35. Federal Law, with which the Medicines Act, the Federal Act on Hospitals And Spa Institutions, the Medicinal Products Act 2002 and the Federal Act on the Establishment of a Fund "Österreichisches Bundesinstitut für Healthcare" be modified

The National Council has decided:

Article I

Amendment of the Medicines Act

The Drug Law, BGBl. No. 185/1983, as last amended by the Federal Law BGBl. I n ° 12/2003, shall be amended as follows:

1. § 1 (3) Z 1 and 2 are:

" 1.		Food in the sense of the Food Law 1975, BGBl. No 86, unless they are used for the purpose of the general approach to transport, or are intended to fulfil the purposes of paragraph 1 (1) (1) to (4) by the nature and form of the in-traffic Bringens,
2.		Articles of use and additives as defined in the Food Law 1975, "

2. § 2 para. 1 after the turn "Doctors," the twist "Dentists," inserted.

3. In accordance with § 2 (10), the following paragraph 10a is inserted:

"(10a)" Maximum amounts of residues " are those referred to in Article 1 (1) (1) (1). (b) Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin, OJ L 327, 31.12.1990, p. No. L 224 of 18 August 1990, defined quantities. '

4. In accordance with Article 2 (11), the following sections 11a and 11b are inserted:

'(11a)' Magistral preparation ' means any medicinal product which is produced in a pharmacy on the basis of a medical or dental prescription for a particular patient or a prescription for a given animal.

(11b) "Offical preparation" means any medicinal product which is produced in a pharmacy according to a monograph of the pharmacopoeia according to § 1 of the Pharmacopoeia and is intended to be used in the pharmacy in which it has been manufactured, to be delivered directly to the consumer. "

Section 2a reads as follows:

" § 2a. (1) 'Clinical examination' shall be a systematic examination of a medicinal product to a test participant carried out on the basis of the objective of:

1.		the effects of investigational medicinal products, or
2.		the adverse reactions of investigational medicinal products should be observed, or
3.		to examine the absorption, distribution, metabolism and excretion of investigational medicinal products.
This shall include clinical trials carried out in one or more test centres in one or more Contracting Parties to the European Economic Area. No clinical trial is an application observation within the meaning of paragraph 3.

(2) 'multi-centre clinical trial' means a clinical trial carried out in more than one test centre in accordance with a single test plan and therefore carried out by more than one auditor, the test centres being in a single test centre; or in a number of Contracting Parties to the European Economic Area, or in Contracting Parties and third countries.

(3) 'Application observation' shall be a systematic examination of authorised proprietary medicinal products to patients, provided that:

1.		the proprietary medicinal product is used exclusively under the conditions laid down in the authorisation;
2.		it does not require any additional diagnostic or therapeutic measures to be observed,
3.		application observation does not bring any additional strain on the patient, and
4.		the application of a particular treatment strategy is not pre-determined in a test plan, it corresponds to the medical practice and the decision on the regulation of the proprietary medicinal product is clearly separated from the decision, a To include patients in application monitoring.
Epidemiological methods are used for the analysis of the data collected.

(4) "Final Report" shall be a complete and detailed presentation of the clinical trial after termination thereof.

(5) "Audit" means the comparison of the raw data with the corresponding records in the test sheets with the aim of determining whether the raw data have been reported correctly and the conduct of the clinical trial in accordance with the test plan and the Standard Operating Procedures (SOPs). An audit must be carried out either through an internal unit of the sponsor, which is independent of the unit responsible for clinical research, or through an external scientific institution.

(6) "Ethics Commission" is an independent body composed of health professionals and persons working in non-medical areas and whose task it is to protect the rights, security and well-being of the persons concerned. To ensure that the participants have confidence and trust in this.

(7) "Inspection" means a review of documents, facilities, records, carried out by the Federal Ministry of Health and Women, or by an expert appointed by it or by a foreign health authority; Quality assurance systems and all other resources which, in the opinion of the Federal Ministry of Health and Women or a foreign health authority, are in the context of the clinical trial. These can be found in the test centre, in the institutions of the sponsor or the contract research institute, or in other facilities (e.g. in laboratories, in ethics committees), which according to the Federal Ministry of Health and Women's or be inspected by a foreign health authority.

(8) "Monitor" means a person who is employed or contracted by the sponsor or a contract research institute and is responsible for the monitoring and reporting of the progress of the study and the verification of the data.

(9) 'Authorisation application in order and proper amendment' means an approval or amendment which meets the generally accepted scientific principles and requirements. These generally accepted scientific principles and requirements can be found in the detailed instructions issued by the Commission in accordance with Article 9 of Directive 2001 /20/EC.

(10) "test sheet" means a document which, in accordance with the test plan, contains data and other information relating to each individual test participant involved in the clinical trial.

(11) "examiner" means a doctor or dentist who is authorised to practise an independent profession in Austria, who is responsible for conducting the clinical trial in a test centre. If an examination is carried out in a test centre by a team, the auditor shall be the responsible head of the team.

(12) "examiner information" is a compilation of the clinical and non-clinical data on the products concerned relevant for the examinations of the investigational medicinal products in humans.

(13) 'Audit plan' means the totality of the documents describing objectives, planning, methodology, statistical considerations and the organisation of an audit. The term "test plan" refers to the test plan as well as to its subsequent versions and modifications.

(14) 'investigational medicinal product' means a pharmaceutical form of an active substance or placebo which is tested or used as a reference substance in a clinical trial; and an authorised proprietary medicinal product if it is in a non-approved Form used or provided or used for an unauthorised field of application, or used to obtain additional information on the approved form.

