Regulation Concerning The Placing On The Market Of Medicines Without Authorisation Or Approval 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 products-hardness-case-Regulation-AMHV)

Non-official table of contents

AMHV

Date of delivery: 14.07.2010

Full quote:

" Medicines-Härtefall-Verordnung vom 14. July 2010 (BGBl. I p. 935) "

footnote

(+ + + text evidence from: 22.7.2010 + + +)

unofficial table of contents

input formula

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

§ 1 Scope

application (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 under the conditions laid down in Article 21 (2) (6) of the Medicinal Products Act, in conjunction with Article 83 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 December 2004 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 327, 30.4.2004, p. 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 which do not fall within the scope of the Medicines Act or in another Member State of the European Union or any other State Party to the Agreement authorised or authorised by the European Economic Area, but subject to the authorisation requirement laid down in Article 3 (1) and (2) of Regulation (EC) No 726/2004 or by the authorisation requirement in accordance with Article 21 (1) of the Medicines Act.(2) This Regulation shall not apply to the individual use of an unauthorised or unauthorised medicinal product in the case of only one patient or one of the patients under the direct responsibility of a doctor or doctor. Non-official table of contents

§ 2 Definitions

(1) A hardship case program is a compassionate-use program provided for in 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 of the Federal Republic of Germany, or a competent authority of a Member State.(2) A case of hardship within the meaning of this Regulation is to be found when a group of patients who suffer from a disease that is likely to have a severe disability or are life-threatening, do not have a medicinal product can be satisfactorily dealt with, which is authorised or authorised to be placed on the market within the scope of the Medicines Act. Non-official table of contents

§ 3 View of the hardship case program

(1) A person who is responsible for the initiative, organization, and Financing of a hardship case programme (responsible person), has to display 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 in another State Party to the Agreement on the European Economic Area.(2) The following information and documents are required for the display:
1.
Name or company as well as the address of the responsible person and, if any, of the person responsible for the display in the Member of the European Union or in another State Party to the Agreement on the European Economic Area,
2.
Name or code of the Medicinal product, name of the active substances by type and quantity, other ingredients by type, administration form, type of administration, dosage and regiming scheme,
3.
Description of the life-threatening or life-threatening illness that the patients suffer from and for which the medicine is intended to be ,
4.
Criteria for the selection of patients and the number of patients expected,
5.
Justification that these patients are not satisfactorily approved or approved for placing on the market within the scope of the Medicines Act. medicines can be treated,
6.
Justification that patients are not included in a current clinical trial ,
7.
evidence that the medicinal product has the appropriate quality in accordance with the recognized pharmaceutical rules, as well as a confirmation from the competent person. in accordance with § 14 of the Medicines Act, that the medicinal product is manufactured in accordance with the principles and guidelines of good manufacturing practice for medicinal products,
8.
Belege and Justification for the assumption that the medicinal product is safe and effective in the intended use, usually by presenting the results of confirmatory clinical trials,
9.
Criteria for setting out or premature termination of the hardship program,
10.
More details
a)
for the approved clinical examination of the medicinal product in the designated field of application, indicating the EudraCT number or
b)
for the clinical examination of the medicinal product in the intended application in a third country and proof that these are in accordance with the internationally harmonised standards of good clinical Practice, or
c)
on the permit or permit application for the medicinal product in the intended use in the European medicines agency, the competent national authority or a competent authority of a Member State
11.
Medicinal products consisting of or containing a genetically modified organism or of a combination of genetically modified organisms, documents listed in Annex II and III of Directive 2001 /18/EC of the European Parliament and of the Council of 12 1 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90 /220/EEC (OJ L 327, 30.4.1990, p. 1),
12.
Statement of reasons for a treatment with a medicinal product for which a request for authorisation or authorisation of the medicinal product is being denied, withdrawal, revocation or retirement, or the approval of a clinical trial has been denied, withdrawn, withdrawn or dormant, or has been granted under secondary conditions, with the indication of the Decision Reasons,
13.
The current audit information provided in the clinical trial of the examiner or the examiner, or the one in the application for authorisation or approval draft of a summary of product characteristics of the product,
14.
Information and documentation to patients and patients , in German, as well as a presentation of the procedure for informed consent by a participating doctor, or a participating doctor,
15.
Requirements for the medical facilities and the qualification of the participating doctors,
16.
Description of the measures provided to ensure safe storage, use, and retention of the medicinal products provided
17.
Information, where applicable, on current hardship case programmes in Member States of the European Union or other States Parties to the Agreement on European Union Economic area and, where available, opinion of the Committee for Medicinal Products for Human Use, as provided for in Article 83 (4) of Regulation (EC) No 726/2004,
18.
Declaration of consent to pass the information on the basic features of the displayed hardship program to the public.
(3) The display and the required The documents referred to in paragraph 2 shall be in writing and in electronic form. The documents may be submitted in German or English, except in the case of 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 its website. Non-official table of contents

