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Regulation on prescribing, issuing and demonstrating the whereabout of narcotic drugs

Original Language Title: Verordnung über das Verschreiben, die Abgabe und den Nachweis des Verbleibs von Betäubungsmitteln

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Regulation on prescribing, issuing and proving the whereabout of narcotics (narcotics prescribing prescription-BtMVV)

Unofficial table of contents

BtMVV

Date of completion: 20.01.1998

Full quote:

" Narcotics Prescription regulation of 20 January 1998 (BGBl. 74, 80), as last amended by Article 2 of the Regulation of 5 December 2014 (BGBl I). I p. 1999) "

Status: Last amended by Art. 2 V v. 5.12.2014 I 1999

For more details, please refer to the menu under Notes

Footnote

(+ + + Text evidence from: 1.2.1998 + + +)
The regulation was adopted as Article 3 V 2121-6-24/4 v. 20.1.1998 I 74 (BtMÄndV 10) by the Federal Government with the consent of the Federal Council. She's gem. Article 6, first sentence, entered into force on 1 February 1998. Unofficial table of contents

§ 1 Principles

(1) The narcotic agents referred to in Annex III to the Narcotics Act may only be prescribed as preparations. The provisions of this Regulation shall also apply to salts and molecular compounds of narcotic drugs which, according to the findings of medical science, are subject to medical, dental or veterinary use. Unless otherwise specified in the individual case, the maximum quantity fixed for a narcotic agent shall also apply to its salts and molecular compounds. (2) Narcotic drugs for a patient or an animal and for the practical needs of a physician, Dentists or veterinarian may only have to submit a finished stun prescription (prescription), for the station requirements, for the emergency requirements according to § 5c and the rescue service requirements according to § 6 (1) only after presentation of a Stunning agent requirement (prescription for the station requirement, the (3) The whereabout and the inventory of the narcotics are to be demonstrated in full:
1.
in pharmacies and veterinary skin pharmacies,
2.
in practices of doctors, dentists and veterinarians,
3.
at stations of hospitals and veterinary clinics,
4.
in old-and nursing homes, in hospices and institutions of specialized outpatient palliative care,
5.
in the provision of rescue services,
6.
in institutions referred to in Article 5 (9b) and
7.
on fishing boats carrying the flag of the Federal Republic.
Unofficial table of contents

§ 2 Letter from a doctor

(1) For a patient, the doctor may prescribe within 30 days:
a)
up to two of the following narcotic drugs, in accordance with the maximum limits set below:

1. Amfetamine 600 mg,
2. Buprenorphine 800 mg,
2a. Cannabis extract (referred to the 9 -tetrahydrocannabinol content) 1 000 mg,
3. Codeine as a substitution agent 40 000 mg,
3a. Dexamfetamine 600 mg,
3b. Diamorphine 30 000 mg,
4. Dihydrocodeine as a substitution agent 40 000 mg,
5. Dronabinol 500 mg,
6. Fenetyllin 2 500 mg,
7. Fentanyl 500 mg,
7a. Flunitrazepam 30 mg,
8. Hydrocodon 1 200 mg,
9. Hydromorphon 5 000 mg,
10. Levacetylmethadol 2 000 mg,
11. Levomethadon 1 500 mg,
11a. Lisdexamfetamine dimesilate 2 100 mg,
12. Methadone 3 000 mg,
13. Methylphenidate 2 400 mg,
14. (dropped)
15. Morphine 20 000 mg,
16. Opium, adjusted 4 000 mg,
17. Opiumextrakt 2 000 mg,
18. Opium tincture 40 000 mg,
19. Oxycodone 15 000 mg,
20. Pentazocin 15 000 mg,
21. Pethidin 10 000 mg,
22. (dropped)
23. Piritramid 6 000 mg,
23a. Tapentadol 18 000 mg,
24. Tilidine 18 000 mg
or
b)
one of the other narcotics referred to in Annex III of the Narcotic Drugs Act other than Alfentanil, Cocaine, Etorphin, Remifentanil and Sufentanil.
(2) In justified individual cases and in compliance with the necessary safety of the movement of drugs, the physician may, for a patient who is in his/her permanent treatment, be subject to the provisions of paragraph 1, in respect of:
1.
the number of narcotic narcotics and
2.
the maximum quantities fixed
different. Such a prescription shall be marked with the letter "A". (3) For his practical use, the physician shall be allowed to use the narcotics listed in paragraph 1 as well as alfentanil, cocaine in the case of intervention on the head as a solution up to a content of 20 of the hundred. or as an ointment up to a level of 2 of the hundred, reifentanil and sufentanil, up to the amount of its average two-week requirement, but at least the smallest packing unit. The supply of stocks shall not exceed the monthly requirements of the physician for each anesthetic. Diamorphine may prescribe the doctor up to the amount of its average monthly requirement. The storage system should not exceed the average two-month requirement of the doctor for Diamorphin. (4) Only the doctor who heads a hospital or a unit of a hospital may prescribe for the station's need for the station. Absence of the director. It may prescribe the narcotics referred to in paragraph 3, in accordance with the restrictions on the purpose, the content and the form of administration laid down therein. This also applies to a staff doctor if the beds assigned to him are spatially and organizationally delimited by other sub-units. Unofficial table of contents

§ 3 Verwrite by a dentist

(1) For a patient, the dentist shall be allowed to prescribe within 30 days:
a)
one of the following narcotics, subject to compliance with the limits set out below:

1. Buprenorphine 40 mg,
2. Hydrocodon 300 mg,
3. Hydromorphon 1 200 mg,
4. Levomethadon 200 mg,
5. Morphine 5 000 mg,
6. Oxycodone 4 000 mg,
7. Pentazocin 4 000 mg,
8. Pethidin 2 500 mg,
9. Piritramid 1 500 mg,
9a. Tapentadol 4 500 mg,
10. Tilidine 4 500 mg
or

b)
one of the other narcotic agents listed in Appendix III of the Narcotics Act, other than alfentanil, amfetamine, cocaine, diamorphine, dronabinol, eptorphin, fenetylline, fentanyl, levacetylmethadol, methadone, methylphenidate, nabilone, normethadone, Opium, Papaver somniferum, Pentobarbital, Remifentanil, Secobarbital and Sufentanil.
(2) For practical use, the dentist may use the narcotic agents listed in paragraph 1, as well as alfentanil, fentanyl, reifentanil and sufentanil, up to the amount of its average two-week requirement, but at least the smallest packing unit, Prescribe. The storage facility shall not exceed the monthly requirement of the dentist for each anaesthetic. (3) Only the dentist who runs a hospital or a sub-unit of a hospital, or in absentia, may prescribe for the station's need for the station. of the head. It may prescribe the narcotics referred to in paragraph 2, in accordance with the restrictions on the purpose, the content and the form of administration laid down therein. This also applies to a staff dentist, if the beds assigned to him are spatially and organizationally delimited by other subunits. Unofficial table of contents

