Regulation On Prescribing, Dispensing, And Proof Of The Fate 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 whereabouts of narcotics (narcotics prescribing ordinance-BtMVV)

Non-official table of contents

BtMVV

Date of delivery: 20.01.1998

Full quote:

" Narcotics presenter regulation of 20. January 1998 (BGBl. 74, 80), as last amended by Article 2 of the Regulation of 5 June 2000. December 2014 (BGBl. I p. 1999) "

:Last modified by Art. 2 V v. 5.12.2014 I 1999

For details, see Notes

Footnote

(+ + + Text evidence from: 1.2.1998 + + +)
. The regulation has been used as a Article 3 V 2121-6-24/4 v. 20.1.1998 I 74 (BtMÄndV 10) issued 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. Non-official table of contents

§ 1 Principles

(1) The narcotic agents listed in Appendix III of the Narcotics Act may only be used as Preparations are to be prescribed. 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 individual cases, 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 doctor, dentist or veterinarian may only be made after the presentation of a finished narcotic prescription (prescription), for the station requirement, the emergency requirement according to § 5c and the rescue service requirements according to § 6 (1) only after the submission of a finished stunning medium request (prescription for the station requirement, the emergency needs and the rescue service requirement).(3) The whereabout and the stock of narcotics shall be unbroken:
1.
in pharmacies and veterinary medicinal products,
2.
in physicians, dentists and veterinarians,
3.
at hospitals and in the hospitals Animal clinics,
4.
in old and nursing homes, in hospices and facilities of specialized outpatient palliative care,
5.
in rescue services,
6.
in facilities in accordance with § 5, paragraph 9b, and
7.
on }
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Non-official Table of contents

§ 2 prescribable by a doctor

(1) For a patient, the doctor may prescribe within 30 days:
a)
up to two of the following narcotics in compliance with the following maximum levels:

1.Amfetamine600 mg,
2. Buprenorphine800 mg,
2a.Cannabis extract (based on the 9-tetrahydrocannabinol content)1 000 mg,
3.Codeine as a substitution agent 40 000 mg,
3a.Dexamfetamine600 mg,
3b.Diamorphin30 000 mg,
4. dihydrocodeine as a substitution agent40 000 mg,
5.dronabinol 500 mg,
6.Fenetyllin2 500 mg,
7.Fentanyl500 mg,
7a. Flunitrazepam30 mg,
8.Hydrocodon1 200 mg,
9.Hydromorphon5 000 mg,
10. Levacetylmethadol2 000 mg,
11.Levomethadon 1 500 mg,
11a.Lisdexamfetamine dimesilate2 100 mg,
12.methadone3 000 mg,
13. methylphenidat2 400 mg,
14.(omitted)
15.Morphin20 000 mg,
16.Opium, adjusted4 000 mg,
17. Opiumextrakt2 000 mg,
18.Opiumtinktur 40 000 mg,
19.Oxycodon15 000 mg,
20.Pentazocin15 000 mg,
21. Pethidine10 000 mg,
22.(omitted) 
23.Piritramid6 000 mg,
23a. Tapentadol18 000 mg,
24.Tilidin 18 000 mg
or
b)
one of the other narcotic agents listed in Appendix III of the Narcotics Act Alfentanil, cocaine, ectorphin, reifentanil and sufentanil.
(2) In substantiated individual cases and in accordance with the required safety of the movement of drugs, the physician may be required to provide a patient who is in his/her permanent treatment, the provisions of paragraph 1 with regard to
1.
the number of narcotic agents prescribed and
2.
the set maximum quantities
. Such a prescription shall be marked with the letter "A".(3) For its practical use, the physician may 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 content of 2 of the hundred, reifentanil and Prescribe 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 narcotic. Diamorphine may prescribe the doctor up to the amount of its average monthly requirement. The storage system shall not exceed the average two-month requirement of the doctor for Diamorphin.(4) Only the doctor who directs a hospital or a unit of a hospital or oversees in the absence of the head may prescribe for the station's need for station. It may prescribe the narcotics referred to in paragraph 3, in compliance 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. Non-official table of contents

§ 3 prescribtion by a dentist

(1) For a patient, the dentist may prescribe within 30 days:
a)
one of the following narcotics, subject to compliance with the following Maximum quantities:

1.Buprenorphin40 mg,
2.Hydrocodon300 mg,
3. Hydromorphon1 200 mg,
4.Levomethadon 200 mg,
5.Morphin5 000 mg,
6.Oxycodon4 000 mg,
7. Pentazocin4 000 mg,
8.Pethidine2 500 mg,
9.Piritramid1 500 mg,
9a. Tapentadol4 500 mg,
10.Tilidin 4 500 mg
or

b)
one of the other narcotic agents listed in Appendix III of the Narcotics Act Alfentanil, amfetamine, cocaine, diamorphine, dronabinol, eptorphin, fenetylline, fentanyl, levacetylmethadol, methadone, methylphenidate, nabilone, normethadone, opium, papaver somniferum, pentobarbital, reifentanil, secobarbital and sufentanil.
(2) For its 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 supply of stocks shall not exceed the monthly requirements of the dentist for any narcotic.(3) Only the dentist who directs a hospital or a unit of a hospital or oversees in the absence of the director shall be required to prescribe for the station's station requirements. 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 separated from other subunits. Non-official table of contents

