Source: https://www.global-regulation.com/translation/germany/384676/licensure-for-pharmacists.html
Timestamp: 2018-10-21 13:05:11
Document Index: 512038873

Matched Legal Cases: ['art. 1', '§ 23', '§ 14', '§ 2', '§ 3', '§ 22', '§ 22', '§ 6', '§ 3', '§ 4', '§ 4', '§ 8', '§ 6', '§ 15', '§ 9', '§ 17', '§ 11', '§ 12', '§ 13', '§ 13', '§ 12', '§ 14', '§ 15', '§ 16', '§ 4', '§ 4', '§ 4', '§ 4', '§ 22', '§ 4', '§ 4', '§ 4', '§ 11', '§ 4', '§ 4', '§ 4', '§ 11', '§ 4', '§ 4', '§ 4', '§ 4', '§ 4', '§ 4', '§ 6', '§ 4', '§ 6', '§ 4', '§ 4', '§ 6', '§ 4', '§ 6', '§ 3', '§ 4', '§ 22', '§ 9', '§ 16', '§ 17', '§ 17', '§ 18', '§ 19', '§ 21', '§ 22', '§ 22', '§ 22']

Machine Translation of "Licensure For Pharmacists" (Germany)
Licensure For Pharmacists
Original Language Title: Approbationsordnung für Apotheker
Read the untranslated law here: http://www.gesetze-im-internet.de/aappo/BJNR014890989.html
Licensure for pharmacists (AAppO) AAppO Ausfertigung date: 19.07.1989 full quotation: "licensure for pharmacists by July 19, 1989 (BGBl. I p. 1489), most recently by article 1 of the Decree of 2 August 2013 (BGBl. I S. 3005) is changed" stand: last amended by art. 1 V v. 2.8.2013 3005 for more information on the stand number you find in the menu see remarks footnote (+++ text detection from: 1.10.1989 +++) (+++ changes due to EinigVtr cf. § 23 +++) input formula on the basis of section 5 of the Federal Pharmacists order of June 5, 1968 (BGBl. I s) 601), whose article 1 through article 1 No. 2 of the Act of June 19, 1989 (BGBl. I p. 1106) revised and its paragraph 2 article 1 No. 2 point (b) of the Act of 23 July 1988 (BGBl. I p. 1077) is been inserted as well as § 14 para 3 of Federal Pharmacists order, by article 23 of the Act of June 25, 1969 (BGBl. I p. 645) is has been modified , is prescribed: first section the pharmaceutical education section 1 outline of education (1) the pharmaceutical training includes 1 a Bachelor of Pharmacy four years at a University.
2. a clinical elective of eight weeks;
3. practical training of twelve months;
4. the pharmaceutical testing, to drop is in three sections of the exam.
(2) be filed the examination sections of pharmaceutical testing: 1 the first section after a Bachelor of Pharmacy by at least two years, 2 the second section after existence of the first section of pharmaceutical testing and studying pharmacy at least four years, 3. the third section after passing of the second section, and after the subsequent practical training after paragraph 1 No. 3 (3) the standard period of study in the sense of article 10 paragraph 2 of the Hochschulrahmengesetz is four years.
§ 2 (1) University education university education to students, taking into account the requirements and changes in the professional world the requisite knowledge, skills and methods to convey, that they be empowered to critically assess of the scientific knowledge and scientific work to the responsible exercise of the profession of pharmacist.
(2) the University education includes training as the fabric areas listed in Appendix 1 and an elective to give seminars and practical courses with the given rule numbers and certificates are in the form of lectures.
§ 3 clinical elective (1) through the clinical elective to pursuant to section 1 para 1 No. 2 of the trainees with the pharmaceutical activities are made familiar. In addition, he should receive insight into the Organization and operating procedures, as well as in the legislation for pharmacies and in the jargon.
(2) the clinical elective is to serve all day during the free course of study before reporting to the first section of the pharmaceutical inspection under direction of a pharmacist. Are at least four weeks of clinical elective in a public pharmacy that is not branch pharmacy to serve; the remainder can also available in 1.
a hospital or pharmacy, Bundeswehr, 2. the pharmaceutical industry or 3. a drug investigation authority or a comparable institution including the Bundeswehr will be completed. In sentence 2 last half sentence called time can also in similar institutions in one of the other Member States of the European Union or be completed in another Contracting State to the agreement on the European economic area or in a Contracting State to which Germany and the European Union have admitted a corresponding right to contract. A community service in sections of at least four weeks is allowed. About the clinical elective paid off of trainees will receive a certificate after pattern of attachment 7 (3) for pharmacist Assistant, pharmaceutical engineers, pharmaceutical technical assistant and pharmacy assistants the clinical elective is required.
Section 4 practical training (1) find practical training pursuant to section 1 para 1 No. 3 place after the passing of the second section of pharmaceutical testing. Either in a divided you into training 1 six months in a public pharmacy that is not branch pharmacy, and 2 six months,) a pharmacy referred to in point 1, b) a hospital or Bundeswehr pharmacy, c) of the pharmaceutical industry, d) a University Institute or in other appropriate scientific institutions, including those of the Bundeswehr, e) to afford a drug investigation authority or a comparable institution including the Bundeswehr are. Three months of training pursuant to sentence 2 can no. 2 letter b also on the ward of a hospital or Bundeswehr hospital be completed.
(2) during the full-day practical training, you should be acquired pharmaceutical knowledge deepens, expands and practically applied in previous studies. In particular development, production, testing, assessment and distribution of medicines, the collection, evaluation and dissemination of information, in particular about drug risks, and to advise on drug belong to the training. The training includes also medical devices marketed in the pharmacies on the market. The training must be guided by a pharmacist who is professionally active in the training facility. If it is done at a University Institute, includes pharmaceutical research under the direction of Professor, University or lecturers.
(3) the apprentice has to make its workforce regular work available and to prepare for the third section of pharmaceutical testing. It can be used only to activities that promote his education. Receives practical training the trainee a certificate according to the model of the system 5 (4) during the practical training has the teaching events accompanying apprentices to take part where the fabric areas listed in the annex 8 are taught. The competent authority carries out the accompanying educational events or shall designate one or more appropriate bodies which carry out these educational events. Through participation in the accompanying educational events, the trainee receives a certificate according to the model of the system 6 (5) on the training referred to in paragraph 1 interruptions are credited up to the vacation periods laid down by Federal collective framework agreement.
Second phase General examination regulations article 5 National Audit Office (1) the examination sections provided for in this regulation are placed before the national law competent (National Audit Office).
(2) the examination sections are put before the State examination Office of the country, in which the DUT to the notification to the test has studied Pharmacy or most recently studied Pharmacy. Repeat tests are to drop before the State examination Office where the examination section is not been passed. Exceptions of set 1 and 2 may be admitted for an important reason. The decision is the national examination Office where the authorization is sought in consultation with the State examination Office competent pursuant to sentence 1 or 2.
(3) in the case of examination candidates, where hours of related studies or one outside the scope of this regulation-driven Pharmacy studies or related studies and, if necessary, the checks pursuant to § 22 dropped in the course of such studies can be applied, applies if a jurisdiction pursuant to sentence 1 is omitted, § 22 paragraph 5 accordingly.
§ 6 decides the State Audit Agency message to the examination (1) on admission to the individual exam sections.
(2) the application for admission to a test section is to put in writing in the form prescribed by the State Audit Office and must be received for the first phase of pharmaceutical testing until January 10th or 10th June the National Audit Office. The application for admission to the second and third section of the pharmaceutical inspection must be received to the National Audit Office to the date of each specified by him.
(3) the application for admission to the first section of the pharmaceutical inspection shall be attached 1. birth certificate, for married couples also the marriage certificate, 2. the proof of the higher education entrance qualification, in certificates, purchased outside the scope of this regulation have been also the recognition decision of the competent authority, 3. evidence about the clinical elective (annex 7), or in cases of § 3 paragraph 3 the relevant certificates , 4. the proof of a Bachelor of Pharmacy two years, 5. the certificates of the regular and successful participation in the events to the fabric areas listed in the annex 1 to letter A to D according to the pattern of attachment 2. 6 (dropped out) (4) the request for approval to the second section of the pharmaceutical inspection shall be accompanied by 1 the testimony about the existence of the first section of the pharmaceutical inspection (annex 10) , 2. the proof of a Bachelor of Pharmacy by at least four years, 3 the certificates on the regular and successful participation in the events to the fabric areas listed in the annex 1 to letter E to I according to the model of annex 2, 4.
