480. Regulation of the Federal Minister for Health, Family and Youth, amending the Suchtgiftverordnung

Pursuant to Section 10 (1) Z 2, 4 to 7 and (2) of the Suchtmittelgesetz (SMG), Federal Law Gazette (BGBl). I n ° 112/1997, as last amended by the Federal Law BGBl. I n ° 143/2008, shall be:

The Suchtgiftverordnung-SV, BGBl. II No 374/1997, as last amended by the BGBl Regulation. II No 166/2008, shall be amended as follows:

1. § 1 (5) is deleted.

2. § 2 (1) and (2) reads:

" (1) The production, processing, conversion, acquisition and possession of narcotic venom, unless § 6, 7 or 10a determine otherwise, and without prejudice to any permits required under other legislation, only in accordance with Permission of the Federal Minister for Health, Family and Youth and only allowed in the maximum amount granted by this authorized quantity.

(2) The authorisations granted in accordance with paragraph 1 may, in so far as not otherwise determined by paragraph 3, be permitted only to traders with a right to manufacture medicinal products and poisons and to wholesale trade in medicinal products and poisons in accordance with Section 94 (32) of the Industrial Regulations 1994, and shall be granted only to the extent necessary to fix a maximum quantity. For the wholesale trade of medicinal products, such authorization may only be granted if it does not lead to a detailed transaction at all or if it does not lead to a complete separation of the details. "

3. In Article 2 (4), the following Z 2a and 2b shall be inserted after Z 2:

" 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);
2b.		that addiction poison or a list of those addictive poisons for which the authorization shall be granted, including the maximum quantity likely to be required in each calendar year and the purpose (s) referred to in (2) or (3) for which the narcotic gift is required; "

4. § 5 (1) reads:

"(1) The persons entitled under § 2 para. 2 may only hand in addiction venom to trader with an entitlement to manufacture medicinal products and poisons and to wholesale trade in medicinal products and poisons in accordance with § 94 Z 32 of the Industrial Code of 1994, to which the § § § § 94 (2) of the German Industrial Code (" Gewerbeordnung ") 6 (1) referred to in Article 7 (1) of the Federal Republic of Germany and the authorities responsible for the enforcement of the law on addiction (Section 7 (1)), to the public authorities of the Federal Government (Section 7 (2)), to organised emergency services (Section 7 (2a)), to public pharmacies and "anstaltsapotheken" (Section 7 (3)) as well as against the application of the authorization to the beneficiaries pursuant to § 2 paragraph 3. "

5. § 7 (1) reads:

" (1) The institutions of the Civil Security Service, the customs bodies and the authorities which are responsible for the enforcement of the Suchtmittelgesetz require no authorization from the Federal Minister for the acquisition and possession of addiction venom in this respect. Health, family and youth, when they need it for education and training purposes, or are given addictive poison in law enforcement of the Suchtmittelgesetz. "

(6) A new paragraph 2a shall be inserted in accordance with Article 7 (2). Section 7 (2) and (2a) reads:

" (2) The medical institutions of the Federal Army do not require the Federal Minister for Health, Family and Youth for the processing, acquisition and possession of narcotic venom to the extent that they are responsible for the medical or dental treatment. It is necessary to supply the members of the federal army or it is necessary for the veterinary treatment as well as for the training of the animals in use in the federal army.

(2a) In this respect, the organised emergency services do not require the Federal Minister for Health, Family and Youth to approve the acquisition and possession of addiction venom in so far as they need it for emergency medical care. "

7. § 7 (4) reads:

' (4) The acquisition and possession of narcotic drugs by doctors, dentists, veterinarians, dentists, hospitals, other institutions which have a drug depot (Section 9 (1) of the Suchtmittelgesetz) as well as persons to which it is from a pharmacy. Due to medical or dental prescription, § 2 para. 1 shall not be applied. "

8. Section 8 (4) and (5) reads as follows:

" (4) The Federal Minister for Health, Family and Youth decides on the appropriateness of the respective preliminary remarks in accordance with paragraphs 1 to 3. Copies of the documents on the quantities of addictive toxins issued must be sent to the Federal Ministry of Health, Family and Youth at the request of the Federal Ministry of Health.

