Regulation For The Evidence Of Expertise In The Retail Sale Of Over-The-Counter Medicines

Original Language Title: Verordnung über den Nachweis der Sachkenntnis im Einzelhandel mit freiverkäuflichen Arzneimitteln

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Regulation for the evidence of expertise in the retail sale of over-the-counter medicines AMSachKV Ausfertigung date: 20.06.1978 full quotation: "regulation for the evidence of expertise in the retail sale of over-the-counter drugs by June 20, 1978 (BGBl. I p. 753), most recently by article 1 of the Decree of 6 August 1998 (BGBl. I S. 2044) has been changed" stand: last amended by art. 1 V v. 6.8.1998 I 2044 more details to the stand number found in the menu see remarks footnote (+++ text detection from) : 1.1.1978 +++) input formula due to § 50 para 2 sentence 2 to 4 of the medicines Act of 24 August 1976 (Federal Law Gazette I p. 2445, 2448) is prescribed in the agreement with the Federal Minister of Economics, the Federal Ministry of education and science and the Federal Ministry of food, agriculture and forestry with the consent of the Federal Council: § 1 proof of expertise proof of expertise for the retail trade outside of pharmacies with drugs in the sense of § 2 paragraph 1 or paragraph 2 No. 1 of the German medicines Act , to the traffic outside of pharmacies released are (over-the-counter medicines) can by a test according to the paragraphs 2 to 9, by certificates of other paid off vocational training according to § 10, or in any other manner pursuant to section 11 be provided.

Section 2 establishment and activities of the Audit Committee (1) for the acceptance of inspection established the competent authority an Audit Committee or several Prüfungsausschüsse. Multiple authorities can establish a joint Audit Committee.
(2) upon determination by the competent authority, the Audit Committee consists of at least three and not more than five members. The members must be competent for the examination and for the participation in the auditing. The Audit Committee must be members one of the competent of officer as well as at least a self-employed salesman and clerk of the retail trade. Pharmacists must be a member. Each Member has a Deputy.
(3) the Chairman of the Audit Committee is the Audit Committee member appointed by the competent authority or his representative.
(4) the members and deputy members are appointed for three years by the competent authority. The activities of the Audit Committee is voluntary.
(5) on the voluntary work of the members and their deputies in the Audit Committee, the §§ 83 to 86 are to apply to the activity of the Prüfungsausschusses the sections 89 to 91 and 93 of the Administrative Procedure Act.

§ 3 examination dates and registration for the examination (1) the competent authority determines the dates for the conduct of the examination. These are recognised as necessary, at least once in the year. The competent authority Announces these dates and the deadlines in the appropriate form in a timely manner.
(2) the uniform national examination papers test is performed, are uniform examination day by the competent authorities to apply as far as the feasibility can be ensured.
(3) the test candidate has to login to the competent authority, in whose district is his place of employment or his off - or Fort educational establishment or the applicant is habitually resident or had.

Section 4 testing requirements (1) the examination is to determine whether the subject has sufficient knowledge and skills about the proper filling, packing, marking, camps and placing on the market of over-the-counter medicines knowledge of the rules for these medicines.
(2) in particular is to determine whether the candidates 1 overlooks the range of free negotiable medicines, 2. knows the plants commonly used in over-the-counter medicines and chemicals, as well as the dosage forms, 3 can be seen obviously mistook, distorted or corrupted non-prescription medicines, 4 properly, can store non-prescription medicines in particular, taking into account the storage temperature and the expiry date, 5 allowing for the proper filling, packaging and dispensing free negotiable medicines has necessary knowledge , 6. the risks associated with the improper handling of over-the-counter medicines knows, 7 knows the rules applicable to non-prescription drugs of pharmaceutical law and law of advertising on the areas of the health system.