This certificate in Appendix 1 letter K prescribed electives according to the pattern of attachment 3. 5 (dropped out) (5) include the application for admission to the third section of the pharmaceutical inspection 1 the testimonies about the existence of the first and second section of the pharmaceutical inspection (annex 10), 2. the evidence of the practical training (Appendix 5), 3. proof of participation on the accompanying educational events (Appendix 6).
(6) as far as which are Nos. 4 and 5, as well as the No. 2 to 4 above evidence still not can be attached the request in paragraph 4, in paragraph 3 to submit in one of the State Audit Office they period specified. Has the examination candidates the message to the third section of the pharmaceutical inspection not yet completed practical training according to article 4, paragraph 1, he submit a provisional certificate of the person responsible for the training, stating that he will complete the training up to the expected date of the examination. The final certificate according to the model of annex 5 is to furnish without delay after receipt; She must be the State examination Office not later than at the beginning of the third section of pharmaceutical testing.
(7) indications are given that a reason for examination candidates, which would lead to the denial of licensure as a pharmacist because of absence of one of the conditions of § 4 para 1 sentence 1 No. 2 or 3 of the federal order of pharmacists, the National Audit Office can request the submission of further documents, in particular medical certificates or a certificate of good conduct. The special concerns of disabled examinees are promoting their equality of opportunity when carrying out the tests to be considered.
Article 7 refusal of admission (1) who is admitted to a testing section to fail if 1 the examination candidate to the in section 6 paragraph 2 the application not or not due date referred or not submit the prescribed evidence, except that a major reason he makes believable, still allows test applicant's participation in the stage of the examination procedure and the omitted Act is completed at the latest four weeks prior to the exam date , 2. exam candidates in the case of article 6, paragraph 6 does not timely enough after the missing evidence, 3. the portion of the examination may are not repeated.
(2) admission to an examination section shall be refused if there is a reason which would lead to the denial of licensure as a pharmacist because of absence of one of the conditions of § 4 para 1 sentence 1 No. 2 or 3 of the federal order of pharmacists.
§ 8 kind of examination (1) In the first section of which pharmaceutical testing is in writing, in the second and third section of pharmaceutical testing orally examined.
(2) the competent body under national law allow by way of derogation from paragraph 1, that instead of the written test the knowledge required in the first phase of pharmaceutical testing and skills in a different way can be detected (alternative testing method).
(3) the admission as alternative test procedure requires that 1 the goal of reform is described and reveals what qualitative improvements for pharmaceutical training from this examination are expected, 2. There is a special study regulations to be issued by the University, 3 ensure is that which to be assigned to knowledge and skills in this test procedure in one of the written exam equivalent way are examined in the first section of the pharmaceutical inspection , 4. a proper accompanying and final evaluation of this test procedure is guaranteed, 5. minimum and maximum of run time of this examination procedure are laid down and renewal applications based on evaluation results are substantiated, 6 access to a course of study with a corresponding to the regulation review process in the first section of the pharmaceutical inspection or to a Department with an alternative test procedure is optional, 7 the conditions under which the University may terminate this test procedure , are named, 8 is regulated, proceed as in a transition to a different course of pharmacy in terms of further studies, the recognition of periods of study and academic achievements and 9 is set, how the requirements are described in appendices 1, 2, 12 and 13 are met in this process.
(4) the alternative test procedure stipulates that the first section of the pharmaceutical inspection must be filed not, you are in § 6 ABS. 3 submit documents referred in the message to the second section of the pharmaceutical inspection no. 1 to 4; the time requirements of § 15 5 do not apply in this case. Is a certificate according to the model of annex 10 granted, where the scan results which according to paragraph 3 No. 3 performed and the first section of the pharmaceutical inspection-equivalent tests separately are listed.
§ 9 following notes are assessment of audit services (1) for the evaluation of the performance of the test specimen to use: excellent performance = 'very good' (1), "good" (2) a power, which is considerably above the average requirements =, 'satisfactory' (3) = a performance which meets average requirements in every respect, 'sufficient' (4) a power, which is sufficient to satisfy the requirements despite its shortcomings =, 'not sufficient' (5) a power = , due to significant defects the requirements no longer suffice.
(2) the note of a testing section is calculated from the average of individual scores of the exam subjects.
(3) for the assessment of pharmaceutical testing is under consideration of the notes (numeric value referred to in paragraph 2 in conjunction with paragraph 4 sentence 1) of the first, second and third section of the pharmaceutical inspection to form an overall rating. The overall score for the pharmaceutical inspection is determined as follows: a) the note (number value) for the first phase will be reproduced with two, the note (number value) for the second section three and the note (number value) for the third section with two.
(b) the sum of the numbers obtained for 2(a) will be divided by seven.
(4) the notes of the examination sections and the overall score for the pharmaceutical inspection be calculated up to the second place after the comma. The value so determined is to specify in the certificates according to the plants 10 and 11. The scores of each test section as well as the overall grade of pharmaceutical testing are valued as follows: "very good" with a numerical value to 1.5, "good" at a value of 1.5 to 2.5 "to satisfying" with a numerical value of 2.5 to 3.5, 'sufficient' with a numerical value of 3.5 to 4.0.
The examinee in supervisory work to answer in writing questions has 10 written tests (1) at the written exam. He has to specify which of the responses provided with the questions he considers to be true.
(2) the exam questions must be tailored to the knowledge required for the apothecary General and reliable testing results.
(3) in the written test, same exam questions are all specimens each to make. In determining the exam questions, the National Audit Office are expected to serve in accordance with an agreement of the countries of an institution, which has the task to make exam questions for the first phase of pharmaceutical testing. In establishing the test questions and the answers is to determine what response is recognized as applicable. The State Audit Office for the objects, the exam questions relate publicly may disclose.
(4) the examination papers are to check whether they are measured obviously failed to fulfil the requirements of paragraph 2, by the State examination Office before finding out of the check results. Paragraph 3 sentence 2 and 3 shall apply mutatis mutandis. Results in this review that individual examination papers are obviously flawed, they are not provided. The prescribed number of the questions for the exam (§ 17 para 2) reduces accordingly. In the assessment of the written test pursuant to paragraphs 5 and 6 is the reduced number of exam questions. The reduction in the number of test questions may not affect to the detriment of a DUT.
(5) a written certified specialist is passed, if the percentage of questions answered correctly by the DUT is located no more than 18 per cent below the average test performance of examinees of the respective examination date in the entire Federal territory, or if candidate at least 50 per cent of the questions applicable to has answered.
(6) the services in the written test are as follows: has the examinee required minimum of applicable answered questions reached for passing the examination under paragraph 5, the note is 'very good', if he at least 75 per cent, "good", if he at least 50, but less than 75 per cent "satisfactory", if he at least 25, but less than 50 per cent , 'sufficient', if he the minimum number, but less than 25 per cent
the examination questions in addition rightly answered has. The examinee has not reached the required for passing the examination minimum of applicable answered questions, the note is "not enough" is.
(7) the result of the written examination is determined by the State Audit Office and immediately communicated to the DUT. Here are the notes for the audit section and the scores for the individual subjects, the number of questions answered by the DUT in the individual subjects applicable to, as well as the average test performance to specify.
§ 11 oral exams (1) for the second and third section of pharmaceutical testing be ordered examination committees of the State Audit Office. They consist of the Chairman of the Committee, other members and the assessors. For the Chairman and the other members are appointed. The maintenance of order is the Chairman.
