358. Regulation of the Federal Minister of Health, which changes the Psychotropic Regulation

On the basis of § 10 (1) Z 1 to 3, 5 and 6 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 Psychotropic Ordinance-PV, BGBl. II No 375/1997, as last amended by the BGBl Regulation. II No 202/2011, 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 case of changes in the nature of the psychotropic substances, the intended use or the products for which it is intended, and in the event of changes in the person responsible (Section 2 (4) (3)), of the entreprenter, of the form of business or in the location of the premises, with the exception of a building, a new authorization shall be applied for. "

2. § 5 (1) reads:

" (1) The persons entitled under § 2 (2) may only hand in psychotropic substances to the trader with a right to manufacture medicinal products and poisons and to wholesalers with medicinal products and poisons in accordance with § 94 Z 32 of the Industrial Code of 1994. the scientific institutes and public institutions referred to in § 6 (1), the Federal Republic of Germany's security bodies and the authorities responsible for the enforcement of the Suchtmittelgesetz (§ 7 para. 1), to the medical institutions of the Federal Army (Section 7 (1)). 2), to the organized 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 paragraph (2b) is inserted in accordance with paragraph 2a:

" (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 the preventive measures associated with deprivation of liberty (§ § 158 to 160 of the StVG) do not require the approval of the Federal Minister for the acquisition, processing and possession of psychotropic substances. Health, when they need it for the statutory medical care of the accused, the accused, the prisoners or the people who have been brought to justice. "

4. The following paragraphs 3 and 4 are added to § 10:

" (3) The Federal Minister of Health may be responsible for individual psychotropic substances by means of endorsements in the Appendix 1 Order that they may only be prescribed for narcotic drugs (Suchtgift-Einzelprescriptions). In these cases, § § 17 (2), (18), (19), (20) (1) to (3) and (23) (1) of the Suchtgiftverordnung, BGBl. II No 374/1997, as amended, in so far as they do not refer to substitution treatment, with the proviso that the prescription shall be subject to a psychotropic substance for which the order applies instead of a search for addiction.

(4) In the case of prescribtion of medicinal products containing psychotropic substances from the group of benzodiazepines, no repeated charges may be ordered. "

5. In accordance with § 11, the following § 11a including the heading is inserted:

" Cross-border movements of psychotropic medicinal products in international travel

§ 11a. (1) Medicinal products containing psychotropic substances (in short: psychotropic medicinal products) may be used by travellers to whom they have been prescribed abroad and to meet their personal medical or dental needs during the period of In a quantity not exceeding the requirements for a maximum of 30 days, travel must be transferred to the Federal territory in accordance with the conditions laid down in paragraphs 2 to 6, carried along in the Federal territory and returned from the Federal territory.

(2) Psychotropic medicinal products may be transferred to the territory of the Federal Republic of Germany without proof of medical or dental prescription issued abroad, and may be brought back from the territory of the Federal Republic if:

1.		the quantity supplied does not exceed the requirements of the travelling person for a maximum period of five days, or
2.		the content of a psychotropic substance in accordance with paragraph 4 does not exceed the quantity laid down for the substance in paragraph 4, or
3.		other than the psychotropic substances referred to in paragraph 4 or 5.

(3) Medicinal products,

1.		the content of a psychotropic substance in accordance with paragraph 4 exceeds the quantity laid down for the substance in paragraph 4, or
2.		the content of a psychotropic substance in accordance with paragraph 5 does not exceed the quantity laid down for the substance in question (5),
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 psychotropic substance 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 of the State of origin shall be replaced by a certificate issued by the competent authority in the country of origin. Appendix 2 (certificate for the carrying out of psychotropic medicinal products in the travel sector in accordance with Article 75 of the Schengen Convention) 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 Narcotics Control Council for rules on travellers under treatment with internationally controlled narcotic drugs (samples) Appendix 3 ) 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 content of a psychotropic substance (psychotropic substance in pure substance) shall be for medicinal products as referred to in paragraph 3 (1).

