Last Updated on May 29, 2021 by LawEuro
Medicinal Products Act (Laws / Regulations of Germany)
Section 10
Labelling
(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 not intended for clinical trials on human beings or exempted from the obligation to obtain a marketing authorisation, pursuant to Section 21 sub-section 2 number 1a, 1b or 6, may only be placed on the market within the purview of this Act provided that the following information is displayed on the containers and, where used, on the outer packaging in easily legible and indelible characters, in easily comprehensible German and pursuant to the details referred to in Section 11a:
1. the name or the company and the address of the pharmaceutical entrepreneur and, if available, the name of the local representative appointed by him,
2. the name of the medicinal product, followed by details of the strength and pharmaceutical form and, if applicable, information stating that it is intended for administration to babies, children or adults unless this information is already included in the name; if the medicinal product contains up to three active substances, the international non-proprietary name (INN) must be stated or, if the latter does not exist, the common non-proprietary name; this shall not apply if the name contains the name of the active substance pursuant to number 8.
3. the marketing authorisation number with the abbreviation ‘Zul.-Nr.’,
4. the batch identification, if the medicinal product is placed on the market in batches, with the abbreviation ‘Ch.-B.’; if it cannot be placed on the market in batches, the date of manufacture,
5. the pharmaceutical form,
6. the content by weight, nominal volume or number of units,
7. the method of administration,
8. the active substances by type and quantity and other constituents by type in so far as this is imposed as a condition by the competent higher federal authority pursuant to Section 28 sub-section 2 number 1 or provided for by an ordinance pursuant to Section 12 sub-section 1 number 4, also in conjunction with sub-section 2, or pursuant to Section 36 sub-section 1; in the case of medicinal products intended for parenteral or topical use, including application to the eye, all constituents by type,
8a. in the case of medicinal products produced using genetic engineering, the active substance and the name of the genetically modified organism or cell line used in its manufacture,
9. the expiry date with the instruction ‘verwendbar bis’ (to be used by),
10. in the case of medicinal products that may only be dispensed upon prescription by a physician, dentist or veterinarian, the indication ‘Verschreibungspflichtig’ (prescription-only), in the case of other medicinal products that may only be dispensed to consumers in pharmacies, the indication ‘Apothekenpflichtig’ (pharmacy-only),
11. in the case of samples, the indication ‘unverkäufliches Muster’ (sample – not for sale),
12. the indication that medicinal products are to be kept out of the reach of children unless they are curative waters,
13. where necessary, special precautions for the disposal of unused medicinal products or other special precautions to avoid hazards to the environment,
14. the intended use in the case of non-prescription medicinal products.
In so far as the information pursuant to sentence 1 is also provided in another language, the information provided in that language shall be identical. Furthermore, space should be provided to state the prescribed dose; this shall not apply to the containers and ampoules referred to in sub-section 8 sentence 3 and to medicinal products intended exclusively for use by members of the medical profession. Medicinal products that are manufactured using a homeopathic manufacturing procedure and are authorised pursuant to Section 25, are to be additionally labelled so as to indicate their homeopathic nature. 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, 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.
(1a) (repealed)
(1b) In the case of medicinal products that are intended for use in human beings, the name of the medicinal product shall also be placed on the outer packaging in Braille. The other information specified in sub-section 1 sentence 1 number 2 on the pharmaceutical form and the group of persons for which the medicinal product is intended does not have to be written in Braille; this shall also apply if this information is contained in the name of the medicinal product. Sentence 1 shall not apply to medicinal products that:
1. are intended for the exclusive use of members of the medical professions,
2. are placed on the market in containers with a nominal volume of not more than 20 millilitres or not more than 20 grammes.
(1c) In the case of medicinal products that are intended for use in human beings, the outer packaging shall also bear safety features as well as a device to indicate possible tampering with the outer packaging of the medicinal product, in so far as this required by Article 54a 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 174 of 1.7.2011, p. 74) or stipulated on the basis of Article 54a of Directive 2001/83/EC.
(2) Moreover, warnings, specific storage instructions for the consumer as well as storage instructions for experts shall be given, in so far as this is deemed necessary according to the current level of scientific knowledge or has been imposed as a condition by the competent higher federal authority pursuant to Section 28 sub-section 2 number 1 or provided for by ordinance.
(3) In respect of sera, information on the type of living organism from which the sera were obtained, in respect of virus vaccines, information about the host system which was used for the multiplication of the virus shall be indicated.