(2) for the second phase of the pharmaceutical inspection, an examination Board is formed at each University. Its Chairman, the members and their deputies are professors or university or lecturers of the subjects, which are the subject of the examination to order persons who have at least to be determined by the examination or equivalent qualification, assessors. To auditors of in article 18, paragraph 1 point V. of above compartment also others at the College in this compartment can be ordered independently teachers. The examination in the individual subjects is carried out by the Member of the examination Board in the presence of another Member or assessor ordered for the relevant subject. The Chairman or his Deputy can take part in the tests, in which he is not even Inspector, and exam questions. Retries the Chairman or a member of the examination Board of this particular has except for the examiner to be present; This can be also exam questions. The investigator decides on the rating of audit services; the remaining members present when assessing the Audit Commission can be heard beforehand.
(3) the examination Board for the third phase of the pharmaceutical inspection consists of the Chairman and at least two and not more than four other members. Members are professors and University or lecturers of the University, as well as pharmacists who belong to the Faculty of a University, to order. In addition, other suitable tester can be ordered. The Chairman opened the investigation; He is even Auditors. He has to ensure that the specimens in a suitable manner will be interviewed. The examination Board has during the entire exam to be present. The examination Commission shall take its decision by a majority vote. Vote the vote of the Chairman shall be decisive.
(4) the test specimens should be tested individually or in groups of up to four people.
(5) the competent authority may send observers to the oral tests. In the second section of the pharmaceutical inspection the Chairman of the examination Board may permit the Auditor, in the third section of the pharmaceutical inspection up to five people, who are preparing on the same section of the pharmaceutical inspection, as well as a representative of the competent Chamber of pharmacists with the consent of the candidate to be present at the tests. The public can be excluded due to important reasons or at the request of the sample and repeat tests. With the announcement of examination results, the persons referred to in sentence 2 must be absent.
(6) over the course of the examination of each candidate has the examiner or a protocol guide certain by this or the Chairman of the Committee, which itself can be member of the examination Board to make a transcript to the model of Annex 9. From this, the object of the audit, the evaluation of the overall performance, as well as any serious irregularities must be judged. The minutes shall be signed by all present members of the Committee and the Secretary.
(7) the performance of an oral exam must be evaluated in accordance with section 9, paragraph 1. An oral examination is considered passed if the DUT has received at least the note 'sufficient'. The scores for the individual examination subjects are to announce the DUT on the day of the examination. The National Audit Office inform in writing the result of the test specimen.
§ 12 exam dates (1) that put State examination Office the schedule for the written examination uniform for the scope of this regulation firmly. The oral exams of the second section of pharmaceutical testing take place usually during the semester break. The dates for the oral tests of the second and third section of pharmaceutical testing be set in consultation with the Board of examiners by the National Audit Office.
(2) the repetition of a written examination will in the context of the next paragraph 1 sentence 1 carried out examination dates referred to. The date for the repetition of an oral examination or oral exam section shall be determined by the State examination Office in consultation with the Audit Commission. To participate in the repetition of a written exam is the candidate for the next exam date, to repeat an oral exam usually to an examination which is assessing unsuccessfully pushed three months after the date, to load by virtue of the State Audit Office. § 13 finds appropriate application.
(3) the summons to the examination the examinee is delivered no later than seven calendar days prior to the exam date.
§ 13 is a resignation of an examination only with approval of the State Audit Office allowed resignation and failure (1) for admission to an examination section. The examinee has to communicate the reasons for his resignation immediately to the National Audit Office. The National Audit Office approved the resignation of the entire test section, multiple examinations or a technical examination, the checks will apply in so far as not taken. The approval is only granted if there is an important reason. In case of illness, the National Audit Office may require the submission of a medical or occupational certificate. It's not, approved the resignation of the entire test section, multiple examinations or a technical examination testing applies in so far as not passed.
(2) paragraph 1 shall apply accordingly if the examinee failed an exam appointment, gives a supervisory work not or not timely or interrupts the examination or cancels.
(3) § 12 para 2 for the passing of the examination in a test section applicable under paragraph 1 or paragraph 2 as not taken or testing specialist shall apply accordingly.
§ 14 fault or deceit interferes with the proper functioning of a check to a considerable extent a DUT or he is taking an illusion, so can the State examination Office, at oral exams in consultation with the Commission, explaining that examination or the entire exam section for "fail".
§ 15 anniversary and repetition of tests (1) a test section is passed, if the exams in all subjects are passed. Pharmaceutical examination is considered passed if the three sections of the test are passed.
(2) a passed exam may not be repeated.
(3) each failed test in a subject can be repeated twice. Is the second repeat examination in a subject is not passed, the entire section of the exam is not passed.
(4) a test section is definitely fail, pharmaceutical testing is finally failed altogether. A repetition of the exam even after renewed studies of pharmacy is not allowed.
(5) certificates, which are required for admission to the second section of the pharmaceutical inspection, can be purchased only in the semester following test section on the initial approval for the first prior existence of the first section of pharmaceutical testing.
(6) a professional examination of the third section of the pharmaceutical examination is not passed, the examination Board immediately decide whether and for how long the examinee to participate again has a training pursuant to section 4. The time of participation must be a maximum of three months. The State Audit Office shall in writing the decision the test specimen.
§ 16 certificates and notifications (1) after the passing of the first, second and third section of the pharmaceutical inspection granted the State examination Office each a certificate according to patterns of annex 10, after the passing of the three sections of the pharmaceutical inspection a certificate according to pattern of the attachment 11 (2) the State Audit Office informed the test specimen and the other national audit office when pharmaceutical testing definitively not is has been passed.
Third section the pharmaceutical examination article 17 first section of pharmaceutical examination (1) the first section of the pharmaceutical inspection covers following subjects: I. General, inorganic and organic chemistry, II. basics of pharmaceutical biology and human biology, III. foundations of physics, physical chemistry, and the product morphology, IV. basics of pharmaceutical analysis.
(2) the checks occur on four days in the order of paragraph 1. The exam lasts two hours on the two first days two and a half hours each, and on the following two days. The number of questions to be answered in the supervision work and their distribution on the individual subjects arising from the plant 12 (3) which must ask parked on the examination syllabus laid down in the annex 13 be.
18-second section of pharmaceutical testing (1) the second section of the pharmaceutical examination covers the following subjects: I. pharmaceutical/medicinal chemistry, II. pharmaceutical biology, III. pharmaceutical technology/biopharmaceutical, IV. Pharmacology and toxicology, V. clinical pharmacy.
(2) the examinations in the individual subjects should be placed generally immediately one after the other, with interruptions up to a maximum of eight days. Each test will last at least 20, 40 minutes for a sample.
(3) the questions must be set to the examination syllabus specified in annex 14.
19-third section of the pharmaceutical examination (1) the third section of the pharmaceutical inspection covers the following subjects: I. pharmaceutical practice, II. special jurisdictions for pharmacists.
(2) the examination should take at least a half, and no more than an hour for a test piece.
(3) the examination questions must be set to the examination syllabus laid down in annex 15. In the examination is to determine whether the candidate has the knowledge to the profession of pharmacist.
Fourth section approval section 20 request for approval (1) the application for licensure as a pharmacist is to set, in which the applicant has passed the third section of the pharmaceutical inspection to the competent authority of the country. The application shall be accompanied by 1 a brief curriculum vitae, 2. the birth certificate for married couples also the marriage certificate, 3. a proof of identity, 4. a registration certificate, which not earlier than one month before the template be made may 5. a declaration of the applicant, whether against him judicial criminal proceedings, or an staatsanwaltschaftliches investigation is pending, 6. a medical certificate, which must not be older than one month , indicating that the applicant is not in health ways to practice the profession is unsuitable and 7 the testimony about the existence of pharmaceutical testing.
(2) where the evidence not in the German language are issued, they are in addition to present certified translation. The competent authority can request the submission of further evidence, in particular about the authenticity of the submitted documents and the previous activity. Sentence 2 does not apply to that in the annex to section 4 paragraph 1a sentence 1 of the federal order of pharmacists listed pharmaceutical diplomas, certificates and other evidence of formal qualifications.