§ 4 Letter from a veterinarian

(1) For an animal, the veterinarian may prescribe within 30 days:
a)
one of the following narcotics, subject to compliance with the limits set out below:

1. Amfetamine 600 mg,
2. Buprenorphine 150 mg,
3. Hydrocodon 1 200 mg,
4. Hydromorphon 5 000 mg,
5. Levomethadon 750 mg,
6. Morphine 20 000 mg,
7. Opium, adjusted 12 000 mg,
8. Opiumextrakt 6 000 mg,
9. Opium tincture 120 000 mg,
10. Pentazocin 15 000 mg,
11. Pethidin 10 000 mg
12. Piritramid 6 000 mg
13. Tilidine 18 000 mg
or
b)
one of the other narcotic agents listed in Appendix III of the Narcotics Act, other than Alfentanil, Cocaine, Diamorphine, Dronabinol, Etorphin, Fenetylline, Fentanyl, Levacetylmethadol, Methadone, Methaqualon, Methylphenidate, Nabilon, Oxycodon, Papaver somniferum, Pentobarbital, Remifentanil, Secobarbital and Sufentanil.
In duly substantiated individual cases and with due regard for the necessary safety of the movement of narcotic drugs, the veterinarian may, in a particularly serious case, be subject to the provisions of paragraph 1, in respect of:
1.
the number of narcotic narcotics and
2.
the maximum quantities fixed
different. Such a prescription shall be marked with the letter "A". (3) For his practical use, the veterinarian may use the narcotic agents listed in paragraph 1 as well as alfentanil, cocaine for local anaesthesia in the case of intervention on the head as a solution up to a 20 of the hundred or ointment, up to a content of 2 of the hundred, ectorphin only for immobilization of animals kept in the zoo, circus or in wild animals, by means of their own hands or in the presence of the prescriber Administration, fentanyl, pentobarbital, reifentanil and sufentanil up to the amount of its average two-week requirements, but at least the smallest packing unit. The stockpinning system shall not exceed the monthly requirements of the veterinarian for each anaesthetic. (4) Only the veterinarian who directs an animal clinic or a subunit of a veterinary clinic may prescribe for the station's needs or in the absence of the veterinary medicinal product. Supervisor oversees. It may prescribe the narcotics referred to in paragraph 3, with the exception of etorphin, in compliance with the restrictions on the purpose, the content and the form of administration laid down therein. Unofficial table of contents