(4) In the case of medicinal products included in the Register of Homeopathic Medicinal Products, instead of the information referred to in sub-section 1 sentence 1 numbers 1 to 14 and apart from the clearly recognisable reference: ‘Homöopathisches Arzneimittel’ (homeopathic medicinal product), the following information shall be included:
1. the nature and quantity of the stocks and the degree of dilution; in this regard, symbols from the pharmacopoeias currently used officially, should be utilised; the scientific name of the stock can be supplemented by an invented name,
2. name and address of the pharmaceutical entrepreneur and, if available, of his/her local representative,
3. method of administration,
4. expiry date; sub-section 1 sentence 1 number 9 and sub-section 7 shall apply,
5. pharmaceutical form,
6. the content by weight, nominal volume or number of units,
7. information stating that medicinal products should be kept out of the reach of children, other special precautions for storage and warnings, including additional information for safe use if required or if stipulated in sub-section 2,
8. batch identification,
9. registration number abbreviated to ‘Reg.-Nr.’ and the phrase ‘Registriertes homöopathisches Arzneimittel, daher ohne Angabe einer therapeutischen Indikation’ (registered homeopathic medicinal product therefore no therapeutic indication stated),
10. information advising the user to seek medical advice if medical symptoms persist during the use of the medicinal product,
11. for medicinal products to be dispensed only in pharmacies, the information ‘Apothekenpflichtig’ (pharmacy-only),
12. in the case of samples, the indication ‘unverkäufliches Muster’ (sample – not for sale).
Sentence 1 shall apply accordingly to medicinal products exempted from registration pursuant to Section 38 sub-section 1 sentence 3; sub-section 1b shall not apply.
(4a) In the case of traditional herbal medicinal products pursuant to Section 39a, the following information shall also be included in addition to the information pursuant to sub-section 1:
1. the medicinal product is a traditional medicinal product registered for the therapeutic indication exclusively based on long-standing use, and
2. if medical symptoms persist, or in the event of adverse reactions other than those referred to in the package leaflet, the user should consult a physician or other medically qualified person.
The information in sub-section sentence 1 number 3 is replaced by the registration number abbreviated to ‘Reg.-Nr.’.
(5) In respect of medicinal products that are intended for administration to animals, sub-sections 1 and 1a shall apply subject to the proviso that, instead of the information pursuant to sub-section 1 sentence 1 numbers 1 to 14 and sub-section 1a, the following information is to be provided:
1. name of the medicinal product, followed by information on the strength, pharmaceutical form and the animal species, unless this information is already contained in the name; if the medicinal product contains only one active substance, the international non-proprietary name recommended by WHO or, in the absence thereof, the common name unless the name already contains the information on the active substance,
2. the active substance by nature and quantity and other constituents by nature, if this is stipulated by conditions imposed by the competent higher federal authority pursuant to Section 28 sub-section 2 number 1, or stipulated by an ordinance pursuant to Section 12 sub-section 1 number 4, also in conjunction with sub-section 2 or pursuant to Section 36 sub-section 1,
3. the batch identification,
4. the marketing authorisation number with the abbreviation ‘Zul.-Nr.’,
5. the name or the company and the address of the pharmaceutical entrepreneur and, if available, the name of the local representative appointed by him,
6. the animal species for which the medicinal product is intended,
7. the method of administration,
8. the withdrawal, if the medicinal products are intended for administration to food-producing animals,
9. the expiry date pursuant to sub-section 7,
10. if necessary, special precautions for the disposal of unused medicinal products,
11. the indication that the medicinal products are to be kept out of the reach of children, additional special precautions for storage and warnings, including additional information if required for safe use or if stipulated in sub-section 2,
12. the indication ‘Für Tiere’ (for animals),
13. the pharmaceutical form,
14. the content by weight, nominal volume or number of units,
15. in the case of medicinal products that may only be dispensed upon veterinary prescription, the indication ‘Verschreibungspflichtig’ (prescription-only), in the case of other medicinal products which may only be dispensed to customers in pharmacies, the indication ‘Apothekenpflichtig’ (pharmacy-only),
16. in the case of samples, the indication ‘unverkäufliches Muster’ (sample – not for sale).
Medicinal products intended for administration to animals, which have been entered into the Register for Homeopathic Medicinal Products, shall be clearly and visibly labelled ‘Homöopathisches Arzneimittel’ (homeopathic medicinal product); instead of the information pursuant to sentence 1 numbers 2 and 4, the information pursuant to sub-section 4 sentence 1 numbers 1, 9 and 10 shall be provided. Sentences 1 and 2 shall apply mutatis mutandis to medicinal products that are exempted from registration pursuant to Section 38 sub-section 1 sentence 3 or pursuant to Section 60 sub-section 1. In the case of traditional herbal medicinal products for administration to animals, the registration number with the abbreviation ‘Reg.-Nr.’, instead of the information pursuant to sentence 1 number 4; furthermore, the indications pursuant to sub-section 4a sentence 1 number 1 and, corresponding to the administration to animals, pursuant to number 2, shall be given. The information pursuant to sentence 1 numbers 13 and 14 only need to be given on the outer packaging where an outer packaging exists.