(3) has the applicant already exercised the profession of pharmacist in the State of origin, as the authority responsible for granting the approval as a pharmacist with the competent authority of the home Member State may obtain information about penalties imposed as against the applicant or any other professional or criminal measures due to serious and specific stand adverse behavior or criminal acts relating to the exercise of the profession in the State of origin. The authority responsible for granting the approval as a pharmacist in cases of sentence 1 of facts which occurred outside the scope of the federal order of pharmacists and with regard to the requirements of § 4 para 1 sentence 1 No. 2 of the Federal Pharmacists order of importance can be, so she has to inform the competent authority of the home Member State and to ask them , to check these facts and to tell you the result and the conclusions that pulls them in terms of certificates issued by it and evidence from it,.
(4) (lapsed) (5) the request under article 4, paragraph 1, of the federal order of pharmacists is to decide the following documents to be submitted to paragraphs 1 and 2, as well as § 4 paragraph 6 the Federal Pharmacists order of the applicant not later than three months after submission. The competent authority confirmed the receipt of the request and the receipt of documents the applicant according to § 4 paragraph 1 to 3 the Federal Pharmacists order within one month after receipt of the application and tells him what documents are missing. The competent authority confirmed the receipt of the request and the receipt of documents of the applicant or the applicant within one month after receipt of the application and informs him or her, what documents are missing.
Article 21 approval certificate the certificate of approval is issued according to the pattern of plant 16. It is handed over to the applicant against acknowledgement or to deliver with certificate of service.
Fifth section supplementary rules, permits, transitional and final provisions article 22 recognition of training periods and checks (1) that pays authority on the training provided for in this regulation, the national law as far as equivalence is given, wholly or partially to 1 times of related studies in the scope of this regulation, 2 hours of studies of pharmacy or a related course operated outside the scope of this regulation , 3 times a practical training provided outside the scope of this regulation on the training recognizes number 2 (2) under the conditions of paragraph 1 pursuant to § 4 paragraph 1 the National Audit Office checks on, which laid off Nos. 1 and 2 in the course of studies referred to in paragraph 1. This does not apply to the examination of the third section of pharmaceutical testing.
(3) in the case of a recognition of an examination in the course of studies referred to in paragraph 1 No. 1 is to use the note of recognized examination in the formation of the touch of that section of the test. No. 2 are not made in the case of recognition of a test in the course of studies referred to in paragraph 1 a note of the test section, as well as an overall rating of the pharmaceutical inspection. The credit checks is to note on the testimonies of the exam sections and the testimony of pharmaceutical testing according to the plants 10 and 11.
(4) (dropped out) (5) the credit or recognition is carried out on request. The State Audit Office of the country in which the applicant for the Bachelor of pharmacy is enrolled or admitted is responsible for the decisions taken pursuant to paragraphs 1, 2 and 4. Students still do not have obtained a registration or approval for the studies in pharmacy at a University within the scope of this regulation, the State examination Office of the country in which the applicant was born is responsible. No authority, arises after the State examination Office for the State of Hesse is responsible.
§ 22a of the land authority according to article 12, paragraph 3, of the federal order of pharmacists to set permission in accordance with article 11, paragraph 1 of the Federal Pharmacists order of (1) which is the application for a permit to temporary exercise of the profession of pharmacist according to article 11, paragraph 1, of the federal order of pharmacists. The applicant the permit, for the first time he has the request to enclose the following documents: 1. proof of identity, 2. officially certified a tabular list of completed courses and the performed activities, 3. one copy of certificate of completed training for the profession of pharmacist, as well as, where appropriate, the certificate of the experience acquired by the applicant, 4. a declaration, where and exert the pharmacy profession in the domestic manner in which the applicant wants to , 5. if applicable, the communication pursuant to § 4 paragraph 3 sentence 2 of the federal order of pharmacists and the minutes of the State knowledge examination according to article 22d paragraph 5, 6 the following documents: a) an official domestic record, b) the documents which have been issued by the competent authorities of the home Member State and showing that the applicant is not a behavior has guilty, from the results of his unworthiness or unreliability to the profession of pharmacist , or, c) if in the country of origin the documents not be issued according to point (b), an affidavit or in States where there is no affidavit, a solemn declaration, issued by the person concerned in the State of origin or in the country before a competent judicial or administrative authority or, where appropriate, a notary or an accordingly authorised professional organization, a certificate confirming this affidavit or solemn declaration , given has, 7th one domestically issued medical certificate stating that the applicant is not in health ways to practice the profession is unsuitable; as far as the place of residence of the applicant is not at home, an appropriate proof that is required in the State of origin will be accepted or, if no such proof is required in the State of origin, a by a competent authority of the home Member State issued certificate, 8.
If applicable, evidence of the knowledge of the German language, an assessment about allow the competent authority, to what extent the applicant to the profession of pharmacist required language possesses.
The evidence pursuant to sentence 2 number 6 and 7 may be used in your template not older than three months. The application the applicant is the extension of the permit, he has recently granted permission if it was issued by another authority, as well as an official domestic clearance and a medical certificate issued in the country, which must be not older than three months in their template to add. The authorities have justified doubts as to the authenticity of the certificates issued in the country of origin and qualifications, they may require a confirmation of the authenticity of these certificates and supporting documents by the competent authorities of the home Member State. Article 20, paragraph 2 and 3 shall apply mutatis mutandis.
(2) on the application, it is in the short term, not later than three months after submission pursuant to paragraph 1 to be submitted to the applicant documents, to decide which. The competent authority confirmed the receipt of the request and the receipt of documents to the applicant within one month after receipt of the application and tells him what documents are missing. Is the question, whether by the applicant pursuant to paragraph 1 sentence 2 number 3 presented the completion of training in the country of origin information by the Central Office for foreign education or similar institutions provide evidence required, so the authority shall also inform the applicant. The end of the period pursuant to sentence 1 is suspended pending the response to the request of the authority in the cases of the set of 3. The same applies to the existence of a certificate of authenticity by the authority of the home Member State in accordance with paragraph 1 set 5 (3) has the competent authority when deciding on the grant of permission to take into account the education level of the applicant including proven relevant work experience and checks its technical suitability for the intended pharmaceutical activity based on this. Unless the applicant has already submitted a request for granting the approval, the competent authority draws the findings of the notification according to § 4 paragraph 2 set 8 of the federal order of pharmacists and, where available, the transcript of the State knowledge examination according to article 22d-paragraph 5 at. An already started or completed yet not according to section 4, paragraph 3, of the federal order of pharmacists with a recognition of the approval process does not preclude granting permission.
(4) the competent authority provides the permission with the restrictions and incidental provisions that are necessary to prevent a threat to public health in the light of the training state of the applicant, his knowledge of the German language and his health fitness according to paragraph 3. If the danger to public health cannot be excluded by constraints and incidental provisions, is the permission to fail. Permission shall be refused if the requirements pursuant to § 4 paragraph 1 not number 2 of the League pharmacist also.
(5) the permission can be temporary when they were first granted only to less than two years if required in a particular case the restrictions with the permission and incidental provisions and employment proposed by the applicant.
(6) where the validity of the permission is limited to a country and the activity requires a use in more than one country, the competent authority has the permission with the note to provide, in which other countries permission applies.
(7) the permit for the temporary exercise of the profession of pharmacist will be issued after the pattern of the plant 17 to this regulation.
§ to set 22 b permission according to § 11 paragraph 1a of the Federal Pharmacists order (1) that application for the temporary exercise of the profession of pharmacist pursuant to section 11 is paragraph 1a of the federal order of pharmacists on the authority of the country according to article 12, paragraph 3, of the federal order of pharmacists. The applicant the permit, for the first time he's got the request to attach the following documents: 1. the documents, which are known as number 1, 1a, 2, and 3 to 7 of the Federal Pharmacy regulations in § 4, paragraph 6, sentence 1, and 2. a declaration where and in what way the applicant wants to practice the profession of pharmacist domestically and how this turns a particular interest in the licence.
