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Law on the monitoring of transport of raw materials which may be used for the illicit manufacture of narcotic drugs

Original Language Title: Gesetz zur Überwachung des Verkehrs mit Grundstoffen, die für die unerlaubte Herstellung von Betäubungsmitteln missbraucht werden können

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Law for the supervision of transport of basic substances which can be misused for the illicit manufacture of narcotic drugs (Basic Surveillance Act-GÜG)

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GÜG

Date of completion: 11.03.2008

Full quote:

" Basic monitoring law of 11 March 2008 (BGBl. 306), as last amended by Article 2 (22). Article 4 (9) of the Law of 7 August 2013 (BGBl. I p. 3154).

G replaces G 2121-6-26 v. 7.10.1994 I 2835 (GÜG) mWv 19.3.2008
Status: Last amended by Art. 2 (22) and Art. 4 (9) G v. 7.8.2013 I 3154

For more details, please refer to the menu under Notes

Footnote

(+ + + Text proof: 19.3.2008 + + +) 

The G was enacted as article 1 of the G v. 11.3.2008 I 306 of the Bundestag. It's gem. Art. 4 of this G mWv 19.3.2008 entered into force.

Section 1
General provisions

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§ 1 Definitions

For the purposes of this law,
1.
Basic substance: a material covered by Article 2 (a) in conjunction with Annex I to Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors (OJ L 327, 30.11.2004, p. EU No 1), as amended and in Article 2 (a), in conjunction with the Annex to Council Regulation (EC) No 111/2005 of 22 December 2004 laying down rules for the supervision of trade in Drug precursors between the Community and third countries (OJ C 327, 28.4.2002 EU 2005 No L 22 p. 1, 2006 No 23), as amended;
2.
Community: the European Communities;
3.
Third country: a State outside the Community;
4.
Import: any transfer of basic materials into the customs territory of the Community within the meaning of Article 2 (c) of Regulation (EC) No 111/2005 or into a part of the territory of the Federal Republic not belonging to the customs territory of the Community Germany;
5.
Export: any shipment of basic materials from the customs territory of the Community within the meaning of Article 2 (d) of Regulation (EC) No 111/2005 or from a part of the territory of the Federal Republic not belonging to the customs territory of the Community Germany;
6.
Mediation business: any activity to initiate the purchase, sale or supply of basic materials within the meaning of Article 2 (e) of Regulation (EC) No 111/2005;
7.
" placing on the market " means any supply of basic substances within the meaning of Article 2 (c) of Regulation (EC) No 273/2004;
8.
Manufacture: the winning, synthesizing, preparing, preparing, working or processing and converting basic materials;
9.
Economic operator: a natural or legal person, referred to in Article 2 (d) of Regulation (EC) No 273/2004 or in Article 2 (f) of Regulation (EC) No 111/2005.
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Section 2 Application of Regulations (EC) No 111/2005 and No 1277/2005

To the extent that Regulation (EC) No 111/2005 and Commission Regulation (EC) No 1277/2005 of 27 July 2005 laying down detailed rules for the application of Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and on Council Regulation (EC) No 111/2005 laying down rules for the supervision of trade in drug precursors between the Community and third countries (OJ L 327, 30.12.2005, p. EU No 7), as amended, to the customs territory of the Community, they must also be applied to the part of the territory of the Federal Republic of Germany which is not part of the customs territory of the Community. Unofficial table of contents

§ 3 Prohibitions

It is prohibited to have a basic substance intended to be used for the illicit manufacture of narcotic drugs, to trade with it, to import it without trade, to import it, to carry it out, through the scope or in the scope of the application. (b) to transport, dispose of, dispose of, or otherwise allow another person to obtain, acquire, or otherwise obtain the actual disposition of the law. Unofficial table of contents

