Regulation on the proof of expertise in the retail sector with free-selling medicinal products

Unofficial table of contents

AMSachKV

Date of completion: 20.06.1978

Full quote:

" Regulation on the proof of expertise in retail trade with free-selling medicinal products of 20 June 1978 (BGBl. 753), as last amended by Article 1 of the Regulation of 6 August 1998 (BGBl I). I p. 2044).

Status:

Last amended by Art. 1 V v. 6.8.1998 I 2044

For more details, please refer to the menu under Notes

Footnote

(+ + + Text evidence from: 1.1.1978 + + +) Unofficial table of contents

Input formula

Pursuant to Section 50 (2), second sentence, sentence 2 to 4 of the Medicines Act of 24 August 1976 (BGBl. 2445, 2448), the Federal Minister for Economic Affairs, the Federal Minister of Education and Science and the Federal Minister for Food, Agriculture and Forestry, with the approval of the Federal Council, shall be responsible for the following: Unofficial table of contents

§ 1 Proof of expertise

Proof of expertise for the retail trade outside pharmacies with medicinal products within the meaning of Article 2 (1) or (2) (1) of the Medicines Act, which are released for circulation outside pharmacies (free-selling medicinal products), may be provided by an examination in accordance with § § 2 to 9, by examination certificates of another professional training completed in accordance with § 10 or in any other way according to § 11. Unofficial table of contents

§ 2 Establishment and activity of the Audit Committee

(1) The competent authority shall set up an audit committee or several audit committees for the acceptance of the test. A joint audit committee may be set up by a number of authorities. (2) The Audit Committee shall consist of at least three, not more than five members, as determined by the competent authority. Members must be knowledgeable and qualified to participate in the examination process. Members of the Audit Committee must be members of a responsible authority and at least one independent businessman and commercial employee of the retail trade. A member must be a pharmacist. Each member has a deputy. (3) Chairman of the Audit Committee shall be the examination committee member or his deputy appointed by the competent authority. (4) The members and alternates shall be appointed by the competent authority for three years. The activity in the Audit Committee is honorary. (5) On the honorary activity of the members and their substitutes in the Audit Committee, § § 83 to 86, to the activity of the Audit Committee are § § 89 to 91 and 93 of the Administrative procedure law. Unofficial table of contents

§ 3 Examination dates and registration for examination

(1) The competent authority shall determine the dates for the conduct of the audit. These are scheduled as required, at least once a year. The competent authority shall give notice of these dates and the notifying parties in good time. (2) If the examination is carried out with uniform superregional examination tasks, uniform examination days shall be carried out by the competent authorities. (3) The applicant has to register with the competent authority in whose district his place of employment or his training or training centre is situated or the applicant has his habitual residence or last. Unofficial table of contents

§ 4 Test requirements

(1) The examination shall establish whether the test participant has sufficient knowledge and knowledge of the proper filling, packaging, identification, storage and placing on the market of medicinal products for sale, as well as knowledge of the rules applicable to these medicinal products. (2) In detail, it is necessary to determine whether the test participant

1.

Overseeing the range of free-selling medicinal products,

2.

knows the commonly used plants and chemicals used in free-selling medicinal products, as well as the forms of administration,

3.

evidently mistaken, adulterated or spoiled, free-selling medicinal products,

4.

Free-selling medicinal products may be stored properly, in particular taking into account the storage temperature and the decay date,

5.

knowledge of the knowledge required for the proper filling, packaging and release of free-of-products medicinal products,

6.

is aware of the dangers inherent in the improper use of free-selling medicinal products,

7.

the rules governing medicinal products for free-selling medicinal products and the right of advertising in the field of medicinal products.

Unofficial table of contents

Section 5 Implementation of the examination

(1) The examination shall be filed verbally or in writing. At the request of the Chairperson, the participants of the examination shall be informed of their person. Before the beginning of the examination, you shall be informed about the course of the examination, the time available, the permitted work and tools, the consequences of acts of deception and the violation of order. (2) Participants who are involved in a treatise or a treatise or (3) The Audit Committee decides on the final exclusion and the consequences of the examination after hearing the examination subject. In serious cases, in particular in the case of preparatory acts of deception, the examination may be declared unpassed. In such cases, the examination may subsequently be declared unpassed if the deception is determined within one year of the conclusion of the examination. (4) The competent authority may send an observer to the examination. The chairperson shall allow persons who prepare for the examination as guests during an oral examination. Only the members of the Audit Committee may be present at the advice on the results of the examination. Unofficial table of contents

