Medical Specialty Register 2013

Original Language Title: Arzneispezialitätenregister 2013

Read the untranslated law here: https://www.global-regulation.com/law/austria/2996126/arzneispezialittenregister-2013.html

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277. Regulation of the Federal Minister for health, the medical specialty register 2013

On the basis of article 27 par. 3 of the medicines Act, Federal Law Gazette No. 185/1983, as last amended by the Federal Act Federal Law Gazette I no. 162/2013, is prescribed:

§ 1. At the Federal Office for security in healthcare, a pharmaceutical speciality register is to lead, in that each



1 approval a medicinal, 2. registration of a pharmaceutical speciality, 3. approval for distribution in the parallel import, 4. change and transfer authorisation to enter registration or approval for distribution in the parallel imports, and 5. abolition of approval, registration, or approval for distribution in the parallel import is. In addition, the medical speciality register shall contain all medicinal products which are approved in accordance with § 88 par. 1 of the German medicines Act.

2. (1) the entries referred to in article 1 are Nos. 1 and 2 to publish, specifying the following data:



1 authorisation or registration number, 2. name of medicinal, 3. authorisation or registration holder, 4. information about, to what extent the dispensing of medicinal is subject to the prescription or the provisions concerning narcotic drugs, 5. composition according to type and quantity of components that affect the efficacy, tolerability or shelf life of the medicinal, and 6 at medicinal products to be applied to animals indicating whether a wait is required , or the medicinal not on animals must be applied from which foods or drugs can be won.

(2) the entries referred to in article 1 are no. 3, stating the following to publish data:



1 authorisation or registration number according to § 4 para 3, 2. name of the medicinal, 3. holder of the permit for the distribution in the parallel import, 4. information about to what extent the dispensing of the medicinal subject to the prescription or the rules on addictive drugs, and 5 exporting country.

§ 3. The publications referred to in § 2 are without delay, but no later than two months after the validity of the approval or registration of medicinal or approval for distribution in parallel import, its modification, transmission or suspension on the home page of the Federal Office for security in healthcare to make.

§ 4 (1) for registrations in accordance with § 1 Z 1 to 3 is to grant a registration or approval number for each medicinal.

(2) for medicinal products, the registration / approval numbers are to be awarded according to the following classification:



1. for medicinal products approved in accordance with section 7 of the medicines Act, provided they are not medicinal products within the meaning of the Z 2 to 4, 8 and 9 the number 100001-199999, 2nd for biogenic medicinal numbers 200001-299999, 3rd for homeopathic medicinal products approved the numbers 300001-399999, 4th for radioactive medicinal products the numbers 400001-499999, 5th for registered pharmacy own medicinal the number 500001-599999 , 6 for homeopathic medicinal products registered the numbers 600001-699999 7 for registered traditional herbal medicinal numbers 700001-799999, 8 for proprietary medicinal products to be applied to animals the number 800001-899999, and 9 for approved Pharmacopoeial monographs the numbers 900001-999999.

(3) medicinal products, which has been granted a permit for the distribution in the parallel imports, are to record under the approval number of the corresponding approved or registered medicinal (related approval). This is to supplement P and the sequence by the letter.

§ 5. The pharmaceutical speciality register is to lead in the way of electronic data processing.

The regulation of the Federal Minister for health and women about the pharmaceutical speciality register 2006, § 6 (1) with the entry into force of this regulation occurs Federal Law Gazette II No. 21/2006, as last amended by Federal Law Gazette II No. 79/2010, except force.

(2) the registration or registration numbers of pharmaceutical specialties, 2006 issued pursuant to section 6 of the regulation of the Federal Minister for health and women about the pharmaceutical speciality register, stay still upright. This does not comply with article 4 of this regulation.

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