§ 4 General arrangements against diversion

(1) Economic operators are required, within the framework of the diligence required in the transport sector, to take precautions to prevent the diversion of basic substances to the illicit manufacture of narcotic drugs. (2) Notifications pursuant to Article 8 (1) Regulation (EC) No 273/2004 and Article 9 (1) of Regulation (EC) No 111/2005 shall be addressed to the Joint Basic Surveillance Authority in accordance with § 6. Oral reports shall be repeated in writing within three days. The personal data transmitted may only be used in order to be able to use criminal offences and administrative offences in accordance with § § 19 and 20, the diversion of basic substances which can be used for the illicit manufacture of narcotic drugs, the the illicit manufacture of narcotics and the offences directly related to the aforementioned acts, offences in accordance with § 95 of the German Medicines Act and § § 324, 324a, 326, 330 and 330a of the Criminal Code, as well as to prevent and to prevent the offences referred to in § 100a (2) of the Code of Criminal Procedure (3) Anyone who, in accordance with the first sentence of paragraph 2, notifies facts of facts that may be concluded in respect of an offence pursuant to § 19, cannot be held responsible for this communication unless the communication is intentional or grossly negligent. has been reimbursed

Section 2
Competence and cooperation of the authorities

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§ 5 competent authorities

(1) The Federal Institute for Drugs and Medical Devices is the competent authority
1.
pursuant to Article 3 (notification by the responsible officer, permit, registration, charging of fees) and Article 8 (2) (information on operations relating to the substances covered) of Regulation (EC) No 273/2004,
2.
pursuant to Article 6 (permit), Article 7 (1) (registration), Article 9 (2) (information on export, import and brokering activities), Article 11 (subject to advance import), Article 12 (2), Article 13 (2), Article 14 (1), first subparagraph, and Articles 15 to 19 (export authorisation), Articles 20, 21 (2) and 23 to 25 (import authorisation) and Article 26 (5) (charging) of Regulation (EC) No 111/2005, and
3.
pursuant to Article 3 (notification by the responsible person responsible), Articles 5, 7 and 8 to 11 (permit), Articles 17 to 19 (information and notifications), Article 21 (subheading), Articles 23, 25, 26 (2) and 27 (1) and (3) (export and import authorisation) and Article 31 (revocation of open individual export licences) of Regulation (EC) No 1277/2005.
The customs authorities shall be responsible for the surveillance of the import and export of raw materials and of the movement of goods between the Member States of the Community. (3) Appointed authorities within the meaning of Article 11 (1) and (2). The second sentence of Regulation (EC) No 273/2004 and the second sentence of Article 27 of Regulation (EC) No 111/2005 are the Federal Institute for Medicinal Products and Medical Devices, the Customs Crime Office and the Common Basic Surveillance Authority in accordance with § 6. The Federal Institute for Medicinal Products and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, Bundesinstitut für Arzneimittel und Medizinprodukte) is responsible for the receipt of information, including personal data concerning the permit and approval procedures as well as the internal supervision of the medical device. Receipt of information on the monitoring of import and export as well as of the movement of goods between the Member States of the Community is the customs office of the customs office, and for the reception of information on criminal and other investigations shall be responsible for the Joint Basic Surveillance Authority in accordance with § 6. Unofficial table of contents

§ 6 Common base monitoring office of the Customs Crime Office and the Federal Criminal Police Office of the Federal Criminal Police Office

(1) The Joint Basic Surveillance Authority of the Customs Crime Office and the Federal Criminal Police Office is established at the Federal Criminal Police Office. It is responsible for the duties of the Customs Crime Office and the Federal Criminal Police Office in the field of basic monitoring. The tasks of the Joint Basic Monitoring Centre as well as the distribution of tasks and responsibilities within this body shall be consensual in detail by the Federal Ministry of the Interior and the Federal Ministry of Finance (2) As far as is necessary for the prevention and prosecution of the offences and administrative offences referred to in § 4 (2) sentence 3, the Joint Basic Surveillance Authority shall direct communications pursuant to Section 4 (2), § 5 (3) sentence 2 and § 11 (1) sentence 2 and 3 immediately continue to
1.
the Federal Criminal Police Office (Bundeskriminalamt) for the performance of its tasks in accordance with § § 2 to 4 (1) and (2) of the Federal Criminal Law Act,
2.
the competent national criminal office for the purpose of carrying out its task as a central office and for the prevention and prosecution of criminal offences,
3.
the customs office for the purpose of carrying out its duties in accordance with § § 3 and 4 of the Customs Obligations Service Act, or
4.
the competent customs office for the prevention and prosecution of criminal offences and administrative offences in accordance with Section 24 (2) of the Customs Code of Obligations.
(3) The Joint Baseline Monitoring Body shall immediately forward the notifications pursuant to § 4 (2) and § 5 (3) sentence 2 to the Federal Institute for Drugs and Medical Devices, insofar as they view the knowledge of the data for the performance of the The Federal Institute for Medicinal Products and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte-Bundesinstitut für Arzneimittel und Medizinprodukte-Bundesinstitut für Arzneimittel und Medizinprodukte-Bundesinstitut für Arzneimittel und Medizinprodukte-Bundesinstitut für Arzneimittel und Medizinprodukte) is required under this Act. (4) Furthermore, the Joint Basic Surveillance Authority may only 4 (2) sentence 3. Unofficial table of contents

