Regulation Of Addictive Poison

Original Language Title: Änderung der Suchtgiftverordnung

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

On the basis of § § 2 (3) and 10 (1) (1) (1) to (3), (5) and (6) and (2) of the Suchtmittelgesetz (SMG), BGBl. I n ° 112/1997, as last amended by the Federal Law BGBl. I No 50/2012, shall be arranged:

The Suchtgiftverordnung (SV), BGBl. II No 374/1997, as last amended by the BGBl Regulation. II No 264/2010, shall be amended as follows:

1. § 4 reads:

" § 4. Persons who have been granted an authorization pursuant to § 2 have to inform the Federal Ministry of Health without delay of any change to the information referred to in § 2 (4). In the event of any change in the nature or maximum quantity of the addictive poisons, the intended use or the products intended to be manufactured, and in the event of changes in the person responsible (Section 2 (4) (3)), of the entrepellent, the Company form or the location of the premises, with the exception of a building, shall apply for a new authorization. "

2. § 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 the institutions and authorities of the Enforcement of sentences as well as the execution of preventive measures connected with deprivation of liberty (§ 7 para. 2b), to the public pharmacy and hospital pharmacy (§ 7 para. 3) as well as against the prior instruction of the authorization to the persons entitled under § 2 para. 3. "

3. In § 7, the following subsection (2b) is inserted:

" (2b) The institutions and authorities of the enforcement of sentences (§ 8 of the Criminal enforcement Act-StVG, BGBl. No 144/1969) as well as the execution of preventive measures connected with deprivation of liberty (§ § 158 to 160 of the StVG) do not require the Federal Minister for Health to acquire, process and possess addiction venom as far as the Federal Minister of Health is concerned. they need it for the medical care provided for by law for the accused, the accused, the prisoner or the person who has been brought to justice. "

4. § 14 Z 3 reads:

" 3.

Heroin preparations, cannabis (excluding preparations of cannabis extracts authorised for use as proprietary medicinal products), coca leaves, ecgonine and the Annex V of this Regulation. "

5. § 15 (1) Z 18 and 19 reads:

" 18.

Piritramid ............................................................................ 0,4500 g,

19.

Remifentanil ........................................................................ 0,0500 g, "

6. § 16 (1) Z 4 reads:

" 4.

Methadone ........................................................................... 0,500 g, "

7. The last sentence of Section 17 (2) of the last sentence and the last sentence of Section 18 (1) shall not apply. "(§ 22 (1) (1) (1))" .

8. The entry rate in section 19 (1) reads:

"Suchtgiftprescriptions shall be completed with ballpoint pens, provided that they are not provided with support for automation, and shall contain the following information:"

9. § 19 (1) Z 4 reads as follows:

" 4.

the pharmaceutical form, quantity and strength of the medicinal product prescribed; the quantity of drug contained in the medicinal product contained shall be indicated in such a way as to indicate clearly that the quantity of addictive toxins prescribed is clear; in the case of proprietary medicinal products, the quantity of drug Description of the trade name, the size of the pack and the number of packages prescribed; in prescriptions of preparations of the Anhanges III of this Regulation, as well as in the case of automation-assisted narcotics prescriptions, are not required to provide the verbatim information; "

10. In § 19 (1) Z 7, the words "Before and surname" by the words "First name and family name or surname" replaced.

Article 20 (1) reads as follows:

" (1) Individual prescriptions of addiction poisons in Annexes I, II and IV of this Regulation shall cease to be valid if the levy is not not later than one month, in the case of substitution individual prescriptions at the latest 14 days after the date of the submission of the charge Date of issue. "

12. The second sentence of section 21 (1) and the second sentence of the second sentence of the second sentence of the second sentence "(Section 22 (1) (2))" .