§ 4 Start of the hardship case program, contradiction

(1) The responsible federal authority confirms the responsible person within two weeks, the receipt of the proper display, indicating the date of receipt (confirmed display). 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, if the notification is now complete and correct. is.(2) The implementation 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 conditions for the implementation of the hardship case programme are not available or if there is evidence that the information provided is incorrect or that no safe application is available. of the medicinal product. 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 federal authority has contradicted, the hardship program must not be started or continued.(4) By way of derogation from paragraph 1, the notification to a medicinal product for advanced therapy or to a medicinal product which has not yet been evaluated by the competent authority of the competent authority of the competent authority of the competent authority of a clinical trial shall be considered to be: a reasonable period of time, which shall not exceed 60 days.(5) In the case of medicinal products consisting of or containing a genetically modified organism or of a combination of genetically modified organisms, the approval of the clinical trial by the competent authorities shall include: Federal Supreme Authority also authored the release of these genetically modified organisms as part of the hardship case program. 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. Non-official table of contents

§ 5 Duration of the hardship case program, redisplay

(1) The hardship case program ends without prejudice to § 4, paragraph 3, with the Cancellation by the person responsible or with the actual availability of the medicinal product on the market, but at the latest one year after receipt of the confirmed notification or the approval required pursuant to § 4 (5).(2) Reviewing is allowed. Reference may be made to documents which have already been submitted in so far as no changes have been made to this effect. Non-official table of contents

§ 6 Responsible person's notification obligations

(1) The responsible person in accordance with § 3 paragraph 1
1.
Any suspected case of a serious side effect, communicated to it by the participating doctors or brought to the attention of the participating physicians. shall be documented and communicated to the competent authority without delay, but no later than 15 days after the notification has been made,
2.
Any change to the information specified in § 3 of the competent federal authority immediately and to accompany the relevant documents,
3.
to inform the competent federal authority immediately of the cancellation of the hardship program, giving the reasons,
4.
after completion of the hardship case program of the competent federal authority to submit a safety report, which in particular is all serious side effects and not all Serious unexpected adverse reactions are recorded and evaluated,
5.
The competent authority of the Federal Republic of Germany shall give new opinions pursuant to Article 83 (4) of Regulation (EC) No 726/2004 and findings from other hardship case programmes carried out in another Member State of the European Union or in another State Party to the Agreement on the European Economic Area, shall be submitted without delay, or
(2) Changes relating to the field of application, the strength or pharmaceutical form of the medicinal product under the hardship programme, and any changes that may be appropriate to the safety of patients and to the safety of patients. Patients should not be given access to a new confirmed ad in accordance with § 4.(3) The responsible person shall ensure that medicinal product risks are immediately communicated to the competent authority of the Federal Republic of Germany. It shall immediately take the measures necessary for the prevention of risks. Non-official table of contents

§ 7 Responsible person's responsibility

The responsible person referred to in § 3 paragraph 1 shall ensure that: that
1.
will correctly implement the hardship program,
2.
all conditions and restrictions on the safe and effective use of the medicinal product are fulfilled and the persons involved are given the necessary information,
3.
the medicine will only be placed on the market if at least the following information is included on the outer enclosure and where used on the outer envelopes:
a)
name or code of the medicine,
b)
the name and address of the responsible Person,
c)
Chargen label,
d)
Application type,
e)
active ingredient name,
f)
expiration date,
g)
as far as required, storage and storage notes,
h)
Note that the medicine is not Approval or approval in the context of a hardship program is provided
4.
the manufacture, import and release of the product in the medicinal product. and the Regulation on the preparation of active substances for investigational medicinal products,
5.
the essential documentation of the hardship case programme after its termination or Cancellation for at least ten years is kept; other regulations for the storage of medical records shall remain unaffected.
Non-official Table of contents

§ 8 Information requirements of the competent federal authority

(1) In the case of medicinal products consisting of a genetically modified organism or a combination of genetically modified organisms, or such , the competent federal authority shall inform the Federal Office of Consumer Protection and Food Safety of the receipt of the notification.(2) The competent federal authority shall inform the European Medicines Agency about the case of hardship programmes which are indicated.(3) The competent federal authority shall ensure that any suspected serious adverse reaction indicated to it is recorded and that the European Medicines Agency shall immediately, but no later than 15 days after receipt of the information, shall be communicated.(4) The competent federal authority shall make available to the public information about the hardship case programmes which are indicated. Non-official table of contents

§ 9 Transitional Regulation

Hardship programs that are implemented at the time of entry into force of the Regulation can be independent of , the provisions of this Regulation shall be continued. Non-official table of contents

§ 10 Entry into force

This Regulation enters into force the day after the announcement.