Regulation on the authorisation of exceptions to the provisions of the Medicines Act for the fields of civil protection and civil protection, the Bundeswehr, the Federal Police and the Preparedness Police of the countries (AMG Civil Protection Exception Regulation)

Unofficial table of contents

AMG1976ZSAusnV

Date of completion: 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 March 2006 (BGBl I). I p. 594).

Status:

Last amended by Art. 1 V v. 29.3.2006 I 594

For more details, please refer to the menu under Notes
The obligations laid down in Directive 98 /34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of the provisions relating to the services of The Information Society (OJ C EC No 37), as amended by Directive 98 /48/EC of the European Parliament and of the Council of 20 July 1998 (OJ L 136, 31.5.1998, p. EC No 18), have been observed.

Footnote

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

  

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

Input formula

It reorders, in conjunction with Section 1 of the Law on Jurisdiction Adjustment of 16 August 2002 (BGBl. 3165) and the Organizational Decree of 22 January 2001 (BGBl I). 127),

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the Federal Ministry of Health and Social Protection on the basis of section 71 (2) in conjunction with Section 3 of the Medicines Act, as amended by the Notice of 11 December 1998 (BGBl. 3586) in conjunction with Section 1 of the Jurisdiction Adjustment Act of 16 August 2002 (BGBl I). 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 pursuant to section 71 (2) in conjunction with Section 3 of the Medicines 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 Purpose and scope of the Regulation

(1) The purpose of this Regulation is to provide, for the production, procurement, storage, distribution and supply of medicinal products for the implementation of the special tasks in the fields of civil and civil protection, the Bundeswehr, the (2) This Regulation applies to medicinal products within the meaning of Article 2 (1) and (2) of the Medicines Act, which are subject to special instigation of the German Medicines Act ( of the competent federal or state authorities responsible for the areas of civil and civil protection, the Federal Armed Forces, the Federal Police or the riot police of the countries, and are placed on the market in these areas by the authorities responsible for filling the tasks. (3) The The final consumption of medicinal products covered by this Regulation shall be subject to the responsibility of a person who is a doctor or a doctor, a veterinarian or a veterinarian or a pharmacist or pharmacist. Unofficial table of contents

§ 2 Exceptions to the Fourth Section of the Medicines Act

(1) By way of derogation from § 21 (1) of the German Medicines Act (Medicinal Products Act), the medicinal products referred to in § 1 (2) may also be placed on the market if they do not permit them to be admitted by the medicinal products referred to in Section 77 (1), (2) or (3) of the Medicines the competent authority of the Federal Republic of Germany shall, in accordance with Article 3 (1) or (2) of Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of human resources, and the establishment of a European Agency for the Evaluation of Medicinal products 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 Bundeswehr, the Federal Police or the riot police of the federal states is indispensable. (2) The pharmaceutical entreprenters and the competent supreme federal or state authority hand over all the documents available to them, which are according to § 22 of the Pharmaceutical law for approval required information on quality, efficacy 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. (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 Section 77 of the Medicinal Products Act. Federal authority immediately, but no later than 15 days after It is known to indicate to him any suspicons of a side effect that have become known to him. This obligation shall also apply to the competent supreme federal or state authorities in whose area such findings are available. (4) The batch of a serum, a vaccine or a test allergen may differ in the cases referred to in paragraph 1. § 32 of the German Medicines Act (Medicines Act) to the competent federal and state authorities, or the bodies appointed by them, and be placed on the market by them. 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 examination 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 the bodies appointed by them, prior to the existence of this audit result, if this is an appropriate means of defence against a the present, non-otherwise possible danger to life or health of people. Unofficial table of contents

§ 3 Exceptions to the seventh section of the Medicines Act

(1) By way of derogation from § 47 (1) of the German Medicines Act, the pharmaceutical companies and the pharmaceutical wholesalers may direct the medicinal products referred to in § 1 (2) directly to the competent supreme federal or state authorities or to the competent authorities of the pharmaceutical industry. (2) § 43 (1) sentence 1, § 48 (1) and § 49 (1) of the Medicines Act shall not apply to the medicinal products referred to in section 1 (2). Unofficial table of contents

§ 4 Exceptions to the Thirteenth Section of the Medicines Act

(1) § 73 (1) sentence 1 of the Medicines Act shall not apply if the medicinal products referred to in § 1 (2) are within the scope of the medicinal product 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 an order shall be deemed to have been issued. Procurement of medicinal products by the responsible body within the meaning of § 1 para. 2 as a certificate according to § 72a Paragraph 1, sentence 1, point 3, of the Medicines Act, that the import is in the public interest. § 72a (1) sentence 4 of the Medicines Act remains unaffected. Unofficial table of contents

§ 5 Exceptions to the Second Section of the Medicines Act

(1) By way of derogation from Section 10 (1) (9) and (8) of the Medicines Act, the medicinal products referred to in Article 1 (2) may also be placed on the market without an indication of the expiry date, if the attached documents clearly show the the date of manufacture of the medicinal product. The competent supreme federal and state authorities shall determine the duration of use of the medicinal product concerned 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 Medicines Act, the ready-to-use medicinal products covered by § 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 German Medicines Act (Medicines Act) shall apply to the provisions of § 1 (1) (1) (a) These medicinal products shall not be used. In accordance with § 1 paragraph 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 an appropriate manner. (4) § 9 (2) of the Medicinal Products Act applies to the provisions of § 1 para. 2 is not an application. Unofficial table of contents

§ 6 Exceptions to the Eighth Section of the Medicines Act

§ 55 (8) of the Medicines Act does not apply if the medicinal products referred to in § 1 (2) are to be found by the competent supreme federal or state authorities or the bodies appointed by them within the scope of the Medicines Act. shall be placed on the market for the purpose of delivery to the consumer, provided that such medicinal products, in respect of the substances contained in them and in respect of their forms of administration, containers and envelopes, are placed on the market in so far as they are used with the medicinal products in question in Contact, at the time of their manufacture, the recognized pharmaceutical regulations . Unofficial table of contents

Section 7 Exceptions to the sixteenth section of the Medicines Act

(1) § 84 (1) (2) of the Medicines Act does not apply to the medicinal products referred to in § 1 (2), provided that these medicinal products are placed on the market under the application of § 5 (1), (2) or (3) of this Regulation. (2) Pharmaceutical companies, 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.

these medicinal products are placed on the market in response to the suspected or confirmed spread of pathogenic agents, toxins, chemicals or a release of ionising radiation, in accordance with section 2 (1) or (4); and

2.

in accordance with the circumstances of the individual case, the deviations from the fourth section of the pharmaceutical law based on § 2 (1) or (4) are liable to cause the damage.

Pharmaceutical companies, manufacturers and health professionals have to represent the consequences of the deviations from the fourth section of the Medicines Act based on § 2 (1) or (4) only in case of gross negligence or intent. In addition, liability for culpable actions remains unaffected. Unofficial table of contents

Section 8 Entry into force

The Regulation shall enter into force on the day following the date of delivery. Unofficial table of contents

Final formula

The Federal Council has agreed.