(5) Doctors, dentists, dentists and veterinarians who need addiction poison in the exercise of their profession, hospitals and veterinary clinics and institutions, as well as the institutes and institutions referred to in Article 6 (1), as well as the organised emergency services relating to the use and use of narcotic drugs of the Annexes I, II, IV and V of this Regulation shall be subject to such precise provisions that they may, on request, give information to the authorities. "

Section 9 (1) reads as follows:

" (1) The public pharmacies, hospital pharmacies and the medical and veterinary medicinal products of the home pharmacy shall have a pre-booklet with a consecutive number of pages in which the stock to be stored in the first place is 1. Jänner of each year, the reference source and the levy of narcotic drugs, with the exception of the pharmaceutical preparations listed in Annex III. Suchtgiftbezüge are to be shown with the delivery notes. The prescription (addiction toxic recipe) serves as proof of the addiction of the addiction toxic to doctors, dentists, dentists or veterinarians for their professional needs or for hospitals. The transfer of addiction to other pharmacies, including medical and veterinary medicinal products, shall be issued with the delivery note or any other appropriate document. Suchtgiftentrances are to be entered immediately, at the latest at the end of the month-in the case of long-term addictive prescriptions, at the latest at the end of the month following the last levy-to be entered in the pre-register. The total number of addictions of Annex II to this Regulation shall be entered at the latest by the end of the year. On 31 December of each year, an inventory of the actual addictive poisons shall be made; any differences shall be drawn up in the pre-register. "

10. § 10 (1) reads as follows:

" (1) The producers and wholesalers referred to in Article 2 (2) shall have up to 31 years of age. Each year, the Federal Office for Health and Safety (Bundesamt für Sicherheit im healthcare) shall be required to submit to the Federal Office for Health Security in two copies remittantes on the marketing of narcotic venom as well as the production, processing and conversion of addiction venom in the previous calendar year. Those referred to in § 2 (3) shall have up to 31. Each year, the Federal Office for Health and Safety (Bundesamt für Sicherheit im healthcare) shall be required to submit to the Federal Office for Health Security in two copies remittantes relating to the purchase of narcotic venom as well as the production, processing and conversion of addiction venom in the previous calendar year. "

(11) The following paragraph 4 is added to § 10:

" (4) The Federal Office for Health and Safety (Bundesamt für Sicherheit im healthcare) has provided the Federal Ministry of Health and Women with the statistical information required for reporting on addiction poisons to the United Nations Control Council by 10 June of each year. to submit data. "

12. In § 10, the following § 10a together with the title is added:

" Cultivation of plants of the genus Cannabis for the production of drugs for the production of medicinal products

§ 10a. (1) The Austrian Agency for Health and Consumer Protection (Österreichische Agentur für Gesundheit), which is entitled under § 6a of the Law on Narcotic Drugs for the cultivation of cannabis plants for the production of drugs for the production of drugs and related scientific purposes. Nutritional security GmbH has to document the processes associated with the cultivation of the cannabis plants through the management of the precursions. The precursions shall include:

1.		the holdings of cannabis plants at the beginning of each cycle of vegetation, ordered by varieties,
2.		any reference to cannabis seeds or plants domesically, ordered by variety, including the date and source,
3.		the place and time of the cultivation of cannabis plants, ordered by variety and quantity; the cultivation, breeding, reproduction and inculturation of cannabis are considered to be cultivated;
4.		the location and size of the cultivated areas on which the cultivation of the cannabis plants takes place, ordered by cannabis varieties,
5.		the location and size of the area on which the storage of the cannabis plants or the cannabis obtained therefrom is carried out,
6.		any supply of cannabis plants or cannabis obtained from cannabis plants, ordered by variety, and the date of the levy, the quantity delivered and the purchaser;
7.		the quantity of crop residues, lethal plants, resection losses and cannabis disposed of in the course of growing in the respective vegetation cycle or after harvesting and drying;
8.		the stock of cannabis plants at the end of each cycle of vegetation, ordered by variety,
9.		the quantity of cannabis obtained from the cannabis plants in the respective vegetation cycle.

