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Regulation on medicinal products treated with radioactive or ionizing radiation

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

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Regulation on medicinal products treated with ionizing radiation (AMRadV)

Unofficial table of contents

AMRadV

Date of completion: 28.01.1987

Full quote:

" Regulation on medicinal products treated with ionizing radiation, as amended by the Notice of 19 January 2007 (BGBl. I p. 48) "

Status: New by Bek. v. 19.1.2007 I 48

For more details, please refer to the menu under Notes

Footnote

(+ + + Text proof: 7.2.1987 + + +) Unofficial table of contents

§ 1 Transport capacity of medicinal products treated with ionising radiation

(1) The prohibition of traffic in Section 7 (1) of the Medicines Act does not apply to medicinal products in the production of which electron beams, gamma rays or X-rays have been used for metrological purposes, if:
1.
have not been used for open radioactive substances and have not been in contact with the medicinal products,
2.
a)
the maximum energy of the electrons is not more than 10 Megaelectronvolts,
b)
the gamma rays are derived from the radionuclide sources Cobalt 60 or Caesium 137,
c)
the maximum energy of the X-rays is not more than 10 mega-electronvolts, unless other energy values are permitted in scientifically justified cases and ensure that no harmful nuclear reactions occur,
3.
the dose of energy in the medicinal product is no more than 0.1 Gray.
(2) The prohibition of traffic in Section 7 (1) of the Medicinal Products Act does not apply to medicinal products within the meaning of Section 2 (1) or (2) (1) to (4) of the Medicines Act, in the production of which electron, gamma or X-rays are produced to reduce the the number of germs or the inactivation of blood components or tumour material or the modification of components has been used if:
1.
have not been used for open radioactive substances and have not been in contact with the medicinal products,
2.
a)
the maximum energy of the electrons is not more than 10 Megaelectronvolts, or, if this value has been exceeded, it is demonstrated that no radionuclides are produced in this product,
b)
the gamma rays are derived from the radionuclide sources Cobalt 60 or Caesium 137,
c)
the maximum energy of the X-rays is not more than 6 Megaelectronvolts, unless other energy values are permitted in justified cases and it is ensured that no harmful nuclear reactions occur,
3.
the energy dose for medicinal products, after
a)
§ 2 (1) or (2) (1) of the Medicines Act only in justified cases is more than 3.2 x 10 (high) 4 Gray, and it is ensured that the quality of the material to be irradiated has not been affected thereby,
b)
§ 2 (2) (1a) to (4) of the Medicines Act is not more than 5 x 10 (high) 4 Gray, and
4.
the medicinal products by the competent federal authority with a view to the treatment with ionising radiation to reduce the number of bacteria or to inactivate blood components or tumour material or to modify components in accordance with § In accordance with Article 21 (2) (1a), (1) (1) (1), (1), (2), (5) or (6) of the Medicines Act, the provisions of Article 25 (1) of the Medicines Act may be placed
An authorisation in accordance with the first sentence of paragraph 4 shall not be required for:
1.
medicines within the meaning of Section 2 (2) (1a), (3) or (4) of the Medicines Act,
2.
Medicinal products within the meaning of Section 2 (2) (2) of the Medicinal Products Act, insofar as they consist exclusively of metallic, ceramic or these two materials, and
3.
Collagen membranes, wound blood preparations, tumour materials and products of fibrin foam, which are not ready-to-use drugs.
(3) The provisions of the fourth section of the Medicines Act on authorisation shall apply to medicinal products in the sense of the
1.
§ 2 (1) and (2) (1) of the Medicinal Products Act, which are not intended for use in human beings and are intended for use in humans, provided that they are not collagen membranes, wound blood preparations, tumour material or products of fibrin foam, and
2.
Section 2 (2) no. 2 of the Medicines Act, insofar as they are not exclusively made of metallic, ceramic or these two materials,
provided that they have been used in the production of electron beams, gamma rays or X-rays in order to reduce the number of bacteria or to inactivate blood components or to modify components. Unofficial table of contents

