical devices placed on the market in pharmacies.

IV.

Pharmacology and toxicology macroscopic, microscopic, pathobiochemical as well as functional changes in organs and organ systems in major diseases; epidemiology, origin, symptoms, progression, prognosis and prevention of important diseases Diseases including those that are accessible to self-medication; assessment of clinical-chemical measurement results; nutritional measures in major diseases; effects of medicinal products, mechanism of action, metabolism, Pharmacokinetics, adverse reactions, interactions, Contraindications and posology, dangers arising from improper use; general pharmacotherapy of important diseases, including those accessible to self-medication; toxicology of the excipients and pollutants; methods for determining of pharmacological and toxicological effects; clinical trial; biometric methods.

V.

Clinical pharmacokinetic Special pharmacotherapy; Special features of drug therapy in pregnancy and breast-feeding, paediatrics, geriatrics, in patients with impaired organ function, multimorbidity; importance of pharmaceutical form and route for therapy; dialysis procedures; special features of certain therapy regimens, in particular for anti-infective therapy, oncological therapy and support therapy, anticoagulant therapy, immune and gene therapy; therapy of intensive care patients; Criteria for the evaluation of medicinal products; medicinal products for medicinal products; Benefit-risk assessment of a drug therapy; assessment of the clinical relevance of adverse effects, interactions and incompatibilities, assessment of combination therapies; the cause of variability in the success of a drug therapy; Therapy recommendations based on specific patient cases; Therapeutic drug monitoring, dealing with medical records; medical devices for the application of drugs and for enteral and parenteral nutrition; compliance/non-compliance; fundamentals and Methods of pharmacist support; pharmacodynamics and pharmacokinetics; population pharmacokinetics; clinical pharmacogenetics; malnutrition, energy and nutritional needs; enteral and parenteral nutrition; health economics, pharmacoepidemiology and economics, pharmacovigilance, Methods of determining the quality of life, ethical aspects.

Unofficial table of contents

Annex 15 (to section 19 (3))
Test substance of the third section of the Pharmaceutical Review

Source of the original text: BGBl. I 2000, 1724

I.

Pharmaceutical basic principles of formulation and defect; incompatibilities; basic principles of the development, production and approval of finished pharmaceuticals; conformity assessment of medical devices; possibilities of influencing the Shelf-life of medicinal products; Procurement, documentation, evaluation, evaluation and dissemination of information on medicinal products and medical devices; information and advice to patients, physicians and other health professionals about Medicinal products and medical devices placed on the market in pharmacies , in particular on proper storage and use, side-effects and interactions; risks of permanent smoking and abuse of medicinal products; quality assurance aspects; applied pharmacotherapy; pharmaceutical advice and -selection in self-medication; interpretation of medical, dental and veterinary prescriptions and their terminology; practical aspects of pharmaceutical supervision; pharmacovigilant services; blood and Blood products; Hospital hygiene; Economic aspects of the use of Pharmaceuticals and medical devices; products for infant and child nutrition as well as nutrition for diseases; nutritional supplements; enteral and parenteral nutrition products; body care products and articles, plant protection and pest control; health promotion; accident prevention, occupational health and safety and measures of first aid; business fundamentals of pharmacy operations, in particular accounting, annual accounts, profitability, Rationalization, taxes.

II.

Special areas of law for pharmacists ' overview of the delimitation of the following areas of law: state law, administrative law, criminal law, civil law, commercial law; distinction between law, decree law, administrative provision, statutes; professional law for pharmacists; training and duties of the other professions in pharmacies, legal bases; chamber laws including professional jurisdiction; pharmacy law, in particular law on pharmacy and pharmacy management; other important provisions for pharmacy operations other jurisdictions; broad lines of the history of pharmacy; drug and narcotics law, in particular the Medicines Act, the Remedies Act and the Narcotics Act, as well as decree-law regulations; medical product law; Special features of the national and international pharmaceutical market, in particular for the provision of rents, advertising and pricing; rules on the handling and transport of hazardous substances; tasks and organisation of health administration at federal, state and national level. Municipalities as well as at international level; Basic principles for the business aspects of pharmacies management, social security law.

Unofficial table of contents

Appendix 16 (to § 21 sentence 1)
Approbationsurkunde

(Fundstelle des Originaltextes: BGBl. I 1989, 1508)

Mr./wife ........................, born on ........................ 
in ........................................., is due to § 4 of the 
Federal pharmacy order with effect from the present day 
  
 the Approbation 
 as pharmacist/pharmacist 
. 
  
 ........................, the ............ 
 Seal 
 ..................................... 
 (Signature)   

Unofficial table of contents

Annex 17 (to § 22a (7))
Permission in accordance with § 11 (1) or (1a) of the Federal Pharmacists ' Order

Mr/wife....................................................................................................................................................................................
(first name, surname-possibly deviating birth name)
born on..............................................	in........................................................................
in accordance with Section 11 (1/1a) of the Federal Pharmacists ' Order, the permit for the temporary exercise of the Pharmacy profession in/on.........................................................................................................................................................................
for the period from.............................................................................	............................................................ Revocable.
Restrictions and secondary provisions:
.....................................................................................................................................................................
.....................................................................................................................................................................
.....................................................................................................................................................................
The permit also includes the activity in the country.................. /in the countries................. /nationwide Activity * .............................................
Seal
............................................. , the..............................................
..................................................................................................
(Signature)

*

Delete not applicable.

Unofficial table of contents

Appendix 18 (to § 22c (6))
Transcript of the state aptitude test in accordance with § 22c of the Approbationsordnung für Apotheker

Mr/wife....................................................................................................................................................................................
born on..............................................	in.....................................................
is on....................................................	in....................................... have been examined.
Start and end of the individual/group check:....................................................................................................................
He/she passed the state aptitude test/did not pass.
Carrying reasons:.....................................................................................................................................................
...........................................................................................................................................................................
Members of the Examination Committee according to § 22c (4) of the Approbationsordnung für Apotheker:
As Chair (r)................................................
As other members
.............................................
.............................................
.............................................
.............................................
The subject matter of the test:.....................................................................................................................................
.....................................................................................................................................................................
(Content and examination procedures are to be reproduced on a valid basis.)
Other observations:.........................................................................................................................................
.....................................................................................................................................................................
...................................................... , the	.............................................
............................................................	.............................................
............................................................
............................................................
............................................................
(Subscript/s of the other Member/other Members of the Examination Commission)	(Signature of the Chairperson of the Examination Commission)

Unofficial table of contents

Annex 19 (to § 22d (6))
Transcript of the state proficiency test according to § 22d of the Approbationsordnung für Apotheker

Mr/wife....................................................................................................................................................................................
born on..............................................	in.....................................................
is on....................................................	in....................................... have been examined.
Start and end of the individual/group check:....................................................................................................................
He/she passed the state aptitude test/did not pass.
Carrying reasons:.....................................................................................................................................................
...........................................................................................................................................................................
Members of the Examination Committee according to § 22d (3) of the Approbationsordnung für Apotheker:
As Chair (r)................................................
As other members
.............................................
.............................................
.............................................
.............................................
The subject matter of the test:.....................................................................................................................................
.....................................................................................................................................................................
(Content and examination procedures are to be reproduced on a valid basis.)
Other observations:.........................................................................................................................................
.....................................................................................................................................................................
...................................................... , the	.............................................
............................................................	.............................................
............................................................
............................................................
............................................................
(Subscript/s of the other Member/other Members of the Examination Commission)	(Signature of the Chairperson of the Examination Commission)