§ 4 Prescribtion by a veterinarian

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

1.Amfetamine600 mg,
2.Buprenorphin150 mg,
3. Hydrocodon1 200 mg,
4.Hydromorphon5 000 mg,
5.Levomethadon750 mg,
6. Morphin20 000 mg,
7.Opium, adjusted 12 000 mg,
8.Opiumextrakt6 000 mg,
9.Opium tincture120 000 mg,
10. Pentazocin15 000 mg,
11.Pethidine 10 000 mg
12.Piritramid6 000 mg
13.Tilidin18 000 mg
or
b)
one of the others in Appendix III of the Narcotic drugs known as narcotic drugs other than Alfentanil, Cocaine, Diamorphin, Dronabinol, Etorphin, Fenetyllin, Fentanyl, Levacetylmethadol, Methadone, Methaqualon, Methylphenidat, Nabilon, Oxycodon, Papaver somniferum, Pentobarbital, Remifentanil, Secobarbital and Sufentanil.
(2) In justified individual cases and in compliance with the required safety of the movement of drugs, the veterinarian may, in a particularly serious case, be subject to the provisions of the Paragraph 1 in respect of
1.
the number of narcotics prescribed and
2.
the set maximum levels
. Such a prescription shall be marked with the letter "A".(3) For his practical needs, the veterinarian may use the narcotics listed in paragraph 1, as well as alfentanil, cocaine for local anaesthesia in the case of intervention on the head, up to a content of 20 of the hundred or as an ointment up to a content of 2 of the A hundred, ectorphin only for immobilization of animals kept in the zoo, circus or in wild animals, by self-contained or in the presence of the prescriber, including fentanyl, pentobarbital, reifentanil and sufentanil, until to the quantity of its average two-week requirement, but at least the smallest packing unit. The stockpinning system shall not exceed the monthly requirements of the veterinarian for each narcotic.(4) Only the veterinarian who directs an animal clinic or a sub-unit of an animal clinic or oversees in the absence of the head shall be required to prescribe for the station's station requirements. 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. Non-official table of contents