The evidence according to § 4, paragraph 6, sentence 1, number 3 and 4 of the federal order of pharmacists may at their template not older than three months. The application the applicant is the extension of the permit, he has recently granted permission if it was issued by another authority, and the documents number 3 and 4 of the Federal Pharmacists order, may be not older than three months according to § 4, paragraph 6, sentence 1 in their template, to add. The authorities have justified doubts as to the authenticity of the certificates issued in the country of origin and qualifications, they may confirmation of authenticity, as well as a confirmation require the competent authorities of the home Member State, that the applicant meets the minimum requirements of education, 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 (OJ L 255 of the 30.9.2005, p. 22, L 271 from October 16, 2007, p. 18), most recently by Regulation (EU) No. 623 / 2012 (OJ L 180 from the start, p. 9) is changed, be required. Article 20, paragraph 2 and 3 shall apply mutatis mutandis.
(2) a special interest within the meaning of § 11 paragraph 1a of the federal order of pharmacists in particular is when can the applicant 1 meets the conditions laid down in article 4, paragraph 1 or 2 of the League pharmacist and applied section 11a of the federal order of pharmacists, or 2. the pursuant to paragraph 1 sentence 2 number 2 targeted pharmaceutical activity can exert, though he does not meet the conditions laid down in article 4, paragraph 1, sentence 1 number 3 or number 5 of the federal order of pharmacists.
(3) the applicant meets not the requirement of § 4 paragraph 1 sentence 1 No. 4 of the federal order of pharmacists and the applicant is not subject paragraph 1 d of the Federal Pharmacists order, paragraph 1a or section 4 section 4 Article 22a, paragraph 3, sentence 1 shall apply accordingly.
(4) the competent authority provides the permission with the restrictions and incidental provisions that are necessary to prevent risks to public health, taking into account the knowledge of the applicant, his knowledge of the German language and his health fitness according to paragraph 3. Article 22a paragraph 2, 4 set 2 and 3, paragraph 5 to 7 shall apply mutatis mutandis.
section 22c aptitude test according to § 4 paragraph 2 set 7 the Federal Pharmacists regulations (1) the qualifying examination according to § 4 paragraph 2 sentence 7 the Federal Government pharmacist order refers to the subjects in which the competent authority has identified significant differences according to § 4 paragraph 2 set 8 of the federal order of pharmacists. In the qualifying examination, the applicant has to prove that he has in these subjects the knowledge and skills in the apothekerlichen interviewing, which are necessary for the exercise of the profession of pharmacist.
(2) the qualifying examination is an oral examination that takes place in one day. The test is performed normally as stand-alone examination. As provided for by the subjects to be tested, up to four applicants can be tested at the same time. The duration of the test depends on the extent of the identified major differences. It takes at least 30 for each applicant, a maximum of 60 minutes.
(3) the countries can use to perform the tests according to section 12, paragraph 1, sentence 3 the regular examination dates of the State tests. The authority of the country pursuant to article 12 paragraph 2 of the federal order of pharmacists delivers no later than seven days before the date of the examination the summons to the aptitude test the applicant. Article 13 shall apply mutatis mutandis.
(4) the qualifying examination is filed in the form of a State examination before a State Commission in the German language. The examination Board shall be appointed by the authorities of the country pursuant to article 12 paragraph 2 of the federal order of pharmacists. The Audit Committee consists of the Chairman and at least two and not more than four other members. For the Chairman and the other members are appointed. Professors and other teachers of the subjects, which are the subject of the examination, be appointed as presiding, more members and alternates. Instead, not associated pharmacists can be ordered as members of the examination board the Faculty of a University. The Chairman of the examination Board opened the investigation and need to check themselves. 11 paragraph 3, 5 sentence 1 and paragraph 6, and article 14 shall apply accordingly §.
(5) the aptitude test is successfully completed when the Audit Commission rated the services in the subjects referred to in paragraph 1 as passed. Passing the exam requires at least that the performance requirements yet despite its shortcomings. Article 11, paragraph 3 shall apply mutatis mutandis.
(6) the aptitude test should be offered at least twice a year. She can be repeated twice in each subject. Over the course of the examination of each applicant is to be signed by all members of the examination Board minutes according to the pattern to make plant 18 to this regulation, of the object of the audit, the existence or absence of testing, for structural reasons, as well as serious irregularities occurring about are the obvious. The Chairman of the examination Board shall forward the minutes of the authority of the country pursuant to article 12 paragraph 2 of the federal order of pharmacists.
Article 22d knowledge verification according to § 4 paragraph 3 sentence 3 of the Federal Pharmacists order (1) refers to the knowledge examination the subjects of pharmaceutical practice and special areas for pharmacists as well as competent authority of the country is set to one of the disciplines in which the competent authority has identified significant differences according to § 4 paragraph 2 set 8 of the federal order of pharmacists and by which according to article 12, paragraph 3, of the federal order of pharmacists. In the test, the applicant has to demonstrate that he has knowledge and skills in the apothekerlichen interviewing, which are necessary for the exercise of the profession of pharmacist.
(2) the knowledge exam is an oral examination that takes place in one day. The test is performed normally as stand-alone examination. As provided for by the subjects to be tested, up to four applicants can be tested at the same time. The duration of the test depends on the extent of the identified major differences. It takes at least 30 for each applicant, a maximum of 60 minutes.
(3) the countries can use to perform the tests according to section 12, paragraph 1, sentence 3 the regular examination dates of the State tests. The authority of the country pursuant to article 12 paragraph 2 of the federal order of pharmacists delivers no later than seven days before the date of examination the summons to the knowledge examination the applicant. Article 13 shall apply mutatis mutandis.
(4) the knowledge examination is filed in the form of a State examination before a State Commission in the German language. The examination Board shall be appointed by the authorities of the country according to article 12, paragraph 3, of the federal order of pharmacists. The Audit Committee consists of the Chairman and at least two and not more than four other members. For the Chairman and the other members are appointed. Professors and other teachers of the subjects, which are the subject of the examination, be appointed as presiding, more members and alternates. Instead, not associated pharmacists can be ordered as members of the examination board the Faculty of a University. The Chairman of the examination Board opened the investigation and must check itself. 11 paragraph 3, 5 sentence 1 and paragraph 6, and article 14 shall apply accordingly §.
(5) the knowledge test is successfully completed when the Audit Commission in an overall rated the services in the subjects referred to in paragraph 1 as passed. Passing the exam requires at least that the performance requirements yet despite its shortcomings. Article 11, paragraph 3 shall apply mutatis mutandis.
(6) the knowledge exam to be offered at least twice a year. She can be repeated twice. Over the course of the examination of each applicant is to be signed by all members of the examination Board minutes according to the pattern to customize system 19 to this regulation, of the object of the audit, the existence or absence of testing, for structural reasons, as well as serious irregularities occurring about are the obvious. The Chairman of the examination Board shall forward the minutes of the authority of the country pursuant to article 12 paragraph 2 of the federal order of pharmacists.
Article 22e notification under article 4, paragraph 2, set of 8 and paragraph 3 sentence 2 of the League pharmacist decision after article 4, paragraph 2, set of 8 and paragraph 3 sentence 2 of the Federal Pharmacists order containing the following information: 1. the level of qualification required in Germany and the level of qualification submitted by the applicants and applicants in accordance with the classification in article 11 of Directive 2005/36/EC in the amended , 2. subjects where significant differences were found, 3. a substantive discussion of the major differences as well as the reason why this cause that the applicant is not in sufficient form has the knowledge needed in Germany to the profession of pharmacist and capabilities, and 4. the reasons why the main differences cannot be compensated through knowledge and skills, has acquired the applicant in the context of his professional practice as a pharmacist.
Article 23 transitional provisions (1) people who took up the study of Pharmacy before 1 October 2001, and annual testing make the application for admission to the first section of the pharmaceutical inspection for one before July 1, 2004, take this test section according to the requirements of this regulation in the version applicable up to September 30, 2001. If they pass this test section after September 30, 2003, they continue studying according to the requirements of this Regulation as amended after September 30, 2001.
(2) individuals who have included the study of Pharmacy before October 1, 2001 and to the second section of the pharmaceutical inspection for a prior to January 1, 2006, annual testing make the application for admission, take this test section according to the requirements of this regulation in the version applicable up to September 30, 2001.