§ 5 Letter to substitution

(1) Substitution within the meaning of this Regulation shall be the application of a medical narcotic drug to an opiate-dependent patient (substitution agent).
1.
Treatment of opiate dependence with the aim of the progressive restoration of narcotic abstinence, including improvement and stabilisation of the health condition,
2.
support for the treatment of a serious disease, in addition to opiate dependence; or
3.
Reduction of the risks of opiate dependence during pregnancy and after birth.
(2) For a patient, the doctor may prescribe a substitution agent under the conditions laid down in § 13 (1) of the Narcotics Act, if and for as long as
1.
the substitution does not preclude medical universally recognized grounds of exclusion,
2.
the treatment involves psychiatric, psychotherapeutic or psychosocial treatment and care measures;
3.
the doctor has fulfilled the reporting obligations under Section 5a (2),
4.
studies and surveys of the physician have not revealed that the patient is
a)
has been prescribed by another physician,
b)
of the treatment and care required under point 2 is not permanently used,
c)
substances whose consumption, by type and quantity, endangers the purpose of substitution; or
d)
the substitution agent prescribed to him is not used in accordance with the intended purpose,
5.
the patient is consulted on the necessary scale, usually weekly, to the attending physician, and
6.
the doctor meets minimum requirements for a suchttherapeutic qualification, which are determined by the medical chambers in accordance with the generally accepted status of medical science.
For the fulfilment of the conditions of admissibility laid down in points 1, 2 and 4, point (c), the generally accepted status of medical science shall prevail. (3) A doctor who does not fulfil the conditions laid down in the first sentence of paragraph 2 shall be entitled to: At most three patients simultaneously prescribe a substitution agent if:
1.
the conditions laid down in the first sentence of paragraph 2 of 1 to 5 shall be met for the duration of the treatment;
2.
at the beginning of the treatment, the doctor shall agree with a doctor who satisfies the minimum requirements laid down in paragraph 2, first sentence, point 6 (Konsiliarius), and
3.
has ensured that its patient will be presented to the consiliary at the beginning of the treatment and at least once in the quarter.
Where the doctor is represented by a doctor in accordance with the first sentence, who also does not fulfil the conditions laid down in point 6 of the first sentence of paragraph 2, the number 1 and 2 of the first sentence shall apply to the representative. A substitute doctor referred to in paragraph 2 shall, in principle, be represented by another doctor who satisfies the conditions laid down in the first sentence of paragraph 2, first sentence of paragraph 6. If the substitute doctor does not succeed in ordering a representative in accordance with the third sentence, he may, for a period of up to four weeks and at the latest in total 12, from a doctor who does not fulfil the conditions laid down in the first sentence of paragraph 2, point 6. Weeks of the year are represented. The representative doctor in accordance with sentence 4 shall complete the substitution treatment with the doctor represented before the start of substitution. If an unforeseen change in substitution therapy is required at the time of representation, the representative shall, in accordance with sentence 4, re-vote with the doctor represented. If a timely vote is not possible, the representative doctor referred to in the sentence 4 shall refer to another doctor who satisfies the conditions laid down in the first sentence of paragraph 2, point 6, in a consiliaral manner. Emergency decisions shall remain unaffected in all cases of representation. The documentation referred to in paragraph 10 shall be accompanied by the correspondence referred to in paragraph 10, on the basis of the above cooperation between the treating physician and the consiliary, the representative and the representative practitioner in accordance with the provisions of sentences 2 and 4. The sentences 1 to 9 shall not apply to the treatment referred to in paragraphs 9a to 9d. (4) The prescription of a substitution agent shall be marked with the letter "S". As a substitute, the doctor may only use
1.
Preparations of levomethadone, methadone and buprenorphine,
2.
In justified exceptional cases, codeine or dihydrocodeine,
3.
Diamorphine as a medicinal product authorised for substitution; or
4.
another medicinal product authorised for substitution
Prescribe. The substitution agents referred to in points 1, 2 and 4 of the second sentence may not be intended for parenteral use. In addition to the provisions of this Regulation, the general accepted status of medical science is decisive for the selection of the substitution agent. Paragraphs 6 to 8 shall not apply to the prescription of diamorphine as defined in point 3. (5) The doctor who prescries a substitution agent for a patient shall not be allowed to prescribe the prescription to the patient except in the cases referred to in paragraph 8. to hand. The prescription may only be submitted by himself, his medical representative, or by the staff of the pharmacy designated in the first sentence of paragraph 6. The physician who prescries diamorphine may submit the prescription only to a pharmaceutical entreprency. (6) The substitution agent shall be the patient from the treating physician, his medical representative in practice or from the person he has instructed. or responsible and controlled medical, pharmaceutical or state-approved facilities of the addictive health care aid and trained personnel for direct consumption. The treating physician must ensure that the staff of the first sentence are instructed to leave a substitution agent for immediate consumption. In case of the prescribing of codeine or dihydrocodeine, the patient may, after the release of one dose for immediate consumption, receive the additional amount of the substitute agent in divided individual doses required for one day. (7) The substitution agent is the patient in practice. (7) The substitution agent is the patient in practice, and the patient is not responsible for the use of the substitute. a doctor, in a hospital or in a pharmacy or in a pharmacist other appropriate facilities recognised by the competent State authority, or, in the case of a physician certified care, to be used for direct consumption during a visit to the house. The doctor may place the necessary substitution in one of the establishments referred to in the first sentence, under his responsibility, without prejudice to the consent of the person entitled to dispose of the substitution in question. § § 13 and 14 shall apply for proof of stay and stock. (8) By way of derogation from paragraphs 5 to 7, the doctor or his medical representative may, by way of derogation from paragraphs 5 to 7, inform the patient of the substitution agent referred to in paragraph 6 of this article. direct consumption, in cases where the continuity of the substitution treatment cannot be otherwise guaranteed, prescribable a substitution agent in the quantity required for up to two days, and the latter to take self-responsible intake as soon as the course of treatment allows this, risks of self-treatment or foreign hazards as far as possible, as well as the safety and control of the movement of narcotic drugs are not affected. Within a week, the doctor may not hand over to the patient any more than a prescription according to sentence 1. Without prejudice to the first sentence of paragraph 4, this prescription shall be marked by the physician in addition to the letter "Z". As soon as the condition of the patient has stabilised and a release of the substitution agent to the immediate end of the patient is immediately If the patient is no longer required, the doctor may give the patient a prescription over the amount of the substitution agent required for up to seven days, and allow him to take his own responsible intake. The suspension of a prescription in accordance with the fourth sentence shall not be allowed, in particular, if the examinations and surveys of the physician have shown that the patient is
1.
substances which endanger it, together with the use of the substitution agent,
2.
it has not yet been adjusted to a stable dose, taking into account the development of tolerance, or
3.
Substances which are abusive.
For the evaluation of the course of treatment by the substitutive physician, the generally accepted status of medical science is also relevant. In the case of a stay abroad of the patient, who is already prescribed substitution agent in accordance with sentence 4, the doctor may, taking into account all the conditions set out in this paragraph, to ensure the supply of this Hand over an amount of the substitution agent for a longer period of time than in the fourth sentence and allow it to be taken on its own account. In one year, these prescriptions may not exceed the amount of the substitution agent required for up to 30 days. They shall be notified immediately to the competent State authority. Each prescription according to sentences 1, 4 or 8 shall be handed out to the patient in the context of a personal medical consultation. (9) Patients who are temporarily or permanently changing the practice of the treating physician shall have the treatment before the patient. To issue a substitution certificate for substitution on a narcotic recipe. The substitution certificate shall indicate:
1.
the name, first name and address of the patient for which the substitution certificate is intended;
2.
Date of issue,
3.
the prescribed substitution agent and the daily dose,
4.
the beginning of the letter and of the charge referred to in paragraphs 1 to 7 and, where appropriate, the beginning of the letter referred to in paragraph 8;
5.
Validity: from/to,
6.
the name of the issuing doctor, his professional title and address, including the telephone number,
7.
Signature of the issuing doctor.
The substitution certificate shall be marked with the words "Only for submission to the doctor". Part I of the substitution certificate is given to the patient, Parts II and III remain with the exhibiting physician. After presentation of Part I of the substitution certificate by the patient and verification of the person's data by comparison with the patient's identity card or passport, another doctor may prescribe the substitution by ; if this is only temporary, the other doctor has to inform the attending physician in writing, immediately after the completion of his letter of writing, of the measures taken. (9a) For the treatment of a severe opiate dependence, the doctor may Substitutes Diamorphine for parenteral administration are prescribed. The doctor may only prescribe Diamorphine if:
1.
he himself has acquired a addiction-therapeutic qualification within the meaning of paragraph 2, first sentence, point 6, which relates to the treatment with diamorphine, or he/she shall, within the framework of the model project "heroin-assisted treatment of opiate-dependent", be at least six months of medical service,
2.
in the case of the patient, an opiate dependence, which has been in existence for at least five years, associated with serious somatic and mental disorders in the current predominantly intravenous use,
3.
proof of two unsuccessful treatment of opiate dependence, of which at least six months of treatment pursuant to paragraphs 2, 6 and 7, including psycho-social care measures, are available; and
4.
the patient's 23. Year of life has been completed.
(9b) The treatment with diamorphine may only be carried out in establishments which have been granted a permit by the competent State authority. Permission shall be granted if:
1.
it is shown that the institution is involved in the local search support system,
2.
ensures that the institution has adequate human and factual equipment,
3.
a knowledgeable person who is responsible for compliance with the requirements set out in point 2, the requirements of the authorisations authority and the supervisory authority's orders (responsible).
(9c) Diamorphine may only be prescribed, administered and left for direct consumption within the body referred to in paragraph 9b. Diamorphine may be used only under the supervision of the physician or the knowledgeable staff within that facility. In the first six months of treatment, psychosocial care must take place. (9d) The treatment with diamorphine must be checked after two years of treatment at the latest in order to determine whether the conditions for the treatment of diamorphine should be met. Treatment is still given and whether the treatment should be continued. The verification shall be carried out by obtaining a second opinion by a doctor who has the qualification referred to in the first sentence of paragraph 2, point 6, and who is not a member of the institution. If this examination shows that the conditions for the treatment are no longer given, the diamorphine-assisted treatment should be terminated. (10) The doctor has the fulfilment of his obligations under the above paragraphs as well as in accordance with § 5a (2) (2). and to document in the necessary extent and in accordance with the generally accepted status of medical science. The documentation must be submitted or submitted for inspection and evaluation at the request of the competent authority of the state. (11) The Federal Medical Association may, in directives, provide the generally accepted status of medical science for
1.
the fulfilment of the conditions of admissibility referred to in the first sentence of paragraph 2, point 1, 2 and 4, point (c),
2.
the choice of substitution agent referred to in paragraph 4, sentence 4, and
3.
the evaluation of the previous success of the treatment referred to in the first and fourth sentences of paragraph 8
, and adopt guidelines for the documentation referred to in paragraph 10. Compliance with the generally accepted status of medical science shall be presumed if and to the extent that the guidelines of the Federal Medical Association have been complied with in accordance with points 1 to 3. (12) Paragraphs 2 to 10 shall apply accordingly, if the substitution agent is left to the stock of the practical needs or station requirements for immediate consumption, or is handed out in accordance with the third sentence of paragraph 6. Unofficial table of contents

