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Regulation concerning the placing on the market of medicines without authorisation or approval in cases of hardship (medicinal hardship regulation - AMHV) AMHV Ausfertigung date: 14.07.2010 full quotation: "medicinal hardship Decree of July 14, 2010 (BGBl. I p. 935)" footnote (+++ text detection from: 22.7.2010 +++) input formula on the basis of section 80, sentence 1 number 3a in conjunction with sentence 3 and 4 and in conjunction with section 83 of the medicines Act, of which section 83 last through article 1, point 70 of the Act of July 17, 2009 (BGBl. I S. 1990) has been modified , ordered the Ministry of health: article 1 scope of application (1) this regulation lays down the procedure for the placing on the market of medicines without authorisation or approval in cases of hardship under the same conditions in article 21 paragraph 2 number 6 of the German medicines Act in conjunction with article 83 of Regulation (EC) No 726 / 2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1) are called. Regulation is for finished product, for use in the or are intended to the people and not approved within the scope of the drug law in another Member State of the European Union or another Contracting State to the agreement on the European economic area or approved are, but the permit requirement referred to in article 3 paragraph 1 and 2 of Regulation (EC) No. 726 / 2004 or the authorisation according to article 21, paragraph 1, of the German medicines Act are subject to.
(2) this regulation is not to apply for individual use of a medicinal product not approved or non-approved only a patient or a patient under the direct responsibility of a doctor or a physician.
Article 2 definitions (1) a hardship program is a "compassionate use" program under Regulation (EC) No 726 / 2004. In a hardship program medicines without approval or approval of a specific group of patients can be provided, if sufficient evidence exists on the efficacy and safety of the medicinal product and a clinical trial is carried out for this or an application for authorisation in the European drug agency, the competent federal authority or a competent for the approval authority of a Member State has been made.
(2) a hardship within the meaning of this regulation occurs when a group of patients, or patients who suffer from a disease, which would lead to a severe disability or is life-threatening, with a drug agent satisfactory cannot be dealt with, it approved for the placing on the market within the scope of the medicines Act or is approved.
§ 3 display of the hardship program (1) a person who assumes responsibility for the initiative, organization and financing a hardship program (person in charge), has to show the hardship program of the competent federal authority. The person in charge is established in a Member State of the European Union or in another Contracting State to the agreement on the European economic area, she shall designate a representative or a representative based in the European Union or in another Contracting State to the agreement on the European economic area.
(2) to display the following information and documents are required: 1. name or company, as well as the address of the person responsible and, if available, of the representative established in the European Union or in another Contracting State to the agreement on the European economic area, 2. name or code of the medicinal product, name of active substances according to type and quantity, other components according to the type, dosage form, type of application , Dosage and regimen, 3. Description of the leading to severe disability or life-threatening disease, the patients suffer and for which the medicinal product is intended, 4. criteria for the selection of patients and patient and indication of the expected number of patients, 5. justification, treat these patients and patients not satisfactory of a medicinal product authorised for the placing on the market within the scope of the medicines Act or approved can be , 6 justification that the patients or patients not can be included in an ongoing clinical trial, 7 evidence that the drug has the quality measured after the pharmaceutical standards, as well as a confirmation of the person in charge according to § 14 of the German medicines Act, that the medicinal product is made according to the principles and guidelines of good manufacturing practice for medicinal products, 8 evidence and justification for the adoption of , that the drug is safe and effective for the intended use, usually by presentation of the results of confirmatory clinical trials, 9. criteria for the suspension or premature quitting of the hardship program, 10 for further information a) to approved clinical trials of the medicinal product in the intended area of application with indication of the EudraCT number or b) to the clinical trial of the medicinal product in the intended application area in a third country and proof of , that is carried out this harmonised according to the international standards of good clinical practice, or c) about the approval or approval has been provided for the drug in the intended area of application with the European Medicines Agency, the competent federal authority or a competent for the approval authority of a Member State, 11 with medicines from a genetically modified organism or a combination of genetically modified organisms which consisting of or containing , Documents referred to in annex II and III to Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release of genetically modified organisms into the environment and repealing Directive 90/220/EEC (OJ L 106 of the 17.4.2001, p. 1), 12 grounds for treatment with a drug for which an application for authorization or approval of the medicinal product has been failed, withdrawn, revoked or dormant provided or the approval failed a clinical trial, withdrawn, revoked or dormant provided or granted under constraints been is, stating the reasons for the decision, 13 in the trial of examiner or current IB asked the investigator to provide or the design referred to in the application for registration or approval a summary of product characteristics of the medicinal product, 14 information and documents received patients in German language as well as a representation of the process of informed consent by a participating doctor or a participating doctor, 15 requirements of the medical facilities and the qualification of participating physicians and doctors, 16 description of the measures to ensure of a safe storage , Application, as well as the whereabouts of the medicines provided, 17 information, if applicable, to ongoing hardship programs in Member States of the European Union or the other Contracting States of the Convention to on the European economic area and, if present, opinion of the Committee for medicinal products for human after article 83 (4) of Regulation (EC) No 726 / 2004, to pass 18 Declaration of consent, the information on the broad guidelines of the hardship program to the public.
