Last Updated on May 29, 2021 by LawEuro
Medicinal Products Act (Laws / Regulations of Germany)
CHAPTER SEVENTEEN
Penal provisions and provisions on administrative fines
Section 95
Penal provisions
(1) A period of imprisonment not exceeding three years or a fine shall be imposed on any person who:
1. in breach of Section 5 sub-section 1, places a medicinal product on the market or uses a medicinal product on another,
2. contravenes an ordinance issued in compliance with Section 6, which forbids the marketing of medicinal products, in so far as it refers to this penal provision for specific cases,
2a. (repealed),
2b. (repealed),
3. places radiopharmaceuticals and medicinal products in the manufacture of which ionizing radiation is used on the market, in breach of Section 7 sub-section 1,
3a. in breach of Section 8 sub-section 1 number 1 or sub-section 2, also in conjunction with Section 73 sub-section 4 or Section 73a, manufactures or places medicinal products or active substances on the market or otherwise trades in them,
4. in breach of Section 43 sub-section 1 sentence 2, sub-section 2 or 3 sentence 1, trades in or dispenses medicinal products which may be dispensed to the consumer on prescription only,
5. dispenses medicinal products which may be dispensed to the consumer on prescription only, in breach of Section 47 sub-section 1, to persons or bodies other than those specified therein, or dispenses them in breach of Section 47 sub-section 1a or obtains them in breach of Section 47 sub-section 2 sentence 1,
5a. in breach of Section 47a sub-section 1, dispenses one of the medicinal products specified therein to any facility other than those specified therein or places such a medicinal product on the market,
6. in breach of Section 48 sub-section 1 sentence 1 in conjunction with an ordinance pursuant to Section 48 sub-section 2 number 1 or 2, dispenses medicinal products intended for use in food-producing animals,
7. in breach of Section 56 sub-section 1, dispenses medicated feeding stuffs to animal keepers without the required prescription,
8. in breach of Section 56a sub-section 1 sentence 1, also in conjunction with sentence 3, or sentence 2, prescribes, dispenses or administers medicinal products that are intended for use on food-producing animals and may be dispensed to consumers on prescription only, or
9. in breach of Section 57 sub-section 1, acquires medicinal products which may be dispensed to consumers on prescription only,
10. in breach of Section 58 sub-section 1 sentence 1, administers medicinal products which may only be dispensed to consumers on prescription, to food-producing animals, or
11. in breach of Section 59d sentence 1 number 1 administers a prohibited substance to one of the animals specified therein.
(2) The attempt to commit such acts shall be punishable.
(3) In particularly serious cases, the penalty shall be imprisonment from one to ten years. A particularly serious case is usually deemed to exist if the perpetrator:
1. by means of one of the actions indicated in sub-section 1:
a) endangers the health of a large number of persons,
b) exposes another person to the risk of death or the risk of serious injury to that person’s body or health,
c) acquires a considerable pecuniary gain for himself/herself or another person out of gross self-interest, or
2. in the cases mentioned in sub-section 1 number 3a, manufactures or places counterfeit medicinal products or active substances on the market acting, in the process, commercially or as a member of a gang which has come together for the recurrent commission of such acts.
(4) If the perpetrator has acted negligently in the instances cited in sub-section 1, the penalty shall be imprisonment for a period of not more than one year or a fine.