Article 5 conduct of the examination (1) the examination is filed orally or in writing. The candidates have to identify themselves at the request of the Chairman on their person. They are prior to commencement of the trial about the testing process, the available time, the permitted work and tools, to instruct the consequences of acts of deception and violations of regulations.
(2) the regulators of the exam participants who are guilty of deception Act or a significant disturbance of the testing process, provisionally to exclude.
(3) the Audit Committee decides after hearing of the subject concerning the final exclusion and the consequences. In serious cases, especially when prepared acts of deception, the test fail can be explained. In these cases the test can be explained subsequently fail, if the deception is detected within a year after completion of the test.
(4) the competent authority may send an observer to the test. The Chairman wants to allow people who are preparing for the exam, as guests in an oral exam. Advising on the test results, only the members of the Audit Committee may be present.

§ 6 resignation, non-participation (1) which can test applicants withdraw after registering prior to commencement of the trial by written declaration. In this case the test is considered to be not filed.
(2) the examination candidate resigns after commencement of the trial or he does not participate in the examination without having an important reason, the test is regarded as fail. The examination Committee shall decide on the existence of an important reason.

Certificate (1) that is testing and test result pass section 7 if at least satisfactory services are rendered.
(2) after the examination, the Chairman of the Audit Committee has immediately handed a certificate to the subjects, whether he has "passed" or "failed". In the case of an oral exam the Audit Committee is to report already the result of the participants on the day of the examination.
(3) passed the examination of subjects gives a certificate by the competent authority according to the pattern of the plant.
(4) in the case of not passing the exam, the exam participant receives a written opinion by the competent authority. On the rules for the repeat test in section 8 be noted.

§ 8 repeat the test a failed test can be repeated. The test can be repeated for the next exam date at the earliest.

§ 9 competent authority determines a position by the competent authority prior to the exam to take is, to apply for this sections 2 to 8, according to. The competent authority may send an observer to the test.

§ 10 other recognition following certificates vocational training paid from be recognised as proof of required expertise in the retail sale of over-the-counter medicines: 1 the certificate a completed University of Pharmacy dropped exam, 2. the testimony of a to completed university studies of chemistry, biology, human or veterinary medicine dropped testing in conjunction with the references according to § 15 par. 2 of the German medicines Act , 3. the certificate of the Veterinary examination dropped to completed university studies of veterinary medicine, as far as it is medicinal products intended for use in animals, 4. the certificate about the passed pharmaceutical preliminary assessment within the meaning of § 1 of the law on the legal status before certified pharmacist candidates from December 4, 1973 (BGBl. I S. 1813), 5 the certificate about the passed State exam for the profession of pharmaceutical Assistant or the proof of the equivalence of training stand under the law on the profession of pharmaceutical Assistant, 6 the testimony to the State-approved apprenticeship as a druggist, 7 the testimony to the State-approved apprenticeship as pharmacy Assistant or pharmaceutical commercial employee/pharmaceutical commercial clerk.
Sentence 1 shall apply accordingly for permits as a pharmaceutical engineer, pharmacy Assistant, pharmaceutical Assistant or pharmacy specialized workers, before the effect of the accession of the German Democratic Republic has been granted are according to the regulations or after effective date of accession in the article 3 of the Unification Treaty, said area be granted.

§ 11 other proof of expertise the expertise in the retail business with over-the-counter medicines has also demonstrated, who can prove that he held until January 1, 1978 the requirements 1.

the competence for the retail sale of medicinal products according to the regulations of the Act on the exercise of the profession in the retail sector and the regulation for the evidence of this competence for the retail market, each in their up to 1 January 1978 amended, or 2. the expertise as a producer pursuant to § 14 para 1 1961 met no. 2 of the medicines Act.

(dropped out) article 13 entry into force sections 10 and 11 apply § 12 with effect from 1 January 1978. Moreover this regulation into force on the day after the announcement.

Concluding formula of the Federal Minister for youth, family and health (§ 7 para 3) facility (site of the original text: BGBl. I, 1978, 756) certificate the expertise in the retail sale of over-the-counter medicinal products according to section 50 of the German medicines Act...
(Family name and given name) born at... in... the test of expertise in the retail business with over-the-counter medicines has most... passed.
.............., den ...................
.................................. ...................................
(Signature) (Signature)