357. Regulation of the Federal Minister for health, modifies the addictive poison regulation
On the basis of articles 2, paragraph 3, and 10 paragraph 1 Z 1 to 3, 5 and 6 and para. 2 of the Narcotics Act (SMG), Federal Law Gazette I no. 112/1997, as last amended by Federal Law Gazette I no. 50/2012, is prescribed:
Addictive poison Regulation (SV), Federal Law Gazette II No. 374/1997, as last amended by regulation Federal Law Gazette II No. 264/2010, is amended as follows:
1. paragraph 4:
"§ 4. persons to whom a permit referred to in paragraph 2 is granted have to immediately report any change in the information referred to in section 2 paragraph 4 the Federal Ministry of health. "Changes with regard to the kind or quantity of narcotic substances, of the purpose or the products, the production of which is intended to and changes in the person of the responsible (§ 2 para 4 No. 3), of the entrepreneur, the corporate form or in the location of the premises, except inside a building, is to apply for a new permit."
2. paragraph 5 paragraph 1:
"(1) which according to § 2 para 2 legitimate may addiction poison only emit professionals with a permission for the production of medicines and Poisons and the wholesale of medicines and Poisons according to § 94 scientific institutes referred Z 32 of the GewO 1994, § 6 para 1 and public institutions, to the watch body of the Federal Government and the authorities, which is the enforcement of the narcotic substances Act (§ 7 para 1)" ", at the facilities of the Federal Army (§ 7 para. 2), to the organized ambulance services (§ 7 para 2a), the institutions and authorities of the execution, as well as the execution of preventive measures associated with deprivation of liberty (section 7 subsection 2 b), community pharmacies and institution pharmacies (§ 7 para 3) and upon presentation of the authorisation to the authorized person according to § 2 para 3."
3. in article 7, b is inserted after paragraph 2a the following paragraph 2:
"(2B) the institutions and authorities of the execution (§ 8 of the Prisons Act - HCP, BGBl. No. 144/1969) as well as the execution of preventive measures (paragraphs 158 to 160 HCP) associated with deprivation of liberty need for the acquisition, processing, and possession of addictive poison as far as no approval of the Federal Minister of health, as they need this accused, defendants, prisoners the statutory medical care by suspended or placed."
4. paragraph 14 No. 3: "3. preparations of heroin, cannabis (excluding preparations of cannabis extracts, which are approved as medicinal), coca leaves, benzoylecgonine and the substances listed in annex V to this regulation."
5. § 15 para 1 Nos. 18 and 19 is: "18 Piritramide... 0,4500 g, 19 remifentanil... ……………………………………………………………. 0,0500 g,"6 § 16 par. 1 Z 4 is:"4. methadone... 0.500 g,"7. § 17 para 2 last sentence and article 18, paragraph 1 the last sentence is not available in each reference "(§ 22 Abs. 1 Z 1)".
8. the introductory phrase in the § 19 para 1 is as follows:
"The addictive poison prescription is, unless she are issued not automatically, to be issued with a ballpoint pen, and shall contain the following information:"
9 § 19 para 1 No. 4 is: "4. the dosage form, quantity and strength of the medicinal product prescribed." the amount of included narcotic drug is given and literally so to specify that the prescribed amount of venom addiction is clearly visible; proprietary medicinal products whose trade name is to specify the packet size and the number of prescribed found literally; in notes of preparations of annex III to this regulation, as well as automatically executed addiction toxic securities, the literal information is not required;"
10. in article 19, paragraph 1, no. 7 are replaced the words "Name and surname" by the words "First name or last name, as well as family".
11 paragraph 20 paragraph 1:
"(1) individual prescriptions of narcotics of the annexes I, II and IV of this regulation will expire, if the tax not later than one month, with individual prescriptions for substitution no later than 14 days after the date of issue indicated on them is."
12 § 21 para 1 second sentence and paragraph 4, second sentence, is not available in each reference "(§ 22 Abs. 1 Z 2)".
13 paragraph 22, section 1:
"(1) the Federal Ministry of health has to put addictive poison vignettes for purposes of prescription of addictive poison to protect against counterfeiting of prescription and to the traceability of prescribing in the Österreichische Staatsdruckerei, which to produce, with safety features, which are subject to the secrecy, as well as a continuous Alpha numbering and provided a bar code be again the consecutive numbering of the alpha are in security printing. The Federal Ministry of health has also set up a form for the prescription of substitution."
14 § 22 para 2 first sentence reads:
"The addictive poison vignettes are, except in cases of reasonable suspicion of abuse from addiction toxic or psychotropic substances prescribed II on the basis of an order of the Federal Minister of health in accordance with § 10 section 3 of the psychotropic regulation, Federal Law Gazette No. 375/1997, as amended, only on addiction poison recipe legitimate doctors, dentists, dentist and veterinary surgeons who need them in the exercise of their profession may be, by the District Administration to independent practice ", or free of charge issued to persons authorized by them, as well as to hospitals against acknowledgement of receipt or send request as Einschreibsendung."