Section 7 Participation of the Federal Police

The Federal Ministry of Finance, in agreement with the Federal Ministry of the Interior, may entrust the officers of the Federal Police, who are entrusted with tasks of border protection pursuant to Section 2 of the Federal Police Act, with the performance of tasks which in accordance with Article 5 (2), the customs authorities are responsible. In this case, Section 67 (2) of the Federal Police Act shall apply accordingly. Unofficial table of contents

Section 8 The powers of the customs authorities

In the case of criminal offences and administrative offences in accordance with § § 19 and 20, the competent prosecution authority may also investigate (Section 161 (1) sentence 1 of the Code of Criminal Procedure, § 46 (1) of the Code of Administrative Offences) also by the main offices or by the Authorities of the Customs Service and their officials. Section 21 (2) to (4) of the Foreign Trade Act shall apply accordingly. Unofficial table of contents

§ 9 Data at the Federal Institute for Drugs and Medical Devices

(1) The Federal Institute for Drugs and Medical Devices may use the personal data contained in the notifications under Articles 17 and 18 of Regulation (EC) No 1277/2005 only in order to prevent the offences referred to in § 19 and (2) In so far as it is necessary for the prevention and prosecution of the offences and administrative offences referred to in § 4 (2) sentence 3, the Federal Institute for Medicinal Products and Drug Law (Bundesinstitut für Arzneimittel und Bundesinstitut für Arzneimittel und Bundesinstitut für Arzneimittel und Bundesinstitut für Arzneimittel und Bundesinstitut für Arzneimittel und Bundesinstitut für Medical devices included in the notifications pursuant to Articles 17 and 18 of Regulation (EC) No 1277/2005 transfer of personal data to
1.
the Federal Criminal Police Office (Bundeskriminalamt) for the performance of its tasks in accordance with § § 2 to 4 (1) and (2) of the Federal Criminal Law Act,
2.
the customs office for the purpose of carrying out its duties in accordance with § § 3 and 4 of the Customs Obligations Service Act; and
3.
the competent customs authority for the performance of its tasks pursuant to Section 5 (2) and for the prevention and prosecution of criminal offences and regularties.
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§ 10 Automated data retrieval

(1) The Customs Crime Office may use the data stored at the Federal Institute for Medicinal Products and Medical Devices from the notifications provided for in Article 18 of Regulation (EC) No 1277/2005, including personal data, in the automated procedure retrieve. According to § 9 of the German Federal Data Protection Act, the Federal Institute for Medicinal Products and Medical Devices meets the relevant state of the art in appropriate measures to ensure data protection and data security, which in particular: Ensure confidentiality, authenticity and integrity of the data. In the case of the use of generally accessible networks, corresponding encryption methods are to be applied to the respective state of the art. (2) For the purpose of establishing an automated retrieval procedure, § 10 (2) to (5) of the Federal Data Protection Act. The Federal Institute for Medicinal Products and Medical Devices informs the Federal Commissioner for Data Protection and Freedom of Information about the establishment of the retrieval procedure and the findings made. (3) The Federal Institute for Drugs and medical devices and the Customs Crime Office record the times of the calls, the retrieved data as well as details that enable a clear identification of the person responsible for the retrieval. The protocol data may be used without the consent of the person concerned only for the control of the admissibility of the calls and shall be deleted after six months. Unofficial table of contents