Section 96
Penal provisions
Any person who:
1. dispenses a medicinal product in breach of Section 4b sub-section 3 sentence 1,
2. contravenes an ordinance pursuant to Section 6, which prescribes, restricts or prohibits the use of certain substances, preparations made from substances or materials in the manufacture of medicinal products, in so far as it refers to this penal provision for specific cases,
3. manufactures or places medicinal products or active substances on the market in breach of Section 8 sub-section 1 number 2, also in conjunction with Section 73a,
4. manufactures or imports a medicinal product, an active substance or other substance specified therein without either the authorisation required by Section 13 sub-section 1 or by Section 72 sub-section 1 sentence 1,
4a. procures tissues or carries out laboratory testing without an authorisation pursuant to Section 20b sub-section 1 sentence 1 or sub-section 2 sentence 7 or, without an authorisation pursuant to Section 20c sub-section 1 sentence 1, processes, preserves, tests, stores or places tissues or tissue preparations on the market,
5. places finished medicinal products or medicinal products intended for administration to animals or medicinal products specified in an ordinance pursuant to Section 35 sub-section 1 number 2 or Section 60 sub-section 3 without a marketing authorisation or without an authorisation from the European Community or the European Union on the market, in breach of Section 21 sub-section 1,
5a. places tissue preparations on the market without an authorisation pursuant to Section 21a sub-section 1 sentence 1,
5b. introduces tissue preparations for the first time without a certificate pursuant to Section 21a sub-section 9 sentence 1,
6. fails to submit fully or correctly the information required pursuant to Section 22 sub-section 1 numbers 3, 5 to 9, 11, 12, 14 or 15, sub-section 3b or 3c sentence 1 or Section 23 sub-section 2 sentence 2 or 3 or fails to submit a document required according to Section 22 sub-section 2 or 3, Section 23 sub-section 1, sub-section 2 sentence 2 or 3, sub-section 3, also in conjunction with Section 38 sub-section 2, or a document required according to an enforceable order pursuant to Section 28 sub-sections 3, 3a, 3b or sub-section 3c sentence 1 number 2 fully or with the correct contents,
7. places a medicinal product on the market in breach of Section 30 sub-section 4 sentence 1 number 1, also in conjunction with an ordinance pursuant to Section 35 sub-section 1 number 2,
8. places a batch which has not been released for marketing on the market, in breach of Section 32 sub-section 1 sentence 1, also in conjunction with an ordinance pursuant to Section 35 sub-section 1 number 3,
9. places finished medicinal products as homeopathic or as traditional herbal medicinal products without registration on the market, in breach of Section 38 sub-section 1 sentence 1 or Section 39a sentence 1,
10. conducts the clinical trial of a medicinal product in breach of Section 40 sub-section 1 sentence 3 numbers 2 and 2a letter a, number 3, 4, 5, 6 or 8, in each case also in conjunction with sub-section 4 or Section 41,
11. begins the clinical trial of a medicinal product in breach of Section 40 sub-section 1 sentence 2,
12. dispenses one of the medicinal products specified therein without a prescription if the act is not punishable pursuant to Section 95 sub-section 1 number 5a, in breach of Section 47a sub-section 1 sentence 1,
13. dispenses medicinal products in breach of Section 48 sub-section 1 sentence 1 number 1, in conjunction with an ordinance pursuant to Section 48 sub-section 2 number 1, 2 or number 7 or in breach of Section 48 sub-section 1 sentence 1 number 3, also in conjunction with an ordinance pursuant to Section 48 sub-section 2 sentence 1 number 1, if the act is not punishable under Section 95 sub-section 1 number 6,
14. engages in wholesale trade without an authorisation pursuant to Section 52a sub-section 1 sentence 1,
14a. engages in the activity of a medicinal product broker, in breach of Section 52c sub-section 2 sentence 1,
15. prescribes or dispenses a medicinal product in breach of Section 56a sub-section 4,
16. in breach of Section 57 sub-section 1a sentence 1, in conjunction with an ordinance pursuant to Section 56a sub-section 3 sentence 1 number 2, is in possession of a medicinal product specified therein,
17. produces foodstuffs in breach of Section 59 sub-section 2 sentence 1,