Section 22 (1) reads as follows:

" (1) The Federal Ministry of Health shall, for the purposes of the prescription of addiction venom, have to be placed in the Austrian State Printing Office for the protection against falsification of the prescription and for the purpose of enforcing the prescription in the Austrian State Printing Office, which in the following To produce safety pressure, with security features that are subject to secrecy, as well as an ongoing alpha-eradication and a bar code that reproduces the continuous alpha-grading process. The Federal Ministry of Health also has to apply a form for the substitution prescription. "

14. § 22 (2), first sentence reads:

" The Suchtgiftvignettes are, except in cases of justified suspicion of the abuse of addiction gift or psychotropic substances, which are due to an order of the Federal Minister of Health pursuant to § 10 para. 3 of the Psychotropic Ordinance, BGBl. II No 375/1997, as amended, may only be prescribed for the purposes of addiction, by the district administrative authority of doctors, dentists, dentists and veterinarians who are self-employed in their self-employed activities, who shall be responsible for their self-employment in the case of their In the event of a professional exercise, or in the case of persons authorised by these persons, as well as to hospitals for receiving confirmation of receipt, to be followed free of charge or to be sent by means of a request as a request for a request. "

15. § 22 (3) reads:

" (3) The search giftvignettes are to be kept safe from theft. Any loss or theft of search giftvignettes shall be notified by the doctor, dentist, dentist or veterinarian or by the hospital without delay to the district administration authority, under the guidance of the relevant alpha-sequence. A copy made available to the safety authority shall be made available in copy. The District Administrative Authority shall immediately enter into one of the consequences of the loss or theft of the succession of the Suchtgiftvignette, including those already applied to addictive pods, of which they are aware of the loss or theft of the Suchtgiftvignette. Federal Ministry of Health and non-public database, provided and secured according to the state of the art. The Federal Ministry of Health has, for the purpose of preventing the release of drug-containing medicinal products to persons for which they have not been prescribed, the alpha-nomic sequences entered into the database in a suitable electronic form To make wise available

1.

on request to the providers of pharmacy software for the technical realization of optoelectronic recognition of the bar codes reproducing the continuous alpha-grading (§ 22 para. 1) in pharmacies with corresponding technical Equipment,

2.

the Austrian Pharmacists ' Chamber, for the purposes of the best information, also to those public pharmacies which do not have the equipment required for optoelectronic bar code recognition, via the corresponding alpha-series sequences. "

16. § 24 with headline reads:

" Cross-border movement of medicinal products containing toxic substances in international travel

§ 24. (1) Drug-containing medicinal products other than those which contain addictive toxins in accordance with paragraph 6 may be used by travellers to whom they have been prescribed abroad and to cover personal medical or dental needs. during the journey, in a quantity not exceeding the requirements for a maximum of 30 days in accordance with para. 2 to 5, spent in the federal territory, carried along in the federal territory and returned from the territory of the Federal Republic.

(2) Without proof of medical or dental prescription issued abroad, medicinal products containing addictive substances, other than those containing addictive poisons in accordance with paragraph 6, may be transferred to the Federal territory, carried along in the Federal territory and re-established to the territory of the Federal Republic of Germany,

1.

the quantity supplied does not exceed the requirements of the travelling person for a maximum period of five days, or

2.

they are preparations of the Annex III .

(3) Medicinal products,

1.

the addictive content of which does not exceed the quantity laid down in paragraph 4 for the addictive venom in question, or

2.

irrespective of the substance of the addictive poison, other than those referred to in paragraph 4, but excluding the addictive poisons referred to in paragraph 6,

in the case of non-paragraph 2, may only be transferred to the territory of the Federal Republic of Germany, carried in the territory of the Federal Republic of Germany and returned from the territory of the Federal Republic of Germany, if proof that the medicinal product is intended for personal medical or medical purposes is not used. Special dental needs during the journey, at least one copy of the medical or dental prescription will be carried. From the prescription, the name of the traveller as a patient, the name of the prescribing physician or dentist, the name and quantity of both the medicinal product and the suchtgifts contained, as well as the dosage, must be produced. If the prescription has not been issued in Latin or not in German or English, a certificate certified by the competent authority in the country of origin shall be replaced by a certificate issued by the competent authority in accordance with the model of the Annex IX (certificate for the carrying out of medicinal products for the carriage of suchttoxic medicinal products in accordance with Article 75 of the Schengen Convention) or, in the case of travellers from countries not parties to the Schengen Convention ,-a comparable certificate within the meaning of the Directive of the International Narcotics Control Council for rules on travellers under treatment with internationally controlled narcotics (samples) Annex X) the person who has received the medicinal product for his or her personal medical or dental needs by a doctor or dentist entitled to do so. The certificate must be issued in Latin and in German or English, the period of validity of the certificate may not exceed the duration of the journey, but not more than 30 days.