§ 5a substitution register

(1) The Federal Institute for Drugs 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)) leads The substitution register data may only be used to:
1.
to prevent the prescribing of a substitution agent by several doctors for the same patient and the same period as early as possible;
2.
to verify that the doctors prescribing a substitution agent comply with the minimum requirements laid down in Article 5 (2), first sentence, point 6, or the requirements set out in Article 5 (3), first sentence, points 2 and 3, and
3.
To statistically evaluate the prescribings of substitution funds in accordance with § 13 (3) (3) (3) (e) of the Narcotics Act (Narcotics Act)
The Federal Institute meets organizational requirements for the guidance of the substitution register. (2) Any physician who prescries a substitution agent for a patient has the Federal Institute immediately in writing or crypt to the Federal Institute for Electronic Report the following information:
1.
the patient code,
2.
the date of the first prescription,
3.
the prescribed substitution agent,
4.
the date of the last prescription,
5.
Name, first name, date of birth, official address and telephone number of the prescribing physician;
6.
in the case of the prescribing in accordance with § 5 (3), first sentence, first name, first name, service address and telephone number of the consiliary.
The patient code is composed of the following:
a) first and second place: first and second letter of first name,
b) third and fourth place: first and second letter of the family name,
c) Fifth place: Gender ("F" for female, "M" for male),
d) sixth to eighth place: each last digit of birthday, month and year.

It is inadmissible to report uncoded information to the Federal Institute of Patient Data. The doctor has to check the person's details by comparison with the patient's identity card or passport. (3) The Federal Institute immediately encrypts the patient code according to the first sentence of the first sentence of the first sentence of paragraph 2, according to one of the Federal Office for Safety in a cryptogram in the information technology, in such a way that it cannot be recovered from it, or can only be recovered with a disproportionately large amount of effort. The cryptogram shall be stored together with the information referred to in the first sentence of paragraph 2, point 2 to 6, and shall be deleted no later than six months after notification of the end of the prescribing. The stored data and the encryption method according to the first sentence are to be protected by appropriate security measures against unauthorized knowledge and use. (4) The Federal Institute compares each newly stored cryptogram with the already existing. If there is no match, the patient code must be deleted immediately. If there are any matches, the Federal Institute shall inform each participating physician, stating the patient code, the date of the first prescription and the names and surnames, the official addresses and telephone numbers of the other doctors involved. without delay. The doctors have to explain whether the patient code is to be assigned to the same patient. If this is the case, they will be able to vote on who will prescribe substitution funds for the patient in the future, and to inform the Federal Institute of the outcome, stating the patient code. If this is not the case, the physicians must also inform the Federal Institute, stating the patient code. The substitution register shall be cleaned up immediately. If necessary, the Federal Institute shall inform the competent surveillance authorities of the doctors involved in order to immediately notify the prescribing of substitution funds from several doctors for the same patient and the same period of time. (5) The medical chambers shall immediately report to the Federal Institute on its request, stating the first name, the name, the address and the date of birth of a doctor notified in accordance with the first sentence of paragraph 2, point 5 or point 6, whether the Doctor satisfies the minimum requirements laid down in § 5 (2), first sentence, point 6. The medical chambers of the Federal Institute of Physicians shall immediately inform the Federal Institute for the indication "Note: Suchttherapeutic qualification is no longer available." to those physicians who were previously reported to the Federal Institute by the Medical Association, to , which have so far complied with the minimum requirements of § 5 (2), first sentence, point 6, but are no longer in compliance with the requirements. For the purpose of data cleansing from the medical chambers, the Federal Institute may also require reports to all members of the chamber who meet the minimum requirements pursuant to Article 5 (2), first sentence, point 6, with the following information:
1.
Name and first name,
2.
the official address,
3.
Date of birth.
The Federal Institute shall immediately inform the competent surveillance authorities of the countries of the name, first name, address and telephone number from the data collection of the substitution register.
1.
of the doctors who have prescribed a substitution agent in accordance with Article 5 (2), and
2.
the consiliaries notified in accordance with point 6 of the first sentence of paragraph 2,
if the doctors and consiliaries referred to in paragraphs 1 and 2 do not meet the minimum requirements laid down in Article 5 (2), first sentence, point 6 in connection with the data transmitted in accordance with the sentences 1 to 3. (6) The Federal Institute shall inform the competent authority of the competent authority of the competent authority. Surveillance authorities on 30 June and 31 December of each year shall provide the following information from the data collection of the substitution register:
1.
the names, first names, addresses and telephone numbers of the doctors prescribed in accordance with Article 5 (2) of the substitution treatment;
2.
the names, first names, addresses and telephone numbers of the doctors who have prescribed substitution materials in accordance with § 5 (3) sentence 1,
3.
the names, first names, addresses and telephone numbers of the doctors who have been reported as members of the Konsiliarius pursuant to the first sentence of paragraph 2, point 6, and
4.
Number of patients for which a doctor referred to in paragraph 1 or 2 has prescribed a substitution agent.
The competent supervisory authorities can also request information from the Federal Institute at any time in individual cases. (7) The Federal Institute shall inform the supreme state health authorities for each country at 31 December of each year. the following data from the data base of the substitution register:
1.
the number of patients to whom a substitution has been prescribed,
2.
the number of doctors who have prescribed substitution products in accordance with § 5 (2),
3.
the number of doctors who have prescribed substitution funds in accordance with the first sentence of Article 5 (3),
4.
the number of doctors who have been reported as a consiliary in accordance with the first sentence of paragraph 2, point 6, and
5.
The nature and proportion of the prescribed substitution agents.
At the request of the supreme State health authorities, the information listed under points 1 to 5 shall also be broken down by surveillance area. Unofficial table of contents

