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Regulation on the placing on the market of medicinal products without authorisation or without authorisation in cases of hardship

Original Language Title: Verordnung über das Inverkehrbringen von Arzneimitteln ohne Genehmigung oder ohne Zulassung in Härtefällen

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Regulation on the placing on the market of medicinal products without authorisation or without authorisation in cases of hardship (medicinal product-hardship-Regulation-AMHV)

Unofficial table of contents

AMHV

Date of completion: 14.07.2010

Full quote:

" Drugs-Härtefall-Verordnung vom 14. Juli 2010 (BGBl. I p. 935) "

Footnote

(+ + + Text certificate: 22.7.2010 + + +) 

Unofficial table of contents

Input formula

Pursuant to § 80, first sentence, point 3a in conjunction with sentence 3 and 4 and in conjunction with § 83 of the Medicines Act, of which § 83 was last amended by Article 1, point 70 of the Law of 17 July 2009 (BGBl. 1990), the Federal Ministry of Health is responsible for the following: Unofficial table of contents

§ 1 Scope

(1) This Regulation lays down the procedure for the placing on the market of medicinal products without authorisation or without authorisation in cases of hardship, subject to the conditions laid down in Article 21 (2) (6) of the Medicines Act, in conjunction with Article 83 of the 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 medicinal products for human and veterinary use and establishing a European Community Pharmaceutical Agency (OJ L 327, 28. OJ L 136, 30.4.2004, p. 1). The Regulation shall apply to finished medicinal products intended for use in or on human beings and not within the scope of the provisions of the Medicines Act, or in another Member State of the European Union or any other Contracting State of the European Union. Agreement on the European Economic Area approved or authorised, but subject to the authorisation requirement laid down in Article 3 (1) and (2) of Regulation (EC) No 726/2004 or the authorisation requirement in accordance with Article 21 (1) of the Medicines Act (2) This Regulation shall not be used for the individual use of a non- authorised or unauthorised medicinal product, in the case of only one patient or a patient under the direct responsibility of a doctor or doctor. Unofficial table of contents

§ 2 Definitions

(1) A hardship programme is a "compassionate-use" programme in accordance with Regulation (EC) No 726/2004. In the context of a hardship programme, medicinal products may be made available without authorisation or without the authorisation of a particular group of patients if there is sufficient evidence of the efficacy and safety of the medicinal product and, if appropriate, for this is a clinical trial, or an application for authorisation has been submitted to the European Medicines Agency, the competent authority or a competent authority of a Member State. (2) Cases of hardship within the meaning of this Regulation shall be subject to a group of Patients who are suffering from a disease which is likely to have a severe disability or are life-threatening cannot be treated satisfactorily with a medicinal product which is placed on the market within the scope of the Medicines Act is approved or approved. Unofficial table of contents