Section 11 Mutual information

(1) If there are actual indications of the suspicion of a criminal offence pursuant to § 19, the customs authorities competent pursuant to § 5 (2) as well as the officers of the Federal Police entrusted in accordance with § 7 shall immediately inform the Customs Crime Office for the performance of the of its tasks in accordance with § § 3 and 4 of the Customs Obligations Service Act. The Customs Criminal Office shall, without prejudice to any other reporting obligations, forward this information without delay to the Joint Basic Surveillance Authority, in compliance with Section 30 of the Rules of the Tax Code. If there are actual indications of the suspicion of a criminal offence pursuant to § 19, the Federal Institute for Medicinal Products and Medical Devices and the Federal Criminal Police Office shall immediately inform the Joint Basic Surveillance Authority. The Joint Baseline Monitoring Centre may use the information provided under sentences 2 and 3 only for the purposes specified in Section 4 (2) sentence 3, including the forwarding pursuant to Article 6 (2). (2) The Federal Criminal Police Office, which The Federal Institute for Medicinal Products and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte) immediately provides information on facts, including personal data, from their point of view for decisions of the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte). for medicinal products and medical devices under this law, Regulation (EC) No 273/2004, Regulation (EC) No 111/2005 or Regulation (EC) No 1277/2005. In case of suspected breaches of regulations, prohibitions and restrictions of this law, the regulation will not be subject to a transmission. (3) In case of suspected violations of the law, prohibitions and restrictions of this law, the regulation (EC) No 111/2005 or Regulation (EC) No 1277/2005, which arises in the context of the performance of the tasks referred to in Article 5 (2), the customs authorities and the Federal Police (Bundespolizei), acting in accordance with Section 7, immediately inform the Federal Institute for Medicinal Products (Bundesinstitut für Arzneimittel) and medical devices and the Customs Crime Office, as far as they are (4) The Federal Institute for Medicinal Products and Medical Devices shall communicate to the customs authorities the information which has become known to him in the performance of his duties in accordance with this Act, in so far as this is done for the purpose of: (5) The Federal Criminal Police Office, the Landeskriminalämter and the Zollkriminalamt (Federal Criminal Police Office) shall transmit to the Joint Basic Monitoring Centre the obligation to comply with the reporting obligations in accordance with § 1 and 3 required information. (6) Third parties to which the data , the data may only be used for the purpose for which they have been transmitted. Use for other purposes is permitted, provided that the data may also have been transmitted for these purposes. Unofficial table of contents

§ 12 Reporting

(1) The Joint Groundwater Monitoring Centre shall report to the Federal Institute for Medicinal Products and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte)
1.
the seizures of basic materials, which have become known in the country, by type and quantity, and
2.
the methods of diversion, including the illicit manufacture of basic materials.
The report shall be submitted annually by 15 April for the last calendar year. (2) The reporting required under Article 13 (1) of Regulation (EC) No 273/2004 and in Article 32 (1) of Regulation (EC) No 111/2005 shall be the responsibility of the Member State. the Federal Institute for Medicinal Products and Medical Devices. (3) The reporting required under Article 29 (1) of Regulation (EC) No 1277/2005 is the responsibility of the Joint Basic Surveillance Authority.

Section 3
Transport of basic materials

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§ 13 Say of the permission in accordance with Article 6 (1) of Regulation (EC) No 111/2005

Article 3 (4), second sentence, of Regulation (EC) No 273/2004 shall apply mutas to the failure to grant permission in accordance with Article 6 (1) of Regulation (EC) No 111/2005. Unofficial table of contents

§ 14 Registration

Within one month, the Federal Institute for Drugs and Medical Devices will confirm the registration pursuant to Article 3 (6) of Regulation (EC) No 273/2004 or Article 7 (1) of Regulation (EC) No 111/2005. Unofficial table of contents

§ 15 Fees and Deposits

(1) The Federal Institute for Drugs and Medical Devices may charge for the individual attributable public services referred to in Article 3 (7) of Regulation (EC) No 273/2004 and Article 26 (5) of Regulation (EC) No 111/2005. to cover administrative burdens and expenses. (2) The Federal Ministry of Health is authorized, in agreement with the Federal Ministry of the Interior, the Federal Ministry of Finance and the Federal Ministry for Economic Affairs and Energy, to Technology by means of legal regulation without the consent of the Federal Council to determine the charges and the fees referred to in paragraph 1, and to provide fixed rates or framework rates. The Federal Fee Act shall be applied in accordance with Article 3 (7) of Regulation (EC) No 273/2004 and Article 26 (5) of Regulation (EC) No 111/2005.