(4) The maximum addictive content (addiction poison in pure substance) shall be for medicinal products as referred to in paragraph 3 Z 1 for

Buprenorphine .............................................................................

300 mg,

Codeine ..............................................................................................

12000 mg,

Dextropropoxyphene ......................................................................

6000 mg,

Dihydrocodeine ...........................................................................

12000 mg,

Dronabinol ................................................................................................

1000 mg,

Fentanyl (plaster for percutaneous administration) ............................................................

100 mg,

Fentanyl in other forms of administration ............................................

20 mg,

Hydrocodon ...............................................................................

450 mg,

Hydromorphon ...........................................................................

300 mg,

Methadone .................................................................................................

2000 mg,

Methylphenidate ..........................................................................

2000 mg,

Morphine ...................................................................................

3000 mg,

Oxycodone ..............................................................................................

1000 mg,

Pentazocin ................................................................................................

6000 mg,

Pethidin ....................................................................................

12000 mg.

(5) Medicinal products containing an addiction venom in accordance with paragraph 4 in an amount surpassing the addictive content in accordance with paragraph 4 may only be transferred to the Federal territory, carried along in the Federal territory and returned from the territory of the Federal Republic if the a person travelling by the competent authority in the country of origin shall certify in accordance with the model in Annex IX or, in the case of travellers from countries not party to the Schengen Convention, a comparable certificate within the meaning of the Directive of the International Suchturgian Control Council for rules on travellers under Treatment with internationally controlled addictive agents (samples Annex X) is the result of the fact that the medicinal product has been prescribed medical or dental prescription. The last sentence of paragraph 3 applies.

(6) The following addiction poisons may not be brought to the federal territory, carried along in the federal territory or returned from the territory of the Federal Republic of Germany:

acetorphine,

Acetyl-alpha-methylfentanyl,

Alpha-methylfentanyl,

Alpha-methylthiofentanyl,

Beta-hydroxy-3-methylfentanyl,

Beta-hydroxyfentanyl,

cannabis herb and cannabis resin,

Desomorphine,

Etorphine,

Heroin,

Ketobemidon,

3-methyl fentanyl,

3-methylthiofentanyl,

MPPP,

Para-fluorofentanyl,

PEPAP,

Thiofentanyl.

(7) Drug-containing medicinal products may be prescribed in the Federal Republic of Germany for the medical or dental needs of the patient during a trip abroad for a period of at least 30 days.

(8) The District Administrative Authority shall have persons responsible for their personal medical or dental needs during the journey to countries which are parties to the Schengen Convention, a suchttoxic Medicinal products requiring medical or dental prescription shall be accompanied by a certificate within the meaning of Article 75 of the Schengen Convention (pattern Annex IX ) , which certify that the person has received the drug-containing medicinal product prescribed by a doctor or a dentist and is required to do so during the journey. The period of validity of the certificate shall not exceed the duration of the journey, but shall not exceed 30 days. The certificate can also be issued by the prescribing physician, dentist or Dentisten, it is in this case to be certified by the district administration authority. A separate certificate must be issued and certified for each narcotic gift. A copy of the certified attestation shall remain with the notifying authority.

(9) The Federal Ministry of Health shall, as the central federal authority for matters relating to Article 75 of the Schengen Convention, set up a form for the certificate referred to in paragraph 8 (model Annex IX ) from which copies may be produced. The district administrative authorities shall, if necessary, copy the form and copy the copies free of charge to the doctors, dentists and Dentist copies.