§ 3 Display of the hardship programme

(1) A person who assumes responsibility for the instigation, organisation and financing of a hardship programme (responsible person) has to indicate the hardship case programme of the competent federal authority. If the person responsible is not established in a Member State of the European Union or in another State Party to the Agreement on the European Economic Area, the person responsible shall appoint a representative or representative established in the European Union or another State Party to the Agreement on the European Economic Area. (2) The following particulars and documents shall be required for the display:
1.
name or company and the address of the person responsible and, where available, the representative established in the European Union or in another State Party to the Agreement on the European Economic Area,
2.
the name or code of the medicinal product, the name of the active substances by type and quantity, other ingredients by type, pharmaceutical form, type of administration, dosage and treatment regimine,
3.
a description of the serious disability or life-threatening condition in which the patients suffer and for which the medicinal product is intended;
4.
Criteria for the selection of patients and the number of patients likely to be expected,
5.
Justification that these patients cannot be treated satisfactorily with a medicinal product authorised or authorised to be placed on the market within the scope of the Medicinal Products Act,
6.
Justification for not being able to include patients in an ongoing clinical trial,
7.
proof that the medicinal product has the appropriate quality in accordance with the recognised pharmaceutical regulations, as well as a confirmation by the competent person in accordance with § 14 of the Medicines Act that the medicinal product shall be subject to the principles and guidelines of good manufacturing practice for medicinal products;
8.
evidence and justification for the assumption that the medicinal product is safe and effective in the intended use, as a rule by presenting the results of confirmatory clinical trials,
9.
criteria for the setting-up or premature termination of the hardship programme,
10.
More information
a)
on the approved clinical examination of the medicinal product in the designated area of application, indicating the EudraCT number, or
b)
on the clinical examination of the medicinal product in the designated area of application in a third country, and proof that it is carried out in accordance with the internationally harmonised standards of good clinical practice, or
c)
on the authorisation or authorisation application for the medicinal product in the intended area of application to the European Medicines Agency, the competent authority or a competent authority of a Member State ,
11.
in the case of medicinal products consisting of or containing a genetically modified organism or of a combination of genetically modified organisms, documents listed in Annexes II and III to Directive 2001 /18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90 /220/EEC (OJ L 139, 30.4.2001, p. OJ L 106, 17.4.2001, p.1),
12.
Justification for treatment with a medicinal product for which a request for authorisation or authorisation of the medicinal product has been failed, withdrawn, withdrawn or dormant, or the approval of a clinical trial has failed, withdrawal, revocation or revocation, or under side conditions, giving the reasons for the decision,
13.
the current audit information provided in the clinical examination of the examiner or the auditor, or the draft summary of product characteristics of the medicinal product, as provided for in the application for authorisation or approval,
14.
Information and documents obtained by the patients, in German, as well as a presentation of the procedure for informed consent by a participating doctor or a participating physician,
15.
requirements for the medical facilities and the qualifications of the participating doctors,
16.
a description of the measures envisaged to ensure safe storage, use and retention of the medicinal products made available,
17.
Information, where applicable, on existing hardship programmes in Member States of the European Union or other States Parties to the Agreement on the European Economic Area and, where available, opinion of the Committee on Medicinal products for human use referred to in Article 83 (4) of Regulation (EC) No 726/2004,
18.
Declaration of consent to pass on the information on the broad guidelines of the indicated hardship case programme to the public.
(3) The display and the required documents referred to in paragraph 2 shall be in writing and in the form of an electronic form. The documents may be submitted in German or English, except for the documents referred to in paragraph 2 (14). (4) The competent federal authority shall publish information on the submission of the particulars and documents on their Website. Unofficial table of contents

§ 4 Start of the hardship program, contradiction

(1) The competent federal authority shall confirm the person responsible within two weeks to the receipt of the proper notification, indicating the date of receipt (confirmed indication). If documents are missing for display or the display is not correct for other reasons, the responsible federal authority shall also request the responsible person within two weeks to correct these shape defects. The competent authority of the federal authority shall confirm the receipt of the proper display (confirmed display) to the responsible person within two weeks after receipt of the subsequent documents, provided that the notification is now complete and correct (2) The execution of the hardship program can be initiated as soon as the confirmed advertisement has been received and the competent federal authority has not objected. (3) The competent federal authority may object if the Requirements for the implementation of the hardship case programme are not available or evidence that the information provided is incorrect or that the medicinal product is not safely administered. The competent authority of the Federal Republic of Germany may also object subsequently if the reasons set out in the first sentence enter into force after the start of the hardship programme. If the competent authority has objected, the hardship programme may not be started or continued. (4) If the notification refers to a medicinal product for advanced therapy or to a medicinal product which is provided by the competent authority of the competent authority of the competent authority. (5) In the case of medicinal products derived from genetically modified organisms, the competent authority of the competent authority of the Federal Republic of Germany shall not be subject to any authorisation procedure for a clinical trial. (5) Organism or a combination of genetically modified organisms The approval of the clinical trial by the competent federal authority also includes the approval of the release of these genetically modified organisms in the context of the hardship programme. This shall apply only in so far as no changes are made to the approved clinical trial, which are likely to alter the risk assessment for the health of third parties and for the environment. In the case of changes which are likely to alter the risk assessment for the health of third parties and for the environment, the competent federal authority in consultation with the Federal Office for Consumer Protection and Food Safety shall be within one of the following: appropriate time limit. By way of derogation from paragraphs 2 and 4, a hardship programme with medicinal products for which a risk assessment as defined in the second sentence is required shall not be commenced until the authorisation required for this purpose is granted. Unofficial table of contents