Section 4
Monitoring

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Section 16 Monitoring measures

(1) The authorities responsible for monitoring the transport of raw materials or the persons responsible for monitoring shall be empowered to:
1.
require economic operators to provide all information necessary for monitoring;
2.
to consult the documents referred to in Article 5 (2) and (3) of Regulation (EC) No 273/2004 and Article 3 of Regulation (EC) No 111/2005 and to draw up copies thereof and to inspect the documents referred to in Article 5 (6) of Regulation (EC) No 101/2005 273/2004 or Article 4, sentence 3 of Regulation (EC) No 111/2005, and to require the expression of these documents in so far as they are intended for the detection or prevention of the illicit diversion of basic substances shall be required;
3.
to use the data processing systems of economic operators to verify the documents referred to in point 2; they may also require that the data be evaluated in an automated manner in accordance with their specifications, or that the data be processed automatically on data carriers that can be processed automatically shall be made available to the extent necessary for the detection or prevention of the illicit diversion of basic materials;
4.
To enter and visit land, buildings, parts of buildings, facilities and means of transport used for the transport of basic materials, in order to verify whether the provisions of this Act and of Regulation (EC) No 273/2004, which Regulation (EC) No 111/2005 and Regulation (EC) No 1277/2005. In order to prevent urgent threats to public safety, in particular to prevent an offence pursuant to § 19 or an administrative offence pursuant to § 20, the designated land, buildings, parts of buildings, facilities and means of transport shall be prohibited. are also entered outside the operating and business hours, as well as spaces used for residential purposes; the fundamental right of the inviolability of the apartment (Article 13 of the Basic Law) is restricted to this extent;
5.
on the prevention of urgent threats to the safety and control of the transport of commodities, provisional arrangements to the extent that the facts justify the assumption that:
a)
a basic substance for the illicit manufacture of narcotic drugs is to be diverted, or
b)
The provisions of this Act, Regulation (EC) No 273/2004, Regulation (EC) No 111/2005 or Regulation (EC) No 1277/2005 are not complied with.
In particular, they can prohibit all or part of the further participation in the transport of raw materials and ensure that the stocks of raw materials are made available. The competent authority shall, within one month of the adoption of a provisional arrangement, have the final decision. Measures taken by the persons responsible for monitoring shall be ineffective one month after the date of their notification. If no announcement is made, they shall become ineffective one month after they have been accepted. The competent authority may already repeal measures of any person responsible for monitoring.
(2) The customs authorities shall, within the limits of their jurisdiction pursuant to Article 5 (2), examine compliance with this law and the acts adopted by the European Communities in this field. For this purpose, they may request information and the submission of documents from the persons directly or indirectly involved in the movement of goods. Where there are doubts as to compliance with the provisions referred to above, in the case of intra-Community trade, the customs authorities shall arrange for the seizure, in the case of import and export, the suspension of the release or the restraint of the goods. Were on. If the doubts are not resolved within a period of seven working days, the customs authorities may order the confiscation of the goods in so far as the confiscation pursuant to section 21 is not taken into consideration. The costs of the security measures referred to in this provision may be imposed on the right of disposal. (3) The information obtained on the basis of surveillance measures pursuant to paragraphs 1 and 2 may only be subject to the information provided for in Article 4 (2) sentence 3 shall be used. The authorities responsible for monitoring the transport of raw materials may also transmit the information to the Joint Monitoring Centre without a request, in so far as, from their point of view, knowledge of the information provided for in Article 4 (2) of this Regulation is not required. Paragraph 3 shall be required. Unofficial table of contents

§ 17 Sample Frame

(1) To the extent necessary for the implementation of this Act, Regulation (EC) No 273/2004, Regulation (EC) No 111/2005 or Regulation (EC) No 1277/2005, the persons responsible for monitoring shall be entitled to: To request or withdraw samples for the purpose of the examination, after their selection. Unless expressly waived, part of the sample, or if the sample is not partially or without endangering the purpose of the examination, is not divisible into parts of the same quality, a second piece of the same type as the sample (2) Withdrawal of rehearsals shall be officially closed or sealed. They shall be accompanied by the date of the sampling and the date of the day after which the closure or sealing shall be deemed to have been lifted. Unofficial table of contents