18. acquires, offers, stores, packages, carries on his/her person or places substances or preparations from substances on the market, in breach of Section 59a sub-section 1 or 2,
18a. in breach of Section 59d sentence 1 number 2 administers a substance to one of the animals specified therein,
18b. without an authorisation pursuant to Section 72 sub-section 4 sentence 2, section 72b sub-section 1 sentence 3 or Section 72c sub-section 1 sentence 2, also in conjunction with Section 72c sub-section 4 sentence 1, imports haematopoietic stem cells, stem cell preparations, tissues or tissue preparations specified therein,
18c. in breach of Section 72a sub-section 1 sentence 1, also in conjunction with sub-section 1b or sub-section 1d, or in breach of Section 72a sub-section 1c, imports a medicinal product, an active substance or another substance listed in the sub-sections cited,
18d. in breach of Section 72b sub-section 2 sentence 1, imports tissues or tissue preparations,
18e. in breach of Section 73 sub-section 1b sentence 1, introduces a counterfeit medicinal product or a counterfeit active substance into the purview of this Act,
19. places a medicinal product intended for administration to human beings on the market even though the third party insurance or the exemption or warranty obligation required in compliance with Section 94 does not or no longer exists or
20. infringes 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 30.04.2004, p. 1), last amended by Regulation (EU) No. 1027/2012 (OJ L 316 of 14.11.2012, p. 38) by:
a) failing to attach information or a document correctly or fully, in breach of sentence 1 of Article 6 paragraph 1 of the Regulation in conjunction with the first indent of Article 8 (3) (1) letters c to e, h to iaa or letter ib 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 2012/26/EU (OJ L 299 of 27.10.2012, p. 1), or
b) failing to attach information or a document correctly or fully, in breach of sentence 1 of Article 31 paragraph 1 of the Regulation in conjunction with sentence 2 of the first indent of Article 12 paragraph 3 (c-e, h-j or k) 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 of the European Parliament and of the Council of 31 March 2004 (OJ L 136, p. 58) shall be liable to imprisonment for a term not exceeding one year or to a fine.
Section 97
Provisions on administrative fines
(1) An administrative offence shall be deemed to have been committed by any person who negligently commits one of the acts indicated in:
1. Section 96 numbers 1 to 5b, 7 to 18e or number 19, or
2. Section 96 number 6 or number 2.
(2) An administrative offence shall also be deemed to have been committed by any person who wilfully or negligently:
1. places medicinal products on the market, in breach of Section 8 sub-section 3,
2. places medicinal products which do not bear the name or the company name of the pharmaceutical entrepreneur on the market, in breach of Section 9 sub-section 1,
3. places medicinal products on the market, in breach of Section 9 sub-section 2 sentence 1 without having his/her place of business within the purview of this Act or in another Member State of the European Union or another State Party to the Agreement on the European Economic Area,
4. places medicinal products without the prescribed labelling on the market, in breach of Section 10, also in conjunction with Section 109 sub-section 1 sentence 1 or an ordinance pursuant to Section 12 sub-section 1 number 1,
5. places medicinal products on the market without the required package leaflet, in breach of Section 11 sub-section 1 sentence 1, also in conjunction with sub-sections 2a to 3b or 4, each also in conjunction with an ordinance pursuant to Section 12 sub-section 1 number 1,
5a. dispenses a partial amount in breach of Section 11 sub-section 7 sentence 1,
6. contravenes an enforceable order pursuant to Section 18 sub-section 2,
7. in breach of
a) Section 20, Section 20b sub-section 5, Section 20c sub-section 6, Section 52a sub-section 8, Section 67 sub-section 8 sentence 1, Section 72b sub-section 2c sentence 1 or Section 73 sub-section 3b sentence 4,
b) Section 21a sub-section 7 sentence 1, Section 29 sub-section 1 sentence 1, also in conjunction with sentence 2, in breach of Section 29 sub-section 1c sentence 1, Section 63c sub-section 2, Section 63h sub-section 2, Section 63i sub-section 2 sentence 1 or
c) Section 67 sub-section 1, sentence 1, also in conjunction with sentence 2, in each case also in conjunction with Section 69a, in breach of Section 67 sub-section 5 sentence 1 or sub-section 6 sentence 1,