§ 5 Write to substitution

(1) substitution within the meaning of this Regulation is the use of a medical in an opiate-dependent patient (substitution agent) for
1.
Treatment of opiatdependence with the goal of the gradual restoration of narcotic abstinence, including the improvement and stabilization of the Health condition,
2.
Support for the treatment of a serious disease that exists in addition to opiate dependence, or
3.
Reducing the risks of opiate dependence during pregnancy and after birth.
(2) For a patient, the doctor may use a substitution agent under the § 13 (1) of the Narcotics Act prescribe if and as long as
1.
of the German Stunning Medium Act substitution do not preclude medically generally accepted grounds of exclusion,
2.
the treatment required psychiatric, psychotherapeutic or psychosocial treatment and care measures,
3.
the doctor has fulfilled the reporting obligations pursuant to § 5a (2),
4.
The doctor's investigations and surveys have revealed no evidence that the patient is
a)
getting substitution agent prescribed by another doctor,
b)
required by number 2
c)
The use of substances whose consumption by type and quantity endangers the purpose of substitution. or
d)
the substitution agent prescribed to him not used as intended
5.
the patient to the required extent, usually weekly, consult the treating physician, and
6.
The doctor meets minimum requirements for a suchttherapeutic qualification set by the medical chambers in accordance with the generally accepted state of medical science
For the fulfilment of the admissibility requirements referred to in points 1, 2 and 4 (c), the generally accepted status of medical science is authoritative.(3) A doctor who does not meet the conditions laid down in the first sentence of paragraph 2 may, for a maximum of three patients, prescribe a substitution agent at the same time if
1.
the requirements of paragraph 2, sentence 1, No. 1 to 5, are met for the duration of the treatment,
2.
this one at the beginning of the treatment this with a doctor who satisfies the minimum requirements of paragraph 2, first sentence, number 6 (Konsiliarius), is correct and
3.
ensured that its patient will be presented to the consiliary at the beginning of the treatment and at least once a quarter.
If the doctor is given the first sentence by a doctor, where the conditions laid down in point 6 of the first sentence of the first paragraph of paragraph 2 are also not fulfilled, the first and second sentence of the first sentence of the first subparagraph 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 during representation, the representative shall vote in accordance with the sentence 4 again 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 provisions of sentences 1 to 9 shall not apply to the treatment referred to in paragraphs 9a to 9d.(4) The prescribtion of a substitution agent shall be marked with the letter "S". As a substitution agent, the doctor may only use
1.
preparations of levomethadone, methadone, and Buprenorphine,
2.
in justified exceptional cases Codeine or dihydrocodeine,
3.
Diamorphine as medicinal products authorised for substitution,
4.
medicinal products authorised for substitution
. 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 in accordance with the second sentence of paragraph 3.(5) The doctor who prescribes a substitution agent for a patient must not hand over the prescription to the patient except in the cases referred to in paragraph 8. 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 doctor, who prescries diamorphine, may only present the prescription to a pharmaceutical entreprenchman.(6) The substitution agent shall be the patient from the treating physician, his medical representative in practice, or from the medical, pharmaceutical or state-approved medical, pharmaceutical or state-approved treatment of the medicinal product, To provide facilities for addictive health assistance and to allow trained personnel to be used 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, be given the additional amount of the substitute agent in divided individual doses required for one day. and to allow him to take his own responsibility if the physician does not have any evidence of the patient's use of the substitute by means of non-intended use.(7) The substitution agent shall be the patient in the practice of a physician, in a hospital or in a pharmacy, or in any other appropriate facility recognised for this purpose by the competent State authority, or, in the case of a medical certificate, In the case of a home visit to direct consumption, the need for care should be left to the patient. The doctor may store the necessary substitution materials in one of the establishments referred to in sentence 1 under his responsibility; this shall not affect the consent of the person entitled to dispose of the substitution in question. § § 13 and 14 shall apply mutas to the proof of the whereabout and stock.(8) By way of derogation from paragraphs 5 to 7, the doctor or his medical representative may, in practice, give the patient to whom a substitution agent referred to in paragraph 6 is left for direct consumption, in cases where the continuity of the Substitution treatment cannot be otherwise guaranteed, prescribe a substitution agent in the quantity required for up to two days and allow it to take its own responsibility as soon as the course of the treatment allows it, Risks of self-or foreign hazards are excluded as far as possible, as well as the safety and control of the narcotics traffic are not impaired. 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 consuming it together with the use of the substitution agent
2.
has not yet been set to a stable dose, taking into account the development of tolerances, or
3.
substances abusively consumed.
For the evaluation of the course of treatment by the substitute doctor, the generally accepted status of the medical Science authoritative. In the case of a stay abroad of the patient, who is already prescribed substitution agent in accordance with sentence 4, the physician 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 referred to in 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 must issue a replacement certificate to the treating physician prior to the continuation of the substitution on a narcotic prescription. The substitution certificate shall indicate:
1.
The name, first name and address of the patient for which: the substitution certificate is determined,
2.
issue date,
3.
the prescribed Substitutes and daily doses,
4.
Start of writing and delivery in accordance with paragraphs 1 to 7 and, where appropriate, the beginning of the letter referred to in paragraph 1 8,
5.
Validity: from/to,
6.
The name of the issuing doctor, his professional title, and Address, including telephone number,
7.
Signature of the issuing doctor.
The substitution certificate is marked "Only for submission to the doctor". shall be identified. 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 of the measures taken, immediately after the completion of his letter of writing.(9a) For the treatment of a severe opiate dependence, the substitution agent can be prescribed diamorphine for parenteral administration. The doctor may only prescribe diamorphine if
1.
he himself qualifies for a suchttherapeutic qualification in the Referred to in the first sentence of paragraph 2, paragraph 6, which relates to the treatment of diamorphine, or has been medically active within the framework of the model project "Heroin-based treatment of Opiate dependants" at least six months,
2.
in the patient, opiate addiction, which has been in existence for at least five years, associated with serious somatic and mental disorders in the currently predominantly intravenous
3.
3.
evidence of two unsuccessful treatments of opiate dependence, including at least six months of treatment referred to in paragraphs 2, 6. and 7 including psycho-social care measures, and
4.
the patient the 23.
treatment with diamorphine may only be carried out in establishments which have been granted a permit by the competent State authority. Permission is granted if
1.
is detected that the facility is placed in the local search support system,
2.
ensures that the facility has an appropriate human and factual equipment,
3.
a knowledgeable person responsible for compliance with the requirements set out in point 2, the requirements of the authorizing authority and the supervisory authority's orders (responsible).
(9c) Diamorphine may only be prescribed, administered and left to direct consumption within the body referred to in paragraph 9b of this Article. 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 measures must take place.(9d) The treatment with diamorphine should be reviewed after two years of treatment, at the latest, to determine whether the conditions for the treatment are still in place 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 check shows that the conditions for the treatment are no longer given, the diamorphine-assisted treatment should be terminated.(10) The physician must document the fulfilment of his obligations under the preceding paragraphs as well as in accordance with § 5a (2) and (4) to the extent necessary and according to the generally accepted status of medical science. The documentation shall be submitted or sent to the competent authority for inspection and evaluation at the request of the competent State authority.(11) The Federal Medical Association may, in directives, provide the generally accepted state of medical science for
1.
the fulfillment of the admissibility requirements referred to in the first sentence of paragraph 2, no. 1, 2 and 4, point (c),
2.
Selection of the substitution agent in accordance with the fourth sentence of paragraph 4 and
3.
the assessment of the previous success of the treatment referred to in the first and fourth sentence of paragraph 8.
guidelines for the documentation referred to in paragraph 10. Compliance with the generally accepted status of medical science is 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 mutatily if the substitution agent is transferred from the stock of practical needs or station requirements for direct consumption, or is handed out in accordance with the third sentence of paragraph 6. Non-official 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) Countries other than the Federal Government, a register of data on the prescribings of substitution funds (substitution register). The substitution register data can only be used to
1.
the prescrip of a To prevent substitution by several doctors for the same patient and the same period as early as possible,
2.
to check if the substitution agent is doctors prescribing the minimum requirements in accordance with § 5 (2) sentence 1 (6) or the requirements of § 5 (3) sentence 1, points 2 and 3, as well as
3.
Prescriber of substitution funds in accordance with § 13 (3) (3) (3) (e) of the German Narcotics Law.
The Federal Institute shall take organisational measures to guide the Substitution register.(2) Any physician who prescries a substitution agent for a patient has to report to the Federal Institute without delay in writing or crypto by electronic means:
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, service address, and Telephone number of the prescribing physician as well as
6.
in the case of the prescribing according to § 5 (3) sentence 1 name, first name, service address and telephone number of the Consiliaries.
The patient code is as follows:
a)first and second location: first and second first first name letter,
b)third and fourth positions: First and second letter (s) 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 of birth and -year.

