Last Updated on May 29, 2021 by LawEuro
Medicinal Products Act (Laws / Regulations of Germany)
Section 11a
Expert information
(1) The pharmaceutical entrepreneur shall be obliged to make available upon request to physicians, dentists, veterinarians, pharmacists and, if the medicinal products concerned are not subject to prescription, to other persons practising medicine or dentistry professionally, instructions for use by experts (expert information) for finished medicinal products that are subject to or exempted from the obligation to obtain a marketing authorisation, are medicinal products within the meaning of Section 2 sub-section 1 or sub-section 2 number 1 and are not released for trade outside of pharmacies. These instructions for expert use shall bear the heading ‘Fachinformation’ (expert information) and include the following information written in clearly legible type in conformity with the Summary of Product Characteristics approved within the framework of the marketing authorisation, and in the following order:
1. the name of the medicinal product followed by the strength and the pharmaceutical form;
2. information on the qualitative and quantitative composition in terms of active substance and other constituents, knowledge of which is required for proper administration of the product, with the usual common or chemical name indicated; Section 10 sub-section 6 shall apply;
3. pharmaceutical form,
4. clinical information:
a) therapeutic indications,
b) dosage and method of administration for adults and, in so far the medicinal product is indicated for administration to children, for children,
c) contra-indications,
d) special warnings and precautions for use, and in the case of immunological medicinal products, any special precautions to be taken by persons coming into contact with and administering these medicinal products to patients, together with any precautions to be taken by the patient, if required as a result of conditions imposed by the competent higher federal authority pursuant to Section 28 sub-section 2 number 1 letter a, or stipulated by Section 7 of the Anti-Doping Act, or by an ordinance,
e) interaction with other medicinal products or other products if this is likely to influence the effect of the medicinal product,
f) use during pregnancy and lactation,
g) effects on ability to drive or operate machinery,
h) adverse reactions when used as intended,
i) overdosage: symptoms, emergency procedures, antidotes;
5. pharmacological properties:
a) pharmacodynamic properties,
b) pharmacokinetic properties,
c) preclinical safety data;
6. pharmaceutical information:
a) list of other constituents,
b) main incompatibilities,
c) shelf life and where necessary, the shelf life after reconstitution of the medicinal product or after first opening the container,
d) special precautions for storage,
e) nature and contents of the container,
f) special precautions for disposal of an opened medicinal product, or waste materials derived from it, in order to avoid any risk to the environment;
7. marketing authorisation holder;
8. marketing authorisation number;
9. the date of first authorisation or prolongation of the authorisation;
10. date of revision of the expert information.
All medicinal products for human use are to carry a standard text that explicitly calls upon health professionals to report every suspected adverse reaction to the competent higher federal authority whereby the report may take any – in particular also electronic – form. Medicinal products for human use that are included on a list compiled pursuant to Article 23 of Regulation (EC) No. 726/2004 must, in addition, carry the following declaration: ‘Dieses Arzneimittel unterliegt einer zusätzlichen Überwachung’ (This medicinal product is subject to additional monitoring). This declaration must be preceded by a black symbol and be followed by an appropriate standardised explanatory text pursuant to Article 23 (4) of Regulation (EC) No. 726/2004. Additional information that is not stipulated by a regulation of the European Community or the European Union, or is already permissible pursuant to such a regulation shall be permitted if it relates to the use of the medicinal product and is not inconsistent with the information referred to in sentence 2; such information must be clearly separate and distinct from the information referred to in sentence 2. Sentence 1 shall not apply to medicinal products, which do not require a marketing authorisation pursuant to Section 21 sub-section 2 or are manufactured according homeopathic procedures. The marketing authorisation holder is required to keep scientifically up-to-date the expert information, which includes the conclusions of assessments and recommendations published on the European internet website set up pursuant to Article 26 of Regulation (EC) No. 726/2004. The standard texts required pursuant to sentences 3 and 5 will be published by the competent higher federal authority in the Federal Gazette.
(1a) In the case of sera, the type of living organism from which they are derived, in the case of virus vaccines, the host system used for virus multiplication and, in the case of medicinal products derived from human blood plasma for fractionation, the country of origin of the blood plasma shall be indicated.
(1b) In respect of radiopharmaceuticals, details of the internal radiation dosimetry, additional detailed instructions for the extemporaneous preparation and the quality control of this preparation shall also be given and, where necessary, the maximum storage time shall also be indicated during which an intermediate preparation, such as an eluate or the medicinal product when ready for use, corresponds to its specifications.
(1c) In the case of medicinal products intended for use in animals, the expert information specified under number 4 ‘klinische Angaben’ (clinical information) must include the following information:
a) information on each target animal species to which the medicinal product is to be administered,
b) instructions for use, specifying the target animal species,
c) contra-indications,
d) special warnings for each target animal species,
e) special precautions for use, including special precautions to be taken by the person administering the medicinal product,
f) adverse reactions (frequency and seriousness),
g) use during pregnancy, lay or lactation,
h) interactions with other medicinal products and other forms of interaction,
i) dosage and method of administration,
j) overdosage: emergency procedures, symptoms, antidotes, if necessary,
k) withdrawal periods for all foodstuffs, including those for which there is no withdrawal period.
The information referred to in sub-section 1 sentence 2 number 5 letter c is not necessary.
(1d) In the case of medicinal products available only on prescription by a physician, dentist or veterinarian, the information ‘Verschreibungspflichtig’ (prescription only) should also be added, for narcotic drugs the information ‘Betäubungsmittel’ (narcotic drugs), in the case of other medicinal products available to consumers only in pharmacies, the information ‘Apothekenpflichtig’ (pharmacy only); in the case of medicinal products containing a substance or a preparation pursuant to Section 48 sub-section 1 sentence 1 number 3 corresponding information shall be given.
(1e) For marketing authorisations of medicinal products pursuant to Section 24b, the information referred to in sub-section 1 relating to therapeutic indications, dosages or other objects of a patent can be omitted if it is still covered by patent law at the time of placing on the market.
(2) The pharmaceutical entrepreneur shall be obliged to make all modifications to the expert information, which are relevant for therapy, accessible to the experts in an appropriate form. In so far as necessary, the competent higher federal authority may, by imposition of a condition, stipulate the form in which the changes are to be made accessible to all or to certain groups of experts.
(3) A sample of the expert information and revised versions thereof shall be sent immediately to the competent higher federal authority unless the medicinal product is exempted from the obligation to obtain a marketing authorisation.
(4) The obligations referred to in sub-section 1 sentence 1 can also be fulfilled in the case of medicinal products that are administered exclusively by members of the health professions by including the information referred to in sub-section 1 sentence 2 in the package leaflet. The package leaflet must be headed with the title ‘Gebrauchsinformation und Fachinformation’ (instructions for use and expert information).
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