(3) persons who have absorbed the Bachelor of Pharmacy before October 1, 2001 and to the third section of the pharmaceutical inspection for a prior to July 1, 2007, annual testing make the application for admission, drop this section of the test according to the requirements of this regulation in the version applicable up to September 30, 2001.
(4) in the case of the admission to the first or second section of pharmaceutical testing the prescribed evidence are no. 5 and 6 and paragraph 4 Nos. 3 and 4 of this regulation in the version applicable up to September 30, 2001 and the evidence to § 6 section 3 in section 6 paragraph 3 see no. 5 and para 4 No. 3 of this regulation in force after September 30, 2001 as equivalent.
(5) repeat tests after not passing the exam, which was filed under the provisions of this regulation in the version applicable up to September 30, 2001 will be the first section of the pharmaceutical inspection until December 31, 2005, the second section of the pharmaceutical inspection up to December 31, 2006 and in the third section of pharmaceutical testing up to filed June 30, 2008 under these regulations; then, this regulation amended after September 30, 2001 also applies such field tests.
(6) the State Audit Office can for one before January 1, 2011 annual examination of article 18, paragraph 1 digit V. of mentioned compartment by way of derogation from article 11, paragraph 2, sentence 3 another Member of the examination Board for the second section of the pharmaceutical inspection order in.
section 24 (dropped out) article 25 entry into force of the regulation and override any provisions this regulation into force on October 1, 1989.
The Federal Minister for youth, family, women and health annex 1 (to section 2 paragraph 2) fabric areas of study of pharmacy site of the original text: BGBl I 2000, 1716-1718 a shift from teaching hours between each fabric areas to the extent up to 42 hours of lessons per area is possible. The total amount of practical exercises and seminars including lectures with exercises or seminars do not touch each as a result. The competent body under national law may require up to four additional certificates in addition to the credentials specified for the fabric areas A through I.
20 practice percent to accompanying seminars are included in the practical exercises.
Fabric in A general chemistry of drug substances, excipients and pollutants lectures, seminars and practical exercises with events to: Chemistry for pharmacists Stereochemistry of chemical nomenclature General and analytical chemistry of inorganic drugs, excipients and pollutants (including Pharmacopoeia methods) Chemistry including the analysis of organic drug substances, excipients, and pollutants toxicology of auxiliary materials and pollutants total: 462 hours of lessons with a share of 336 hours practical exercises and 56 lessons seminars three certificates of successful and regular participation in fabric area of B pharmaceutical analysis lectures , Seminars and practical exercises with events to: pharmaceutical/medicinal chemistry determination of medicinal materials and pollutants (including Pharmacopoeia methods) introduction in the instrumental analysis of instrumental analysis total: 392 hours of lessons with a share of 308 lessons practical exercises two certificates on successful and regular participation in fabric area C scientific foundations, mathematics and medicine morphology lectures, seminars and practical exercises with events to :
Physics for pharmacists foundations of physical chemistry of physical exercises for pharmacists physico chemical exercises for mathematical and statistical methods for pharmacists pharmacists basics of medical morphology medicine morphology pharmaceutical and medical terminology history of science with particular reference to the pharmacy total: 280 hours of lessons with a share of 140 lessons practical exercises and 14 hours seminars three certificates of successful and regular participation in fabric area D basics of biology and human biology lectures , Seminars and practical exercises with events to: general biology for pharmacists systematic classification and physiology of pathogenic and medicinal substance producing organisms pharmaceutical biology I (studies medicinal substance producing organisms) medicinal plants excursions, taxonomic practicals microbiology pharmaceutical biology II (herbal drugs) cytological and histological basis of biology Essentials of Anatomy and Physiology course of Physiology fundamentals of Biochemistry basics of nutrition total: 392 hours of lessons with a share of 210 hours practical exercises four certificates of successful and regular attendance fabric area E biochemistry lectures , Seminars and practical exercises with events to: Biochemistry and molecular biology basics of clinical chemistry and the Pathobiochemistry biochemical research methods including clinical chemistry pathophysiology/Pathobiochemistry total size: 196 hours of lessons with a share of 98 hours practical exercises a certificate of successful and regular attendance fabric area F pharmaceutical technology and Biopharmacy lectures, seminars and practical exercises with events to: pharmaceutical technology including medical device quality assurance in the manufacture and testing of medicinal organic pharmacy including pharmaceutical forms-related pharmacokinetics overall size : 364 hours of lessons with a share of 196 hours practical exercises and 42 hours of teaching seminars two certificates on successful and regular participation in fabric area G biogenic drugs lectures, seminars and practical exercises with events to: pharmaceutical biology; Medicinal plants, biogenic drugs, biotechnology biogenic medicines (herbal medicines, antibiotics, genetically engineered drug) pharmaceutical biology III (biological and phytochemical studies) Immunology, vaccines and Sera total size: 238 hours of lessons with a share of 84 hours practical exercises and 42 hours of teaching seminars a certificate of successful and regular attendance fabric area H medicinal chemistry and drug analysis lectures, seminars and practical exercises with events to: pharmaceutical/medicinal chemistry medicinal analysis (drug monitoring , toxicological and environmental studies) pharmaceutical analysis considering the Pharmacopoeia (quality control and quality assurance for pharmaceutical substances) and the corresponding standards for medical products total: 420 hours of lessons with a share of 280 hours practical exercises two certificates on successful and regular participation in fabric area I Pharmacology and clinical pharmacy lectures, seminars and practical exercises with events to: Pharmacology and Toxicology clinical pharmacy pathology pharmacotherapy pharmacological toxicological demonstration course in Pharmacoepidemiology and Pharmakoökonomie special jurisdictions for pharmacists total : 406 hours of lessons with a share of 112 lessons practical exercises and 98 hours seminars three certificates of successful and regular participation in fabric area K elective seminars and practical exercises in a to the non-pharmaceutical sciences elective total: 112 hours of lessons a certificate of successful and regular attendance; Seminars in the block K held in the form of major seminars.
Annex 2 (to article 6 par. 3 No. 5 and paragraph 4 No. 3) certificate (site of the original text: BGBl. I 2000, 1719) regarding participation in the event... the fabric area...
The students of pharmacy... has in the... of the... to... in the above event regularly and successfully took part.
(Signature of the responsible Professor/Lecturer)
Annex 3 (to section 6 para 4 No. 4) certificate (site of the original text: BGBl. I 2000, 1719) of attendance at the event... the elective...
Annex 4 (dropped out) Appendix 5 (to § 4 para 3 sentence 3, § 6 para 5 No. 2 and para. 6 sentence 3) certificate of practical training (site of the original text: BGBl. I 1989, 1500) Mr/Mrs/Ms... is in the time of the... to... According to § 4 of the licensure of pharmacists practically been trained.
He/she has worked all day in this time and in section 4 paragraph 2 carried out specified activities. The training is of the... until... interrupted/not interrupted been. *)...,...
(Name of the training school)...
(Unterschrift des für die Ausbildung Verantwortlichen) - *) delete as appropriate.
Annex 6 (§ 4 para 4 sentence 3 and § 6 para 5 No. 3) certificate of attendance at the accompanying educational events according to § 4 para 4 of the licensure of pharmacists (site of the original text: BGBl. I 1989, 1500) Mr/Mrs/Ms... the has of the accompanying teaching events... up to the... carried out in... participated.
Annex 7 (to section 3 para 2 sentence 4 and § 6 ABS. 3 No. 3) certificate of the activity as Famulus (site of the original text: BGBl. I 1989, 1501) Mr/Mrs/Ms... is in the time of the... to... According to § 3 of licensure for pharmacists in the below designated facility under my supervision and management as Famulus been working.
He/she has worked all day in this time. The training is of the... until... interrupted/not been interrupted. *)
(Designation of the training school)...
(Unterschrift des verantwortlichen Apothekers) - *) delete as appropriate.
