Regulation On The Authorisation Of Exemptions From Provisions Of The Medicines Act In The Areas Of Civil And Civil Protection, The Bundeswehr, The Federal Police As Well As The Willingness To Police Forces Of The Countries

Original Language Title: Verordnung über die Zulassung von Ausnahmen von Vorschriften des Arzneimittelgesetzes für die Bereiche des Zivil- und Katastrophenschutzes, der Bundeswehr, der Bundespolizei sowie der Bereitschaftspolizeien der Länder

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Regulation on the authorisation of exceptions to the provisions of the Medicines Act for the areas of civil and civil protection, the Bundeswehr, the Federal Police and the riot police of the Länder (AMG Civil Protection Decree)

Non-official table of contents

AMG1976ZSausnV

Date of issue: 17.06.2003

Full quote:

" AMG Civil Protection Decree of 17. June 2003 (BGBl. 851), as last amended by Article 1 of the Regulation of 29 June 2008. March 2006 (BGBl. I p. 594) "

:Last modified by Art. 1 V v. 29.3.2006 I 594

For details, see the menu under Notes
The obligations under Directive 98 /34/EC of the European Parliament and of the European Parliament and of the European Parliament. Council of 22 The European Parliament and of the Council of 19 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of the rules on information society services (OJ C EC No 37), as amended by Directive 98 /48/EC of the European Parliament and of the Council of 20 June 2000, of the European Parliament and of the Council of 20 June 1 July 1998 (OJ L 327, EC No 18), have been observed.

footnote

(+ + + text-proof from: 18.6.2003 + + +)
(+ + + Official note of the norm-provider on EC law:
Implementation of the
EGRL 34/98 (CELEX Nr: 398L0034)

Heading: IdF d. Art. 69 G v. 21.6.2005 I 1818 mWv 1.7.2005 Non-official table of contents

Inbox formula

It is assigned, in conjunction with § 1 of the The Law on Jurisdiction Adjustment of 16. August 2002 (BGBl. 3165) and the organisational decree of 22. January 2001 (BGBl. 127),
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The Federal Ministry of Health and Social Protection on the basis of section 71 (2) of the Link with paragraph 3 of the Medicines Act, as amended by the 11. December 1998 (BGBl. 3586), in conjunction with Section 1 of the Law on Adaptation to Responsibility of 16. August 2002 (BGBl. 3165) and the organisational decree of 22. October 2002 (BGBl. 4206), in agreement with the Federal Ministry of the Interior and with the Federal Ministry of Defence,
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the Federal Ministry of Consumer Protection, Food and Agriculture Agriculture on the basis of Section 71 (2) in conjunction with Section 3 of the Medicinal Products Act, as amended by the Notice of 11. December 1998 (BGBl. 3586), in agreement with the Federal Ministry of the Interior and with the Federal Ministry of Defence:
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§ 1 The purpose and scope of the Regulation

(1) The purpose of this Regulation is to provide, for the manufacture, procurement, storage, distribution and supply of medicinal products for the purpose of carrying out the specific tasks in the fields of Civil protection and civil protection, the Bundeswehr, the Federal Police and the riot police of the countries to allow exceptions to the provisions of the Medicines Act.(2) This Regulation shall apply to medicinal products within the meaning of Section 2 (1) and (2) of the Medicinal Products Act, which shall be subject to special instigation of the competent supreme federal or state authorities in the fields of civil protection and civil protection, the Bundeswehr, the The Federal Police or the riot police of the Länder are procured and brought into circulation by them or by the bodies responsible for the fulfilment of the duties in these areas.(3) The final consumption of medicinal products covered by this Regulation shall be subject to the responsibility of a person who is a physician, a veterinarian, a veterinarian or a pharmacist or pharmacist. Unofficial Table Of Contents

§ 2 Exceptions to the Fourth Section of the Medicinal Products Act

(1) By way of derogation from Section 21 (1) of the Medicines Act shall also be placed on the market in the medicinal product referred to in Article 1 (2) even if they are not authorised by the competent federal authority in accordance with Section 77 (1), (2) or (3) of the German Medicines Act, or if they are not authorised to do so. The placing on the market referred to in Article 3 (1) or (2) of Council Regulation (EEC) No 2309/93 of 22 June 1993. 1 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (OJ L 327, 30.4.1993, p. EC No 1) by the Commission of the European Communities or the Council of the European Union, provided that the placing on the market of non-authorised medicinal products for the performance of civil and civil protection tasks, the The Bundeswehr, the federal police or the riot police of the federal states is indispensable.(2) The pharmaceutical business owner and the competent upper federal or state authority shall submit to them all documents available to them which provide the information required for approval pursuant to section 22 of the German Medicines Act on quality, effectiveness and Safety of the unauthorised medicinal product, which is the federal authority responsible pursuant to Section 77 (1), (2) or (3) of the Medicines Act. The transfer shall take place at the latest at the time when the unauthorised medicinal product is delivered to a competent federal or state authority or to a body commissioned by those authorities. The federal authority responsible pursuant to Section 77 (1), (2) or (3) of the Medicinal Products Act shall examine the dossier as a priority and immediately inform the body responsible for the procurement of medicinal products the result with an evaluation of the medicinal product. with.(3) The pharmaceutical operator who provides an unauthorised medicinal product as referred to in paragraph 1 to a competent top federal or state authority, or a body commissioned by that competent authority, shall have the competent authority in accordance with § 77 of the German Medicines Act (Medicines Act). Federal authority shall immediately, but no later than 15 days after it has been notified, notify any known suspitias of a side effect. This obligation shall also apply to the competent supreme federal or state authorities in whose area such findings are available.(4) In the cases referred to in paragraph 1, the batch of a serum, a vaccine or a test allergen may, by way of derogation from § 32 of the Medicinal Products Act, be submitted to the competent federal and state authorities or the bodies responsible for such tests. and continue to be placed on the market. This also applies to the charge of a blood preparation pursuant to Article 1 (1) of the Regulation on the introduction of the state batch test in the case of blood preparations of 15. July 1994 (BGBl. I p. 1614). The federal authority responsible for the state batch examination in accordance with Section 32 (1) of the Medicinal Products Act shall be accompanied by documents relating to the manufacture and testing of the batch and samples of the medicinal product in one for examination by the pharmaceutical operator. to the appropriate state. The charge is to be examined by the competent federal authority in accordance with § 32 para. 1 of the Medicines Act. The result of the examination shall be communicated to the body responsible for the procurement of medicinal products. The batch may be placed on the market by the competent supreme federal or state authorities or bodies designated by them prior to the existence of this audit result, if this is an appropriate means of defence against a the present, not otherwise, the risk to life or health of people. Non-official table of contents

