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

Read the untranslated law here: http://www.gesetze-im-internet.de/amg1976zsausnv/BJNR085100003.html

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 (AMG civil protection exception regulations) AMG1976ZSAusnV Ausfertigung date: 17.06.2003 full quotation: "AMG civil protection exception Decree of 17 June 2003 (BGBl. I S. 851), most recently by article 1 of the Decree of March 29, 2006 (BGBl. I S. 594) is changed" stand: last amended by art. 1 V v. 29.3.2006 I 594 for details on the stand number found in the menu under notes obligations of the Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 establishing an information procedure in the field of technical standards and regulations and of the rules for the services of the information society (OJ EC No. L 204, p. 37), as amended by Directive 98/48/EC of the European Parliament and of the Council of 20 July 1998 (OJ EC No. L 217, p. 18), have been observed.
Footnote (+++ text detection from: 18.6.2003 +++) (+++ official note of the standard authority on EC law: implementation of EGRL of 98 at the 34 (CELEX Nr: 398 L 0034) heading: IdF d. Article 69 G v. 21.6.2005 I 1818 mWv entered input formula's prescribe, each in conjunction with § 1 of the jurisdiction adjustment Act of 16 August 2002 (BGBl. I S. 3165) and the Organization Decree of 22 January 2001 (BGBl. I p. 127), the Federal Ministry for health and social security on the basis of section 71 paragraph 2 in conjunction with § 3 of the German medicines Act in) Amended by the notice of 11 December 1998 (BGBl. I S. 3586) in conjunction with § 1 of the jurisdiction adjustment Act of 16 August 2002 (BGBl. I S. 3165) and the adoption of the Organization of 22 October 2002 (BGBl. I S. 4206) in agreement with the Federal Ministry of the Interior and the Federal Ministry of defence, the Federal Ministry for consumer protection, food and agriculture on the basis of § 71 paragraph 2 in conjunction with § 3 of the German medicines act as amended by the notice of 11 December 1998 (BGBl. I S. 3586) in agreement with the Federal Ministry of the Interior and the Ministry of defence: article 1 purpose and scope of the Regulation (1) the objective of this regulation is for the manufacture, procurement, storage, distribution and the dispensing of medicines to carry out the specific tasks in the areas of civil and civil protection to allow exceptions to the provisions of the medicines Act of the Bundeswehr, the Federal Police, as well as the willingness to police forces of the countries.
(2) this Regulation shall apply to medicinal products within the meaning of § 2 para 1 and 2 of the medicines Act, which are procured at the special request of the competent Supreme Federal or State authorities in the areas of civil and civil protection, the Bundeswehr, the federal police or the willingness to police forces of the countries and to the fulfilment of tasks in these areas in the traffic brought by them or by the bodies designated by them.
(3) the dispensing of pharmaceutical products covered by this regulation to the final consumption takes place under the responsibility of a person who is doctor or doctor, veterinarian or veterinary surgeon or pharmacist or pharmacist.

§ 2 exceptions to the fourth section of the medicines Act (1) by way of derogation may be brought called medicines even by § 21 ABS. 1 of the German medicines Act in section 1 para 2 in the traffic, if for them neither by the authorisation according to article 77, paragraph 1, paragraph 2 or paragraph 3 of the German medicines Act competent federal authority or an authorisation for the placing on the market referred to in article 3 paragraph 1 or 2 of Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the approval and monitoring of human and veterinary use and establishing a European Agency for the evaluation of medicinal products (OJ EC No. L 214, p. 1) is granted by the Commission of the European communities or the Council of the European Union, provided that the placing on the market of non-approved drug for the fulfilment of the tasks of civil and civil protection, the Bundeswehr, the federal police or the willingness to police forces of the countries is essential.
(2) the pharmaceutical entrepreneur and the competent Supreme Federal or State authority passed all available documents, that containing necessary information on quality, efficacy and safety of the medicinal product not approved pursuant to § 22 of the medicines Act for admission, the federal upper authority according to article 77, paragraph 1, paragraph 2 or paragraph 3 of the German medicines Act. Are transferred at the latest at the time of the unapproved drug is delivered to a competent federal or State authority or a body authorized by those authorities. The federal authority competent under article 77, paragraph 1, paragraph 2 or paragraph 3 of the German medicines Act primarily examines the documents and immediately shall the Agency safeguard the medicines procurement the outcome with an evaluation of the medicinal product.
(3) the pharmaceutical entrepreneur who gives a medicinal product not approved under paragraph 1 to a competent Supreme Federal or State authority or a body authorized by this has known the competent federal authority immediately, everyone him according to article 77 of the medicines Act at the latest but within 15 days after the announcement, to display that has become suspected case of a side effect. This obligation also applies to the competent Supreme Federal or State authorities, such findings are available in their area.
(4) the charge of a serum, a vaccine or a test allergen may be in the cases of paragraph 1, given by way of derogation from § 32 of the German medicines Act to the competent Supreme Federal and land authorities or the bodies appointed by them and of these further put into circulation. This also applies to the batch of a blood article 1 § 1 of the regulation on the introduction of the State batch testing in blood preparations of 15 July 1994 (Federal Law Gazette I p. 1614). The federal authority responsible for the State examination in charge according to § 32 para 1 of the German medicines Act are to submit documents about the manufacture and testing of the batch, as well as patterns of the medicinal product in a condition suitable for testing by the pharmaceutical entrepreneur. The batch is ABS by the competent federal authority according to § 32.1 of the German medicines Act to check. The result of the test is to inform the body inducing drug procurement. The batch must be taken by the competent Supreme Federal or State agencies or the bodies appointed by them already before the existence of this check results in the transport, if this is an appropriate way to ward off a present, otherwise preventable risk to life or health of people.