Annex 8 (to § 4 para 4 sentence 1) areas of fabric, which during the practical training be taught site of the original text: BGBl. 2000 I, 1720 basic principles of formulation and Defektur including the assessment of production rules and procedures; Development, approval and production of finished pharmaceutical products;
Planning, monitoring and dispatching of goods purchasing; technical procedures and problems of storage; Influencing the shelf life of pharmaceutical products and medical devices marketed in the pharmacies on the market, transport and storage;
Procurement, analysis, evaluation and dissemination of information on medicinal products and medical devices including safety aspects;
Information and advice to patients, physicians and other health professionals about drugs and medical devices marketed in the pharmacies on the market, in particular about the proper storage, application, incompatibilities and interactions, and the dangers of continuous use and abuse of drugs;
Communication techniques for dealing with healthy, patients and their families, physicians and other health professionals;
Aspects of quality assurance and quality control;
Applied pharmacotherapy; Drug selection in the self-medication; Special therapy directions; Limits of self-medication; Interpretation of medical, dental and veterinary instruments and their terminology; Pharmaceutical care; usual pharmacy services;
Hospital hygiene;
Economic aspects of the use of medicinal products and medical devices;
Comparative assessment of products for infant and child nutrition; comparative evaluation of nutrition measures including dietary foods and food supplements; comparative assessment of products of enteral and parenteral nutrition;
Comparative assessment of products and items for body care, pharmacy-conventional medical products as well as pesticides and pesticides;
Characteristics of the veterinary medicinal products;
Special aspects of health promotion;
Accident prevention in the Pharmacy and pharmaceutical companies including the proper handling of hazardous materials, cytotoxic drugs, radiopharmaceuticals and radioactive diagnostic products; General measures in case of accidents and poisoning (first aid);
Business management for pharmacists, taking into account the commercial law, tax law and commercial accounting;
Tasks and fields of activity of the pharmacist;
General jurisprudence, professional law; Legislation for the operation of the pharmacy, the marketing of medicines, drugs, medical devices, dietary foods, products for body care, hazardous substances and plant protection products; Remedy seekers real;
Special features of the national and international pharmaceutical market;
Tasks and organization of the health administration at federal, State and local, as well as at international level;
Pharmaceutical organizations and institutions;
Introduction to the social legislation and the social security system.
Annex 9 (to section 11 paragraph 6 sentence 1) minutes of the oral exam in the second / third party *) section of pharmaceutical testing in the subject...
(Site of the original text: Federal Law Gazette I, 1989, 1503; regarding the details of the changes see footnote)
Mr/Mrs/Ms..., born at... in... is most... in... has been tested.
He/she has... passed/not passed the oral examination with a score. *)
(Signature of the Chairman of the...) Prüfungskommission +++)) (Unterschrift(en) of the / of the investigator (s) *))...
(Signature of the assessor) (Unterschrift des Protokollführers) - *) delete as appropriate.
)) Here is also to note whether and, where appropriate, to the many repeat test is or, if necessary, for whatever reason the test is been fail.
) This is true for the third examination phase and in the event that the Chairman participates in an examination of the second section of the exam.
Annex 10 (to section 6 para 4 No. 1, para 5 No. 1, section 9, paragraph 4, sentence 2, article 16, paragraph 1 first half-sentence, and § 22 para 3 sentence 3) (site of the original text: BGBl. I 1989, 1504) issuing authority in...
Testimony about the first/second/third party *) section of pharmaceutical testing of Mr/Mrs/Ms..., born at... in... has most... in... the first/second/third party *) section of pharmaceutical verification according to the licensure of pharmacists with the touch of...
(..............) passed.
Annex 11 (to § 9 para 4 sentence 2, § 16 para 1 second half-sentence, and article 22, paragraph 3, sentence 3) (site of the original text: BGBl. I, 1989, 1504) issuing authority in...
Testimony about the pharmaceutical examination of Mr/Mrs/Ms..., born at... in..., the pharmaceutical inspection with the overall score has... (..............) passed.
Annex 12 (to § 17 para 2 sentence 3) number and distribution of examination questions in the individual subjects of the first section of the test site of the original text: BGBl. I 2000, 1721 I. General, inorganic and organic chemistry 100 questions II. basics of pharmaceutical biology and the Biology 100 questions III. fundamentals of physics, physical chemistry and morphology of the drug 80 questions IV. basics of pharmaceutical analysis 80 questions annex 13 (to § 17 para 3) examination syllabus of the first segment of pharmaceutical testing site of the original text : BGBl. 2000 I, 1721 I. General, inorganic and organic chemistry concepts and laws of chemistry; Nuclear construction and periodic table of the elements; chemical bonding, Intermolecular forces, solutions and heterogeneous systems; Thermodynamics of chemical reactions and kinetics; chemical equilibrium; Acid/base and redox systems; Stoichiometry of chemical reactions;
Occurrence, production, properties and reactivity of elements of the periodic table and their compounds, as well as their manufacture; General Chemistry of drug substances, excipients and pollutants; Sum formula and geometry of important connections; Nomenclature;
Binding types and their theoretical basis; Reaction equations and mechanisms; Basics of chemistry; Chemistry of functional groups and classes of substances, as well as their manufacturing and properties; Molecular, structural, and stereo formulas; Properties and reactivity of Synthetika and natural products; chemical fundamentals of synthetic polymers and biopolymers; Nomenclature.
II. fundamentals of pharmaceutical biology and the human biology fundamentals of cytology and histology; Basic principles and molecular basis of metabolism and genetics; Systematic classification, characteristics and physiology of plants and micro-organisms, focusing on pharmaceutically and medically important organisms; Fours;
Basics of Anatomy and morphology of plants; ecological concepts; drogenkundliche and microbiological concepts and techniques; important medicinal and poisonous plants; Root plants of more commonly used drugs;
Macroscopic and microscopic structure of the human body, its organs and tissues; Function of organs and organ systems, including regulatory mechanisms and cell-biological aspects; Basic principles of the immune system; Reproductive organs and their functions, pregnancy; Composition and extent of normal nutrition.
III. foundations of physics, physical chemistry and morphology of the medicine concepts and measurement systems of physics; Basic laws of mechanics of solid bodies, liquids, and gases; States of matter and their changes; Phase systems; Interfacial phenomena; Fundamentals of thermodynamics and kinetics; Kinetics of diffusion and distribution; Basics of electricity including electrochemistry; Fundamentals of optics, vibration and wave theory; Structure and properties of atoms and molecules; Basics of radioactivity and isotope application; physical foundations of measurement methods under consideration of the needs of Pharmacy;
General requirements for the manufacture of medicinal products; Basic operations; Recipe medicines; homeopathic preparations.
IV. principles of pharmaceutical analysis in pharmaceutical analysis, basic methods. Basis, ways of working and use Classic qualitative and quantitative methods for the analysis of drug substances, excipients and pollutants (cations, anions and neutral substances) including Pharmacopoeia methods; Analysis of functional groups of organic compounds;
Instrumental methods of pharmaceutical analysis including trace analytical procedures: principles, practices and applications thermoanalytical, electrochemical, radiochemical, chromatography, optical and spectroscopic methods for the qualitative (identification and structure elucidation) and quantitative analysis; Validation of methods of analysis; Quality assurance.