(15) "Examination participant" (healthy proband or patient) is a person who participates in a clinical trial either as a recipient of the investigational medicinal product or as a member of a control group.

(16) "Sponsor" means any physical or legal person who assumes responsibility for the planning, initiation, care and financing of a clinical trial. The sponsor or his authorised representative must be established in a Contracting Party of the European Economic Area. The auditor shall assume the duties and responsibilities of the sponsor in addition, if he carries out a clinical trial independently of the manufacturer of the medicinal product and in full ownership.

(17) "Standard Operating Procedures (SOPs)" shall be standardised, in-depth, written procedural rules of the sponsor for all activities necessary in connection with the clinical trial.

(18) "undesirable event" means any adverse incident which is contrary to a test participant and which is not necessarily causally related to the clinical trial.

(19) "side effect" means any harmful and unintended reaction to a test preparation.

(20) "Serious Adverse Event or Serious Adverse Reaction" is an adverse event or adverse event, which is an adverse event or an adverse event, which is an adverse event, or which is fatal or life-threatening irrespective of the dose, requires hospitalisation or renewal thereof, leads to a permanent or serious disability or invalidity, or a congenital anomaly or an invalidity Birth defects result.

(21) "Unexpected side effect" means a side effect which is not to be expected according to the nature or severity of the present product information. "

6. In § 4 paragraph 3 Z 2 the word "or" shall be replaced by a paint. In Z 3, the point is replaced by a dash and the word "or". In accordance with Article 4 (3) Z 3, the following Z 4 is added:

" 4.		which are intended for use in animals used for the production of foodstuffs and whose pharmacologically active ingredients are not included in Annexes I to III to Regulation (EEC) No 2377/90. "

7. § 8 (2) Z 7 reads:

" 7.		Dosage, if appropriate, indicating that it is only valid if the doctor, dentist or veterinarian is not prescribable otherwise, "

8. In Section 11 (1) (2), the word order shall be " Pharmaceutical Goods Import Act, BGBl. No. 179/1970, " through the phrase " Medicinal goods import law 2002, BGBl. I n ° 28, " as well as the phrase § 5 Proprietary Medicinal Products Import Act through the phrase § 5 Proprietary Medicinal Products Act 2002 " replaced.

9. § 11 (7) shall be applied in accordance with the word " Doctor " a dash and the word " Dentist " inserted.

10. § 11a (1) reads:

" (1) Medicinal products containing antigens or halbantigens and the detection of specific defence and protective agents, desensitisation or hyposensitisation may be used, unless they are medicinal products subject to authorisation. , only if the Federal Minister of Health and Women's Federal Minister for Health and Women's manufacturing process is to be used for the purposes of the application, including the chemical pharmaceutical documentation has been approved by the decision. "

11. § 11b is deleted.

12. In § 12 paragraph 1 Z 2, after the word "Doctor" a dash and the word "Dentist" inserted.

13. In accordance with Section 12 (1) Z 3, the word shall be referred to after the following: "or" inserted.

14. In § 12, para. 2, the word order shall be " Pharmaceutical Goods Import Act, BGBl. No. 179/1970, " through the phrase "Medicinal goods import law 2002" replaced.

15. § 15 (1) Z 26 reads as follows:

" 26.		in the case of proprietary medicinal products for use in animals intended for the production of medicinal products or foodstuffs, documents relating to the waiting time. Whereas, in order to protect health, it is necessary to ensure that these foodstuffs do not exceed the maximum residue limits laid down in Regulation (EEC) No 2377/90, taking into account the conditions of use authorised; '

16. § 15a (1) Z 2, first sentence reads:

' the first-time authorisation of the proprietary medicinal product authorised for the former applicant in a Contracting Party to the Agreement on the European Economic Area (EEA Agreement) shall be at least six years, and this proprietary medicinal product shall be located in the territory of the Member State concerned. or in accordance with Regulation (EEC) No 2309/93, and marketed. "

17. Section 15a (4) is deleted.

18. § 15b reads:

" Section 15b . By way of derogation from § 15 (1) Z 17 and 18, the applicant shall not be obliged to present the results of the toxicological and pharmacological tests or the results of the clinical trials, if he/she is provided with detailed bibliographical information. documentation can show that:

1.		the constituent or components of the proprietary medicinal product are generally used in medicinal products; and
2.		the efficacy and safety of the proprietary medicinal product required for authorisation is given.

19. § 15c is given the title "§ 15d". In accordance with § 15b, the following new § 15c is inserted:

" § 15c. In the case of a new proprietary medicinal product consisting of known components within the meaning of § 15b which have not previously been authorised in this combination, results of the toxicological and pharmacological tests and of the clinical trials shall be carried out on: to present the proprietary medicinal product, but not to the individual components. "

20. § 24 (2) Z 3 reads:

" 3.		Tax on small and small-scale prescription, unless it is a recipe exemption, which is due to the inaction of the prescription of the prescription, according to § 2 para. 1 of the prescription-care law, BGBl. No 413/1972. "

21. According to Article 24 (8), the following paragraphs 9 and 9a are added:

" (9) Changes in homeopathic proprietary medicinal products within the meaning of Section 11 (2a) are to be reported to the Federal Ministry of Health and Women, unless they are changes to the composition or to changes of the designation. A notification shall be sent to those documents which make it possible to assess the change. Changes in the composition or the name are subject to a new application in accordance with § 11 paragraph 2a and a registration according to § 27.