§ 5b Letter of prescribals for patients in old or nursing homes, hospices and in the specialized outpatient palliative care

(1) The physician who prescribers a narcotic for a patient in an old or nursing home, a hospice or in the specialized outpatient palliative care can determine that the prescription will not be handed out to the patient. In this case, the prescription may only be prescribed by himself or by staff of his or her practice, the old or nursing home, the hospice or the establishment of the specialized outpatient palliative care in the (2) In the case referred to in the first sentence of paragraph 1, the narcotic agent shall be the patient of the treating physician or the personnel of the old or nursing home, of the hospice or of the nurse who have been instructed and controlled by him. To administer the specialized outpatient palliative care or to provide (3) In the case referred to in the first sentence of paragraph 1, the physician shall be allowed to use the anesthetic agents of the patient in the old or nursing home, the hospice or the establishment of the specialized outpatient palliative care under his Responsibility shall be stored; the consent of the person entitled above the respective premises shall remain unaffected. § § 13 and 14 apply mutas. (4) Narcotics, which are stored in accordance with paragraph 3 and are no longer required, can be found by the physician.
1.
to another patient of this old or nursing home, of this hospice, or of this institution of specialized outpatient palliative care,
2.
be returned to a supplying pharmacy for re-use in an old or nursing home, a hospice or a facility of specialized outpatient palliative care, or
3.
be transferred to the emergency supply in accordance with § 5c (1) sentence 1.
Unofficial table of contents

§ 5c Prescribable for emergency needs in hospices and in specialized outpatient palliative care

(1) Hospize and facilities of specialized outpatient palliative care may hold a supply of narcotic drugs in their premises for the unpredictable, urgent and short-term needs of their patients (emergency supplies). Beneficiaries who make use of the option set out in the first sentence shall be obliged to:
1.
to instruate one or more doctors to prescribe the narcotics needed for the emergency supply in accordance with § 2 (4) sentence 2,
2.
the complete detection of the inclusion in the emergency supply and the withdrawal from the emergency supply by means of internal regulations with the doctors and nurses involved in the care of patients with narcotic drugs, to ensure and
3.
agree in writing with a pharmacy supply for emergency supplies and at least half-yearly inspection of emergency stocks, in particular on their flawless nature, as well as proper and safe storage; the A pharmacist shall indicate in writing the agreement of the competent State authority before the first delivery; § 6 (3) sentence 2 to 4 shall apply accordingly.
(2) The doctors or doctors referred to in the second sentence of paragraph 1 may prescribe the narcotics required for the emergency supply up to the quantity of the average two-week requirement, but at least the smallest packing unit. The supply of stocks may not exceed the average monthly requirement for each anesthetic. Unofficial table of contents

§ 6 Letter of prescribable for institutions of the rescue service

(1) The prescribers for the prescribtion of the need for narcotics for facilities and sub-units of facilities of the rescue service (rescue service requirements) shall find the prescribers for the prescribings for the station requirements in accordance with § 2 para. 4 Application. (2) The carrier or the person in charge of the rescue service has to ask a doctor to prescribe the necessary narcotics in accordance with § 2 para. 4. The recording of the whereabouts and stocks of the narcotics shall be carried out by the respective treating physician in accordance with § § 13 and 14 in the facilities and subunits of the facilities of the rescue service. (3) The institution or the person responsible for carrying out the procedure with a pharmacy the supply of prescriptions for the rescue services and at least a half-yearly review of the stocks of narcotic drugs in the facilities or subunits of the institutions of the Rescue services, in particular on their flawless nature and to make correct and safe storage in writing. A pharmacist of the respective pharmacy is to be commissioned with the examination of the narcotic supplies. A protocol is to be made. In order to remedy the deficiencies identified by the inspection, the pharmacist responsible for the inspection shall set a reasonable time limit for the carrier or the carrying person of the rescue service and, in the event of non-compliance, inform the competent authority of the competent State. (4) In the event of a major damage case, the necessary narcotics are to be written by the responsible leading emergency doctor in accordance with § 2 para. 4. The narcotics used shall be immediately notified by the conductive emergency physician for the event of major damage and shall be notified to the competent authority of the country, indicating the non-used narcotic agents. The competent authority of the State shall take a decision on the whereabouts of non-used narcotics. Unofficial table of contents

§ 7 Letter of prescribable for ship-to-carriage

(1) § § 8 and 9 shall apply to the prescribting and delivery of narcotic drugs for the equipment of commercial vehicle-making vessels. The particulars referred to in paragraph 4 (4) to (6) shall be affixed to the drugs referred to in Article 9 (1) (1) and (5) instead of those referred to in Article 9 (1) (1) and (5). Only one of the competent authorities may be required to supply the equipment for the collection of a collection of food. Doctor may prescribe narcotics; for this purpose, he may prescribe the narcotics of morphine in the case of squatting without a ship's doctor. In the case of ship-occupancy vessels with a ship's doctor and those who do not carry the national flag, other narcotics listed in Appendix III of the Narcotics Act may also be prescribed. (3) By way of exception, narcotics for the equipment of a pharmacy may be given by a pharmacy without prescribing, if:
1.
the doctor referred to in paragraph 2 shall not be reached in good time before the ship is run out,
2.
the delivery by type and quantity only for replacement
a)
spent,
b)
unusable or
c)
outside the scope of the narcotics law of ships carrying the federal flag, procured by the Federal Ministry of Transport and Digital Infrastructure pursuant to Section 108 (2) sentence 1 of the Maritime Labour Act State of medical knowledge to be exchanged
the use of anaesthesials,
3.
the donor has previously been satisfied that the anesthetic still present is in accordance with the type and quantity of the entries in the ship's narcotics book; and
4.
the donor shall be responsible for receiving the person responsible for the proper conduct of medical care in accordance with the provisions laid down by the seeemployment legislation.
(4) The certificate referred to in paragraph 3 (4) shall contain the following information:
1.
Name of the prescribed medicinal products in accordance with § 9 (1) (3),
2.
the quantity of medicinal products dispensed pursuant to § 9 (1) (4),
3.
the date of delivery,
4.
the name of the ship,
5.
Name of the shipowner,
6.
Marina of the ship and
7.
Signature of the person responsible for medical care in accordance with the provisions of the seelabour law.
(5) The donor shall submit the certificate referred to in paragraph 3 (4) without delay to the doctor responsible for the post-prescrib/rewriting by the competent authority. This is obliged to immediately return the prescription to a drug prescription of the pharmacy which has supplied the narcotic agent in accordance with § 7 para. 3. The prescription shall be marked with the letter "K". The certificate in accordance with § 7 para. 3 no. 4 shall be permanently connected to the part of the prescription remaining in the pharmacy. If the conditions set out in paragraph 3 (1) and (2) have not been met, the competent authority shall be informed without delay. (6) For the prescriber and the supply of narcotic drugs for the equipment of ships which do not In the case of transport vessels, paragraphs 1 to 5 shall apply mutas to the provisions of paragraphs 1 to 5. Unofficial table of contents