§ 18 Dulunding and co-action obligations

(1) Each economic operator shall be obliged to take measures in accordance with § § 16 and 17 and to assist in the implementation of the surveillance, in particular at the request of the persons responsible for monitoring the bodies in which they are responsible. the transport of raw materials takes place, the premises, buildings, rooms, containers and containers must be opened, information should be provided, documents must be provided and samples must be taken. (2) The information provided may be provided by the following: refuse to answer any such questions, the answers to which shall be answered by themselves or by a of its members of the Civil Procedure Code, referred to in Article 383 (1) (1) to (3) of the Code of Civil Procedure, would suspend criminal proceedings or proceedings under the Law on Administrative Offences. The person who is obliged to provide information on his/her right to refuse to provide information is to be provided with information.

Section 5
Criminal and penal rules

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Section 19 Criminal Code

(1) With a custodial sentence of up to five years or a fine shall be punished, who
1.
Contrary to § 3, a basic substance has, manufactures, trade with him, imports, carries out, carries out, carries out, carries out, through or in the scope of this law, disposeates, disposeates or in any other way, the possibility of another , to obtain, acquire or otherwise procured the actual disposition of the person,
2.
has, contrary to Article 3 (2) of Regulation (EC) No 273/2004, a basic substance listed in category 1 of Annex I to this Regulation, without authorisation or placing on the market,
3.
, contrary to Article 6 (1) of Regulation (EC) No 111/2005, a basic substance listed in category 1 of the Annex to this Regulation introduces, carries out, or operates a mediation business with, without authorisation,
4.
is, contrary to Article 12 (1) of Regulation (EC) No 111/2005, carrying out a non-export basic substance referred to in category 1, 2 or 3 of the Annex to this Regulation, or
5.
, contrary to Article 20 of Regulation (EC) No 111/2005, introduces a basic substance, referred to in category 1 of the Annex to this Regulation, without the import authorisation.
(2) The trial shall be punishable. (3) In particularly serious cases of paragraph 1, the penalty shall be not less than one year. A particularly serious case is usually present when the perpetrator
1.
commercial or
2.
as a member of a gang that has committed itself to continuing the commission of such acts.
In particularly serious cases, Section 73d of the Penal Code shall apply. (4) If the offender is negligent in the cases referred to in paragraph 1, the penalty shall be a custodial sentence of up to one year or a fine. (5) Insofar as Regulation (EC) No 273/2004 or Regulation (EC) No 111/2005 is to be referred to in each case the version in force on 18 August 2005. Unofficial table of contents