(9a) Homeopathic proprietary medicinal products within the meaning of Section 11 (2a) of which amendments are made in accordance with paragraph 9 may not be subject to any such amendments.

1.		by the pharmaceutical operator within one year of the notification referred to in paragraph 9,
2.		from other persons entitled to charge up to the respective expiry date of the proprietary medicinal product
shall be placed on the market unless this transitional period is not acceptable for reasons of pharmaceutical safety. "

22. § 26 (2) reads:

" (2) The batch release shall be subject to immunological proprietary medicinal products consisting of vaccines, toxins, sera or allergens for use on or in the animal, and for the prevention of notifiable animal diseases in accordance with § 16 of the Regulation. Animal disease law, RGBl. No. 177/1909. "

23. § 29 (1) and (2) are:

" (1) In the planning, installation and execution of clinical trials, the health risks and stresses for the examination participant must be kept as low as possible.

(2) Clinical examination of medicinal products may only be carried out if the risks associated with it for the test participant are acceptable in relation to the expected significance of the outcome of the examination for medicine and the risks associated with the risk of the risk of the risk of the risk of the risk of the risk of the risk of the risk of the risk of the risk being Non-exclusive risk of impairment of the health of the test participant

1.		is not significant, or
2.		is outweighed by the benefit to be expected from the use of the medicinal product for its health. "

24. § 29 (4) deleted.

25. § 30 reads:

" § 30. Clinical testing of medicinal products may only be carried out or continued for women of childbearing potential, with the exception of § 44, if the absence of a medicinal product before and in sufficient repetition during the clinical trial of a medicinal product may be carried out or continued. Pregnancy is noted. "

26. § 32 (1) Z 3 reads:

" 3.		assess the audit plan and, where appropriate, confirm by signing it and, in the event of any changes, to act within the meaning of section 37a, "

27. § 32 (1) Z 5 reads:

" 5.		before commencement of the clinical trial, submit a proper application for approval of the clinical trial pursuant to § 40 (1), to refer the case to the Ethics Committee and to terminate the clinical trial of the Federal Ministry of Health and Women and to report to the Ethics Committee within 90 days of premature termination within 15 days, with clear indication of all reasons for the termination of the event, "

28. § 32 (1) Z 9 reads:

" 9.		to document all adverse events according to § 41d paragraph 4, to evaluate them immediately together with the auditor and to take the appropriate measures in accordance with § 37a (4), as well as in accordance with § 41e presumed unexpected serious Adverse reactions should be reported, "

29. In § 32 (1) Z 11, the word order shall be "the test person through the" through the phrase "of the examination participant by means of the" replaced; in section 32 (2) (1), the word order shall be replaced by "the test person" through the phrase "the test participant" ; in § 32 (3) the expression shall be replaced by "subjects" by the expression "Review participants" and in § 34 Z 5 of the expression "subjects" by the expression "Review Participants" replaced.

30. The word "and" at the end of section 32 (1) (12) shall be replaced by a supplement. The point after Z 13 shall be replaced by the word 'and' and the following Z 14 and 15 shall be added:

" 14.		ensure that a contact point is made available to the examination participant, where the examination participant can obtain further information independently or with the help of the patient's lawyer, and
15.		for the assessment to be carried out by the Ethics Committee to pay a fee. "

30a. § 32 (2) Z 5 reads as follows:

" 5.		The extent of the insurance must be proportionate to the risks associated with the clinical trial. More details can be determined by regulation of the Federal Minister of Health and Women. In particular, account shall be taken of the risk resulting from the number of test subjects and test sites, the nature of the clinical test and the nature of the test substance. "

31. § 35 (1) The first sentence of the first subparagraph is:

"Examiner may only be a doctor or dentist who is entitled to exercise his profession in a self-employed person in Austria, and"

32. § 36 Z 2 reads:

" 2.		ensure that it has sufficient time to carry out the clinical trial and is likely to terminate it, or to ensure that it is replaced by adequate staff and facilities for the whole duration of the clinical trial and to ensure that appropriate countermeasures within the meaning of section 37a (4) may be carried out in the event of adverse events, "

33. § 36 Z 4 reads:

" 4.		to proceed with amendments to the audit plan within the meaning of section 37a (4), "

34. § 36 Z 9 reads:

" 9.		to report without delay to the sponsor of serious adverse events and to take the necessary measures to protect the participants of the test, "

35. In accordance with § 36 Z 10, the word "and", the point after Z 11 is replaced by the word "and", and the following Z 12 is added:

" 12.		in the case of the death of a test participant, to inform persons of confidence about the participation of the deceased in a clinical trial and the insurance cover in accordance with § 32 (1) Z 11. "

36. According to § 37, the following § 37a and heading is inserted:

" Changes to the audit plan

§ 37a. (1) After the start of the clinical trial, the sponsor may make changes to the test plan. If these changes are significant and have an effect on the safety of the participants, or may influence the interpretation of the scientific documents to which the conduct of the examination is based, or if it is under any The sponsor has to inform the Federal Ministry of Health and Women and the relevant Ethics Committee about all the reasons and the content of the changes.

2. On the basis of the criteria listed in § 41a (1) and in accordance with § 41b, the competent Ethics Committee shall deliver an opinion within a maximum of 35 days from the date of receipt of the proper amending proposal. ,

(3) If the Ethics Committee does not issue a favourable opinion, or if the Federal Ministry of Health and Women considers that there are other objections to the planned changes to the audit plan, the Federal Minister for Health and Women has the following: Amendment of the audit plan for the case to prohibit the sponsor from taking the objections into account.