§ 5 Duration of the hardship program, redisplay

(1) The hardship case programme shall end without prejudice to § 4 (3) with the cancellation by the responsible person or with the actual availability of the medicinal product on the market, but no later than one year after access of the confirmed advertisement or the approval required in accordance with § 4 (5). (2) A new advertisement shall be admissible. Reference may be made to documents which have already been submitted in so far as no changes have been made to this effect. Unofficial table of contents

§ 6 Co-participation obligations of the responsible person

(1) The responsible person pursuant to § 3 paragraph 1 shall have
1.
to document any suspicions of a serious side-effect which has been communicated to it by the participating doctors or brought to the attention of the physicians, and without delay to the competent authority of the Federal Republic of Germany, but no later than 15 days after the date of the notification,
2.
to notify without delay any change in the information referred to in § 3 of the competent authority and to accompany the relevant documents;
3.
inform the competent federal authority without delay of the cancellation of the hardship programme, stating the reasons,
4.
after the completion of the hardship programme, submit a safety report to the competent authority of the Federal Republic of Germany, covering in particular all serious adverse reactions and all non-serious unexpected adverse reactions,
5.
the competent authority of the Federal Republic of Germany, new opinions pursuant to Article 83 (4) of Regulation (EC) No 726/2004 and findings from other hardship case programmes issued in another Member State of the European Union or in another Contracting State of the Agreement on the European Economic Area shall be submitted without delay or communicated.
(2) changes relating to the field of application, strength or pharmaceutical form of the medicinal product under the hardship case programme, as well as changes likely to affect the safety of patients, (3) The responsible person shall ensure that the risk of medicinal products is communicated to the competent federal authority without delay. It shall immediately take the measures necessary for the prevention of risks. Unofficial table of contents

§ 7 Responsibility of the responsible person

The person responsible pursuant to Article 3 (1) shall ensure that:
1.
the implementation of the hardship programme is properly implemented,
2.
all conditions and restrictions with regard to the safe and effective use of the medicinal product are fulfilled and the persons involved are given the information necessary for this purpose,
3.
the medicinal product is placed on the market only if at least the following information is available on the containers and, where appropriate, on the outer envelopes:
a)
the name or code of the medicinal product;
b)
the name and address of the person responsible,
c)
batch name,
d)
the nature of the application,
e)
the active substance name,
f)
Expiry date,
g)
where necessary, storage and storage instructions,
h)
Notice that the medicinal product is made available without authorisation or authorisation in the context of a hardship programme,
4.
the manufacture, import and release shall be carried out in accordance with the arrangements for investigational medicinal products provided for in the medicinal products and active substance manufacturing regulations;
5.
the essential documents of the hardship programme shall be kept for at least ten years after termination or termination of the case; other provisions relating to the storage of medical records shall remain unaffected.
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§ 8 Information obligations of the competent federal authority

(1) In the case of medicinal products which consist of or contain a genetically modified organism or a combination of genetically modified organisms, the competent federal authority shall inform the Federal Office of Consumer Protection (2) The competent federal authority shall inform the European Medicines Agency of its indicated hardship programmes. (3) The competent federal authority shall ensure that each of them , the suspected serious adverse reaction is recorded and the The European Medicines Agency shall be notified without delay, but no later than 15 days after receipt of the information. (4) The competent federal authority shall provide the public with information on the hardship programmes which are shown to the public. Available. Unofficial table of contents

§ 9 Transitional Regulation

Cases of hardship which will be carried out at the time of entry into force of the Regulation may be continued independently of the provisions of this Regulation. Unofficial table of contents

Section 10 Entry into force

This Regulation shall enter into force on the day following the date of delivery.