§ 2 Transport capacity of radioactive medicinal products

(1) The prohibition of traffic in Section 7 (1) of the Medicines Act does not apply to radioactive medicinal products, which
1.
have been authorised by the competent federal authority pursuant to Section 25 (1) of the Medicines Act or may be placed on the market without authorisation in accordance with Article 21 (2) No 1a, 1b, 1c, 2, 5 or 6 of the Medicines Act,
2.
are considered to be medicinal products and are not ready for use in accordance with Article 2 (2) (1) of the Medicines Act; or
3.
apply in accordance with Section 2 (2) (4) of the Medicines Act as a medicinal product
It shall also not apply to radioactive medicinal products which are not manufactured medicinal products and
1.
in the manufacture of which constituents have been used which are naturally contained in radioactive substances, to the extent that the concentration of radioactive substances in these components has not been increased and that these constituents are naturally not more than 500 Microbecquerel per gram of radioactive substances of the uranium, thorium or actinium series, or
2.
the medicinal waters from natural sources whose concentration of radioactive substances of natural origin from the uranium, thorium or actinium series has not been increased.
It does not continue to apply to radiopacs which are
1.
for the detection of the condition, conditions or functions of the body,
2.
produced in a clinical facility on the basis of a manufacturing authorization according to § 13 of the Medicines Act, and
3.
be used there for no more than 20 treatment cases during the week according to the recognised state of scientific knowledge on the basis of a patient-related medical prescription,
, as well as for radiolabelling medicinal products which are used in a hospital pharmacy or in a pharmacy exclusively on the basis of authorised radionuclide generators, radionuclide kits or radionuclide precursors according to the instructions of the relevant (2) The provisions of the Fourth Section of the Medicinal Products Act shall apply to radioactive medicinal products containing medicinal products within the meaning of Article 2 (1) of the German Medicines Act (2). Medicinal products law, no medicinal products for use in manufacture and for use in People are determined. The exceptional provisions of § 21 (2) Nos. 1, 3 and 4 of the Medicines Act are not applicable. Sentence 1 shall not apply to medicinal products as referred to in the second sentence of paragraph 1 and 3. Unofficial table of contents

§ 3 Labelling, Package Leaflet, Fachinformation

Radioactive medicinal products within the meaning of Article 4 (8) of the Medicines Act may only be placed on the market within the scope of this Regulation, if:
1.
the containers and outer envelopes according to § 68 of the Radiation Protection Ordinance of 20 July 2001 (BGBl. I p. 1714, 2002 I p. 1459), the most recent of which is Article 3 (31) of the Law of 1 September 2005 (BGBl. 2618, 2653); the name and address of the manufacturer must be indicated on the containers. Requirements for radioactive medicinal products and their packaging, their identification and transport by road, rail, magnetic-rail, sea and aircraft, in accordance with international, European and national traffic law requirements for the transport of dangerous goods shall remain unaffected;
2.
on the containers and outer envelopes, the total activity per container is designated and a defined time of calibration to which the indicated activities relate and, moreover, the date and time of the expiry date have been indicated. The labelling of the containers shall also include information on the handling of radioactive medicinal products, the disposal of which and, if necessary, special warnings to be included in the package leaflet,
3.
§ § 10, 11 and 11a of the Medicines Act have been applied accordingly to radioactive medicinal products which are medicinal products within the meaning of § 2 para. 1 or para. 2 No. 1 of the Medicines Act. In package leaflets and specialist information, the relevant texts must be preceded by the radiation warning sign with the reference "Radioactive medicinal product", and
4.
in the case of radioactive medicinal products provided for clinical trials, the provisions of § § 5 and 6 of the GCP Regulation of 9 August 2004 (BGBl. I p. 2081).
Unofficial table of contents

§ 4 Relationship with the Radiation Protection and Radiation Ordinance

The provisions of the Radiation Protection Ordinance and the X-ray Ordinance remain unaffected. Unofficial table of contents

§ 5 Administrative Offences

Contrary to § 97 (2) (31) of the German Medicines Act, anyone who intentionally or negligently places a radioactive medicinal product on the market in breach of § 3 (1) sentence 1, no. 2 or 4 is acting in a responsible manner. Unofficial table of contents

§ 6 Transitional Regulation

Medicinal products placed on the market on 30 December 2006 and subject to the requirements of § 3 must be renewed for two years after the first renewal of the authorisation to 31 December 2006 or, in so far as they do not require an extension, on the following: 1 January 2009 shall be placed on the market by the pharmaceutical operator in accordance with the provisions of § 3. Up to the respective dates referred to in the first sentence, medicinal products may be placed on the market by the marketing authorisation holder, after these dates, by wholesalers and retailers, with a labelling, package leaflet and specialist information, in accordance with the rules applicable until 30 December 2006. Unofficial table of contents

§ 6a (omitted)

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§ 7 (omitted)

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§ 8 (Entry into force)

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