(4) Without prejudice to the provisions of paragraphs 1 to 3, the sponsor and the auditor shall, in certain circumstances, in particular with any new circumstance concerning the conduct of the examination or the development of a investigational medicinal product, shall have the security of the participants in the examination. may affect the urgent need for security measures to protect the attendees from imminent danger. The sponsor shall immediately inform the Federal Ministry of Health and Women about these new circumstances and the measures taken and shall ensure that the relevant Ethics Committee is informed at the same time. "

37. § 38 reads:

" § 38. (1) The clinical examination of a medicinal product may only be carried out unless otherwise specified in § § 42, 43 and 43a, if the examination participant is by a physician or a dentist on the nature, meaning, scope and risks of the clinical trial. has been informed and the participant has given his consent to this.

(2) The consent within the meaning of paragraph 1 may be revoked at any time. Where a number of consents are required for the conduct of the clinical trial, the clinical trial shall not be allowed to continue in this examination subject, even if only one of these consent is withdrawn. "

38. § 39 reads:

" § 39. (1) Enlightenment and information must be given both orally and in writing. The information must clarify that the refusal to take part in the clinical trial or the withdrawal from the clinical trial at any time without any adverse consequences, in particular for the further medical care of the Test participant remains.

(2) If a participant agrees to participate in the participation after extensive information, his consent must be recorded in written form. The consent must be dated and given with the signature of the examination participant. If the participant is not in a position to do so, the consent must be given before a witness who has to confirm his/her consent by signing his/her signature.

(3) The participants must be informed that data can be checked during an inspection, but that personal information is treated in an absolutely confidential way and will not be released to the public.

(4) The examiners, if necessary the guardians or guardians, or Expert, must be informed about the insurance cover within the meaning of § 32 paragraph 1 Z 11. "

39. § § 40 and 41 together with the headings are:

" Beginning of clinical trial

§ 40. (1) Before the start of a clinical trial, the sponsor shall submit to the Federal Ministry for Health and Women a proper application for authorisation and shall submit all the necessary documents for the assessment of the clinical trial. In addition, the sponsor has to obtain the opinion of an Ethics Committee. The Ethics Committee can be referred to the Federal Ministry of Health and Women or, at the same time, at the same time as the Federal Ministry for Health and Women's choice.

(2) The examination of an application by the Federal Minister for Health and Women has to be carried out without unnecessary delay, but at the latest within 35 days. The Federal Minister for Health and Women has to examine the regularity of the application and the fundamental justification and relevance of the project. If the Federal Minister for Health and Women does not express his opinion within 35 days, the application shall be deemed to have been approved subject to paragraph 4. These periods shall not apply to clinical trials within the meaning of paragraph 5.

(3) The Federal Minister of Health and Women of the Federal Republic of Germany shall inform the sponsor with a reasoned objection, that the sponsor may, once again, amend the content of the application in order to take into account the objection brought forward. A reasonable period of time shall be allowed for this. If the sponsor does not alter the application accordingly, the application with the decision of the Federal Minister for Health and Women is rejected.

(4) If the Ethics Committee has not delivered a favourable opinion in the proceedings pursuant to Sections 41a and 41b, the Federal Minister of Health and Women shall prohibit the conduct of the clinical trial in the event that the sponsor is the sponsor. Objections of the Ethics Committee are not taken into account. The clinical trial shall be underserved within 60 days of the date of receipt of the application. The Federal Minister for Health and Women will only be able to refrain from any subsaiance, provided that he deals with the clinical examination of the Pharmaceutical Advisory Board and supports the conduct of the clinical trial.

(5) A decision by the Federal Minister of Health and Women requires the start of a clinical trial in relation to medicinal products for gene therapy, somatic cell therapy, including xenogenic cell therapy, and with all medicinal products that are genetically modified in the sense of § 4 Z 3 of the German Genetic Engineering Act, BGBl. No 510/1994.

(6) The Federal Minister for Health and Women has to decide on requests pursuant to paragraph 5 without unnecessary delay, but at the latest within 90 days after the application has been submitted. In cases where an advisory body is referred to it, this period shall be extended by a further 90 days.

(7) In addition to the provisions of this Act, the requirements of § § 74 to 79 of the Gentechnikgesetz (Genetic Engineering Act) shall apply to a clinical trial in relation to medicinal products for gene therapy. An authorisation granted under these provisions shall replace the authorisation provided for in paragraph 5 within the scope of its funding.

(8) For the approval of a clinical trial of medicinal products containing genetically modified organisms, § § 76 to 79 of the Genetic Engineering Act shall be subject to the proviso that the clinical testing of such medicinal products shall also apply. is treated like a gene therapy. An authorisation granted in accordance with the provisions of the Gentechnikgesetz (Gentechnikgesetz) shall replace the authorisation in accordance with paragraph 5 in the context of its funding.

Ethics Commissions

§ 41. (1) As regards clinical trials outside hospitals, the Governor of the State shall ensure that an Ethics Committee is set up to carry out the tasks in accordance with § 41a and that all necessary measures are necessary. Measures will be taken to enable this Ethics Committee to work. The members of the Ethics Committee may not be subject to any instructions within the framework of this activity.