It is inadmissible to uncode patient data to the Federal Institute. The doctor has to check the details of the person by comparison with the patient's ID or passport.(3) The Federal Institute shall immediately encrypt the patient code referred to in the first sentence of the first sentence of paragraph 2 in accordance with a procedure prescribed by the Federal Office for Security in Information Technology in a cryptogram in such a way that it does not or only with a disproportionately large amount of effort can be recovered. 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 referred to in the first sentence shall be protected by appropriate security measures against unauthorised knowledge and use.(4) The Federal Institute compares each newly stored cryptogram with the already existing cryptograms. 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 physicians 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 prevent the prescribing of substitution funds from several doctors for the same patient and the same period.(5) The medical chambers shall immediately notify the Federal Institute of its request, stating the first name, name, address and date of birth of a doctor notified in accordance with the first sentence of paragraph 2, point 5 or point 6, whether the doctor has Minimum requirements laid down in Article 5 (2), first sentence, point 6. The medical chambers shall immediately inform the Federal Institute of the indication " Note: Suchttherapeutic qualification is no longer available." to those physicians who were previously reported by the Medical Association to the Federal Institute, who have fulfilled the minimum requirements pursuant to § 5 (2), first sentence, number 6, but are currently no longer fulfilling the minimum 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 § 5 (2), first sentence, point 6, with the following information:
1.
Name and First Name,
2.
service_address,
3.
date of birth.
The Federal Institute shall be informed of the data collection the substitution register without delay the competent surveillance authorities of the countries by name, first name, address and telephone number
1.
the physicians who have prescribed a substitution agent in accordance with § 5, paragraph 2, and
2.
as referred to in paragraph 2 1 (6),
where 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 conjunction with the data transmitted in accordance with sentences 1 to 3.(6) The Federal Institute shall inform the competent surveillance authorities of the 30. June and 31. December of each year, the following data from the data base of the substitution register with:
1.
Doctors ' names, first names, addresses, and phone numbers prescribed by § 5 (2) substitution agent,
2.
Doctors ' names, first names, addresses and phone numbers, prescribed by § 5, paragraph 3, sentence 1, substitution agent,
3.
The names, first names, addresses and phone numbers of the doctors who have been reported as Konsiliarius in accordance with paragraph 2, first sentence, point 6, and
4.
Number of patients for which a physician referred to in paragraph 1 or number 2 has prescribed a substitution agent.
The competent surveillance authorities can also at any time require information from the Federal Institute in individual cases.(7) The Federal Institute shall inform the supreme state health authorities for the country in question at the 31. December of each year, the following data from the data base of the substitution register:
1.
Number of patients who have been prescribed a substitution agent,
2.
the number of physicians prescribed in accordance with § 5 (2) substitution ,
3.
the number of physicians who have prescribed substitution funds according to § 5, paragraph 3, sentence 1,
4.
the number of doctors who have been reported as Konsiliarius according to paragraph 2 sentence 1, number 6, as well as
5.
Art and proportion of the prescribed substitution materials.
On request, the supreme state health authorities will also receive the information listed under points 1 to 5 Broken down by surveillance area. Non-official table of contents

