Regulation On Orphan Medicinal Products Treated With Ionising Radiation Or Radioactive

Original Language Title: Verordnung über radioaktive oder mit ionisierenden Strahlen behandelte Arzneimittel

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Read the untranslated law here: http://www.gesetze-im-internet.de/amradv/BJNR005020987.html

Regulation on orphan medicinal products treated with ionising radiation or radioactive (AMRadV) AMRadV Ausfertigung date: 28.01.1987 full quotation: "regulation on radioactive or treated with ionising radiation drugs as amended by the notice of January 19, 2007 (Federal Law Gazette I p. 48)" stand: Neugefasst by BEK. v. 19.1.2007 48 for more information on the stand number in the menu see remarks footnote find (+++ text detection from: 7.2.1987 +++) § 1 traffic ability of medicinal products which have been treated (1) with ionising radiation the traffic prohibition of § 7 para 1 of the medicines Act shall not apply to medicinal products during their manufacture electron, gamma or x-rays for metrological purposes have been used if 1 open radioactive substances have been used and have wrapped radioactive material with the drugs not in contact , 2. a) the maximum energy of the electrons amounted to no more than 10 mega electron Volt, b) the gamma rays from the radio-nuclide sources are cobalt 60 or cesium 137, c) the maximum energy of x-rays amounted to no more than 10 mega electron volts, except that where scientifically justified, other energy values are allowed and it is ensured that no harmful nuclear reactions occur, 3. amounted to the absorbed dose no more than 0.1 gray in the medicinal.
(2) the prohibition on marketing section 7 paragraph 1 of the German medicines Act does not apply to medicines in the sense of § 2 paragraph 1 or paragraph 2 No. 1 to 4 of the medicines Act, in the manufacture of electron, gamma or x-rays have been used to reduce the bacterial count or the inactivation of blood components or tumor material or for the modification of components, if 1 open radioactive substances have been used and have wrapped radioactive material with the drugs not in contact , 2. a) amounted to no more than 10 mega electron volts the maximum energy of the electrons, or, if this value has been exceeded, is demonstrated, that caused no radionuclides in this product, b) the gamma rays from the radio-nuclide sources are cobalt 60 or cesium 137, c) the maximum energy of x-rays amounted to no more than 6 mega electron volts, except that in justified cases other energy values are allowed, and ensures , that no harmful nuclear reactions occur, 3. the energy dose medicines after a) article 2, paragraph 1 or paragraph 2 No. 1 of the German medicines Act only in justified cases more as 3.2 x 10(hoch)4 gray has and is ensured, that thereby the quality of the radiation was unaffected, b) § 2 para 2 No. 1a to 4 of the medicines Act, not more than 5 x 10(hoch)4 amounted to gray and 4. the medicinal products by the competent federal authority in terms of the treatment with ionising radiation to reduce the bacterial count or the inactivation of blood components or tumor material or for the modification of components according to § 25 (1) of the medicinal products Act have been admitted or pursuant to § 21 para 2 may be placed no. 1a, 1B, 1 c, 2, 5 or 6 of the German medicines act without approval in the traffic.
An authorisation pursuant to sentence 1 No. 4 is required for 1 medicinal products within the meaning of § 2 para 2 No. 1a, 3, or 4 of the medicines Act, 2. medicinal products within the meaning of § 2 paragraph 2 No. 2 of the German medicines Act, where they exclusively made of metallic, ceramic or these two materials exist, and 3. collagen membranes, wound blood preparations, tumor material and products from fibrin foam, which are not finished medicines.
(3) the provisions of the fourth section of the German medicines Act authorising find appropriate application on medicinal products within the meaning of 1 § 2 para 1 and para. 2 No. 1 of the German medicines Act, no finished product and are intended for use in people as long as they are not collagen membranes, wound blood preparations, tumor material or fibrin foam products, and 2. § 2 paragraph 2 No. 2 of the German medicines Act, where they not only from metallic , ceramic or these two materials exist, if gamma or x-rays have been used in its manufacture of electron, to reduce the bacterial count or the inactivation of blood components or for the modification of components.

