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Anesthesiological external trade regulation

Original Language Title: Betäubungsmittel-Außenhandelsverordnung

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Anaesthesiological Foreign Trade Regulation (BtMAHV)

Unofficial table of contents

BtMAHV

Date of completion: 16.12.1981

Full quote:

" Narcotics Trade Ordinance of 16 December 1981 (BGBl. 1420), as last amended by Article 3 of the Regulation of 19 June 2001 (BGBl I). I, p. 1180).

Status: Last amended by Art. 3 V v. 19.6.2001 I 1180

For more details, please refer to the menu under Notes

Footnote

(+ + + Text evidence from: 1.1.1982 + + +) Unofficial table of contents

Input formula

On the basis of Section 11 (2) of the Narcotics Act of 28 July 1981 (BGBl. 681), the Federal Government decrees:

I.
Import

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§ 1 Import application

(1) Anyone wishing to import narcotics shall apply for an import permit from the Federal Institute for Medicinal Products and Medical Devices for each import consignment using an official form. (2) The applicant shall have the following information: The following information shall be submitted:
1.
BtM number, name or company and address of the importer; in the case of a importer with a number of premises, the BtM number and address of the importing establishment,
2.
name or business name and address of the non-resident exporter and the BtM number and name of the exporting country,
3.
for any narcotics to be introduced:
a)
Pharmacist's number, as far as it is disclosed,
b)
number of package units,
c)
Pack unit (for substances and undivided preparations, the quantity by weight, in the case of preparations which have been divided up, the number of units),
d)
Name of the narcotic agent, in addition:
-
in the case of preparations which have been divided, the form of administration and the weight of the pure substance contained in milligrams per unit of form,
-
in the case of preparations not divided, the form of administration and the weight of the pure substance contained per unit of pack,
-
in the case of raw, uncleaned and undivided narcotic drugs, the percentage by weight of the pure substance contained;
4.
the designated transport route and the names and addresses of the carriers;
5.
a)
in the case of imports from a State which is not a member of the European Union, the name and address of the customs office which is to be introduced in accordance with the first sentence of Article 4,
b)
on imports from a Member State of the European Union, the words 'EU trade in goods',
6.
in so far as the narcotic agents are to be stored under customs control, the name and address of the warehouse and the name and address of the warehousekeeper or the warehousekeeper.
(3) In order to introduce certain and manufactured narcotics for transit, the import application shall be accompanied by the export authorisation or export declaration of the exporting country which has accompanied the narcotic agents. The Federal Institute for Drugs and Medical Devices shall return these to the competent authority of the exporting country responsible for the control of narcotic drugs. Unofficial table of contents

§ 2 Reasons for the sayoning

(1) The Federal Institute for Drugs and Medical Devices shall fail to approve the import authorisation if the import of the stunning agent to a financial institution is to be made available to a person other than that of the importer or to a mail box. (2) The Federal Institute for Medicinal Products and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte) has also failed to approve the import authorisation or to limit the amount of the narcotic agent to be introduced, if the Importation shall not be carried out within the limits of the estimate of the Federal Republic of Germany published by the International Narcotics Control Board, unless proof is provided by the importer that the said narcotic agent is not (3) The Federal Institute for Medicinal Products and Medical Devices may refuse import authorisation if the safety or control of the medicinal product is subject to the There is no guarantee of the transport of anesthetic drugs. Unofficial table of contents

§ 3 Import approval

(1) The Federal Institute for Medicinal Products and Medical Devices shall issue an import permit using official forms in triplicate and to be issued in three copies. It shall send two copies to the importer and a copy of the authority of the exporting country responsible for the control of narcotic drugs. (2) The import authorisation shall not be transferable. It shall be limited to a maximum of three months and, in the case of imports to be carried out by sea, for a maximum period of six months. The time limits may be extended upon application if the importer proves that the narcotic drugs are already on the transport. Unofficial table of contents

Section 4 Import duty

Anesthetic agents may only be introduced via a customs office designated by the Federal Minister of Finance. They shall be notified to this customs office, upon presentation of a copy of the import permit, and shall be presented on request. This provision shall not apply to imports from a Member State of the European Union. Unofficial table of contents