fails to notify or fails to do so correctly, fully or on time,
7a. in breach of Section 29 sub-section 1a sentence 1, sub-section 1b or 1d, fails to notify or fails to do so correctly, fully or on time,
8. introduces medicinal products into the purview of this Act in breach of Section 30 sub-section 4 sentence 1 number 2 or Section 73 sub-section 1 or 1a,
9. conducts the clinical trial of a medicinal product in breach of Section 40 sub-section 1 sentence 3 number 7,
9a. conducts a clinical trial without designating a deputy pursuant to Section 40 sub-section 1a sentence 3,
9b. in breach of Section 42b sub-section 1 or sub-section 2, fails to make the reports available, or fails to do so correctly, fully or on time,
10. in breach of Section 43 sub-sections 1, 2 or 3 sentence 1, places medicinal products on the market professionally or commercially or trades in or dispenses any medicinal products which may be dispensed to consumers without prescription,
11. in breach of Section 43 sub-section 5 sentence 1, dispenses medicinal products intended for administration to animals and not released for trade outside of pharmacies in a manner which is in breach of the relevant provisions,
12. in breach of Section 47 sub-section 1, dispenses medicinal products which may be dispensed to consumers without prescription to persons or bodies other than those specified therein or dispenses them in breach of Section 47 sub-section 1a or obtains the same in breach of Section 47 sub-section 2 sentence 1,
12a. in breach of Section 47 sub-section 4 sentence 1, dispenses samples or has samples dispensed without a written request, in a package size other than the smallest one or in quantities exceeding the admissible limit,
13. fails to keep the records specified in Section 47 sub-section 1b or Section 47 sub-section 4 sentence 3 or in Section 47a sub-section 2 sentence 2, fails to do so correctly or fails to submit them to the competent authority upon request,
13a. in breach of Section 47a sub-section 2 sentence 1, dispenses any medicinal product specified therein without the prescribed labelling,
14. retails medicinal products in breach of Section 50 sub-section 1,
15. in breach of Section 51 sub-section 1, offers medicinal products for sale in the context of itinerant trading or seeks to procure orders for medicinal products,
16. in breach of Section 52 sub-section 1, places medicinal products on the market on a self-service basis,
17. in breach of Section 55 sub-section 8 sentence 1, also in conjunction with sentence 2, uses a substance, container or packaging or manufactures a pharmaceutical form,
17a. in breach of Section 56 sub-section 1 sentence 2, fails to send a copy of the prescription or fails to do so on time,
18. in breach of Section 56 sub-section 2 sentence 1, sub-section 3 or 4 sentence 1 or 2, manufactures medicated feeding stuffs,
19. in breach of Section 56 sub-section 4 sentence 2, fails to label a ready feed mixture, fails to do so correctly, fully, in the required manner or on time,
20. in breach of Section 56 sub-section 5 sentence 1, prescribes a medicated feeding stuff or has it manufactured,
21. in breach of Section 56a sub-section 1 sentence 1 numbers 1, 2, 3 or 4, in each case also in conjunction with sentence 3, prescribes, dispenses or administers medicinal products which:
a) are intended for use on animals not used in food production and may be dispensed to consumers on prescription only,
b) may be dispensed to consumers without a prescription,
21a. in breach of Section 56a sub-section 1 sentence 4, prescribes or dispenses medicated pre-mixes,
22. in breach of Section 57 sub-section 1, acquires medicinal products which may be dispensed to consumers without a prescription,
22a. uses medicinal products in breach of Section 57a,
23. administers medicinal products to food-producing animals in breach of Section 58 sub-section 1 sentence 2 or 3,
23a. in breach of Section 58a sub-section 1 sentence 1 or 2 or sub-section 3, sub-section 4 sentence 1, sentence 2 or sentence 3, or Section 58b sub-section 1 sentence 1, 2 or 3 or sub-section 2 sentence 2 number 2 or sub-section 3 fails to make a notification or fails to do so correctly, fully, in the required manner or on time,
23b. in breach of Section 58d sub-section 1 number 2, fails to record an ascertainment, or fails to do so correctly or on time,