§ 3 exceptions from the seventh section of the medicines Act (1) by way of derogation from article 47, paragraph 1 of the medicines Act may medicines listed emitted in section 1 para 2 of the pharmaceutical business and the pharmaceutical wholesalers directly to the competent Supreme Federal or State agencies or the bodies appointed by them.
(2) section 43, paragraph 1, sentence 1, § 48 para 1 and § 49 paragraph 1 of the German medicines Act on the medicinal products referred to in article 1, paragraph 2 does not apply.

Article 4 exceptions to the thirteenth section of the medicines Act (1) § 73 para 1 sentence 1 of the German medicines Act does not apply if the drug referred to in section 1 para 2 are spent by the competent Supreme Federal or State agencies or the bodies appointed by them within the scope of the medicines Act.
(2) a certificate under section 72a para 1 sentence 1 No. 1 of the German medicines Act nor a certificate exists according to section 72a para 1 sentence 1 No. 2 of the medicines Act, the placing of an order for the procurement of drugs by the initiating agent within the meaning of § 1 para 2 as a certificate applies to section 72a para 1 sentence 1 No. 3 of the German medicines Act , that imports in the public interest lies. section 72a paragraph 1 sentence 4 of the German medicines Act remain unaffected.

Section 5 exceptions from the second section of the medicines Act (1) by way of derogation from article 10, paragraph 1 No. 9 and paragraph 8 of the medicines Act allowed in section 1 para 2 medicines listed without specifying the expiration date in the transport be brought if the enclosed document clearly the date of manufacture of the medicinal product. The competent Supreme Federal and land authorities set the life of the respective medicinal product and make sure that this information is kept up to full output or destruction of the drug.
(2) by way of derogation from section 11 of the German medicines Act, the finished product covered by article 1 paragraph 2 without a leaflet in the traffic may be placed. In this case, the competent Supreme Federal and land authorities ensure that the end user of the medicinal product in an appropriate manner receives the necessary product information.
(3) § 11a of the medicines Act shall not apply to medicinal products referred to in article 1, paragraph 2. The competent Supreme Federal and land authorities provide the responsible persons according to § 1 paragraph 3 adequately specialized information to the relevant medicines available.
(4) § 9 par. 2 of the German medicines Act shall not apply to medicinal products referred to in article 1, paragraph 2.

Article 6 exceptions by the eighth section of the medicines Act § 55 para. 8 of the German medicines Act does not apply if the medicines listed are placed in § 1 para 2 of the competent Supreme Federal or State agencies or the bodies appointed by them within the scope of the German medicines Act for the purpose of sale to the consumer in the traffic, provided that these medicines as regards the substances contained in them and their dosage forms , Containers and packages, unless they come with the medicines in contact, at the time of their production corresponded to the pharmaceutical standards.

Section 7 exceptions to the sixteenth section of the medicines Act (1) article 84, paragraph 1 No. 2 of the German medicines Act applies to the medicinal products referred to in article 1, paragraph 2 No, provided these medicinal products, application section 5, paragraph 1, paragraph 2 or paragraph 3 be brought to this regulation on the market.
(2) for use in people subject to pharmaceutical contractors, manufacturers and health professionals about the impact of the use of the medicinal products referred to in article 1, paragraph 2, certainly are not the liability when 1 these medicines under application of § 2 para 1 or 4 in response to the suspected or confirmed spread of pathogenic agents, toxins, chemicals or a release of ionizing radiation in traffic are brought and 2nd according to the facts of the case based on article 2, paragraph 1 or 4 Are deviations from the fourth section of the medicines Act, doing the damage.
Pharmaceutical entrepreneur, manufacturers and health professionals have to represent the impact of deviations based on article 2, paragraph 1 or 4 of the fourth section of the German medicines Act only for gross negligence or willful misconduct. In addition, the liability for culpable act remains unaffected.

Article 8 entry into force of the regulation enters into force on the day after the announcement.

Concluding formula the Federal Council has approved.