(2) In the event that the Austrian Agency for Health and Food Safety GmbH is responsible for the cultivation of plants of the genus Cannabis for the purpose of obtaining narcotics for the production of medicinal products or related scientific purposes has established a subsidiary (Section 6a (1) of the Suchtmittelgesetz), it is responsible for the documentation provided for in paragraph 1.

(3) § 8 para. 6, first and third sentences shall apply. The official bodies responsible for monitoring must have access to the areas under cultivation, premises and storage facilities.

(4) The supply of cannabis plants and cannabis may not, as a rule, exceed the quantity required for the production of addiction venom during the following six months. "

13. § 12 together with the title is:

" Addiction to addiction by doctors, dentists, didsters and veterinarians

§ 12. Doctors and dentists, Dentists and veterinarians are allowed to receive addiction poison for their skin pharmacies and for their practical needs only from domestic public pharmacies. "

14. § 13 together with the title is:

" Treatment, prescribtion and delivery

§ 13. Drug-containing medicinal products may only be used in accordance with the knowledge and experience of medical, dental or veterinary science, and in particular for pain and for withdrawal and substitution treatment, , or are directly applied in the context of a medical, dental or veterinary treatment on the or in the human or animal body. "

15. The entry rate in § 15 (1) reads:

"(1) The doctor or dentist shall be allowed to prescribe the maximum quantity in one day for the practical use:"

16. § 17 (2) reads:

" (2) Every medical, dental or veterinary prescription of narcotic drugs is subject to the special formal requirements of § § 18 to 22. In the case of a prescription of addiction for the needs of a hospital, which is covered by a hospital pharmacy of the same legal entity, as well as the prescription of addiction poison for the needs of stations within a hospital, it can replace of the form in accordance with § 18 (1), another suitable form shall also be used; from the marking as a suchtgiftprescription by sticking up the Suchtgiftvignette (§ 22 para. 1 Z 1), it may be waived. "

17. § 18 reads:

" § 18. (1) Suction of the Annexes I, II and IV of this Regulation, insofar as they are not prescribed in the context of substitution treatment (§ 21) and insofar as the doctor or dentist is responsible for the regulation of medicinal products at the expense of the institution of a social health insurance or a Health care institution is entitled to prescribe on the prescription form of the social health insurance institution or health care institution. Other doctors or dentists and veterinarians have to prescribe the prescription on a private prescription. In any case, the doctor, dentist or veterinarian has to mark this as a suchtgifting prescription by sticking the Suchtgiftvignette (§ 22 para. 1 Z 1) on the front of the presenter.

(2) Only in case of 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 addichtgiftvignette or, in the case of doctors or dentists with entitlement to the regulation with medicinal products at the expense 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. The pharmacy has to inform the prescribing physician, dentist or veterinarian immediately after the submission of the emergency prescription, and if possible before the submission of the addiction poison, about the levy. It is obliged to immediately submit the prescription to the pharmacy which has been issued by the pharmacy on a Suchtgift-solitary prescription provided with a Suchtgiftvignette. 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. .

(3) The regulation of the addiction poison is to be documented by the prescribing physician, dentist or veterinarian, the delivery of the addictive poison from the pharmacy. The documentation shall be made in a suitable form and shall include the continuous increase of the alpha-cult vignette applied to the Regulation as well as the information referred to in Article 19 (1) (1) (1) to (6). The documentation shall be kept for three years after the date of issue of the recipe, and shall be sent or submitted to the authorities at the request of the authorities. "

18. § 19 (1) Z 1 reads:

" 1.		the name and place of business-in the case of resident doctors, the place of residence of the doctor, dentist or veterinarian (Stampiglie); "

19. § 19 (3) reads:

" (3) Missing

1.		the literal particulars referred to in paragraph 1 (4) or (4)
2.		the indication cited in paragraph 1 (5), or
3.		the date of issue referred to in paragraph 1 Z 6, or
4.		the words "praescriptio indicata" or "praescriptio indicata", to be added pursuant to section 16 (4
5.		the endorsement "on substitution treatment" to be applied in accordance with Article 21 (5);

the pharmacist may, after the doctor's instructions have been obtained, or, in the case of the Z 1 to 3, the dentist's night, the dentist's doctor's doctor's instructions. At the same time, in the documentation of the prescription (§ 18 para. 3), the doctor or dentist must carry out this supplement and make it recognizable as a supplement. "

20. § 22 (2) and (3) reads:

" (2) The vignettes and forms referred to in paragraph 1 are, except in cases of justified suspicion of addictive drug abuse, by the district administrative authority, doctors, dentists and veterinarians who are entitled to self-employed professional practice, who are responsible for the of their professional activities, or of persons authorised by such persons, as well as of hospitals, to be issued free of charge, or to be sent by means of a request for a request, as a request for a request. The local authority of the district administrative authority shall be determined by the place of occupation or place of service of the doctor, dentist or veterinarian, or the place of residence of the hospital, in the case of resident physicians and residents of the residence of the patient.

(3) The search giftvignettes are to be kept safe from theft. Any loss or theft of search giftvignettes shall be without prejudice to any notification to the safety authority by the doctor, dentist or veterinarian or by the hospital under the guidance of the relevant alpha-sequence sequence to the Federal Ministry for Economic Affairs Health, family and youth immediately to be announced. A copy of the notification made to the safety authority shall be notified to the announcement. "

21. At the end of Section 23b (2) of the Z 5, the accoration shall be replaced by one point and the Z 6 to 8 shall be omitted.

22. § 23f (5) reads:

" (5) The institution in which the patient is responsible, where appropriate, with a psychosocial care, is in the case of relapses of the patient in the abuse of addiction, in particular also of positive urine findings, in accordance with § 8a (2) of the to inform the Suchtmittelgesetz (Suchtmittelgesetz) so that it can deal with the relapse with the patient. "

23. § 23j reads:

" § 23j. Doctors have the registration form for notifications and communications pursuant to Section 8a (1) of the Suchtmittelgesetz (Suchtmittelgesetz) ( Annex VIII ) to use. "

24. § 24 (1) and (2) first sentence reads as follows:

" (1) Suchttoxic medicinal products may be imported into the territory of the Federal Republic of Germany by persons to whom they have been prescribed medical or dental treatment in a quantity corresponding to paragraph 3, and may be carried in the territory of the Federal Republic of Germany, provided that: shall be in possession of a certified statement within the meaning of Article 75 of the Schengen Convention, which is certified by the prescribing physician or dentist or by the competent authority of the home State.

(2) For the purposes of travel, in particular to the other parties to the Schengen Agreement, the doctor or dentist who prescries a medicinal product shall have one in the following: Annexes I, II, or IV or, where it is prescribed for substitution treatment, in Annex III, contains the narcotic substance listed in Annex III, or the district administrative authority to issue a certificate within the meaning of Article 75 of the Schengen Convention, if the Person needs the addiction gift during the trip. "

25. § 24 (3) reads:

"(3) For the purpose of travel, the doctor or dentist may prescribe addictive medicinal products for personal use for a period of not more than 30 days."

26. § 24 (5) reads:

" (5) The Federal Ministry of Health, Family and Youth is the central Federal Service for Questions in connection with Article 75 of the Schengen Convention. Forms of the certificate referred to in paragraph 2 shall be laid down by the Federal Minister for Health, Family and Youth and shall be followed free of charge by the district administrative authorities. Doctors, dentists or persons authorised by them shall be required to follow up forms free of charge from the district administrative authority. For the purposes referred to in paragraph 2, the forms shall be made and used, including the back pages. "

27.		The previous Annex VIII shall be replaced by the new Annex VIII attached to it.
28.		Annex IX is deleted.

Kdolsky