(2) The Ethics Committee shall be united in a balanced proportion of women and men and shall at least consist of:

1.		a doctor who is legally entitled to exercise self-employment in the country and is not the examiner,
2.		a specialist in whose special subject the clinical trial is subject, or, where appropriate, a dentist, and who are not examiners,
3.		a representative of the upscale service for health and nursing care,
4.		a jurist,
5.		a pharmacist,
6.		a patient representative,
7.		a representative of a representative disability organisation,
8.		of a person who has biometric expertise and
9.		a further person not covered by Z 1 to 8, who is entrusted with the exercise of matters of pastoral care or who otherwise has the appropriate ethical competence.
For each member, a representative shall be appointed in the same way.

(3) The Landeshauptmann shall be entitled to demand from the sponsor a cost contribution according to the cost of an assessment in the context of a clinical trial, which is based on the experience, on average. "

40. In accordance with § 41, the following § § 41a, 41b, 41c, 41d and 41e shall be inserted together with the headings:

" § 41a. (1) In the implementation of § 8c of the Federal Act on hospitals and hospitals according to national regulations, which according to university law provisions and the ethics committees established pursuant to § 41 have the same in the sections 2 to 7 shall comply with the procedures laid down in the procedure and, in particular, in their opinion:

1.		the relevance of the clinical trial and its planning,
2.		the appropriateness of the assessment of the expected benefits and the expected risks imposed by Section 29;
3.		the audit plan;
4.		the suitability of the auditor and his staff,
5.		the audit information,
6.		the adequacy of the facilities,
7.		the appropriateness and completeness of the written information to be provided and the procedure for obtaining informed consent and the justification for research on persons who do not have the right to obtain informed consent in the where the specific restrictions in accordance with Articles 29, 38, 39, 42, 43 and 43a are concerned,
8.		the personal liability insurance concluded pursuant to Article 32 (1) (11), and any kind of insurance or compensation to cover the liability of the examiner and the sponsor;
9.		the amounts and the arrangements for the possible remuneration or compensation for auditors and the participants in the examination and the relevant elements of any contract provided between the sponsor and the test centre; and
10.		the modalities for the selection of the participants in the examination.

(2) The Ethics Committee shall have monthly meetings in a timetable to be published in advance for one year and shall set the deadline for the submission of applications for the meetings concerned. The Ethics Committee must ensure that the deadlines for the submission of applications are respected when setting the dates of the sittings and the related dates for the submission of applications.

(3) Upon receipt of an application, the Ethics Committee shall verify whether a proper application for authorisation is available and inform the sponsor immediately, but no later than within five working days of receipt of the request.

(4) The Ethics Committee shall give the sponsor an opportunity to deliver an opinion within the framework of the meeting on the assessment fields referred to in paragraph 1.

(5) The Ethics Committee shall forward its reasoned opinion to the sponsor within 35 days from the date of the deadline. The Ethics Committee must ensure that the time limit laid down in paragraph 6 is also observed. This does not apply to applications within the meaning of Section 40 (5).

(6) The Ethics Committee shall send a reasoned opinion to the sponsor, in any event within 60 days and within 50 days of receipt of the proper application, to the Federal Ministry of Health and Women. In the case of applications within the meaning of section 40 (5), the time limits apply in accordance with § 40 (6)

(7) During the examination of the application, the Ethics Committee may request only one additional information on the information already submitted by the applicant. The time limits laid down in paragraphs 5 and 6 shall be inhibited until such time as the additional information is received.

Multi-centre checks

§ 41b. (1) For multi-centre examinations, the opinion of a single Austrian Ethics Committee is sufficient. The sponsor has to deal with an ethics committee that meets the special requirements laid down by the Federal Minister for Health and Women's Regulation. This Regulation shall in particular:

1.		the organizational framework,
2.		the circumstances relevant to the assessment of the necessary comprehensive experience; and
3.		the internal quality assurance measures
shall be considered.

(2) Ethics committees aiming at an activity in the context of multi-centre examinations shall report this to the Federal Ministry of Health and Women under the conditions required in accordance with paragraph 1. The Federal Minister for Health and Women has published the Ethics Commissions, which fulfil the conditions laid down in paragraph 1, in the Official Journal of the Vienna newspaper.

(3) In the event of a multi-centre examination, the sponsor shall select one of the ethics committees referred to in paragraph 2, which shall be responsible for one of the test centres. If none of the ethics committees referred to in paragraph 2 is responsible for one of these test centres or if it rejects the acceptance of an application in accordance with paragraph 4, the sponsor may choose freely from the ethics committees made known in accordance with paragraph 2.

(4) In the event of temporary work overload, the elected Ethics Committee shall be entitled to refuse the acceptance of an application temporarily. This is to be communicated to the applicant in writing immediately when the application is submitted.

(5) The sponsor shall at the same time have the ethics committees, which would be responsible for the prospective test centres in the case of a monocentric clinical trial, all documents at the same time as the application was submitted in accordance with the provisions of paragraph 2. Commission of Ethics.

Suspension and undersawing of clinical trial

§ 41c. (1) Insofar as the Federal Minister for Health and Women has objective reasons to believe that the conditions of the permit application are no longer met in accordance with § 40 (1), or has information available in respect of the If safety or the scientific basis of the clinical trial raises concerns, the clinical trial may suspend or prohibit the clinical trial.

(2) Prior to the decision in accordance with paragraph 1, except in the event of danger in default, the sponsor shall be heard and informed by the examiner. The sponsor has to deliver its opinion within a week.