§ 8 Narcotic prescription

(1) Narcotic drugs for patients, the need for practical use and animals may only be prescribed on a three-part official form (narcotic prescription). The anesthetic recipe may only be used for prescriber of other medicinal products if this is done in addition to that of a narcotic agent. Parts I and II of the prescription are intended for submission in a pharmacy, in the case of the prescribing of diamorphine in accordance with § 5 (9a), for submission to a pharmaceutical entreprenate, Part III shall remain with the doctor, dentist or veterinarian, (2) Narcotic drugs are issued by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte) on request to the individual physician, dentist or veterinarian. The Federal Institute for Medicinal Products and Medical Devices may refuse the issue if there is a reasonable suspicion that the narcotics prescriptions are not used in accordance with the law of narcotics. (3) The numbered Anaesthetic recipes are only intended for use by the requesting physician, dentist or veterinary surgeon and may only be transferred in case of representation. The non-used anesthetic recipes must be returned to the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte-Bundesinstitut für Arzneimittel und Medizinprodukte-Bundesinstitut für Arzneimittel und Medizinprodukte). (4) The doctor, dentist or veterinarian has the following: To secure the prescriptions of the anesthetic against deprivation. A loss is to be reported immediately to the Federal Institute for Drugs and Medical Devices, which informs the competent supreme state authority. (5) The doctor, dentist or veterinarian has part III of the prescription and To keep parts I to III of the incorrectly prepared narcotics recipes according to the exhibition data or according to the requirement of the competent State authority for three years and at the request of the persons referred to in § 19 (1) sentence 3 of the German Narcotics Act to the competent national authority or representative of that authority (6) Except in the cases of § 5, narcotic drugs may be prescribed for patients, practical needs and animals in emergencies, subject to a restriction to the quantity required to remedy the emergency, by way of derogation from the first sentence of paragraph 1. Prescriptions in accordance with sentence 1 shall be provided with the information in accordance with § 9 (1) and shall be marked with the word "emergency prescription". The pharmacy has to inform the prescribing physician, dentist or veterinarian immediately upon presentation of the emergency prescription and, if possible, before the release of the narcotic agent on the delivery. This is obliged to immediately return the prescription to a drug prescription of the pharmacy which has supplied the emergency prescription. The prescription shall be marked with the letter "N". The emergency prescription is to be permanently connected to the part of the post-depleted prescription that remains in the pharmacy. Unofficial table of contents

Section 9 Information on the prescription of narcotic drugs

(1) To be stated on the narcotic agent's prescription:
1.
the name, first name and address of the patient for which the narcotic agent is intended; in the case of prescriptions for veterinary use, the type of animal and the name, first name and address of the keeper;
2.
Date of issue,
3.
the name of the medicinal product, in so far as one of the following information is not clearly determined, in each case the additional name and amount by weight of the stunning agent contained in each pack unit, in the case of divided preparations, in each form of divided form, the pharmaceutical form,
4.
the quantity of the medicinal product prescribed in grams or millilitres, unit number of divided form,
5.
Instructions for use with individual and daily administration, or in the event that a written instructions for use has been handed over to the patient, an indication of this written instructions for use; in the case of § 5 (8), in addition, the duration of the substitution agent in days,
6.
in the cases of § 2 para. 2 sentence 2 and § 4 para. 2 sentence 2 of the letter "A", in the cases of § 5 (4) sentence 1 of the letter "S", in the cases of § 5 paragraph 8 sentence 1 in addition to the letter "Z", in the cases of § 7 para. 5 sentence 3 of the letter "K", in the cases of § 8 (6) sentence 5 of the letter "N",
7.
the name of the prescribing physician, dentist or veterinarian, his professional title and address, including the telephone number,
8.
in the cases of § 2 (3), § 3 (2) and § 4 (3) of the note "practical requirements", instead of the information in points 1 and 5,
9.
Signature of the prescribing physician, dentist or veterinary surgeon, in case of representation, the note "i.V.".
(2) The information referred to in paragraph 1 shall be permanently marked and shall be included in all parts of the prescription. The information referred to in points 1 to 8 may be provided by a person other than the prescribing person. In the event of a change of prescription, the prescribing physician must note the change on all parts of the narcotics recipe and confirm by his signature. Unofficial table of contents

§ 10 Narcotics Requirement Certificate

(1) Narcotics for the station requirements according to § 2 para. 4, § 3 para. 3 and § 4 para. 4, the emergency requirements according to § 5c and the rescue service requirements according to § 6 (1) may only be applied on a three-part official form (narcotics request form) shall be prescribed. Parts I and II of the prescription for the station requirement, the emergency need and the rescue service requirement are intended for submission in the pharmacy, Part III remains with the prescription doctor, dentist or veterinarian. (2) Stunning agent requirements are issued by the Federal Institute for Drugs and Medical Devices on request to:
1.
the doctor or dentist who runs a hospital or a hospital ward,
2.
the veterinarian who is leading an animal clinic,
3.
an authorized physician in accordance with § 5c (1) sentence 2, point 1,
4.
the doctor of the rescue service as instructed in accordance with Article 6 (2); or
5.
the competent executive notary in accordance with § 6 (4).
(3) The numbered narcotics request certificates are intended for use only in the institution for which they have been requested. They may be passed on by the requesting physician, dentist or veterinarian to the head of subunits or to another authorized doctor in accordance with § 5c (1) sentence 2, point 1. The transfer shall be subject to proof. (4) Part III of the prescription for the station requirements, the emergency needs and the rescue service requirements and the parts I to III of incorrectly manufactured narcotics requirements as well as the Evidence documents referred to in paragraph 3 shall be kept by the requesting doctor, dentist or veterinarian for three years from the date of the last entry, and shall be kept at the request of the national authority responsible pursuant to section 19 (1) sentence 3 of the Narcotics Act. , to be sent or to be submitted to representatives of those authorities. Unofficial table of contents