Section 20 Penal rules

(1) Contrary to the law, those who intentionally or negligently act
1.
in an application pursuant to Article 5 of Regulation (EC) No 1277/2005, make an incorrect indication or insert an incorrect document,
2.
Contrary to Article 3 (3) of Regulation (EC) No 273/2004, a basic substance referred to in category 1 of Annex I to this Regulation shall be issued in the Community,
3.
contrary to Article 3 (6) of Regulation (EC) No 273/2004, the Federal Institute for Medicinal Products and Medical Devices, the address of the premises in which a basic substance referred to in category 2 of Annex I to this Regulation is manufactured or which is operated on the market, does not, before placing on the market, does not indicate correctly, does not indicate in full or not in time or does not notify the modification of the change, not correct, not complete or not in time,
4.
Contrary to Article 7 (1) of Regulation (EC) No 111/2005, the Federal Institute for Medicinal Products and Medical Devices, the address of the premises, of which a basic substance referred to in category 2 of the Annex to Regulation (EC) No 111/2005 is , is not, not properly, not correct, not correct, not correct, not fully or not communicated in time, not in full or in full or in time,
5.
contrary to Article 7 (1) of Regulation (EC) No 111/2005, including in conjunction with the second subparagraph of Article 14 (2) or (2) and Annex II to Regulation (EC) No 1277/2005, the Federal Institute for Medicinal Products and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte), the address of the premises of which a basic substance referred to in category 3 of the Annex to Regulation (EC) No 111/2005 is exported, not correctly, not fully or not in good time, is not correct, is not correct, is not correct, does not fully or not in a timely manner,
6.
contrary to Article 5 (1) and (2) of Regulation (EC) No 273/2004, a procedure leading to the placing on the market of a basic substance referred to in category 1 or 2 of Annex I to this Regulation shall not be properly used in commercial documents such as invoices, documentation of cargo, administrative documents or freight and other transit documents, or, contrary to Article 5 (3) of this Regulation, do not include a statement by the customer,
7.
Contrary to Article 3 of Regulation (EC) No 111/2005, imports or exports of commodities or brokering with commodities are not properly carried out in customs and commercial documents such as summary declarations, customs declarations, invoices, documentation of cargo or cargo and other shipping documents,
8.
contrary to Article 5 (5), including in conjunction with paragraph 6 of Regulation (EC) No 273/2004, the commercial documents referred to in Article 5 (2) and (3) of this Regulation shall not, or not at least three years after the end of the calendar year, in which the trade document referred to in Article 5 (1) of this Regulation has taken place,
9.
contrary to Article 4 of Regulation (EC) No 111/2005, the customs and trade documents referred to in Article 3 of that Regulation shall not, or not at least three years after the end of the calendar year, in which the operation referred to in Article 3 of this Regulation has been held,
10.
contrary to Article 7 of Regulation (EC) No 273/2004, a basic substance, referred to in category 1 or 2 of Annex I to this Regulation, including mixtures and natural products containing such basic substances, before they are delivered in the Community not, or not in the prescribed form,
11.
contrary to Article 5 of Regulation (EC) No 111/2005, a basic substance, including mixtures and natural products containing raw materials, does not appear before import or export, or does not mark the prescribed form,
12.
in accordance with the provisions of Article 17 (1) of Regulation (EC) No 1277/2005, in conjunction with Article 19 (1) of Regulation (EC) No 1277/2005, a notification of the quantities of products listed in category 1 or 2 of Annex I to Regulation (EC) No 1277/2005 273/2004, which have been supplied by it in the previous calendar year within the Community, shall not be reimbursed, not properly, in full or in good time,
13.
Contrary to Article 18, in conjunction with Article 19 (1) of Regulation (EC) No 1277/2005, the Federal Institute for Medicinal Products and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, Bundesinstitut für Arzneimittel und Medizinprodukte, Bundesinstitut für Arzneimittel und Medizinprodukte), a report on exports, imports or the calendar year has not been reimbursed, not correct, not fully or in good time,
14.
does not, contrary to Article 13 (1) of Regulation (EC) No 111/2005, make an indication, not correct or complete, in an application for export authorisation,
15.
a comprehensive export authorisation requirement referred to in the first sentence of Article 14 (1) of Regulation (EC) No 111/2005, by indicating at the place of transfer from the customs territory of the Community a declaration of the route or the route of transport the means of transport do not make, not correct or not complete,
16.
does not, contrary to Article 21 (1) of Regulation (EC) No 111/2005, make an indication, not correct or complete, in an application for import authorisation, or
17.
Contrary to Section 18 (1) of the Dulling or Obligation To Participate, it does not comply.
(2) The administrative offence can be punished with a fine of up to twenty-five thousand euros. (3) The Federal Institute for Drugs and Drug Administration is the administrative authority within the meaning of Section 36 (1) (1) of the Law on Administrative Offences. Medical devices. (4) Where reference is made to Regulation (EC) No 273/2004, Regulation (EC) No 111/2005 or Regulation (EC) No 1277/2005, the version in force on 18 August 2005 shall be applicable in each case. Unofficial table of contents

Section 21 confiscation

Items to which a criminal offence pursuant to § 19 or an administrative offence pursuant to § 20 relates may be collected. Section 74a of the Penal Code and Section 23 of the Code of Administrative Offences shall apply.

Section 6
Final provisions

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Section 22 Bundeswehr

(1) This Act, as well as Regulation (EC) No 273/2004, Regulation (EC) No 111/2005 and Regulation (EC) No 1277/2005 apply accordingly to the Bundeswehr (Bundeswehr). (2) In the area of the Bundeswehr, the monitoring of traffic is incumbable with the Bundeswehr. The Federal Ministry of Defence, in agreement with the Federal Ministry of Health, may, in individual cases, make exceptions to this Act and to the Federal Ministry of Defence. Regulation (EC) No 273/2004, Regulation (EC) No 111/2005 and Regulation (EC) No 273/2004 Regulation (EC) No 1277/2005, in so far as these are compelling reasons for the defence, and the international addictive surplus income does not preclude it.