Last Updated on May 29, 2021 by LawEuro
Medicinal Products Act (Laws / Regulations of Germany)
CHAPTER FOURTEEN
Information officer, pharmaceutical consultant
Section 74a
Information Officer
(1) Any person who, as a pharmaceutical entrepreneur, places medicinal products within the meaning of Section 2 sub-section 1 or sub-section 2 number 1 on the market, shall commission a person with the necessary expert knowledge and the reliability required to perform his/her activities, to responsibly fulfil the tasks of providing scientific information on the medicinal products (information officer). The information officer shall, in particular, be responsible for ensuring compliance with the prohibition contained in Section 8 sub-section 1 number 2 and ensuring that the labelling, the package leaflets, the expert information and advertisements correspond with the content of the marketing authorisation or registration or, in so far as the medicinal product is exempted from the need for a marketing authorisation or registration, with the content of the ordinances governing the exemption from marketing authorisations or registrations pursuant to Section 36 or Section 39 sub-section 3. Sentence 1 shall not apply to persons who, pursuant to Section 13 sub-section 2 sentence 1 numbers 1, 2, 3 or 5, do not require a manufacturing authorisation. Persons other than those specified in sentence 1 shall not be allowed to exercise the functions of an information officer.
(2) The information officer can be the Graduated Plan Officer at the same time.
(3) The pharmaceutical entrepreneur shall notify the competent authority about the identity of the information officer and shall make notification of any change beforehand. In the case of an unforeseen change in the person of the information officer, a notification shall be made immediately.
Section 75
Expert knowledge
(1) Pharmaceutical entrepreneurs may only appoint persons in possession of expert knowledge, as defined in sub-section 2, to visit members of the medical professions on a full-time basis, in order to give technical information on medicinal products within the meaning of Section 2 sub-section 1 or sub-section 2 number 1 (pharmaceutical consultant). Sentence 1 shall also apply to information given by telephone. The activities of a pharmaceutical consultant may not be carried out by persons other than those indicated in sentence 1.
(2) The following persons shall be deemed to possess the necessary expert knowledge:
1. pharmacists or persons holding a certificate testifying to a successfully completed course of university studies in pharmacy, chemistry, biology, human or veterinary medicine and the corresponding passed examination,
2. assistants of pharmacists, as well as persons who have completed training as technical assistants in the fields of pharmacy, chemistry, biology, human or veterinary medicine,
3. pharmaceutical sales representatives.
(3) The competent authority is hereby empowered to recognize a passed examination or a successfully completed course of training as being sufficient if it is at least equivalent to the level of training of any of the persons specified in sub-section 2.
Section 76
Duties
(1) The pharmaceutical consultant shall have to make the expert information pursuant to Section 11a available, in so far as he/she provides expert information on individual medicinal products to members of the medical professions. He/she shall record, in writing or electronically, any notifications made to him/her by members of the medical professions on adverse reactions and contraindications or other risks associated with the medicinal products and notify his/her contract-giver thereof in writing.
(2) In so far as the pharmaceutical consultant is commissioned by the pharmaceutical entrepreneur to distribute samples of finished medicinal products to those persons entitled to receive them pursuant to Section 47 sub-section 3, he/she shall keep a record of the recipients of the samples, as well as the type and quantity thereof and the time and date of their distribution and must present these records, upon request, to the competent authorities.
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