Section 5 Storage under customs control

If only the storage under customs control is authorised in the import authorisation, the narcotic agents may only be stored in a customs facility, a customs clearance or a free port. The stored narcotic agents must not be subjected to any treatment which is likely to alter the nature, packaging or marking. They may only be executed in accordance with the provisions of § § 7 to 12. If the narcotics are to remain within the scope of the Narcotics Act, the written consent of the Federal Institute for Medicinal Products (Bundesinstitut für Arzneimittel und Bundesinstitut für Arzneimittel und Bundesinstitut für Arzneimittel und Bundesinstitut für Arzneimittel und dem Bundesinstitut für Arzneimittel und dem Bundesinstitut für Arzneimittel und dem Freihafen) Medical devices required. Unofficial table of contents

§ 6 Import indication

(1) The importer shall immediately notify the Federal Institute for Medicinal Products and Medical Devices of the import and the indication of the actual importation of the products according to § 1, paragraph 2, the number and the date of issue of the Import authorisation and import date. The import notification shall be accompanied by the import permit issued with a customs clearance notice. An official form shall be used for the display. (2) Paragraph 1, second sentence, shall not apply to the importation from a Member State of the European Union. In such a case, the importer shall, on the back of the import authorisation to be annexed, give the following information in the field designated for the customs clearance entry:
a)
the number and date of issue of the commercial invoice or packing list; and
b)
Number and date of issue of the freight document, indicating the carrier
(3) If the narcotics are not introduced within the time limit specified in the import permit, this shall be the Federal Institute for Medicinal Products and Medical Devices without delay. The notification shall be accompanied by the import permit.

II.
Export

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Section 7 Export application

(1) Anyone wishing to carry out narcotics shall apply for an export authorisation from the Federal Institute for Medicinal Products and Medical Devices for each export consignment using an official form. (2) The applicant shall have the following: The following information shall be provided:
1.
BtM number, name or company name and address of the exporter; in the case of an exporter with a number of premises, the BGA number and address of the operating establishment,
2.
the name or business name and address of the non-resident importer, the shipping address and the BtM number and name of the importing country,
3.
the number and date of issue of the import authorisation and the name and address of the issuing authority of the importing country,
4.
for any narcotics to be carried out:
a)
Pharmacist's number, as far as it is disclosed,
b)
number of package units,
c)
Pack unit (for substances and undivided preparations, the quantity by weight, in the case of preparations which have been divided up, the number of units),
d)
Name of the narcotic agent, in addition:
-
in the case of preparations which have been divided, the form of administration and the weight of the pure substance contained in milligrams per unit of form,
-
in the case of preparations not divided, the form of administration and the weight of the pure substance contained per unit of pack,
-
in the case of raw, uncleaned and undivided narcotic drugs, the percentage by weight of the pure substance contained;
5.
the number and type of packages in which the narcotics are to be carried out and the markings placed on them,
6.
the transport route and the names and addresses of the carriers;
7.
a)
in the case of export to a Member State which is not a member of the European Union, the name and address of the customs office which is to be exported in accordance with the first sentence of Article 11 (1),
b)
in the case of export to a Member State of the European Union, the words 'EU trade in goods',
8.
provided that the narcotic agents are stored under customs control, the name and address of the warehouse, and the name and address of the warehousekeeper or the warehousekeeper.
(3) The export application shall be accompanied by the import authorization of the country of import responsible for the control of narcotics in the importing country. It must comply with the formal requirements of the international substandard income even if the importing country has not acceded to this Convention. (4) To transit certain and manufactured narcotic drugs into a country other than in the case of where the country of destination indicated in the accompanying export authorisation or declaration of export is diverted or returned to the exporting country, the export application shall be accompanied by such an export permit or export declaration. The Federal Institute for Drugs and Medical Devices shall return these to the competent authority of the exporting country responsible for the control of narcotic drugs. Unofficial table of contents

§ 8 Reasons for the Say

(1) The Federal Institute for Drugs and Medical Devices shall fail to approve the export authorisation if:
1.
the export of narcotic drugs to a financial institution is to be made available to a person other than that of the non-resident consignee or to a post,
2.
they are narcotics of Annex I of the Narcotics Act, which are to be exported for storage in a customs warehouse of the importing country,
3.
the drugs are to be exported for storage in a customs warehouse of the importing country and the storage of the consignment in a customs warehouse is not authorised in the import permit,
4.
the export application is not accompanied by a foreign import permit or a foreign import permit corresponding to the formal requirements of the international drug-addicts ' income;
5.
The importing country of the Federal Republic of Germany has informed the Secretary-General of the United Nations of the fact that it prohibids the import of the narcotic drugs.
(2) The Federal Institute for Medicinal Products and Medical Devices shall also refuse to grant an export authorisation or to restrict the quantity of the narcotic agent to be exported if the export is not within the scope of the International Narcotics Control Board the declared estimate of the importing country for this narcotic agent may be carried out, unless the import permit indicates that the narcotic agent is intended for re-export, or that the exporter provides evidence of the presence of the anesthetic, that the narcotic agent is indispensable for the treatment of a patient. (3) The Federal Institute for Medicinal Products and Medical Devices may refuse the export authorisation if there are reasonable grounds for suspecting that the anesthetic in the importing country is not intended for medical, scientific or other permitted purposes. or if the safety or control of the movement of narcotic drugs is not guaranteed. Unofficial table of contents