(10) The Federal Ministry of Health also has to apply a form within the meaning of the Directive of the International Narcotics Control Board for rules on travellers under treatment with internationally controlled addictive agents, who shall District managing authorities to certify the medical or dental needs of addictive medicinal products when travelling from patients to countries which are not parties to the Convention implementing the Schengen Agreement (pattern Annex X ). Copies may be produced from the form. The last sentence of paragraph 9 shall apply. "

17. The following paragraph 3 is added to § 25:

" (3) An authorization pursuant to para. 1 and 2 shall be granted in the case of foreign missions of the Bundesheeres pursuant to § 2 para. 1 lit. d of the Wehrgesetz 2001 (WG 2001), BGBl. I No 146/2001, in order to ensure the medical or dental care of the members of the Federal Army or the veterinary treatment of the animals used in the Bundesheer, not required. '

18. In § 31 (2), the words "Before and surnames" by the words "First names and family names or surnames" replaced.

19. The following paragraph 9 is added to § 35:

" (9) § 22 (3) in the version of the BGBl Regulation. II No 357/2012 will enter into force on 1 November 2012 ".

20. In Annex I (I.1.a.) of the Suchtgiftverordnung, under the heading "Cannabis (marijuana)" the rows

" 1.

in the Common Catalogue of varieties of agricultural plant species referred to in Article 18 of Council Directive 70 /457/EEC of 29 September 1970, OJ L 327, 31.12.1970, p. No. L 225 S 1, as amended or

2.

in the current version of Annex B to Article 3 (1) of Commission Regulation (EEC) No 1164/1989 of 28 April 1989, OJ L 327, 31.12.1989, p. No. L 121 S 4, or

3.

in the list of varieties in accordance with § 65 Seed Law 1997, BGBl. I n ° 72/1997, as amended, and whose content of tetrahydrocannabinol does not exceed 0.3%, provided that abuse is excluded as a narcotic drug, and '

through the rows

" 1.

in the Common Catalogue of varieties of agricultural plant species referred to in Article 17 of Council Directive 2002/53/EC of 13 June 2002, OJ 2002 L 327, p. No. L 193/2002 p. 1, or

2.

in the Austrian variety list according to § 65 seed law 1997, BGBl. I n ° 72/1997, as amended, and whose content of tetrahydrocannabinol does not exceed 0.3%, provided that abuse is excluded as a narcotic drug, and '

replaced.

21. In Annex I.2. is between the lines "Remifentanil" and " the isomers of the under I.2. listed addiction poisons " the line "Tapentadol" inserted.

22. Annex III is:

" Annex III

III.1. Pharmaceutical preparations containing the following addictive poisons of Annex II:

Acetyldihydrocodeine

Codeine

Dihydrocodeine

Ethylmorphine

Nicocodin

Nicodicodin

Norcodeine

Pholcodin

in the case of preparations containing one or more ingredients which are not subject to the provisions of addiction, and these preparations per individual dose are not more than 100 mg of addiction gift (calculated as base) or 2.5% in undivided preparations. Preparations containing

Propiram preparations if they do not contain more than 100 mg of propiram (calculated as base) and at least the same amount of methyl cellulose per unit dose

Preparations of dextropropoxyphene for oral use without a further component subject to the provisions of Austrian law on addiction, if the individual dose does not more than 135 mg of dextropropoxyphene (calculated as base) or in the case of a single dose. undivided preparations not containing more than 2.5 per cent of this substance

III.2. Further:

Preparations of Tramadol

Preparations of difenoxin if the dose does not contain more than 0.5 mg of difenoxin (calculated as base) and at least 5% of this amount of atropine sulphate per unit dose

Preparations of diphenoxylate if these do not contain more than 2.5 mg of diphenoxylate (calculated as base) and at least 1 per cent of this amount of atropine sulphate per single dose "

23. In Annex IV.2. is between the lines "Buprenorphine" and "Pentazocin" the line "Cannabis only in the form of preparations of cannabis extracts which are authorised as proprietary medicinal products" inserted.

24. Annex VIII shall be deemed to be " Annex IX " The "Certificate for the carrying of medicinal products for the carriage of suchttoxic medicinal products in accordance with Article 75 of the Schengen Convention" as well as " Annex X " The "Certificate for the carrying out of medicinal products containing suchttoxic medicinal products in international travel, in accordance with the Directive of the International Suchturgian Control Council for regulations on travellers under international control of addictive substances" .

Stöger