(3) the display and the documents required pursuant to paragraph 2 shall require the written form and electronic form. The documents can be submitted in German or English language. it excluded the documents are the competent federal authority referred to in paragraph 2, number 14 (4) published instructions for the submission of information and documents on their website.
§ 4 start of the hardship program, opposition (1) the responsible federal authority confirmed the person responsible within two weeks from the receipt of proper notice, stating the date of receipt (confirmed display). If missing documents relating to the display or the display for other reasons is not properly, the competent federal authority calls on the responsible person also within two weeks to fix these deficiencies of form. The competent federal authority confirms the receipt of the proper indicator (confirmed) the responsible person within two weeks after receipt of the subsequent documents, provided that the display is now complete and properly.
(2) with the implementation of the hardship program can be started as soon as the confirmed ad is gone too and has not objected to the competent federal authority.
(3) the competent federal authority can object, if the conditions for the implementation of the hardship program are not available or evidence, that the details are incorrect or that no safe use of the medicinal product is guaranteed. The competent federal authority may oppose later if the reasons referred to in sentence 1 shall occur after the beginning of the hardship program. Has objected to the competent federal authority, the hardship program may be started or continued.
(4) if the display refers to a medicinal product for advanced therapies or a medicinal product that has been assessed by the competent federal authority in any approval of a clinical trial, a reasonable period of time, which should not exceed 60 days is considered by way of derogation from paragraph 1.
(5) in the case of medicinal products which from a genetically modified organism or a combination of genetically modified organisms consisting of or containing, the approval of the trial by the competent federal authority includes also the approval of the release of these genetically modified organisms in the framework of the hardship program. This applies only if made no changes from the approved clinical trials that are suitable, the risk assessment for the health of third parties and to change for the environment. Changes that are suitable, the risk assessment for the health of third parties and for the environment to change, is to decide within a reasonable period of time by the competent federal authority in consultation with the Federal Office for consumer protection and food safety. By way of derogation from paragraph 2 and 4 a hardship program with medicines for which a risk assessment is required pursuant to sentence 2, must be started with access of the necessary approval.
§ 5 duration of the hardship program, another display (1) the hardship program ends without prejudice to § 4 paragraph 3 with the demolition of the actual availability of the medicinal product on the market or by the person responsible, but no later than one year after receipt of confirmed display or according to § 4 paragraph 5 required approval.
(2) a renewed display is allowed. It can reference be made to already presented documents, as far as no changes, have shown.
§ 6 duties of notification of the responsible person (1) the person responsible for § 3 paragraph 1 has 1 any suspicion of a serious side effect, she informed which of the participating doctors or brought her to the attention otherwise been is, to document and the competent federal authority without delay, at the latest however within 15 days after the announcement, to communicate electronically 2. any change of data from article 3 of the competent federal authority without delay to display and attach the relevant documents , 3 the competent federal authority immediately canceling the hardship program, stating the reasons to tell 4. after completion of the hardship program of the competent federal authority to submit a safety report, which captures all serious adverse events and all non serious unexpected adverse reactions and rated, 5 the competent federal authority new opinion according to article 83 paragraph 4 of Regulation (EC) No 726 / 2004 and findings from other hardship programs , carried out in another Member State of the European Union or in another Contracting State to the agreement on the European economic area, immediately to submit or notify.
(2) changes that relate to the field of application, the strength or the pharmaceutical form of the medicinal product in the frame of the hardship program, as well as changes that are impacting on the safety of patients and patients, may be carried out only with receipt of a renewed confirmed notification according to § 4.
(3) the person in charge has to take care, that drug risks of the competent federal authority be communicated immediately. It has measures to take against the risk.
§ 7 responsibilities of the responsible person the person in accordance with § 3 paragraph 1 has to make sure that 1 of the hardship program properly implemented, 2. all conditions and restrictions with respect to the safe and effective use of the medicinal product are met and are at least the following information on the outer packages the people involved that this be given the necessary information, the medicinal product on the market only reaches 3, if the containers and used as far as : a) name or code of the medicinal product b) name and address of the person responsible, c) batch number, d) type of application, e) active ingredient name, f) expiration date, g) where necessary, retention and storage instructions, h) indicating that the medicinal product without authorization or approval under a hardship program is made available, 4. the manufacturing, import and release in accordance with the arrangements provided in the medicinal and active ingredient production regulation for investigational medicinal products , 5. the main documents of the hardship program; kept at least 10 years after its termination or cancellation This does not affect other provisions for the storage of medical records.
Article 8 information obligations of the competent federal authority (1) medicines, that genetically modified organism from one or a combination of genetically modified organisms or contain such, informed the Federal Office for consumer protection and food safety, on the receipt of the notification the competent federal authority.
(2) the competent federal authority the European Medicines Agency informed her displayed hardship programs.
(3) the competent federal authority makes sure that each of your displayed suspected serious adverse reaction recorded and immediately, at the latest within 15 days of receipt of this information informs the European Medicines Agency.
(4) the competent federal authority provides information on their displayed hardship programs available to public.
Section 9 transitional hardship programs, performed upon entry into force of the regulation can be continued regardless of the requirements of this regulation.
Article 10 entry into force this regulation enter into force on the day after the announcement.
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