Last Updated on May 29, 2021 by LawEuro
Medicinal Products Act (Laws / Regulations of Germany)
Section 11
Package leaflet
(1) Finished medicinal products that are medicinal products within the meaning of Section 2 sub-section 1 or sub-section 2 number 1 and are intended neither for clinical trial nor residue testing, or are exempted from the obligation to obtain a marketing authorisation pursuant to Section 21 sub-section 2 numbers 1a, 1b or 6, may only be placed on the market within the purview of this Act with a package leaflet bearing the heading ‘Gebrauchsinformation’ (Instructions for Use) and containing, in the same order as below, in easily legible, readily comprehensible German and in conformity with the information referred to in Section 11a:
1. for the purpose of identifying the medicinal product:
a) the name of the medicinal product, Section 10 sub-section 1 sentence 1 number 2 shall apply mutatis mutandis,
b) the substance or indication group or the mode of action;
2. the therapeutic indications;
3. a list of information that must be read before taking the medicinal product:
a) contra-indications,
b) corresponding precautions for use,
c) interactions with other medicinal products or other products, if they are able to influence the effect of the medicinal product,
d) warnings, especially if imposed as a condition by the competent higher federal authority pursuant to Section 28 sub-section 2 number 2 or based on Section 7 of the Anti-Doping Act or stipulated by ordinance pursuant to Section 12 sub-section 1 number 3;
4. the instructions under normal conditions of use, relating to:
a) dosage,
b) method of administration,
c) frequency of administration, if necessary stating the exact time when the medicinal product can or must be taken
and, if required, depending on the nature of the medicinal product:
d) duration of treatment if a specific duration is required,
e) warnings in the event of an overdose, forgotten doses or warnings on the risk of adverse consequences if the treatment is stopped,
f) the specific recommendation that a physician or pharmacist should be consulted in the event of queries relating to the use;
5. a description of the adverse reactions which can occur when the medicinal product is used as intended; the counter measures to be taken in the event of adverse reactions if required according to the current state of scientific knowledge; all medicinal products for human use must bear an additional standard text which explicitly instructs the patient to inform their physicians, pharmacists, health professionals or the competent higher federal authority directly of every suspected adverse reaction whereby the report can be made in any – in particular an electronic – form;
6. mention of the expiry date stated on the packaging and also:
a) a warning that the medicinal product may not be used after expiry of this date,
b) if required, special precautions for storage and information on shelf life after opening of the container or after preparation of the ready-to-use preparation by the user,
c) if required, a warning about specific visible signs indicating that the medicinal product may no longer be used,
d) complete qualitative composition in terms of active substances and other constituents and quantitative composition in terms of the active substances, using the usual common names for each of the medicinal product’s pharmaceutical forms; Section 10 sub-section 6 shall apply,
e) pharmaceutical form and content by weight, nominal volume or number of items for each of the medicinal product’s pharmaceutical forms,
f) name and address of the pharmaceutical entrepreneur and, where applicable, of his/her local representative,
g) name and address of the manufacturer or importer who released the finished medicinal product for placing on the market;
7. in the case of a medicinal product known by other names in other Member States of the European Union and approved for placing on the market pursuant to Articles 28 to 39 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use (OJ L 311 of 28.11.2001, p. 67), last amended by Directive 2011/62/EU (OJ L 299 of 27.10.2012, p. 1) a list of the names approved in each Member State;
8. the date of the last revision of the package leaflet.
Medicinal products for human use that are included on a list compiled pursuant to Article 23 of Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136 of 30.4.2004, p. 1), last amended by Regulation (EU) No. 1027/2012 (OJ L 316 of 14.11.2012, p. 38) 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. Explanatory information on the terms listed in sentence 1 is admissible. In so far as information referred to in sentence 1 is also rendered on the package leaflet in another language, the information provided in this language shall be identical. Sentence 1 shall not apply to medicinal products that do not require a marketing authorisation pursuant to Section 21 sub-section 2 number 1. Additional information, which is not stipulated by a regulation of the European Community or the European Union, or is already permissible pursuant to such a regulation, is permitted provided it relates to the use of the medicinal product, is important for the health education of patients and is not inconsistent with the information referred to in Section 11a. With regard to the information referred to in sentence 1 number 3 letters a to d, account is to be taken of the special situation of specific groups of persons such as children, pregnant women or nursing mothers, the elderly or persons with specific diseases, in so far as this is deemed necessary in the light of the current level of scientific knowledge; furthermore, where necessary, the effects which the use of the medicinal product could have on a person’s ability to drive or to operate specific machines should also be indicated. The marketing authorisation holder is required to keep scientifically up-to-date the package leaflet 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.
(1a) A sample of the package leaflet and modified versions shall be sent to the competent higher federal authority unless the medicinal product is exempted from the obligation to obtain a marketing authorisation or registration.
(1b) The standard texts required pursuant to sub-section 1 sentence 1 number 5 and sentence 3 will be published by the competent higher federal authority in the Federal Gazette.
(2) Furthermore, the package leaflet shall contain references to constituents, the knowledge of which is necessary for the safe and effective use of the medicinal product, as well as specific storage instructions for the consumer in so far as this is deemed necessary according to the current level of scientific knowledge or if imposed as a condition by the competent higher federal authority pursuant to Section 28 sub-section 2 number 2, or provided for by ordinance.
(2a) In the case of radiopharmaceuticals, sub-section 1 shall apply mutatis mutandis with the proviso that the precautions that are to be taken by the user and the patient in the preparation and administration of the medicinal product, as well as special precautions for the disposal of the containers used for transport and for the disposal of medicinal products that are not used, are taken.