§ 2 (1) the traffic prohibition of section 7 paragraph 1 of the German medicines Act marketability of radioactive drugs shall not apply to radiopharmaceuticals, the 1st by the competent federal authority according to § 25 (1) of the medicinal products Act have been admitted or no. 1a, 1B, 1 c, 2, 5 or 6 of the medicines act without approval on the market may be brought pursuant to section 21 para 2, 2. According to section 2 paragraph 2 are apply and no finished product no. 1 of the German medicines act as a medicinal or 3rd according to § 2 para 2 No. 4 of the medicines Act be regarded as medicinal products.
It is also not components have been used for radiopharmaceuticals that are not finished medicines and 1 that are produced containing radioactive material by nature as far as the concentration of radioactive substances in these components has not been increased and these components by nature no more than 500 micro becquerel per gram of radioactive substances of the uranium, thorium or Actinium series or the medicinal waters from natural sources are 2. , the concentration of radioactive substances of natural origin from the uranium - thorium and Actinium series has been enhanced not.
Not still applies for radiopharmaceuticals, the 1st to detect the nature of States or intended functions of the body are, 2nd in a clinical set up on the basis of a manufacturing authorization pursuant to § 13 of the German medicines Act made and 3 there for no more than 20 cases in the week after the recognized State of scientific knowledge on the basis of a patient-related medical prescription applied , as well as for radiopharmaceuticals, which are prepared according to the instructions of the relevant marketing authorisation in a hospital pharmacy or hospital serving pharmacy solely on the basis of approved radio radionuclide generators, radionuclide kits or radio nuclide precursors.
(2) the provisions of the fourth section of the German medicines Act authorising corresponding apply to radiopharmaceuticals intended medicinal product in the meaning of § 2 para 1 of the medicines Act, no finished product and for use in people. The exception provisions of § 21 ABS. 2 Nr. 1, 3 and 4 of the medicines Act does not apply. Sentence 1 shall not apply to medicinal pursuant to paragraph 1 sentence 2 and 3.

§ 3 labelling, package insert, SMPC radioactive medicinal products within the meaning of § 4 para 8 of the German medicines Act may be brought within the scope of this regulation only, if 1 the containers and outer packages pursuant to § 68 of the Radiation Protection Ordinance of 20 July 2001 (BGBl. I S. 1714, 2002 I p. 1459), most recently by article 3 paragraph 31 of the law of September 1, 2005 (BGBl. I p. 2618) , 2653) is changed, are marked. Name and address of the manufacturer shall be indicated on the containers. Requirements for radiopharmaceuticals and their packaging, their marking and transport by road, rail, monorail, sea and air vehicles was 2nd on the containers and outer packages the total activity per container named the international, European and national traffic regulations for the transport of dangerous goods remain unaffected, and a defined calibration time, to which the specified activities relate, and also the point of expiration time with date and time specified. The marking of containers has also a reference to information recorded in the leaflet on the handling of radiopharmaceuticals, whose disposal and, if necessary, to include specific warnings, 3. sections 10, 11 and 11a of the medicines Act on radioactive medicines the medicinal products within the meaning of article 2, paragraph 1 or paragraph 2 are no. 1 of the German medicines Act, have been appropriately applied. In leaflets and information the radiation warning signs pointing to prepend 'Radioactive medicinal product', and 4 in the case of radioactive drugs intended for clinical trials the respective texts is the provisions of §§ 5 and 6 of GCP regulation of 9 August 2004 (BGBl. I p. 2081) were applied accordingly.

§ 4 relative to the radiation - and X-ray Ordinance the provisions of the Radiation Protection Ordinance and the German X-ray Ordinance remain unaffected.

§ 5 offences any person within the meaning of § 97 para 2 No. 31 of the German medicines Act is, who intentionally or negligently violates § 3 No. 1 sentence 1, no. 2 or 4 a radioactive medicinal product on the market brings.

Section 6 transitional arrangements


Medicinal products which are on December 30, 2006 in traffic and are subject to the provisions of paragraph 3, must be two years after the first following on the 31 December 2006 renewal of the authorisation or, if they require any extension, brought on 1 January 2009 by the pharmaceutical entrepreneur according to the provisions of article 3 on the market. Up to the respective dates, medicines may be placed pursuant to sentence 1 by the pharmaceutical entrepreneur, after these times further from wholesalers and retailers with a labelling, package leaflet and information for professionals in the transport complies with the requirements applicable up to 30 December 2006.

§ 6a (dropped out) - section 7 (dropped out) - section 8 (entry into force) -.