§ 5b prescribals for patients in old or nursing homes, hospices and in the specialized outpatient department Palliative care

(1) The doctor who prescribers a narcotic for a patient in an old or nursing home, a hospice or in the specialized outpatient palliative care, may determine that prescribing is not the Patients will be handed out. 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 Pharmacy is submitted.(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 staff of the old or nursing home, the hospice or the establishment of the specialized staff who have been instructed and controlled by him. to administer ambulatory palliative care or to leave it for direct consumption.(3) In the case referred to in the first sentence of paragraph 1, the physician may store the narcotics of the patient in the old or nursing home, the hospice or the establishment of the specialized outpatient palliative care under his responsibility; the consent of the The respective premises shall remain unaffected by the respective premises. § § 13 and 14 shall apply mutas to the proof of the whereabout and stock.(4) A narcotic agent stored in accordance with paragraph 3 and no longer required may be used by the physician
1.
another patient of this old or nursing home, this hospice, or this facility of specialized outpatient palliative care,
2.
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.
will be transferred to the emergency supply according to § 5c (1) sentence 1.
A non-official table of contents

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

(1) Hospize and facilities of specialised care ambulant 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). Authorized persons who make use of the option after the first sentence are obliged to
1.
one or more to ask several doctors to prescribe the narcotics needed for the emergency supply in accordance with § 2 (4) sentence 2,
2.
the gap-free Demonstration 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.
with a pharmacy supplies the supply for emergency supplies and at least a half-yearly review of emergency stocks, in particular on their flawless Condition as well as proper and safe storage in writing; the undersigned pharmacist shall indicate in writing the agreement of the competent State authority prior to the initial delivery; § 6 (3) sentence 2 to 4 shall apply
() 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. Non-official table of contents

§ 6 Letter for rescue service bodies

(1) For prescriber of the need for narcotics for Facilities and subunits of emergency service facilities (rescue service requirements) shall be subject to the requirements of the prescribable for the station requirements in accordance with § 2 para. 4.(2) The carrier or the person responsible for the rescue has to ask a doctor to prescribe the necessary narcotics in accordance with § 2 (4). The recording of the whereabouts and stocks of the narcotics is to be carried out in accordance with § § 13 and 14 in the facilities and subunits of the facilities of the rescue service by the respective treating physician.(3) The carrier or the transit officer of the rescue service shall, with a pharmacy, supply the prescriptions for the rescue service requirements as well as an at least half-yearly review of the narcotic stocks in the facilities, or In writing, sub-units of the rescue service bodies shall, in particular, agree in writing on their flawless nature, as well as proper and safe storage. A pharmacist of the respective pharmacy is to be commissioned with the examination of the narcotic resources. 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 competent authorities 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 physician according to § 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 State authority, indicating the non-used narcotic agents. The competent authority of the State shall take a decision on the whereabouts of non-used narcotics. A non-official table of contents

§ 7 Write for Kauffehrteiships

(1) For the prescriber and delivery of narcotic drugs for the equipment § § 8 and 9 shall apply to the vessels of the carriage. The information referred to in paragraph 4 (4) to (6) shall be affixed to the drugs referred to in Article 9 (1) (1) and (5).(2) Only a doctor appointed by the competent authority may prescribe narcotic drugs for the equipment of a commercial vehicle; for this purpose, he may prescribe the narcotic morph for this purpose 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) For the first time, the use of narcotic drugs for the equipment of a pharmacy may be given by a pharmacy without prescription if
1.
the doctor referred to in paragraph 2 is not reachable in time before the ship is run out,
2.
the Delivery by type and quantity only to replace
a)
consumer,
b)
become useless or
c)
outside the scope of the narcotics law of ships, that lead the federal flag, procured and, according to the state of the medical findings announced by the Federal Ministry of Transport and Digital Infrastructure pursuant to § 108 (2) sentence 1 of the Maritime Labour Code to be exchanged
Narcotic drugs,
3.
the donor has previously convinced that the still existing anesthetic agents are in accordance with type and quantity with the Entry in the narcotics book of the ship agree, and
4.
the delivery is the receipt of that for the proper conduct of the medical The
referred to in paragraph 3 (4)
contain the following information: style="font-weight:normal; font-style:normal; text-decoration:none; ">
1.
Label of Prescribed Medicines in accordance with § 9 para. 1 no. 3,
2.
The quantity of medicines given in accordance with § 9 para. 1 no. 4,
3.
delivery date,
4.
name of the ship,
5.
Reeders name,
6.
home port of the ship and
7.
signature of the for medical care after the (
) The donor shall submit the certificate referred to in paragraph 3 (4) without delay to the physician instructed by the competent authority for the purpose of subsequent prescribable. 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 fulfilled, the competent authority shall be informed without delay.(6) Paragraphs 1 to 5 shall apply mutaly to the prescriber and the supply of narcotic drugs for the equipment of ships other than those of a transport vessel. Non-official table of contents

