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Anesthetic domestic trade regulation

Original Language Title: Betäubungsmittel-Binnenhandelsverordnung

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Anaesthesiological Federal Trade Regulation (BtMBinHV)

Unofficial table of contents

BtMBinHV

Date of completion: 16.12.1981

Full quote:

" Narcotic Domestic Trade Ordinance of 16 December 1981 (BGBl. 1425), as last amended by Article 1 of the Regulation of 17 August 2011 (BGBl I). I p. 1754).

Status: Last amended by Art. 1 V v. 17.8.2011 I 1754

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 12 (4) of the Narcotics Act of 28 July 1981 (BGBl. I p. 681) shall be assigned: Unofficial table of contents

§ 1

Anyone who surrenders narcotics according to § 12 (1) of the Narcotics Act has to submit a delivery receipt in writing, using the official form pursuant to § 6 (1) sentence 1 or electronically in accordance with § 6 (1) sentence 2. create. Unofficial table of contents

§ 2

(1) The donating person shall, in accordance with the following information, agree on all parts of the delivery receipt (submission, receipt, delivery note, and delivery note):
1.
BtM number, name or company name and address of the donor; in the case of a delivery with several premises, the BtM number and address of the issuing plant,
2.
BtM number, name or company name and address of the acquirer; in the case of purchasers with a number of premises, the BtM number and address of the working plant,
3.
for any given narcotics:
a)
Pharmaceutical Central Number,
b)
number of package units,
c)
Package unit according to the pharmaceutical central number used (in the case of 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.
Submission date.
The transferor has to sign the submission by hand with a pen or with his electronic signature. (2) If the transferor or acquirer is a public authority referred to in § 4 (2) or § 26 of the Narcotics Act, or The reference to the BtM number referred to in the first sentence of paragraph 1 (1) or (2) shall not be specified. The indication of the pharmacological centre number of the narcotic agent referred to in the first sentence of paragraph 1 (3) (a) shall be deleted if such a number is provided by the Federal Institute for Medicinal Products and Medical devices have not been made known. (3) (dropped) Unofficial table of contents

§ 3

(1) The acknowledgement of receipt and the delivery note shall be sent to the acquirer together with the narcotics as documents or electronic documents. (2) For the notification of the levy in accordance with § 12 para. 2 of the Narcotics Act, the Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices) to send the delivery notification within one week after the delivery. (3) The delivery note shall be kept subject to the provision of § 4 (2) to the receipt of the acknowledgement of receipt. Unofficial table of contents

§ 4

(1) The acquirer has
1.
check the information on the parts of the delivery receipt (receipt and delivery note) that have been delivered to him,
2.
, where appropriate, any discrepanation made by him in writing or in an electronic manner in such a way that the information provided by the donor as such shall not be altered,
3.
to provide these parts in writing or in electronic form with the date of receipt and to sign them with ball-point pens or to provide them with their electronic signature; and
4.
to return the acknowledgement of receipt to the donor at the latest on the working day following the receipt of the narcotics.
(2) In the case referred to in paragraph 1 (2), the donor shall:
1.
in writing or in electronic form on the delivery note
a)
the date of receipt of the acknowledgement of receipt and
b)
the deviations referred to by the acquirer referred to in paragraph 1, point 2, to be identified as such and to be declared correct, and then
2.
send the delivery note to the Federal Institute for Medicinal Products and Medical Devices within one week after receipt of the acknowledgement of receipt.
Unofficial table of contents

§ 5

The receipt confirmations or up to the receipt thereof shall be kept by the transferee in accordance with the delivery data, the delivery notes shall be kept separately from the acquirer by the acquirer according to the working data for three years and at the request of the according to § 19 para. 1 of the To send a competent authority to the competent authority, to submit to this authority or to make it available to them in the case of electronic storage. The time limit shall begin for the donor with the date of delivery, for the acquirer with the date of receipt of the narcotics. Unofficial table of contents

§ 6

(1) The Federal Institute for Drugs and Medical Devices publishes the official form according to § 1 and makes it known in the Federal Gazette (Bundesanzeiger). For the electronic procedure, the Federal Institute for Drugs and Medical Devices lays down the conditions for processing and, on its website www.bfarm.de, announcites in particular the following:
1.
the electronic design to be used and the format in which the electronic documents must be submitted,
2.
the details of the procedure to be followed in the case of electronic transmission, including the encryption standard.
(2) 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-Bundesinstitut für Arzneimittel und Medizinprodukte-Bundesinstitut für Arzneimittel und Medizinprodukte) assigns the persons and persons Pharmacist numbers for narcotic drugs (§ 2 (1) sentence 1 no. 3 (a)) on its website www.bfarm.de. Unofficial table of contents

§ 7

Contrary to the provisions of Section 32 (1) No. 6 of the Narcotics Act, who intentionally or negligently
1.
contrary to § 1, does not draw up a delivery receipt,
2.
Contrary to § 2 (1) sentence 1 on a delivery receipt, an indication is not made, not correct, not complete, not consistent or not in the prescribed manner,
3.
Contrary to the second sentence of Article 2 (1), the submission of the report is not subject to or is not prescribable by means of an electronic signature, or
4.
Contrary to § 3 (3), the delivery note is not retained,
5.
Contrary to § 4 (1), the receipt of the receipt or the delivery note does not appear with the date of receipt, does not sign or does not prescribe the receipt of the receiving date, or does not provide for its electronic signature, or does not provide for any discrepanic deviations in them or not properly remarked or the acknowledgement of receipt does not return in due time,
6.
Contrary to § 4 (2), the delivery note does not appear with the date of receipt of the acknowledgement of receipt, does not accept any discrepanic deviations or does not apply in accordance with the rules of the delivery note, or does not take this in good time to the Federal Institute for medicinal products and medical devices, or
7.
Contrary to § 5, the parts of the delivery document referred to there are not kept or not kept in accordance with the rules.
Unofficial table of contents

§ 8 (omitted)

- Unofficial table of contents

§ 9

(1) This Regulation shall enter into force on 1 January 1982. (2) Unofficial table of contents

Final formula

The Federal Minister for Youth, Family and Health