(3) In the case of medicinal products included in the register of homeopathic medicinal products, sub-section 1 shall apply mutatis mutandis with the proviso that the information stipulated in Section 10 sub-section 4, with the exception of the batch identification, the expiry date and the indication stipulated for samples, are included, as well as the name and address of the manufacturer who released the finished medicinal product for placing on the market, where this person is not the pharmaceutical entrepreneur. Sentence 1 shall apply mutatis mutandis to medicinal products that are exempted from registration pursuant to Section 38 sub-section 1 sentence 3.
(3a) In the case of sera, sub-section 1 shall apply mutatis mutandis with the proviso that 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 should be stated.
(3b) In the case of traditional herbal medicinal products pursuant to Section 39a, sub-section 1 shall apply mutatis mutandis with the proviso that the information referred to in sub-section 1 sentence 1 number 2, shall state that the medicinal product is a traditional medicinal product, registered for the specific therapeutic indication, exclusively on the basis of long-standing use. In addition, the package leaflet should include the advice referred to in Section 10 sub-section 4a sentence 1 number 2.
(3c) The marketing authorisation holder shall ensure that at the request of patients’ organisations, the package leaflet is made available in formats appropriate for the blind and partially-sighted persons in the case of medicinal products intended for administration to human beings.
(3d) In the case of spa-waters, notwithstanding the requirements referred to in sub-section 2, the information referred to in sub-section 1 sentence 1 number 3 letter b number 4 letters e and f number 5, provided that the information stated therein is stipulated, and number 6 letter c, can be omitted. Furthermore, in the case of spa-waters, the order stipulated in sub-section 1 is not compulsory.
(4) In the case of medicinal products that are intended for administration to animals, sub-section 1 shall apply accordingly provided that, instead of the information referred to in sub-section 1 sentence 1, the following information specified in sub-section 1 sentences 2 and 3 is given in the same order as below, in clearly legible, readily comprehensible German and in conformity with the information referred to in Section 11a:
1. the name and address of the pharmaceutical entrepreneur and, where applicable, of his/her local representative, and the manufacturer who released the finished medicinal product for placing on the market;
2. the name of the medicinal product, followed by details of the strength and pharmaceutical form; the common name of the active substance shall be included if the medicinal product contains only one active substance and its name is an invented name; in the case of a medicinal product that has been granted marketing authorisation under Articles 31 to 43 of Directive 2001/82 EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, p. 1), amended by Directive 2004/28/EC (OJ L 136, p. 58), under different names in Member States of the European Union, a list of the names approved in each Member State;
3. therapeutic indications;
4. contra-indications and adverse reactions, provided that this information is relevant for use; should it not be possible to provide information in this respect, the indication ‘keine bekannt’ (none known) shall be given; the instruction that the user or animal keeper is to notify the veterinarian or pharmacist of any adverse reaction that is not listed in the package leaflet;
5. the animal species for which the medicinal product is intended, dosage instructions for each species, method and route of administration, if necessary, instructions for use in keeping with its intended purpose;
6. the withdrawal period, if the medicinal products are intended for administration to food-producing animals; should a withdrawal period not be necessary, this shall be indicated;
7. special precautions relating to storage;
8. special warnings in so far as this is imposed as a condition by the competent higher federal authority or provided for by an ordinance;
9. if necessary due to the current state of scientific knowledge, special precautions for the disposal of unused medicinal products or other special precautions to avoid risks to the environment.
The date of the last revision of the package leaflet shall be stated. In respect of medicated pre-mixes, indications for the correct manufacture of medicated feeding stuffs and information on the shelf life of the medicated feeding stuffs shall be included. Additional information is permitted in so far as it relates to the use of the medicinal product, is important for the user or animal keeper and is not inconsistent with the information referred to in Section 11a. In the case of medicinal products for use in animals, which are included in the Register of Homeopathic Medicinal Products or which are exempted from the registration pursuant to Section 38 sub-section 1 sentence 3 or pursuant to Section 60 sub-section 1 sentences 1, 2 and 4 shall apply mutatis mutandis subject to the proviso that the information stipulated in Section 10 sub-section 4, with the exception of the batch identification, the expiry date and the indication stipulated for samples must be provided. In the case of traditional herbal medicinal products for use in animals, a corresponding indication pointing to the use in animals pursuant to Section 10 sub-section 4a sentence 1 number 2 shall be given in addition to the indications pursuant to sub-section 3b sentence 1.
(5) Should it not be possible to provide the information stipulated in sub-section 1 sentence 1 number 3 letters a and c as well as number 5, the indication ‘keine bekannt’ (none known) shall be given. Should additional information be given on the package leaflet, it shall be clearly set out and well separated from the information specified in sub-sections 1 to 4.
(6) The package leaflet may be omitted provided that the information specified in sub-sections 1 to 4 is to be found either on the container or on the outer packaging. Sub-section 5 shall apply mutatis mutandis.
(7) Partial amounts removed from finished medicinal products, intended for use in human beings, may only be dispensed together with a copy of the package leaflet prescribed for the finished medicinal product. Sub-section 6 sentence 1 shall apply mutatis mutandis. By way of derogation from sentence 1, in the case of the regular dispensing of partial amounts removed from finished medicinal products and dispensed in new, customised patient blisters in the context of long-term medication, copies of the package leaflet prescribed for the specific finished medicinal product must only be inserted if they have been modified compared with those previously inserted.
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