(3) The Federal Minister of Health and Women shall have the other competent authorities of all the Contracting Parties of the European Economic Area in whose territory the clinical trial is conducted, the Ethics Committee concerned, which shall: European Agency for the Evaluation of Medicinal Products and the Commission, stating the reasons for its decision to suspend or prohibit the clinical trial.

(4) If the Federal Minister for Health and Women has objective reasons for believing that the sponsor or the auditor or any other person involved in the clinical trial no longer fulfils his obligations, it shall immediately inform the person concerned of the need to: to give him the opportunity to comment, and then to inform him of an action plan which he must carry out in order to remedy the situation. The Federal Minister for Health and Women has the other competent authorities of all the Contracting Parties of the European Economic Area in whose territory the clinical trial is conducted, the Ethics Committee and the Commission to inform without delay of this action plan.

Adverse event reports

§ 41d. (1) The auditor shall report to the sponsor immediately on all serious adverse events, except for events which, according to the audit plan or the audit information, do not need to be reported immediately. Detailed written reports must be followed to report without delay. In the case of immediate reporting and in the follow-up reports, the examination participants must be named with a code number.

(2) Undesirable events and anomalies of laboratory values identified as critical in the safety assessment test plan shall be the sponsor in accordance with the reporting requirements within the time limits specified in the audit plan .

(3) In the event of the death of a test participant, the examiner shall provide the sponsor with all additional information required.

(4) The sponsor shall document in detail all the adverse events that are communicated to him by the examiners. These records shall be submitted to the competent authorities of all the Contracting Parties to the European Economic Area in whose territory the clinical trial is carried out, on the request of the latter.

Reports of serious adverse reactions

§ 41e. (1) The sponsor shall ensure that all important information about suspected unexpected serious adverse reactions that have occurred during the same clinical trial at home or abroad and which resulted in a death have been or are life-threatening, recorded and the Federal Ministry of Health and Women and the competent authorities of all the contracting parties to the European Economic Area in whose territory the clinical trial is carried out, and the ethics committees concerned as soon as possible, but in any case, within a period of seven days after the sponsor has been informed of the case in question, and subsequently, within a further period of eight days, information on the further measures shall be communicated.

(2) All other suspected unexpected serious adverse reactions occurring in the context of the same clinical trial at home or abroad are the authorities referred to in paragraph 1 as well as the ethics committees concerned as soon as possible, as , but in any case within 15 days from the date on which the sponsor first became aware of it, to be notified.

(3) The sponsor shall also provide the other examiners of the same clinical trial with information within the meaning of paragraphs 1 and 2. Once a year for the entire duration of the clinical trial, the sponsor shall list the authorities referred to in paragraph 1 and the ethics committees concerned with a list of all suspected serious adverse reactions throughout the entire duration of the clinical trial, including the following: period of examination, as well as a report on the safety of the participants in the examination. "

41. § § 42 with title and 43 are:

" Protection of certain categories of persons

§ 42. (1) The clinical examination of a medicinal product may only be carried out on minors if:

1.		the medicinal product being tested for identification, healing, alleviation or prevention of disease in the case of minors, and the clinical trial for the validation of data obtained in clinical trials in adults or by means of of other research methods, it is absolutely necessary to
2.		the use of the medicinal product which is being considered is indicated according to the findings of medical science in order to identify, heal or alleviate diseases in the case of the minor in which the clinical trial is carried out, or protect against disease and the benefit of inclusion in the clinical trial outweighs the risk for the test participant,
3.		the consent of the legal guardian has been shown to be verifiably and in writing after appropriate clarification,
4.		the minor, prior to the commencement of the clinical trial, has received, by means of an examiner who has been experienced in dealing with minors, one of his ability to understand the relevant information;
5.		the consent of the minor, who is able to see the nature, the importance, the scope and risks of the clinical trial and its determination to be identified, and to ensure that the person who is a minor's express wish not to participate in the clinical trial or to terminate it at any time shall be taken into account by the auditor,
6.		the consent can be revoked at any time without any disadvantage to the minor,
7.		no incentives or financial benefits, with the exception of compensation for costs, are linked to the participation in the clinical trial,
8.		the clinical trial is planned to be associated with the least possible pain, discomfort, anxiety and other foreseeable risks, taking into account the disease and the development stage of the minor, with the following: the risk threshold as well as the degree of stress must be specifically defined and constantly reviewed,
9.		the audit plan is supported by an Ethics Committee, which has knowledge of the field of children's and adolescents ' medicine or who has been advised in clinical, ethical and psychosocial questions in the field of child and youth medicine. , and
10.		In doubt, the interests of the patient are always above the public interests and the interests of the scientific community.

(2) By way of derogation from paragraph 1 (2), a clinical trial on minors shall be permitted even if:

1.		the clinical trial is an essential extension of the scientific understanding of the condition, disease or malfunction of the minor, and thereby either the patient or the group of patients who are the minor is a member of the European Parliament, and
2.		the clinical trial for the minor entails minimal risk and minimal exposure; a clinical trial has a minimal risk and a minimal burden, if it is expected that it will not exceed a minimum risk of exposure to the risk of the child. minor and temporary impairment, and the symptoms or inconveniences may only occur temporarily and will be very slight.