§ 8 Narcotics recipe

(1) Stunning agents for patients, practical requirements and animals may only be used 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 paragraph 9a, for submission to a pharmaceutical entreprenate, Part III shall remain with the doctor, dentist or veterinarian, on that was spent on the narcotics recipe.(2) Narcotics prescriptions are issued by the Federal Institute for Drugs and Medical Devices 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 legislation on narcotics in accordance with the law.(3) The numbered narcotics prescriptions are intended only for the use of the requesting physician, dentist or veterinarian and may only be transferred in the case of a representative case. The non-used narcotic drugs are to be returned to the Federal Institute for Medicinal Products and Medical Devices in the case of medical, dental or veterinary activities.(4) The physician, dentist or veterinarian has to secure the narcotic remedies against deprivation. A loss must be reported immediately to the Federal Institute for Medicinal Products and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte-Bundesinstitut für Arzneimittel und Medizinprodukte-Bundesinstitut für Arzneimittel und Medizinprodukte).(5) The doctor, dentist or veterinarian has to keep part III of the prescription and the parts I to III of the incorrectly prepared narcotics prescriptions according to the exhibition data or according to the requirement of the competent State authority for three years and to submit, at the request of the national authority responsible pursuant to section 19 (1) sentence 3 of the Narcotics Act, or to submit to the competent authority of that authority.(6) Except in the cases referred to in § 5, narcotic drugs may be prescribed for patients, in cases of practical use and animals in emergencies, subject to limitation 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. Non-official table of contents

§ 9 Information on the narcotics recipe

(1) On the narcotics prescription, be indicated:
1.
The name, first name and address of the patient for which the narcotic is intended; in veterinary Prescriptions of the species of the animal as well as the name, first name and address of the keeper,
2.
date of issue,
3.
The name of the medicinal product, if any of the following information is not clearly defined, in each case the additional name and weight of the contained stunning agent Package unit, in the case of divided preparations, each divided form, presentation form,
4.
Quantity of the medicinal product prescribed in grams or millilitres, unit number of the medicinal product divided form,
5.
Instructions for use with single and daily doses, or in the event that a written instructions for use has been submitted to the patient, an indication of this written instructions for use; in the case of § 5 (8), in addition, the period of validity of the substitution agent in days,
6.
in the cases of § 2 para. 2 sentence 2 and the § 4 (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 para. 6 sentence 5 of the Letter "N",
7.
Name of the prescribing physician, dentist or veterinary surgeon, his professional title and address, including telephone number,
8.
in the cases of § 2 (3), § 3 (2) and § 4 (3) of the note "Practical Requirements" instead of the information in numbers 1 and 5,
9.
Signature of the prescribing physician, dentist or veterinarian, in the case of representation, the note "i.V.".
(2) The information referred to in paragraph 1 shall be permanently , and must 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. Non-official table of contents

§ 10 Narcotics request form

(1) Narcotics for the station requirements according to § 2 para. 4, § 3 para. 3 and § 4 Section 4, the emergency requirements according to § 5c and the rescue service requirements in accordance with § 6 (1) may only be prescribed on a three-part official form (narcotics request form). 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 prescribable doctor, dentist or veterinarian.(2) The Federal Institute for Medicinal Products and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte) issued a request for drugs on request to:
1.
The doctor or dentist who has a hospital or hospital ward,
2.
the veterinarian who directs an animal clinic
3.
a commissioned doctor in accordance with § 5c (1) sentence 2 number 1,
4.
the doctor appointed in accordance with § 6 paragraph 2 of the rescue service or
5.
the relevant leading emergency physician in accordance with § 6 (4).
(3) The numbered narcotics request certificates are only for use 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 physician 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 verification documents referred to in paragraph 3 are of the following: a doctor, a dentist or a veterinarian, three years from the date of the last registration, and, at the request of the national authority responsible pursuant to section 19 (1) sentence 3 of the Narcotics Act, to be sent or appointed by the competent authority of the to present authorities. Non-official table of contents

§ 11 Information on the narcotics request slip

(1) On the narcotics request form, please specify:
1.
Name or name and address of the facility for which the narcotics are determined ,
2.
Date of issue,
3.
Name of the prescribed medicinal products in accordance with § 9 para. 1 No. 3,
4.
Amount of the prescribed medicinal products according to § 9 para. 1 no. 4,
5.
Name of the doctor, dentist or veterinarian, including telephone number,
6.
Signature of the prescribing physician, dentist or veterinary surgeon, in case of representation
thereferred to in paragraph 1 shall be permanently marked and shall be included in all parts of the prescription for the station 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. Non-official table of contents