Annex 14 (to § 18 para 3) examination syllabus of the second section of pharmaceutical testing site of the original text: BGBl I 2000, 1722-1723 I. pharmaceutical/medicinal chemistry structure, stereochemistry and common representation or extraction, development (particularly rational drug development), properties, stability analysis (identity, purity, content) synthetic, partial synthetic and natural substances, narcotic, drug substances, excipients and pollutants as well as biocides and other Xenobiotics. Radiopharmaceuticals, synthesis, and quality control of sterically single optically active drug substances; Bioreaktivität and biotransformation of drugs and Xenobiotics;
Qualitative and quantitative relationships between structure and pharmacokinetic and pharmacodynamic properties of the active ingredients including stereochemischer influences;
Chemical, physico chemical, physical, radiochemical and biochemical methods of medical books and the corresponding harmonized standards for medical devices, structure and function of important reagents; other physical, physico chemical, chemical, radiochemical and biochemical methods for the study of materials used in the manufacture of medicinal products; Application and validation of methods for the quality control of the active ingredients and excipients; Quality assurance measures within the analytical laboratory;
Chemical toxicology and dealing with hazardous substances and other substances; Environmental analysis (soil, water, air); Fundamentals of Biochemistry (including pharmaceutical chemical aspects of genetic engineering and biotechnology) as well as the ecological, physiological and clinical chemistry; Methods for the examination of body fluids and interpretation of results; Medicines and Metabolitenanalytik, also in biological materials; pharmaceutical and chemical aspects of Sera, vaccines and Immunology;
Pharmaceutical and chemical examinations of finished medicinal products, such as separation and isolation of active ingredients and auxiliary materials and analysis; pharmaceutical and chemical aspects of major, minor - and interactions and incompatibilities of finished medicinal product; Nomenclature and terminology of the active ingredients and Excipients, including aspects of stereochemischer;
II. pharmaceutical biology common medicinal plants, drugs and herbal medicines; whose production, ingredients, effect, therapeutic application, as well as pharmaceutical and clinical assessment thereof; Identification, purity, and quality control of drugs; analytical procedures for the examination and standardization of herbal raw materials and finished products; Isolation procedure of natural products;
Commonly used antibiotics and biogenic cytostatics; their extraction, mechanisms of action and therapeutic application; Mechanisms of resistance development;
Basic principles of the biosynthesis of plant and microbial natural products;
Biochemistry and clinical chemistry; Basics of Immunology; Application of immunological and enzymatic methods in analysis and Diagnostics;
Preparation, testing and application of vaccines, immunoglobulins and Sera; Blood products;
Molecular biological techniques, genetic engineering techniques to the production of pharmaceutical substances; Gene therapy medicinal products;
Medicines of special treatment directions.
III. pharmaceutical technology/bio-pharmaceutical development, manufacturing, properties, testing and bio-pharmaceutical evaluation of dosage forms; modern drug delivery systems; tissues - and organ-specific application forms, special features of medicinal biotechnology and genetically produced drugs and Zytostatikazubereitungen; Construction principle, composition, handling and performance characteristics of finished medicines; Special dosing systems;
Requirements of pharmacopoeia of pharmaceutical preparations; Dosage forms of the Homeopathic Pharmacopoeia;
Properties, testing and assessment to the manufacture of medicines of necessary reason and AIDS as well as common ingredients and packaging materials;
Pharmaceutical and technological operations, process engineering, machinery, control engineering;
Organic pharmacy, Applikationswege and resorption sites, pharmacokinetic principles for the development and testing of pharmaceuticals, bio-availability, bio-equivalence testing and assessment, in-vitro / in-vivo correlation;
Quality assurance in the manufacture and testing of medicinal products including statistical methods; legal aspects of quality assurance, validation, in-process and final inspections;
Stability and stabilization of medicinal products; Incompatibilities and interactions;
Substitutes as well as blood and its preparations, Sera and vaccines;
Medical devices marketed in the pharmacies on the market.
IV. Pharmacology and Toxicology macroscopic, microscopic, pathobiochemische and functional changes of organs and organ systems in major diseases; Epidemiology, origin, symptoms, history, forecast and prevention of major diseases including those available to self-medication; Assessment of clinical chemical measurement results; Nutritional intervention in major diseases;
Effects of medicines, mechanism of action, metabolism, pharmacokinetics, side effects, interactions, contraindications and dosage, hazards due to improper use; General pharmacotherapy of important diseases including those available to self-medication; Toxicology of auxiliary and pollutants; Methods for determination of pharmacological and toxicological effects; Clinical examination; biometric methods.
V. clinical pharmacy specific pharmacotherapy; Characteristics of drug therapy in pregnancy and lactation, Pediatrics, geriatrics, in patients with organ failure, Multimorbidity. Importance of dosage form and path for the therapy. Dialysis procedures; Characteristics of specific therapeutic regimen, in particular for the anti-infective therapy, Oncology therapy and Supportivtherapie, the antikoagulative therapy, immune and gene therapy; Therapy of ICU patients; Criteria for the evaluation of medicinal products;
Medicinal history; Risk-benefit assessment of drug therapy; The clinical relevant of adverse effects, interactions and incompatibilities, evaluation of combination therapies; Cause of variability in the success of a drug therapy; Treatment recommendations based on specific patient cases; Therapeutic drug monitoring, dealing with patient records; Medical devices for the application of medicines and of enteral and parenteral nutrition;
Compliance/non-compliance; Principles and methods of pharmaceutical care;
Relationship between the pharmacodynamics and pharmacokinetics; Populationspharmakokinetik; Clinical pharmacogenetics;
Malnutrition, energy and nutrient requirements; enteral and parenteral nutrition;
Health Economics, Pharmacoepidemiology and economy, pharmacovigilance, methods for determining the quality of life, ethical aspects.
Annex 15 (to § 19 para 3) examination syllabus of the third section of the pharmaceutical inspection site of the original text: BGBl I 2000, 1724 I. pharmaceutical practice basic principles of formulation and Defektur; Incompatibilities; Principles of the development, production and approval of finished medicinal product; Conformity assessment of medical devices;
Possibilities of influencing the shelf life of pharmaceutical products;
Procurement, documentation, evaluation, assessment, and dissemination of information on medicinal products and medical devices;
Information and advice to patients, physicians and other health professionals about drugs and medical devices marketed in the pharmacies on the market, in particular through proper storage and application, minor, and interactions; Dangers of continuous use and abuse of drugs;
Aspects of quality assurance;
Applied pharmacotherapy; Medicinal advice and selection in the self-medication; Interpretation of medical, dental and veterinary instruments and their terminology; practical aspects of pharmaceutical care; usual pharmacy services;
Products for infant and child nutrition and nutritional intervention in diseases; Dietary supplements; Products for enteral and parenteral nutrition;
Products and items for personal hygiene, pesticides and pesticides;
Accident prevention, safety and first aid;
Business fundamentals of the pharmacy, in particular accounting, financial statements, profitability, streamlining, taxes.
II. special jurisdictions for pharmacists overview of the definition of the following areas of law: constitutional law, administrative law, criminal law, civil law, commercial law. Distinction between law, regulation, administrative provision, statute;
Professional law for pharmacists; Training and tasks of the other professions in pharmacies, legal basics; Chamber laws including professional jurisdiction;
Pharmacy Law, especially law on the pharmaceutics and pharmacy operating regulations; important for the operation of the pharmacy regulations from other jurisdictions; Outline of the history of the Pharmacy;
Medicines and narcotics law, law on Narcotics, in particular medicines Act, Heilmittelwerbegesetz and regulations adopted pursuant to it; Medical product law; Special features of the national and international pharmaceutical market, especially peddling, advertising and pricing;
Provisions on the handling and transport of hazardous substances;
Legal bases for the business aspects of Pharmacy Management, social security law.
Appendix 16 (to § 21 set 1) approval certificate (site of the original text: BGBl. I 1989, 1508) Mr./Mrs...., born at... in... the approval as a chemist/pharmacist is granted on the basis of section 4 of the Federal Pharmacists order with effect from today.
Attachment 17 (to § 22a paragraph 7) permission in accordance with article 11, paragraph 1 or paragraph 1a of the Federal Pharmacists order Mr/Ms...
will be in accordance with article 11 paragraph 1 / 1a of the federal order of pharmacists permission to the temporary exercise of the profession of pharmacist in/on... for the time of the...
granted until... revoked.
Plant 18 (to section 22c paragraph 6) of the national qualifying examination held pursuant to § 22 c of the licensure for pharmacist Mr/Mrs/Ms... born on... .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Members of the examination Board pursuant to § 22 c paragraph 4 of licensure for pharmacists: as scientifically... .
Unit 19 (to article 22d paragraph 6) of the State knowledge examination held according to article 22d of licensure for pharmacist Mr/Mrs/Ms... born on... .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Members of the Committee pursuant to section 22d paragraph 3 of the licensure of pharmacists: as scientifically... .