§ 9 Export Authorisations

(1) The Federal Institute for Drugs and Medical Devices shall issue an export permit using official forms in triplicate. It shall send two copies to the exporter and a copy of the authority of the importing country responsible for the control of narcotic drugs. (2) The export authorisation shall not be transferable. It shall be limited up to the expiry of the import authorisation of the importing country, but not more than three months. Unofficial table of contents

§ 10 Labelling

Narcotics intended for export are to be described in the commercial invoices, delivery notes, loading lists, shipping and customs documents in accordance with § 14 (1) sentence 1 of the Narcotics Act. In the commercial invoice and the delivery note, the markings on the packages and the numbers and exhibition data of the export licence and the associated import permit shall be indicated. The Federal Institute for Drugs and Medical Devices may, on a case-by-case basis, grant exemptions if this is necessary in accordance with the rules of the importing country. Unofficial table of contents

Section 11 Export duties

(1) Narcotic drugs may only be exported via a customs office designated by the Federal Minister of Finance. They shall be notified to this customs office on presentation of a copy of the export authorisation and shall be presented on request. This provision shall not apply to the export to a Member State of the European Union. (2) A further copy of the export authorisation shall be attached to the transit documents. It accompanies the narcotics into the importing country. Non-consignments of anesthetic material shall not be dispatched or dispatched. Unofficial table of contents

§ 12 Export indication

(1) The exporter shall immediately notify the Federal Institute for Medicinal Products and Medical Devices of the export effected and shall indicate with the information corresponding to the actual export in accordance with § 7 (2) No. 1 to 7, the number and the Date of issue of the export authorisation and the date of export. The export notification shall be accompanied by the export authorisation issued with a customs clearance note. An official form shall be used for the display. (2) Paragraph 1, second sentence, shall not apply to exports to a Member State of the European Union. In such a case, the exporter shall, on the back of the export authorisation to be annexed, provide the following information in the field designated for the customs clearance entry:
a)
the number and date of issue of the commercial invoice or packing list; and
b)
Number and date of issue of the freight document, indicating the carrier
(3) If the narcotics are not exported within the time limit specified in the export authorisation, this shall be the Federal Institute for Medicinal Products and Medical Devices without delay. The display shall be accompanied by both copies of the export licence.

III.
Transit

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§ 13

(1) A narcotic agent may not be subject to the provisions of the Narcotics Act but may not be subject to customs supervision other than that caused by the carriage or cover, and without the narcotic agent being used for any purpose. The date of the introduction is actually made available to the person carrying out the procedure or to a third person. They must not be subjected to any treatment during transit, which is suitable for changing the nature, labelling, packaging or markings. In the case of the movement of narcotics with a Member State of the European Union, customs supervision is not required. (2) Insofar as narcotic agents do not carry out transit operations on the basis of the international drug-related income Export authorisation or export declaration of the exporting country shall be accompanied only with the approval of the Federal Institute for Medicinal Products and Medical Devices for transit. (3) For the transit of certain narcotic drugs may be authorized. in each case only through a customs office designated by the Federal Minister of Finance in the from the scope of the Narcotics Act. They shall be notified to these customs authorities, on presentation of the export authorisation or export declaration of the exporting country accompanying them, or the approval of the Federal Institute for Medicinal Products and Medical Devices referred to in paragraph 2, and on request. . This does not apply to the movement of narcotic drugs with a Member State of the European Union. (4) The use of narcotic drugs to transit may only be used to amend this purpose.
1.
in accordance with the provisions of § § 1 to 6, or
2.
in accordance with the provisions of § § 7 to 12, are diverted to a destination other than the country of destination specified in the export authorisation or export declaration, or returned to the exporting country.
(5) Paragraphs 2 to 4 shall not apply to the transit of narcotic drugs in the case of stopover in the air transport sector or in the case of landings in maritime transport if the narcotics are not discharged from the aeroplane or the seagoing ship.