§ 6 Resignation, non-participation

(1) The examination applicant may withdraw by written declaration after the application has been filed before the examination begins. In this case, the examination shall be deemed not to have been filed. (2) If the applicant withstands or does not take part in the examination after the examination begins, the examination shall be deemed not to have been passed. The Audit Committee decides on the existence of an important reason. Unofficial table of contents

§ 7 Examination result and certificate

(1) The examination shall be passed if at least sufficient benefits are provided. (2) After completion of the examination, the chairman of the examination board shall immediately issue a certificate to the examination participant, whether he or she is the subject of the examination "passed" or "did not pass". In the case of an oral examination, the examination committee is to inform the participant of the results on the day of the examination. (3) The examination participant receives a certificate from the competent authority according to the model of the examination. (4) If the examination is not passed, the examination participant shall receive a written notice from the competent authority. Reference should be made to the provisions relating to the repeat examination in § 8. Unofficial table of contents

Section 8 Repeal of the examination

An unpassed test can be repeated. The test can be repeated at the earliest for the next examination date. Unofficial table of contents

§ 9 The competent authority

If a body is appointed by the competent authority before which the examination is to be deposited, the provisions of Sections 2 to 8 shall apply mutatily to those bodies. The competent authority may send an observer to the examination. Unofficial table of contents

§ 10 Recognition of other evidence

The following certificates of professional training shall be recognised as proof of the necessary expertise in the retail trade with free-selling medicinal products:

1.

the certificate of examination of a pharmacy after a university degree,

2.

the Certificate of Examination in connection with the evidence in accordance with Section 15 (2) of the Medicinal Products Act, after university studies in chemistry, biology, human medicine or veterinary medicine have been completed,

3.

the certificate of veterinary examination laid down after university studies in veterinary medicine has been completed, in so far as it concerns medicinal products intended for use in animals,

4.

the certificate of the passed pharmaceutical preliminary examination within the meaning of § 1 of the law on the legal status of pre-examined pharmacist contenders of 4 December 1973 (BGBl. I p. 1813),

5.

the Certificate of State Examination for the Occupation of Pharmaceutically Technical Assistants, or evidence of equivalence of the state of training in accordance with the Law on the Occupation of the Pharmaceutically Technical Assistant,

6.

the certificate of a state-recognised training occupation as a drug,

7.

the certificate of a state-recognized training occupation as a pharmacist or as a pharmaceutical and commercial clerk.

The first sentence shall apply, mutagenically, to a pharmacist, assistant pharmacist, pharmacist or pharmacist who has been granted accession in accordance with the provisions of the German Democratic Republic before the date of entry into force of the accession. or, after the date of accession, they shall be granted in the territory referred to in Article 3 of the Agreement on the integration of the Community. Unofficial table of contents

§ 11 Other proof of expertise

Proof of the expertise in the retail trade of free-selling medicinal products has also been provided by the person who proves that he or she has until 1 January 1978 the conditions for the sale of the products.

1.

the retail trade in medicinal products, in accordance with the provisions of the Law on the Professional Training of Retail Trade and the Regulation on the proof of retail trade, in each case in their up to 1 January 1978 version, or

2.

Knowledge of expertise as production manager in accordance with Section 14 (1) (2) of the Medicines Act 1961

has been fulfilled. Unofficial table of contents

§ 12

(dropped) Unofficial table of contents

Section 13 Entry into force

§ § 10 and 11 shall enter into force with effect from 1 January 1978. Moreover, this Regulation shall enter into force on the day following the date of delivery. Unofficial table of contents

Final formula

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

Annex (to § 7 para. 3)

(Fundstelle des Originaltextes: BGBl. I 1978, 756)

 Audit certificate 
 on the expertise in retail trade, 
 Free-selling medicinal products according to § 50 
 of the Pharmaceutical Act 
............................................................................... 
 (surname and first name) 
born on ................. in ........................................................... 
Has the examination of the expertise in retail trade with free-selling 
Medicinal products 
 on ................................ 
passed. 
.............., the ................... 
........................................................... 
 (Signature) (Signature) 
(seal)