15 paragraph 22, section 3:
"(3) the search poison vignettes are theft-proof to be kept. An any loss or theft of search poison vignettes is from the doctor, dentist, dentist or veterinary surgeon or by the hospital immediately to announce the district administrative authority under leadership of the alpha number sequence. An ad restored the security authority is to be attached in copy. The District Administration has already the alpha numbers follow of those addictive poison vignettes — including the addictive poison notes placed on on, of the loss or theft she gained knowledge immediately in one for this by the Federal Ministry of health available to enter provided and secured according to the State of the art, non-public database. The Federal Ministry of health has for the purpose of preventing the delivery of addiction-gifthaltigen medicines to persons that were not prescribed for, the alpha-number sequences, registered in the database, electronic conveniently available to make the pharmacy software vendors for purposes of technical realization of optoelectronic detection of the barcode giving back the consecutive numbering of the Alpha 1 on request (§ 22 para 1) in pharmacies with the appropriate technical equipment ", 2. the Austrian Chamber of pharmacists for the likely information of also that community pharmacies that do not have equipment required a opto-electronic bar code recognition, the respective Alpha number sequences."
16 paragraph 24 together with the heading:
"Transboundary movement of toxic addiction medicines in international travel
Section 24 (1) Suchtgifthaltige excluded medicines that contain narcotic drugs referred to in paragraph 6, para 2 to 5 in the Federal territory may by travellers, where they from abroad were prescribed and which need to meet the personal medical or dental own needs during the trip, in an amount not exceeding the requirements for a maximum of 30 days in accordance with be spent, carried in the Federal territory and spent again from Germany.
(2) without proof of medical or dental prescription made abroad may addiction gifthaltige drug, except that addictive drugs in accordance with § 6 contain, spent in the Federal territory, carried in the Federal territory and spent again from Germany if 1 the entrained amount does not exceed the drug needs of the traveling person for not more than five days, or 2 it was to preparations listed in annex III.
(3) others as the narcotic drugs referred to in paragraph 4 - medicinal products, 1 whose addiction toxicity does not exceed the amount set for the concerned addiction poison in para 4, or the 2nd regardless of addiction toxicity, are included in the exception however the narcotic in para 6,
may be spent as far as paragraph 2 is to apply in travel only in the Federal territory, carried in the Federal territory and spent again from Germany, if at least a copy of the medical or dental prescription is accompanied by proof that the drug is used for personal medical or dental local consumption during the trip. The name of the passenger must emerge from the prescription as a patient, the name of the prescribing physician or dentist, name and quantity of the medicinal product as well as the included gifts of addiction and the dosage. If the prescription not in Latin script or not in German or English language has been issued, a certificate, certified by the authority in the State of origin must in place of prescription according to the model of annex IX (certificate for carrying toxic addiction medicines in travel in accordance with article 75 of the Schengen Convention) or - in the case of travellers from countries which are not Contracting Parties to the Schengen Convention , - a similar certification under the directive of the International addiction poison control Council for rules concerning travellers under treatment with internationally controlled drugs (pattern annex X) be carried, from stating that the person has received prescribed the drugs for their personal medical or dental needs of an authorized doctor or dentist. The certificate must be issued in Latin and in German or English, their validity period must not exceed but no longer than 30 days the duration of the trip.
(4) the maximum toxicity of addiction (addiction poison in pure substance) is in medicinal pursuant to par. 3 No. 1 for
Fentanyl (patch for percutaneous application)...
Fentanyl in other dosage forms... …………………………………...
(5) medicinal products that contain addictive poison in accordance with para 4 in an amount exceeding the addiction poison content referred to in paragraph 4, may be spent only in the Federal territory, carried in the Federal territory and spent again from Germany if the person travelling is a a certificate certified by the authorities in the country of origin according to the model in annex IX or, in the case of travellers from countries which are not Contracting Parties to the Schengen Convention - comparable certificate under the directive of the International addiction poison control Council for regulations of Travellers under treatment with internationally controlled drugs (model annex X) with leads, stating that she has received medical or dental prescribed the drug. Section 3 last sentence applies.
(6) the following narcotic drugs may be spent not in the Federal territory, carried in the Federal territory, or spent again from Germany:
Cannabis herb and cannabis resin,
(7) Suchtgifthaltige may be prescribed in the Federal territory for medical or dental captive of patient medicines while traveling abroad for a period of not longer than 30 days.