(6) For the designation of the constituents, the following shall apply:
1. for the designation of the type, the World Health Organization’s international non-proprietary names or, if such names do not exist, other common scientific names shall be used. The Federal Institute for Drugs and Medical Devices shall stipulate, in agreement with the Paul Ehrlich Institute and the Federal Agency for Consumer Protection and Food Safety, the names to be used and shall publish these in a database pursuant to Section 67a;
2. for the designation of quantity, units of measure shall be used; if biological units or other specifications regarding valence are customarily in scientific use, then these shall be used.
(7) The month and the year shall be given as the expiry date.
(8) Blister packaging is to be affixed with the name or the firm of the pharmaceutical entrepreneur, the name of the medicinal product, the batch identification and the expiry date. It shall not be necessary to state the name and firm of a parallel importer. In the case of containers with a nominal volume of not more than 10 millilitres and single-dose ampoules, the information specified in sub-sections 1, 2 to 5 need only be displayed on the outer packaging; the containers and the ampoules must, however, at least bear the information specified in sub-section 1 sentence 1 number 2 first half-sentence, numbers 4, 6, 7, 9 as well as pursuant to sub-sections 3 and 5 sentence 1 numbers 1, 3, 7, 9, 12 and 14; adequate abbreviations may be used. Sentence 3 shall also apply to small containers other than those mentioned therein in so far as divergent requirements are placed on small containers in procedures pursuant to Section 25b.
(8a) In the case of fresh plasma preparations and preparations of blood cells, at least the information specified in sub-section 1 sentence 1 numbers 1 and 2 must be included, without stating the strength, pharmaceutical form and target group, number 3 or the approval number with the abbreviation ‘Gen.Nr.’, numbers 4, 6, 7 and 9 as well as the name and volume of the anticoagulant and, if available, the additive solution, storage temperature, blood group and, in the case of allogenic preparations derived from red blood cells, the rhesus formula as well and, in the case of thrombocyte concentrates and autologous preparations from red blood cells, also the rhesus factor. In the case of autologous blood preparations, the information ‘Nur zur Eigenbluttransfusion’ (Only for Autologous Blood Donation) must also be given and, in the case of autologous and directed blood preparations, also an indication of the recipient. In the case of haematopoietic stem cell preparations made from peripheral blood or umbilical cord blood, the Single European Code with the abbreviation ‘SEC’ must be given, as well as the information ‘Biologische Gefahr’ (Biological Danger) in the event that infectivity has been detected.
(8b) In the case of tissue preparations, at least the information pursuant to sub-section 1 sentence 1 numbers 1 and 2, without stating the strength, pharmaceutical form and target group, number 3 or the approval number with the abbreviation ‘Gen.Nr.’, numbers 4, 6 and 9 of the Single European Code with the abbreviation ‘SEC’ must be included, as well as the information ‘Biologische Gefahr’ (Biological Danger) in the event that infectivity has been detected. In the case of autologous tissue preparations, the information ‘Nur zur autologen Anwendung’ (Only for Autologous Use) must also be provided and, in the case of autologous and targeted tissue preparations, an additional indication as to the recipient.
(9) Abbreviations customary in the medicinal product trade may be used in the indications given in compliance with sub-sections 1 to 5. The company to be indicated under sub-section 1 number 1 may be abbreviated, provided that the firm is generally recognizable from the abbreviation.
(10) For medicinal products that are intended for administration to animals and for use in a clinical trial or for residue testing, sub-section 5 sentence 1 numbers 1, 3, 5, 7, 8, 13 and 14 as well as sub-sections 8 and 9 shall be applicable, in so far as they are relevant. Where relevant, these medicinal products shall be labelled ‘Zur klinischen Prüfung bestimmt’ (for clinical trial) or ‘Zur Rückstandsprüfung bestimmt’ (for residue testing). Blister packaging shall bear the name, the batch identification and the information pursuant to sentence 2.
(11) Partial amounts removed from finished medicinal products, intended for use in human beings, may only be dispensed with labelling which corresponds at least to the requirements stipulated in sub-section 8 sentence 1. Sub-section 1b shall not apply.
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