§ 3 Exceptions to the Seventh Section of the Medicines Act

(1) By way of derogation from § 47 (1) of the Medicines Act the medicinal products referred to in Article 1 (2) may be submitted directly to the competent supreme federal or state authorities or to the bodies designated by them by the pharmaceutical operator and the wholesale pharmaceutical distributor.(2) § 43 (1) sentence 1, § 48 (1) and § 49 (1) of the Medicinal Products Act shall not apply to the medicinal products referred to in section 1 (2). Non-official table of contents

§ 4 Exceptions to the Thirteenth Section of the Medicinal Products Act

(1) § 73 (1) sentence 1 of the Medicines Act is to be found shall not apply if the medicinal products referred to in § 1 (2) are brought within the scope of the Medicines Act by the competent supreme federal or state authorities or the bodies appointed by them.(2) If neither a certificate pursuant to Section 72a (1) sentence 1 (1) of the Medicinal Products Act nor a certificate pursuant to Section 72a (1), first sentence, No. 2 of the Medicinal Products Act is available, the issue of a contract for the procurement of medicinal products shall be valid by the In the sense of Section 1 (2) as a certificate pursuant to Section 72a (1), first sentence, No. 3 of the German Medicines Act, that the import is in the public interest. § 72a (1) sentence 4 of the Medicines Act remains unaffected. Non-official table of contents

§ 5 Exceptions to the Second Section of the Medicinal Products Act

(1) By way of derogation from § 10 (1) (9) and (8) of the Medicinal products may be placed on the market without an indication of the expiry date of the medicinal products referred to in Article 1 (2), if the date of manufacture of the medicinal product is clearly indicated in the attached documents. The competent supreme federal and state authorities shall determine the time of use of the medicinal product in question and shall ensure that such information is kept until the medicinal products are completely issued or destroyed.(2) By way of derogation from § 11 of the German Medicines Act (Medicines Act), the ready-to-use medicinal products covered by Section 1 (2) may also be placed on the market without a package leaflet. In this case, the competent federal and state authorities shall ensure that the final consumer of the medicinal product receives the necessary product information in an appropriate manner.(3) § 11a of the Medicines Act shall not apply to the medicinal products referred to in section 1 (2). According to § 1 (3), the responsible persons responsible for the federal and state authorities shall provide the responsible persons with specialist information on the respective medicinal product in a suitable manner.(4) § 9 (2) of the Medicinal Products Act does not apply to the medicinal products referred to in § 1 (2). Non-official table of contents

§ 6 Exceptions to the Eighth Section of the Medicinal Products Act

§ 55 (8) of the Medicines Act does not apply if the medicinal products referred to in Article 1 (2) are placed on the market by the competent supreme federal or state authorities or the bodies designated by them within the scope of the Medicines Act for the purpose of delivery to the consumer , provided that these medicinal products, in respect of the substances contained in them and in respect of their forms of administration, containers and sheaths, in so far as they come into contact with the medicinal products, shall be recognised as the pharmaceutical rules. Non-official table of contents

§ 7 Exceptions to the sixteenth section of the Medicines Act

(1) § 84 (1) no. 2 of the German Medicines Act shall apply to: the medicinal products referred to in Article 1 (2) shall not be used, provided that these medicinal products are placed on the market under the application of Article 5 (1), (2) or (3) of this Regulation.(2) Pharmaceutical operators, manufacturers and health professionals shall not be liable in respect of the effects of the use of the medicinal products referred to in Article 1 (2) which are intended for use in humans, if
1.
this medicine using § 2 para. 1 or 4 in response to the suspected or confirmed the spread of pathogenic agents, toxins, chemicals or a release of ionizing radiation are placed on the market and
2.
in accordance with the conditions of the Individual cases of deviations from the fourth section of the Medicines Act, based on § 2 para. 1 or 4, are likely to cause the damage.
Pharmaceutical entrepreneurs, manufacturers and health professionals have the Consequences of the deviations from the fourth section of the Medicines Act based on § 2 para. 1 or 4 only in case of gross negligence or intent to be represented. In addition, liability for culpable actions remains unaffected. Non-official table of contents

§ 8 Entry into force

The regulation will enter into force on the day after the announcement. Non-official table of contents

Final formula

The Bundesrat has agreed.