Section 11 Information on the narcotics request certificate

(1) In the case of the narcotics request form, the following shall be stated:
1.
the name or the name and address of the facility for which the narcotic agents are intended;
2.
Date of issue,
3.
Name of the prescribed medicinal products in accordance with § 9 (1) (3),
4.
the quantity of medicinal products prescribed in accordance with § 9 (1) (4),
5.
the name of the prescribing physician, dentist or veterinarian, including telephone number,
6.
Signature of the prescribing physician, dentist or veterinary surgeon, in case of representation, the note "i.V.".
(2) The information referred to in paragraph 1 shall be permanently marked and shall be included in all parts of the prescription for the station's requirements, the emergency needs and the rescue service requirements. The information referred to in points 1 to 5 may be provided by a person other than the prescribing person. In the event of a change in the prescription for the station requirement, the emergency needs and the rescue service requirement, the prescriber doctor has to record the change on all parts of the narcotics request line and by his signature to confirm. Unofficial table of contents

§ 12 levy

(1) Narcotic drugs may not be delivered subject to paragraph 2:
1.
on a prescription,
a)
which, according to § § 1 to 4 or § 7 (2), was not to be made visible to the donor,
b)
have not complied with a provision of the second sentence of § 7 (1), the first sentence of § 8 (1) and (2) or the provisions of § 9,
c)
which was made more than seven days ago, except in the case of importation of a medicinal product in accordance with Section 73 (3) of the German Medicines Act, or
d)
marked with the letter "K" or "N";
2.
to a prescription for the station needs, the emergency needs and the rescue service needs,
a)
which, according to § § 1 to 4, § 7 (1) or § 10 (3), was not allowed to be made out for the transferor, or
b)
have not complied with a provision in Section 10 (1) or (11);
3.
on a prescription pursuant to § 8 (6), the
a)
is not marked in accordance with sentence 2, or
b)
was made more than a day ago;
4.
to a prescription in accordance with § 5 (8) if they are not made up in individual doses and in child-proof packaging.
(2) In the case of prescriptions and prescriptions for the station requirements, the emergency needs and the rescue service requirements, which contain an error which can be recognized by the donor, are illegible or the provisions according to § 9 (1) or § 11 (1) do not apply. , the donor is entitled to make any changes after consultation with the prescribing physician, dentist or veterinarian. Information pursuant to § 9 (1) (1) or (11) (1) (1) may be amended or supplemented by the transferor, if the bearer of the prescription or the prescription for the station needs, the emergency needs and the rescue service needs these Provide evidence or credibly insured or otherwise indicate the information. In the case of prescriptions or prescriptions for the requirements of the station, the emergency needs and the emergency services where a change in accordance with the first sentence is not possible, the narcotic narcotic agents or subsets of these agents may be made available, if the bearer is credibly insured or otherwise apparent that there is an urgent case which requires the immediate use of the narcotic agent. In such cases, the head of the pharmacy shall immediately notify the prescribers of the charge received; the necessary corrections to the prescribing or prescribing for the station's requirements, the emergency needs and the Emergency services must be carried out without delay. Amendments and additions made in accordance with the first and second sentences of 1 and 4, as well as the duties referred to in the third sentence, shall be replaced by the transferor in parts I and II, by the prescribing, except in the case of the second sentence, in Part III of the prescribing or the prescription for the station requirements, the emergency needs and the rescue service needs. For the prescription of diamorphine, the sentences 2 to 4 do not apply. (3) The donator has to record the following information on part I of the prescription or the prescription for the station requirement, the emergency need and the rescue service requirement:
1.
the name and address of the pharmacy,
2.
submission date and
3.
Name of the donor.
(4) The head of the pharmacy has to keep part I of the prescriptions and prescriptions for the station requirements, the emergency needs and the rescue service requirements according to the delivery data or according to the requirement of the competent state authority for three years and to Require the Federal Institute for Medicinal Products and Medical Devices or the competent national authority pursuant to § 19 (1) sentence 3 of the Narcotics Act to submit or submit to the competent authorities of these authorities. Part II is intended for settlement. In the case of the dispensing of diamorphine, the first and second sentences shall apply to the person responsible for narcotics of the pharmaceutical entreprentable. (5) The veterinarian may only use anesthetic from his skin pharmacist for use in one of his or her own medicinal products. treated animals and only in compliance with the provisions of Sections 1 and 4 (1) and (2) applicable to the prescribable. Unofficial table of contents

§ 13 Detection

(1) The evidence of whereabation and stock of narcotics in the entities referred to in § 1 (3) shall be carried out without delay after the change in the stock has been changed in accordance with the official form. It is possible to use card cards or narcotics books with consecutively numbered pages. The recording may also be carried out by means of electronic data processing, provided that the printout of the stored information is guaranteed at any time in the order of the official form. In the event of the transfer of a substitution agent for direct consumption pursuant to § 5 (6) sentence 1 or of a narcotic agent according to § 5b (2), the whereabouts must be proven to be patient-related. (2) The entries relating to access, declines and inventories the narcotics and the compliance of the stocks with the led evidence are
1.
by the pharmacist for the pharmacy that he has directed,
2.
from the veterinarian to the veterinary skin pharmacist he has headed, and
3.
from the prescription physician, dentist or veterinarian, designated in § § 2 to 4, for the practice or station requirements,
4.
a doctor responsible for hospices and facilities of specialist outpatient palliative care in accordance with § 5c (1), second sentence, number 1, as well as the doctor responsible for the rescue services provided for in § 6 (2),
5.
the person responsible for carrying out medical care in accordance with the provisions of the seelabour law for the particular vehicle flying the flag of the Federal Republic of Germany,
6.
by the treating physician in the case of the proof referred to in the fourth sentence of paragraph 1,
7.
by the person responsible within the meaning of Article 5 (9b) (3)
shall be examined at the end of each calendar month and, if the stock has changed, to be confirmed by the name and the date of the examination. In the event that the verification is carried out by means of electronic data processing, the verification shall be carried out on the basis of the end-of-month expression of the prints made available. (3) The cards, stun books or EDP printouts referred to in paragraph 2 The second sentence shall be kept for three years in the three-year period referred to in Article 1 (3), from the last registration. In the event of a change in the management of a hospital pharmacy, an establishment of a hospital, an animal clinic or a change of doctor in accordance with § 5c (1) sentence 2 (1) or § 6 (2) sentence 1, the following shall be provided for in paragraph 2. indicate the date of the handover and the submitted stock and to confirm it by signature. The card cards, the narcotics books and the EDP printouts are to be sent to the competent authority or to be submitted to this authority at the request of the national authority responsible pursuant to section 19 (1) sentence 3 of the Narcotics Act. In the meantime, provisional records are to be made which are to be recorded after the return of the cards and the stun books. Unofficial table of contents