	Barbital ........................................................................................	15,000 g,
	Chlordiazepoxide .....................................................................................	1,000 g,
	Clorazepate .........................................................................................	0,600 g,
	Diazepam ..........................................................................................	0,300 g,
	Lorazepam ...........................................................................................	0.075 g,
	Medazepam .......................................................................................	0,600 g,
	Meprobamat ........................................................................................	40,000 g,
	Oxazepam ..........................................................................................	1,500 g,
	Phenobarbital ........................................................................................	6,000 g,
	Prazepam ..........................................................................................	1,000 g,
	Temazepam ........................................................................................	0,600 g,
	Tetrazepam .......................................................................................	3,000 g.

(5) The maximum content of a psychotropic substance (psychotropic substance in pure substance) in medicinal products as referred to in paragraph 3 (2) shall apply to:

	Butalbital ...........................................................................................	1,000 g,
	Flunitrazepam .....................................................................................	0.030 g,
	Pentobarbital ..............................................................................................	3,000 g.

(6) Medicinal products containing a psychotropic substance in accordance with paragraph 5 in a quantity greater than the quantity laid down in paragraph 5 may only be brought to the territory of the Federal Republic of Germany or may be brought back from the territory of the Federal Republic of Germany if the medicinal product in question has been transferred to the Federal Republic of Germany. A person travelling by the competent authority in the State of origin shall certify that the person travelling is certified Appendix 2 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 Suchturgian Control Council for the rules on travellers under treatment with internationally controlled addictive substances (samples Appendix 3 ) She has received medical or dental prescription for the medicine. The last sentence of paragraph 3 applies.

(7) Psychotropic 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 not more than 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 psychotropic medicinal product , a certificate within the meaning of Article 75 of the Schengen Convention on the submission of a medical or dental prescription (model Appendix 2 ) , which certify that the person has received the psychotropic medicinal product prescribed by a doctor or a dentist and that he/she needs it during the journey. The period of validity of the certificate shall not exceed the duration of the journey, but at the latest 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 shall be issued for each psychotropic substance and shall be certified. 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 Appendix 2 ) 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 for the certification of the medical or dental needs of psychotropic medicinal products when travelling from patients to countries not parties to the Schengen Convention (pattern Appendix 3 ). Copies may be produced from the form. The last sentence of paragraph 9 shall apply. "

6. § 12 (1) first sentence reads:

" The import and export of psychotropic substances shall be prohibited, except in the cases of import or export referred to in § 17a of this Regulation or § 30 (3) (1) of the Suchtmittelgesetz, unless the Federal Minister for Health does not have an authorization to do so. has been granted. "

§ 12 The following paragraph 3 is added:

" (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, in order to ensure the medical or dental care of the members of the Federal Army or of the animals used in the Bundesheer for the veterinary treatment of the animals in question. "

8. In § 17 (2), the words "Before and surnames" by the words "First names and family names or surnames" replaced.

9. The previous text of § 21 receives the sales designation "(1)" and the following paragraph 2 is added:

" (2) § 10 (3) and (4) in the version of the BGBl Regulation. II No. 358/2012 shall enter into force on 15 December 2012 and shall apply to all prescriptions issued after 14 December 2012. "

10. The previous "Annex" is given the name " Appendix 1 " .

11. In Appendix 1, point 1. "Substances and preparations of Annex III to the United Nations Convention on Psychotropic Substances (Section 3 (1) of the Law on Narcotic Drugs)" the line "Flunitrazepam" through the row "Flunitrazepam*" replaced .

12. In Appendix 1, at the end of point 1. the line "* prescription only on addiction-toxic recipe (§ 10 para. 3)" inserted.

13. The Appendix 1 shall be " Appendix 2 " The "Certificate for the carrying out of psychotropic medicinal products in the carriage of passengers pursuant to Article 75 of the Schengen Convention" and as " Appendix 3 " The "Certificate for the carrying out of psychotropic medicinal products in international travel to countries not party to the Schengen Convention" .

Stöger