§ 12 levy

(1) Narcotic drugs may not be delivered subject to paragraph 2:
1.
on a prescription,
a)
which cannot be made out for the donor in accordance with § § 1 to 4 or § 7 (2)
)
c)
c)
c)b)
style="font-weight:normal; font-style:normal; text-decoration:none;"> that was made more than seven days ago, except in the case of importation of a medicinal product in accordance with § 73 para. 3 of the Medicines Act, or
d)
which is marked with the letter "K" or "N";
2.
on a prescription for the Station requirements, emergency needs and rescue service requirements,
a)
according to § § 1 to 4, § 7 (1) or § 10 (3) for the transferor was not allowed to be issued or
b)
did not comply with a provision in § 10 (1) or § 11
3.
on a prescription according to § 8 (6), the
a)
not marked after record 2 or
b)
made more than one day ago
4.
on a prescription pursuant to § 5 (8) if they are not made up in single doses and in child-proof packaging.
(2) Prescriptions and prescriptions for the requirements of the station, the emergency needs and the rescue service requirements, which contain an error that can be recognized for the donor, are illegible or do not comply with the provisions of § 9 para. 1 or § 11 para. 1 , 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 narcotics or subsets of which have been prescribed shall be made available if: the provider 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 Rescue services must be carried out immediately. 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. The sentences 2 to 4 do not apply to the prescribtion of diamorphine.(3) In part I of the prescribtion or the prescription for the station requirement, the emergency needs and the emergency requirements and the rescue service requirements shall be permanently marked:
1.
pharmacy name and address,
2.
Delivery Date and
3.
Name of the submitter.
(4) The pharmacy leader has part I of the Prescriptions and prescriptions for the requirements of the station, 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 to be kept and, on request, the Federal Institute for Medicinal products and medical devices or the competent authority of the competent authority in accordance with Section 19 (1) sentence 3 of the Narcotic Drugs Act or to submit them to these authorities. Part II is intended for settlement. In the case of the dispensing of diamorphine, the rates 1 and 2 shall apply mutatily to the person responsible for narcotics of the pharmaceutical entreprenchman.(5) The veterinarian may only use anesthetic from his skin pharmacist for use in an animal treated by him and only in compliance with the provisions of § § 1 and 4 (1) and (2) in force for the prescribing. Non-official table of contents

§ 13 Detection Guide

(1) Proof of whereabation and inventory of narcotics in the above mentioned § 1 para. 3 Facilities shall be carried out immediately after a change in the stock of 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 in accordance with § 5 (6) sentence 1 or of a narcotic agent according to § 5b para. 2, the whereabout is to be proven in a patient-related manner.(2) The entries relating to access, declines and stocks of narcotics, as well as the compliance of the stocks with the led evidence, are
1.
from the pharmacist for the pharmacy directed by him,
2.
from the veterinarian for the one he has directed veterinary skin pharmacies and
3.
from the prescription physician, dentist or veterinarian for the practice referred to in § § 2 to 4-or Station requirements,
4.
from a doctor for hospices and facilities of specialized outpatient palliative care, as instructed in accordance with § 5c (1) sentence 2. the doctor responsible for the rescue service pursuant to § 6 (2),
5.
of the medical care provided for in accordance with the provisions of the seelabour law Regulations in charge of the respective vessel carrying the flag of the Federal Republic
Germany
6.
from the attending physician in the case of proof referred to in the first sentence of paragraph 1 4,
7.
from the person responsible within the meaning of Section 5 (9b) (3)
at the end of each calendar month, and, if the stock has changed, by Confirm the name and the verification date. In the event that the verification is carried out by means of electronic data processing, the test shall be carried out on the basis of the end-of-month expression of the print-outs.(3) The card cards, narcotics books or EDP printouts referred to in the second sentence of paragraph 2 shall be kept for three years from the last entry in the institutions referred to in Article 1 (3). In the event of a change in the management of a hospital pharmacy, establishment of a hospital, a hospital, a veterinary clinic or a change of doctor in accordance with § 5c (1) sentence 2 (1) or (6) (2) sentence 1, the following shall be provided by the Note the date of the handover as well as the submitted inventory and 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 card and stun books. Non-official table of contents