23c. in breach of Section 58d sub-section 2 sentence 1 number 2, fails to draw up a plan as stipulated therein, or fails to do so correctly, fully, in the required manner or on time,
23d. contravenes an enforceable order pursuant to Section 58d sub-section 3 or sub-section 4 sentence 1,
24. contravenes an obligation to keep records or to submit them in compliance with Section 59 sub-section 4,
24a. in breach of Section 59b sentence 1, fails to place substances at the disposal of the competent authority or fails to do so correctly and on time,
24b. in breach of Section 59c sentence 1, also in conjunction with sentence 2, fails to keep any of the records mentioned therein, fails to do so correctly or fully, fails to preserve them or fails to do so for a minimum of three years or fails to submit them to the competent authority or to do so on time,
24c. in breach of Section 63a sub-section 1 sentence 1, fails to appoint a Graduated Plan Officer or, in breach of Section 63a sub-section 3, fails to make a notification or fails to do so fully or on time,
24d. in breach of Section 63a sub-section 1 sentence 5, works as a Graduated Plan Officer,
24e. in breach of Section 63b sub-section 1, fails to operate a pharmacovigilance system,
24f. in breach of Section 63b sub-section 2 number 1, fails to take a measure specified therein, or fails to do so on time,
24g. in breach of Section 63b sub-section 2 number 3, fails to keep a pharmacovigilance master file, fails to do so correctly or fully, fails to make it available or fails to do so correctly, fully, or on time,
24h. in breach of Section 63b sub-section 2 number 4, fails to put into place a risk management system for each individual medicinal product, or fails to do so correctly or fully,
24i. in breach of Section 63b sub-section 3 sentence 1, publishes information specified therein without the prior or simultaneous notification specified therein,
24j. in breach of Section 63d sub-section 1, also in conjunction with sub-section 3 sentence 1 or sub-section 3 sentence 4, fails to submit a safety report or fails to do so correctly, fully or on time,
24k. in breach of Section 63f sub-section 1 sentence 3, fails to transmit a final report or fails to do so on time,
24l. in breach of Section 63g sub-section 1, fails to submit a draft of the study protocol or fails to do so correctly or on time,
24m. in breach of Section 63g sub-section 2 sentence 1, commences a safety study,
24n. in breach of Section 63g sub-section 4 sentence 1, fails to submit a study report or fails to do so correctly, fully or on time,
24o. in breach of Section 63h sub-section 5 sentences 1, 2 or sentence 3, fails to submit a report or fails to do so correctly, fully or on time,
24p. in breach of Section 63i sub-section 3 sentence 1, fails to make a notification or fails to do so correctly or on time,
24q. in breach of Section 63i sub-section 4 sentence 1, fails to submit a report or fails to do so correctly or on time,
25. contravenes an enforceable order pursuant to Section 64 sub-section 4 number 4, also in conjunction with Section 69a,
26. contravenes the obligation to tolerate or to collaborate as defined in Section 66, also in conjunction with Section 69a,
27. in breach of an enforceable order pursuant to Section 74 sub-section 1 sentence 2 number 3, fails to present a consignment for clearance,
27a. in breach of Section 74a sub-section 1 sentence 1, fails to appoint an information officer or, in breach of Section 74a sub-section 3, fails to make a notification or fails to do so fully or on time,
27b. in breach of Section 74a sub-section 1 sentence 4, works as an information officer,
28. in breach of Section 75 sub-section 1 sentence 1, appoints a person as pharmaceutical consultant,
29. in breach of Section 75 sub-section 1 sentence 3, works as a pharmaceutical consultant,
30. contravenes an obligation to keep records, to make notifications or to present records in compliance with Section 76 sub-section 1 sentence 2 or sub-section 2,
30a. (no longer applicable),
31. contravenes an ordinance pursuant to Section 7 sub-section 2 sentence 2, Section 12 sub-section 1 number 3 letter a, Section 12 sub-section 1b, Section 42 sub-section 3, Section 54 sub-section 1, Section 56a sub-section 3, Section 57 sub-section 2 or sub-section 3, Section 58 sub-section 2 or Section 74 sub-section 2 or an enforceable order based on such an ordinance, in so far as the ordinance refers to this provision on administrative fines for specific cases.