(8) the District Administration has people who are for their personal medical or dental own use while traveling in countries, the Contracting Parties to the Schengen Convention, an addiction gifthaltiges drug need, on submission of the medical or dental prescription a certificate within the meaning of article 75 of the Schengen Convention (pattern annex IX) to exhibit, which is certified that the person has received the addiction gifthaltige drug in accordance with medical or dental prescribed and required during the trip. The validity period of the certificate may not exceed but no longer than 30 days the duration of the trip. The certificate can be issued by the prescribing physician, dentist or dentist, to authenticate in this case by the district administrative authority. For every gift of addiction is to issue a separate certificate and authenticate. A copy of the certified certificate remains with the certification authority.
(9) the Federal Ministry of health has as a central federal authority for questions relating to article 75 of the Schengen Convention to create a form for the certificate referred to in paragraph 8 (model annex IX), which copies may be made. The district administrative authorities have to reproduce the form if necessary and free of charge issued copies to doctors, dentists and dentist.
(10) the Federal Ministry of health has also set up a laid down in the directive of the International addiction poison control Council for legislation of travellers under treatment with internationally controlled drugs which serves the district administrative authorities for the certification of medical or dental equity needs of toxic addiction Medicine for travel of patients in countries which are not Contracting Parties to the Schengen Convention (model annex X). Copies may be made of the form. ABS 9 last sentence is to be applied."
17 the following paragraph 3 is added to § the 25:
"(3) a permit is lit at foreign missions of the armed forces pursuant to § 2 para 1 para 1 and 2. "d of the military service Act 2001 (WG 2001), Federal Law Gazette I no. 146/2001, to ensure the medical or dental care of members of the armed forces or the veterinary treatment of standing in the Federal Army in using animals not required."
18. in article 31, paragraph 2, the words be replaced "Name and surname" by the words "Given name or surname and family".
19 the following paragraph 9 is added to the section 35:
"(9) § 22 para 3 as amended the regulation Federal Law Gazette II No. 357/2012 enters into force 1 November 2012".
20. in annex I (I.1.a.) the addictive poison regulation the rows are under the heading "Cannabis (marijuana)" "1 in the common catalogue of varieties of agricultural plant species referred to in article 18 of Directive 70/457/EEC of 29 September 1970 OJ" No. L 225 S 1, amended or 2 as amended in Annex B to article 3 paragraph 1 of Regulation (EEC) No. 1164/1989 of the Commission of 28 April 1989, OJ "No. L 121 S 4, or 3 in the variety list pursuant to section 65 in 1997, Federal Law Gazette I no. 72/1997, as amended, are given seed law and does not exceed its tetrahydrocannabinol content to 0.3%, unless an abuse of addictive poison is excluded, as well as" with the lines "1. in the common catalogue of varieties of agricultural plant species referred to in article 17 of Directive 2002/53/EC of 13 June 2002 , OJ "No. L 193/2002 p. 1, or 2 in the Austrian variety list pursuant to section 65 in 1997, Federal Law Gazette I no. 72/1997, as amended, are given seed law and does not exceed its tetrahydrocannabinol content to 0.3%, unless an abuse of addictive poison is excluded, as well as" replaced.
21. in the annex. 2. is between the lines "Remifentanil" and "isomers under I. 2." given addictive drugs"the row"Tapentadol"inserted.
22 annex III is as follows:
'Annex III III 1. Pharmaceutical preparations containing following narcotic substances of annex II: Acetyldihydrocodein
When dealing with preparations containing one or more ingredients subject not the provisions of addictive poison and these preparations per single dose containing not more than 100 mg addiction poison (calculated as base) or 2.5 percent in unaufgeteilten preparations
Preparations of propiram, when they contain not more than 100 mg of propiram (calculated as base) and at least the same amount of methylcellulose per single dose
Preparations of dextropropoxyphene for oral application without a part subject to further the Austrian addictive poison regulations, if these per single dose no more than 135 mg Dextropropoxyphene (calculated as base) or in unaufgeteilten preparations containing not more than 2.5 per cent of this substance
III. 2 also: preparations of tramadol preparations of Difenoxin, when they contain not more than 0,5 mg Difenoxin (calculated as base) and at least 5 percent of this amount of atropine sulfate per single dose
Preparations of diphenoxylate, when they contain not more than 2.5 mg diphenoxylate (calculated as base) and at least 1 per cent of this amount of atropine sulfate per single dose"
23. in annex IV. 2. is inserted between the lines of "Buprenorphine" and "Pentazocine' the line 'Cannabis in the form of preparations of cannabis extracts, which are approved as medicinal products'.
24 annex VIII are called "Annex IX" the "certificate for carrying toxic addiction medicines in travel in accordance with article 75 of the Schengen Convention", as well as the "certificate for carrying toxic addiction medicines in the international travel in accordance with the policy of the International addiction poison control Council for rules concerning travellers under treatment with internationally controlled drugs" attached as "Annex X".