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Regulation Of Addictive Poison

Original Language Title: Änderung der Suchtgiftverordnung

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485. Ordinance of the Federal Minister of Health, amending the Suchtgiftverordnung

Pursuant to Section 10 (1) (5) and (6) of the Suchtmittelgesetz (SMG), BGBl. I n ° 112/1997, as last amended by the Federal Law BGBl. I n ° 143/2008 and the Federal Ministries of the Federal Ministries of Law 2009, BGBl. I No 3/2009, shall be ordered:

The Suchtgiftverordnung (SV), BGBl. II No 374/1997, as last amended by the BGBl Regulation. II No 173/2009, shall be amended as follows:

1. In § § 2 (1) and 7 (1), (2) and (2a) the words shall be "the Federal Minister for Health, Family and Youth" by the words "the Federal Minister of Health".

2. In § § 2 para. 4 and 5, 4, 6 para. 5, 10 para. 3, 23 para. 2, 25 (2), 26 (2), 3, 5 and 6, 27 (3), (5), (8) and (9) and 29 (2) the words "Federal Ministry of Labour, Health and Social Affairs" by the words "Federal Ministry of Health" is replaced.

3. § 2 (4) Z 2a reads as follows:

" 2a.

in the case of applications pursuant to paragraph 2, proof of a valid authorization pursuant to Section 63 (1) of the German Medicines Act (BGBl). No 185/1983), provided that medicinal products are manufactured, controlled or placed on the market; "

4. In § § 2 (5) and 27 (4), the words "Federal Minister for Labour, Health and Social Affairs" by the words "Federal Minister for Health" replaced.

5. § 2 para. 7 Z 3 reads:

" 3.

facts from which there are reasonable concerns that the person in charge cannot fully fulfil his or her task, or "

6. In § § 6 (1) and 7 (3), the words "the Federal Minister for Labour, Health and Social Affairs" by the words "the Federal Minister of Health".

7. In the § Section 8 (4) , 22 (1) and (3) and 24 (5) the Words "Federal Ministry of Health, Family and Youth" by the words Federal Ministry of Health replaced.

8. In § § 10 (4), 21 Abs 7, 23k para. 1, 31 (2) to 6, 31a (9) and in Point 7. of Annex VI, the words "Federal Ministry of Health and Women" by the words Federal Ministry of Health replaced.

9. § 18 para. 2 reads:

" (2) Only in an emergency (in the case of danger to the life of the patient) is the prescription of narcotic venom by way of exception even without sticking to the addiction poison vignette or, in the case of doctors or dentists with authorization to prescribe medicinal products at the expense of the institution of a social sickness insurance institution or a sickness insurance institution, other than the prescription forms referred to in paragraph 1, first sentence. In these cases, the prescription shall be marked by the note "emergency". In the event of an emergency, only the smallest package commercially available may be used. A clearing of the emergency prescription shall, in so far as it is a substitution prescription, be made by the dispensing pharmacy immediately after the release of the medicinal product, but at the latest before the end of the working day following the submission of the medicinal product after the delivery. Where the person concerned is to be resident, the person concerned shall also be sent in electronic form if it is ensured that the notified emergency prescription shall be made exclusively on a receiving device of the relevant person. Authority. If the emergency prescription cannot be connected in the form of the original in the form of the original document within the meaning of § 9 of the Suchtgiftvormerkbuch for the purpose of accounting purposes, a copy or obligation shall be deemed to be an initial receipt instead. "

10. In § 23a (3), the words "The Federal Minister for Health and Women" by the words "the Federal Minister for Health" replaced.

11. § 23a (5) second sentence reads:

" For people who are the 20. In the course of the diagnostic clarification, the doctor may, in the course of the diagnostic clarification, take the opinion of a doctor in accordance with the Ordinance on Continuing Education and Training, if he does not have completed his/her life year. Substitution, BGBl. II No 449/2006, on the indication and recruitment of patients to a qualified specialist in the field of child and youth (neuro) psychiatry or psychiatry entitled to a substitution agent. "

12. § 23a (6) reads:

" (6) For persons who are the 18. In any case, in the course of the indication, the opinion of a substitution according to the provisions of the Ordinance on Continuing Education, BGBl, is in any case in the course of the indication. II No 449/2006, on the indication and recruitment of patients to a qualified specialist in the field of child and youth (neuro) psychiatry or psychiatry, qualified for substitution. In this age group, morphine preparations may only be prescribed in the form of a sustained release, provided that only further damage caused by the dependence can be held. "

13. § 23e (1) reads:

" (1) When the substitution prescription is issued, the doctor has to arrange a delivery mode which takes the daily controlled administration of the substitution agent under sight in the pharmacy, ordination site, hospital or in the patient. to ensure that drug-aid is provided. Exceptions to the daily controlled intake are only allowed on weekends and holidays; in this case, the patient should not be allowed to take more than one daily dose for Sunday or Sunday, respectively. a daily dose per holiday will be followed. In the case of buprenorphine, the daily controlled intake may be followed by up to seven daily doses in the patient. "

14. § 23e (2) last sentence reads:

"If the substitution agent is a morphine preparation in the form of a release form, the co-administration is only permitted if no other care of the patient with the substitution agent is possible which is to ensure controlled ingestion."

15. § 23e (3) to (5) reads:

" (3) In the case of a professional activity or measure pursuant to paragraph 2 (1) (1), the patient may not be followed by more than seven daily doses. A prerequisite for the co-administration of the substitution agent is also that the physician has convinced that the patient is already over a period of at least twelve weeks, provided that it is a morphine preparation in the form of a release form, via a period of at least six months in the case of a doctor qualified in accordance with Section 1 (1) (1) (1) or (2) of the Training Regulation for oral substitution for the further treatment of patients who have already been recrued on a substitution site and, at least during that period, the conditions set out in the first sentence of paragraph 2 are met .

(4) In the event of a temporary change of residence (para. 2 (2) Z 2), in particular for holiday purposes, the co-administration of the substitution agent is only permissible if it is made credible that no other care of the patient with the substitution agent, which is to be ensured in a controlled manner, is possible. It is also a prerequisite that the doctor has convinced that the patient already has a period of at least six months in the case of an oral substitution for further treatment in accordance with § 1 (1) Z 1 or 2 of the Training Ordinance. is in treatment of a patient who has already been recrued on a substitution agent and, at least during that period, has fulfilled the conditions laid down in paragraph 2, first sentence. The co-administration may not exceed 35 daily doses per calendar year. The daily dose is the dose for a calendar day, regardless of whether it is a working day, Sunday or public holiday.

(5) Other exceptions to the daily-controlled intake are only permitted if this is necessary on a case-by-case basis, in particular for therapeutic reasons, and where the agreement between the has been established by the attending physician and the physician. The particular reason for consideration and the agreement reached shall be documented. The particular reason for consideration shall be indicated by an endorsement on the prescription. "

16. § 23f (4) deleted. The previous paragraph 5 receives the sales designation "(4)" .

17. § 23i (4) reads:

"(4) In fundamental questions of substitution treatment, the Committee on Quality and Security in substitution treatment (§ 23k) or the Federal Drug Forum may be referred to the matter if necessary."

18. § 23k reads:

" § 23k. In order to advise the Federal Minister of Health in matters of substitution treatment and the qualification of the doctors and physicians involved in this treatment, the Federal Ministry of Health is a committee on quality and quality. To establish safety in the substitution treatment, to which the drug or addiction coordinators of all the Länder, and one expert representative, shall be sent by the Office of the State Government of each federal state, by the Austrian Medical Association, from the Austrian pharmacy chamber, from the main association of the Austrian Social insurance institutions, from the medical universities, as well as one representative of the other occupational groups and institutions involved in the accompanying psychosocial care. The Committee may be consulted by other persons, in particular representatives of relevant research bodies, as well as other experts competent in the field of safety or quality in the treatment of substitution. Members shall carry out their duties on a voluntary basis within the framework of the Committee. "

19. In § 24 (5), the words "from the Federal Minister for Health, Family and Youth" by the words "from the Federal Minister of Health".

20. In § 25 (1), the words "Federal Minister for Health and Women" by the words "Federal Minister for Health" replaced.

21. In Annex I.2. is between the lines "Levacetylmethadol" and "Remifentanil" the line "Monoacetylmorphine, 6-Acetyl-Morphine" inserted.

22. The Z 9 in Annex VI is deleted.

Stöger