(2a) Any person who wilfully or by negligence contravenes Article 1 of Regulation (EC) No. 540/95 of the Commission of 10 March 1995 laying down the arrangements for notifying non-serious suspected unexpected adverse reactions that are not serious, whether arising in the Community or in a third country, to medicinal products for human or veterinary use authorised pursuant to the provisions of Regulation (EEC) No. 2309/93 (OJ L 55 of 11.03.1995, p. 5), in conjunction with Section 63h sub-section 7 sentence 2 by failing to ensure that the European Medicines Agency and the competent higher federal authority are notified of an adverse reaction mentioned therein shall be deemed to have committed an administrative offence.
(2b) Any person who fails to comply with Regulation (EC) No. 726/2004 by wilfully or negligently:
1. failing to make a notification specified therein to the European Medicines Agency or the competent higher federal authority, or failing to do so correctly, fully or in time, in breach of Article 16 paragraph 2 first sentence or second sentence in conjunction with Article 8 (3) first sub-paragraph, letters c to e, h to iaa, or letter ib of Directive 2001/83/EC or in breach of Article 41 paragraph 4 first or second sentence in conjunction with Article 12 paragraph 3 first sub-paragraph, second sentence, letters c to e, h to j or letter k of Directive 2001/82/EC each in conjunction with Section 29 sub-section 4 sentence 2,
2. failing to ensure that a notification is available at a location specified therein, in breach of Article 28 (1) in conjunction with Article 107 (1) second sub-paragraph of Directive 2001/83/EC,
3. failing to ensure that the competent higher federal authority or the European Medicines Agency receives notification of an adverse reaction specified therein, in breach of Article 49 (1) first sentence or (2) first sentence each in conjunction with Section 29 sub-section 4 sentence 2,
4. failing to keep a document specified therein or fails to do so correctly or fully, in breach of Article 49 (3) first sentence, shall be deemed to have committed an administrative offence.
(2c) Any person who fails to comply with Regulation (EC) No. 1901/2006 of the European Parliament and the Council of 12 December 2006 on medicinal products for paediatric use and amending Council Regulation (EEC) 1768/92, Directives 2001/20/EC and 2001/83/EC, as well as Regulation (EC) No. 726/2004 (OJ L 378 of 27.12.2006, p. 1), by wilfully or negligently:
1. failing to place a medicinal product mentioned therein on the market or failing to do so on time in breach of Article 33 first sentence,
2. contravening an enforceable order pursuant to Article 34 (2) fourth sentence,
3. failing to submit the report specified therein or failing to do so on time in breach of Article 34 (4) first sentence,
4. failing to transfer the marketing authorisation to one of the third parties specified therein or failing to do so on time and not allowing the latter to use the documentation specified therein or failing to do so in time, in breach of Article 35 first sentence,
5. failing to inform or failing to do so correctly or on time in breach of Article 35 second sentence, or
6. failing to submit the results of the test mentioned therein or failing to do so correctly or on time in breach of Article 41 (2) second sentence shall be deemed to have committed an administrative offence.
(3) The committing of an administrative offence may be liable to a fine not exceeding 25,000 euros.
(4) The administrative authority within the meaning of Section 36 sub-section 1 number 1 of the Act on Administrative Offences shall be the competent higher federal authority pursuant to Section 77, in the cases provided for in:
1. sub-section 1 number 2, sub-section 2 number 7 letter b, numbers 7a, 9b and 24e to 24q, sub-sections 2a to 2c and
2. sub-section 2 number 7 letter c, in so far as the act is committed against the competent higher federal authority.
Section 98
Confiscation
Materials connected with an offence as defined in Section 95 or Section 96 or an administrative offence as defined in Section 97 may be confiscated. Section 74a of the Penal Code and Section 23 of the Act on Administrative Offences shall apply.
Section 98a
(no longer applicable)
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