IV.
Derogations

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Section 14 Imports and exports within the framework of international cooperation

(1) The federal and state authorities may also use narcotics for the field of their official activities and the authorities responsible for the investigation of narcotics in accordance with the simplified procedure laid down in paragraphs 2 to 4. Introduce or execute the method. The provisions of § § 1 to 12 shall not apply in this respect. (2) On importation, the importer shall have the foreign export permit or the corresponding foreign export declaration with a confirmation of the type and quantity of the received (3) For the export of the narcotic drugs, the exporter has to send a Export declaration using an official form in five-time copies , The export declaration shall provide the following information:
1.
the name and address of the exporter,
2.
the name and address of the non-resident importer and the name of the importing country;
3.
the quantity and designation of the narcotics,
4.
Purpose of export,
5.
the transport route and carrier;
6.
Name and address of the competent authority of the importing country responsible for the control of narcotic drugs.
(4) Of the copies referred to in paragraph 3, the first copy shall accompany the narcotic agents in the importing country. The second and third outlays shall be accompanied by the date of dispatch and shall be sent immediately to the Federal Institute for Medicinal Products and Medical Devices, which shall forward a copy of the authority referred to in paragraph 3 (6). The exporter shall send out the fourth copy to the non-resident importer. The fifth copy shall be provided by the exporter with the date of dispatch and shall be kept for three years from the date of the date of issue. Unofficial table of contents

Section 15 Simplified cross-border transport

(1) The provisions of § § 1 to 12 shall not apply to preparations of the substances listed in Annexes II and III of the Narcotics Act, which are either:
1.
by doctors, dentists or veterinarians on the permissible medical, dental or veterinary practice or on the first aid in appropriate quantities, or
2.
By other persons in the duration of the journey reasonable quantities due to medical prescription or certificate for your own needs
(2) The provisions of § § 1 to 12 shall not apply to narcotic drugs if they are used in appropriate quantities as equipment for the first assistance or for other urgent cases in The provisions of § § 7 to 12 shall not apply to narcotics used in the event of a disaster by aid organizations, manufacturers, or any other means of transport. (3) other suppliers who have been authorised to do so in accordance with § 3 (1) of the Stunning Resources Act, based on the Model Guidelines for the International Provision of Controlled Medicines for Emergency Medical Care of the World Health Organization (document WHO/PSA/96.17; World Health Organization, 1211 Geneva 27, Switzerland).

V.
Irregularities

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§ 16

Contrary to the provisions of Section 32 (1) No. 6 of the Narcotics Act, who intentionally or negligently
1.
, contrary to § 1 para. 2 or § 7 para. 2, in the import or export request, inaccurate or incomplete information is provided or
2.
, contrary to § 6 (1) sentence 1 or 2 sentence 2 or § 12 (1) sentence 1 or 2 sentence 2, the entry or export authorisation or the import or export authorisation does not, either correctly or not completely, provide for the information specified therein.

VI.
Final provisions

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Section 17 Insuring customs offices

In the Federal Gazette, the Federal Minister of Finance announctifies the customs offices in which narcotics are made for import, export and transit. Unofficial table of contents

Section 18 Other provisions

The Federal Institute for Drugs and Medical Devices publishes the official forms according to § 1 (1), § 3 (1) sentence 1, § 6 (1) sentence 3, § 7 (1), § 9 (1) sentence 1, § 12 paragraph 1 sentence 3 and § 14 para. 3 sentence 1 and makes them in the Federal Gazette known. It assigns the BtM numbers to the importers or exporters in accordance with § 1 para. 2 No. 1 and § 7 para. 2 no. 1, makes the BtM numbers of the importing and exporting countries according to § 1 para. 2 No. 2 and § 7 para. 2 No. 2 and the pharmaceutical central numbers according to § 1 para. 2 No. 3 Point (a) and § 7 (2) (4) (a) of the narcotics in the Federal Gazette. Unofficial table of contents

§ 19 Berlin-clause

This regulation applies in accordance with § 14 of the Third Transfer Act in connection with § 41 sentence 2 of the Narcotics Act also in the Land of Berlin. Unofficial table of contents

Section 20 Entry into force

(1) This Regulation shall enter into force on 1 January 1982. (2)