§ 43. (1) The clinical trial of a person who is a specialist in medical treatment as a result of a mental illness or mental disability may only be conducted if he/she is a specialist in medical treatment if:

1.		the medicinal product to be tested for the detection, healing, alleviation or prevention of such medicinal products, and the clinical trial for the confirmation of data obtained in clinical trials on persons capable of informed consent or by means of: of other research methods, it is absolutely necessary to
2.		the use of the medicinal product which is being considered, according to the findings of medical science, in order to ensure that the person with mental or mental illness is affected by the disease, to recognise disability or its course, heal or alleviate it or to protect it from other diseases, and the benefit of inclusion in the clinical trial outweighs the risk to the test participant,
3.		the consent of the expert has been verifiably and in writing after appropriate clarification and, except in the case of danger in the event of a non-insignificant risk, the approval of the court of law has been obtained in addition , the presumed will of the examiner shall be taken into account,
4.		the consent of the examination participant has also been proven and in writing, provided that it is able, after appropriate clarification, to see the nature, meaning, scope and risks of the clinical trial and its will to do so , and the examiner's express wish to not participate in the clinical trial or to terminate it at any time shall be taken into account by the examiner,
5.		the consent can be revoked at any time without any disadvantage to the test participant,
6.		the test participant, depending on its ability to understand this, has received information on the test, the risks and the benefit,
7.		no incentives or financial benefits, with the exception of compensation for costs, are linked to the participation in the clinical trial,
8.		the clinical trial is planned to be associated with as little pain, complaints, anxiety and other foreseeable risks as possible, taking into account the disease and the developmental stage; both the risk threshold and the risk threshold The degree of stress must be specifically defined and constantly reviewed,
9.		the audit plan from an Ethics Committee which has knowledge of the disease in question and the patient group concerned, or who has clinical, ethical and psychosocial questions in the field of the disease in question. The disease and related to the patient group concerned was supported, and supported, and
10.		In doubt, the interests of the patient are always above the public interests and the interests of the scientific community.

(2) If a lawyer is appointed for financial matters for the person referred to in paragraph 1, he/she shall also be informed immediately of the person concerned's participation in the clinical trial and the insurance cover related thereto. "

42. According to § 43, the following § 43a is inserted:

" § 43a. (1) If a clinical trial of its kind can only be carried out in emergency situations where the consent of the legal representative cannot be obtained in an appropriate period of time, it may be possible for a person who is not in a position to be able to obtain the consent of the legal representative. , a clinical trial shall be carried out if:

1.		there is no evidence that the patient has rejected or would reject the clinical trial,
2.		such research is strictly necessary for the validation of data obtained in clinical trials on persons capable of informed consent or by means of other research methods, and only in emergency situations can be carried out,
3.		the medicinal product being tested for the detection, healing, alleviation or prevention of diseases in an emergency situation,
4.		the use of the medicinal product which is being considered is indicated in the knowledge of medical science in order to identify, heal or alleviate, or to alleviate, a disease in the case of the emergency patient, or to protect diseases and to outweigh the risk associated with inclusion in the clinical trial for the test participant,
5.		the examination and the examination plan shall be carried out by an Ethics Committee, which has knowledge of the disease in question, the emergency situation and the patient group concerned, or which is in clinical and ethical terms. Advising on the situation of the disease in question, in relation to the emergency situation and the patient group concerned, expressly for the conduct of clinical trials in emergency situations to persons who are not in a position to do so, , and has been approved, and
6.		In doubt, the interests of the patient are always above the public interests and the interests of the scientific community.

(2) The public shall be informed in an appropriate manner of this circumstance at the test centre where a clinical trial in emergency situations to persons who are not in a position to consent is carried out.

(3) The patient acquires the ability to consent, so he is immediately informed that a clinical trial in an emergency situation has been or will be carried out on him. It is to be clarified in the sense of § § 38 and 39. A continuation of the clinical trial is only permitted if the informed consent is given.

(4) As soon as the consent can be obtained by the legal representative, a continuation of the clinical trial is only permissible under the conditions of § 42 or § 43. "

43. § 45 (2) reads:

"(2) The clinical examination of a medicinal product shall not be carried out on persons who are held in court or by the authorities or who are accommodated in accordance with the Lodging Act."

Section 47 (6) reads as follows:

" (6) In addition, all the facilities referred to in § 2a (7), second sentence, as well as any type of data for an inspection shall be made accessible at any time. Testing centres, including laboratories, as well as any type of data, shall also be made available for an audit at all times. "

45. In § 47, paragraph 8, the quote is "§ 2a (13)" by quoting "§ 2a (15)" replaced.

46. § 49 (1) reads:

" (1) In order to advise the Federal Minister for Health and Women on all matters relating to the pharmaceutical sector and to prepare expert opinions in matters of this federal law, the Federal Ministry of Health and Women's Affairs is a commission (Pharmaceutical Advisory Council). "

47. § 49 (11) reads:

" (11) The members of the Medicines Advisory Board, which have been entrusted by the Federal Ministry of Health and Women with the preparation of expert opinions in connection with the assessment of clinical trials in procedures according to § 40, are due in part in As regards the management of the Mühewaltung and the amount of time it takes, appropriate compensation to be borne by the sponsor of the clinical trial. "

47a. The previous text of § 55 is given the sales title (1), the following paragraph 2 is added:

" (2) The Federal Minister for Health and Women may, by means of a regulation, lay down detailed provisions concerning the nature and extent of the permissible framework of representational effort and provisions as to when of a low value or already of a low value of Premiums or financial or material benefits are to be expected. In particular, consideration should be given to the extent to which grants for sales promotion, as well as catering measures in the course of advertising and information events, are of minor importance. "

48. § 57 (5) reads:

"(5) Paragraph 1 shall not apply to proprietary medicinal products according to § 11 (4) and § 59 (7a)."