§ 14 evidence of verification

(1) In the case of evidence of leftovers and inventory of narcotics, the following are: Permanent indication of anesthetic agents:
1.
designation, for medicinal products according to § 9 para. 1 no. 3,
2.
date of access or departure,
3.
quantity received or lost, and the the resulting stock; in the case of substances and preparations not divided, the quantity by weight in grams or milligrams, in the case of preparations which have been divided; in the case of liquid preparations which are used in the context of a treatment which: Quantity also in millilitres,
4.
Name or company and address of the supplier or consignee, or other origin or other whereabout,
5.
in pharmacies in case of prescription for patients as well as for the practical needs of the name and address of the prescribing physician, dentist or veterinarian and the the name of the prescribing physician, dentist or veterinarian and the number of the prescriber's prescriber, in the case of prescribing for the requirements of the station, the emergency needs and the rescue service requirements. Anaesthesiology requirement,
5a.
in hospitals, veterinary clinics, hospices, as well as in institutions of specialized outpatient palliative care and of the Rescue service in case of purchase on prescription for the station needs, emergency needs as well as the rescue service needs of the name of the prescribing physician, dentist or veterinarian and the number of the Stunning agent requirement,
6.
in the pharmaceutical company in the case of the prescription of Diamorphin name and address of the prescriber Physicians and the number of the narcotic medicinal product.
In the case of the entities referred to in § 1 (3), the records shall be kept in these units.(2) In the case of liquid preparations, in the case of liquid preparations, the amount by weight of the narcotic agent, which is contained in the overfilling of the dispensing container, which is necessary for technical reasons, should be taken into account only if this means that the discharge is higher than that of the product. is as access. The difference is to be shown as an access with "overfill". Non-official table of contents

§ 15 Forms

The Federal Institute for Medicinal Products and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte) shall provide the official forms for the Prescriber (narcotics recipes and narcotics request certificates) and for the proof of whereabout and stock (card and stun cards) and makes them known in the Federal Gazette. Non-official table of contents

§ 16 offences

According to § 29 paragraph 1 sentence 1 no. 14 of the narcotics law, it is punished who
1.
contrary to § 1 para. 1 sentence 1, also in conjunction with sentence 2, a narcotic is not 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 paragraph 2 sentence 1 or § 4 para. 3 sentence 1 for its practical needs or
c)
contrary to § 4 paragraph 1 for an animal
other than the narcotics designated there or within 30 days more than a narcotic agent, in the case of § 2 para. 1 letter a more than two narcotics, exceeding the set limit or prescribed for non-compliance with the specified destination or other restrictions,
3.
contrary to § 2 para. 4, § 3 para. 3 or § 4 paragraph 4
a)
Narcotics for other devices other than those designated there,
b)
other than those designated there Narcotics or
c)
narcotics referred to there under non-compliance with the restrictions mentioned there,
4.
contrary to § 7 para. 2 Narcotics for the equipment of Kauffehrteiships prescribing,
5.
§ 5 Paragraph 9c, Sentence 1, Diamorphine, written, administered or transferred.
Non-official table of contents

§ 17 Administrative Offences

Contrary to the provisions of Section 32 (1) No. 6 of the Narcotics Act, who intentionally or recklessly
1.
contrary to § 5 para. 9 sentence 2 and 3, also in conjunction with § 5 para. 12, § 5a (2) sentence 1 to 4, § 7 para. 1 sentence 2 or para. 4, § 8 para. 6 sentence 2, § 9 para. 1, also in conjunction with § 2 2 sentence 2, § 4 (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 § 5 paragraph 10, the necessary measures are not or are not fully documented or the responsible state authority does not submit the documentation for inspection and evaluation or send it,
3.
contrary to § 8 (1) sentence 1, also in conjunction with § 7 para. 1, narcotics, not on a valid narcotic prescription or contrary to § 10 para. 1 sentence 1 of narcotics not prescribing on a valid narcotics request form,
4.
contrary to § 8 (3) for its use In the case of the activities of the Federal Institute for Medicinal Products and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte),
5.
contrary to § 8 (4) " 6.
contrary to § 8 (5), § 10 (4) or § 12 (4) sentence 1, which does not prevent the use of deprivation or a loss of waste against
. 7.
7.
7.
7.
contrary to § 8 para. 6 sentence 4, the prescription does not immediately follow the pharmacy,
8.
contrary to § § § 8. 3 sentence 3 does not provide evidence of disclosure of narcotics requirements,
9.
a provision of § 13 para. 1 sentence 1, para. 2 or 3 or § § 13 (1) sentence 1. 14 for keeping records, checking or keeping them, or
10.
contrary to § 5 (2), first sentence, point 6, or (3), first sentence, points 2 and 3, (2) and (7) or (5) and (6) or (9a), second sentence, point (1), of a substitute, without complying with the minimum requirements for qualification or without involving a consiliary in the treatment or without being represented as a representative, which does not meet the minimum qualification requirements, or without complying with the diamorphine-specific requirements for qualification referred to in paragraph 9a, second sentence, point 1.
Non-official table of contents

§ 18 Transitional rules

(1) § 5 (3) sentence 2 applies to the writing of a substitution agent for narcotic agents that are prior to entry into force this regulation codeine or dihydrocodeine was prescribed for substitution, starting from 1. January 2000 Application.(2) § 5 (7) (1) shall also be deemed to be fulfilled if, at the date of entry into force of this Regulation, codeine or dihydrocodeine was prescribed in the same practice for the purpose of substitution for a patient for at least six months.