Section 14 Information on detection

(1) In the case of the presence and stock of narcotic drugs, the following shall be stated on a permanent basis for each narcotic agent:
1.
Name, for medicinal products according to § 9 para. 1 no. 3,
2.
Date of access or departure,
3.
the quantity received or lost and the resulting stock; in the case of substances and preparations not divided, the quantity by weight in grams or milligrams, in the case of dispatchable preparations, the number of items; in the case of liquid preparations, which are carried out in the context of of a treatment, the amount also in milliliters,
4.
the name or company and address of the supplier or of the consignee or of any other origin or whereaby,
5.
in pharmacies in the case of a prescription for patients and for practical use, the name and address of the prescribing physician, dentist or veterinary surgeon and the number of the narcotic prescription, in the case of prescribing for the Station requirements, emergency requirements and rescue services shall be the name of the prescriber, dentist or veterinarian, and the number of the narcotic agent request certificate,
5a.
in hospitals, veterinary clinics, hospices, as well as in institutions of specialized outpatient palliative care and emergency services in the case of purchase on prescription for the station needs, emergency needs and rescue service requirements the name of the prescribing physician, dentist or veterinary surgeon and the number of the narcotic drug request certificate;
6.
in the case of the pharmaceutical company, in the case of the prescription of diamorphine, the name and address of the prescribing physician and the number of the narcotic agent's prescription.
Where the units referred to in Article 1 (3) consist of sub-units, the records shall be kept in these units. (2) In the case of liquid preparations, the quantity by weight of the narcotic agent used in the case of liquid preparations shall be that for technical reasons. the required overfilling of the dispensing container is to be taken into account only if it is higher than the access. The difference is to be shown as an access with "overfill". Unofficial table of contents

§ 15 Forms

The Federal Institute for Drugs and Medical Devices provides the official forms for the prescriber (narcotic prescription and narcotic drug request certificates) and for the proof of whereabouts and stocks (card cards and Stun medium books) and makes them known in the Federal Gazette. Unofficial table of contents

§ 16 Crime

In accordance with § 29 (1) sentence 1 no. 14 of the Narcotics Act, it shall be punished who
1.
contrary to the first sentence of Article 1 (1), even in conjunction with the second sentence, a narcotic agent is not prescribable as a preparation,
2.
a)
contrary to § 2 para. 1 or 2 sentence 1, § 3 para. 1 or § 5 para. 1 or para. 4 sentence 2 for a patient,
b)
contrary to § 2 para. 3 sentence 1, § 3 para. 2 sentence 1 or § 4 para. 3 sentence 1 for its practical needs or
c)
contrary to § 4 (1) for an animal
other than the narcotics referred to in paragraph 2 (1) (a) more than two narcotic drugs, more than two narcotic drugs, exceeding the maximum amount fixed, or failing to comply with the shall be prescribed for the purposes of destination or other restrictions;
3.
contrary to § 2 (4), § 3 (3) or § 4 (4)
a)
Means of anesthesiation other than those designated therein,
b)
other than the narcotics referred to therein, or
c)
where narcotics referred to there are required to be subject to non-compliance with the restrictions referred to in
4.
, contrary to § 7 para. 2, narcotics for the equipping of commercial vehicle vessels,
5.
, contrary to § 5 (9c) sentence 1 of Diamorphine, it is prescribed, administered or transferred.
Unofficial table of contents

§ 17 Administrative Offences

Contrary to the provisions of Section 32 (1) No. 6 of the Narcotics Act, who intentionally or lightly
1.
contrary to § 5 (9) sentence 2 and 3, also in connection with § 5 (12), § 5a (2) sentence 1 to 4, § 7 (1) sentence 2 or (4), § 8 (6) sentence 2, § 9 para. 1, also in conjunction with § 2 paragraph 2 sentence 2, § 4 para. 2 sentence 2, § 5 para. 4 sentence 1, § 7 para. 5 sentence 3 or § 8 para. 6 sentence 5, § 11 para. 1 or § 12 para. 3, an indication not, not correct, not complete or not in the prescribed form,
2.
Contrary to Section 5 (10), the necessary measures are not or are not fully documented or the competent State authority does not submit or send the documentation for inspection and evaluation,
3.
contrary to § 8 (1) sentence 1, also in connection with § 7 para. 1, narcotics not prescribing on a valid narcotic prescription or contrary to § 10 para. 1 sentence 1 narcotic drugs on a valid narcotics request form,
4.
Contrary to Section 8 (3), for its use, it transfers certain narcotic drugs or does not return it to the Federal Institute for Medicinal Products and Medical Devices for the purpose of carrying out its activities,
5.
Contrary to § 8 para. 4, narcotics prescriptions do not protect against theft or fail to indicate a loss immediately,
6.
, contrary to § 8 (5), § 10 (4) or § 12 (4) sentence 1, the parts of the prescription or the prescription for the station requirements, the emergency requirements and the rescue service are not stored in accordance with the regulations, or are not properly stored,
7.
contrary to § 8 (6) sentence 4, the prescription shall not immediately be followed by the pharmacy,
8.
Contrary to Section 10 (3) sentence 3, no evidence of the passing on of narcotic agent request seems to be disclosed,
9.
a provision in the first sentence of Article 13 (1), (2) or (3) or (14) on the management of records, the verification or retention of which is contrary to the law or
10.
In accordance with the first sentence of Article 5 (2) (1) (6) or (3) (1) (2) and (3), second sentence and (7) or (5) and (6) or (9a), second sentence, point (1), a substitution agent shall be required without complying with the minimum qualification requirements or without: to include consiliaries in the treatment or without, as a representative, who does not meet the minimum qualification requirements, or without the diamorphine-specific requirements for qualification referred to in the second sentence of paragraph 9a, point 1 .
Unofficial table of contents

Section 18 Transitional provisions

(1) § 5 (3) sentence 2 shall apply from 1 January 2000 to the prescribting of a substitution agent for narcotic agents who have been prescribed codeine or dihydrocodeine for substitution before the entry into force of this regulation. (2) § 5 Paragraph 7 (1) shall also be deemed to have been fulfilled if, at the date of entry into force of this Regulation, codeine or dihydrocodeine was prescribed for the purpose of substitution for a patient in the same practice for at least six months.