49. § 57 (7) Z 2 reads:

" 2.		are intended exclusively to be used by dentists, dentists for dental, oral and orthodontic medicine, or digests in the patient, "

50. § 58 (1) first sentence reads:

" Authorisation holders shall be allowed to provide samples of approved proprietary medicinal products to doctors, dentists, veterinarians and dentists only on the basis of their written request, exclusively free of charge and after application of the clearly legible and non-removable Make a reference to "Unsaleable medical equipment" in the smallest trade package in accordance with paragraph 2. "

50a. § 59 (3) reads:

" (3) The Federal Minister of Health and Women, in agreement with the Federal Minister for Economic Affairs and Labour, has to determine, by means of a regulation, those medicines which, even in the case of a daily life, are not foreseeable do not cause any risk to the health or life of humans or animals, and therefore to be used by means of drogists or tradesmen who are entitled to manufacture medicinal products in accordance with the trade regulations in 1994; can be delivered. "

51. In § 59, the following paragraph 7a is inserted after paragraph 7:

" (7a) In the case of proprietary medicinal products for animals intended for external use on the skin or medicinal products for bees, it may, on the basis of the specific composition or indications provided for by the said medicinal products, be used in the case of bees. On the application of the marketing authorisation holder of the Federal Minister for Health and Women, medicinal products shall provide for a charge outside of pharmacies and drugstores. Such a communication shall be revoked if it becomes known subsequently that the conditions for this are not fulfilled. "

52. § 60 para. 2 Z 9 reads:

" 9.		a qualified staff member of the Federal Institute for Medicinal Products. "

52a. § 60 (7) reads:

"(7) The deliberations of the Boundary Commission shall be carried out in accordance with a point of order to be adopted by the Federal Minister for Health and Women in agreement with the Federal Minister for Economic Affairs and Labour."

53. § 61 (1) (1) (1) reads:

" 1.		the levy due to a special arrangement by the doctor, dentist or veterinarian, "

54. § 62 (1) reads:

' (1) As far as it is necessary to ensure the nature of the medicinal products and the supply of medicinal products necessary for the health and life of humans or animals, the Federal Minister for Health and Women has Operating orders for establishments that manufacture, control or place on the market medicinal products. "

55. § 62 (3) Z 11 reads:

" 11.		storage and storage as well as transport, "

Section 68 (1) reads as follows:

" (1) The organs of the Federal Ministry of Health and Women and of the Governor of the State authorized pursuant to Section 67 (1) and the experts commissioned by the Federal Minister for Health and Women shall be entitled to:

1.		undertakings within the meaning of section 62 (1) and
2.		Establishments and means of transport of such establishments which have been entrusted with storage and transport by undertakings within the meaning of Article 62 (1), provided that they can be used for storage or for the transport of medicinal products,
, and to take samples in the quantity and inspection required for an investigation into the records of the holding which are to be carried out in accordance with the provisions of the legislation on medicinal products, and copies thereof, and to make photographs and video recordings in operation, provided that this is necessary for the preservation of evidence. These acts are, except in the case of danger in default, to be carried out during the operating hours. "

57. § 72 (1) (1) (1) reads:

" 1.		have successfully completed a university degree from the fields of human medicine, dentistry, veterinary medicine or pharmacy, or "

Section 72 (4) Z 1 reads as follows:

" 1.		the examination committee as members of the Federal Minister of Health and Women to be appointed experts from the subject areas mentioned in Z 2, as well as one representative of the Austrian Chamber of Commerce, the Federal Chamber of Labour and the Federal Chamber of Commerce and the Federal Chamber of Commerce and the Federal Employment Agency. To belong to the Austrian Medical Association as a co-sitter, "

59. § 72 (4) Z 3 reads:

" 3.		Prerequisite for the filing of the examination is at least the existence of an entitlement to visit an Austrian university as a regular listener or a professional qualification in the upscale service for health care and nursing. "

60. In accordance with § 72 (4), the following paragraphs 5 to 8 are added:

" (5) nationals of an EEA Contracting State who are nationals of an EEA Contracting State who have a proof of competence within the meaning of Council Directive 92/51/EEC of 18 June 1992 on a second general system for the recognition of professional qualifications in addition to the Directive 89 /48/EEC, which entitles the Federal Minister of Health and Women to practise the profession as a Pharmareferent, has been issued by the Federal Minister for Health and Women's Affairs.

(6) Admission to the profession must be made subject to the condition of successful completion of an aptitude test if the knowledge of the applicant, which has been demonstrated by the submission of the relevant documents, is essential to the applicant's shall distinguish the necessary Austrian knowledge.

(7) The decision on admission to the profession shall be taken within four months of the submission of such documents.

(8) The Federal Minister for Health and Women's Health and Women's Regulation shall lay down detailed rules on the documents to be submitted by the applicant as well as on the conduct and evaluation of the aptitude test in a regulation according to paragraph 3. "

61. § 75 (1) Submission sentence is:

Doctors, dentists, veterinarians, dentists, midwives and, in so far as they are not subject to the obligation to notify in accordance with Section 75a, pharmacists and tradesmen who, in accordance with the 1994 Commercial Code, are responsible for the manufacture of medicinal products, for wholesale trade in medicinal products are entitled to have, and have drogists, "

61a. According to § 76, the following § § 76a and 76b are inserted:

" § 76a. (1) Monitoring of the transport of food supplements suspected of being medicinal products (hereinafter referred to as "goods"), and which are in the retail trade after manufacture, shall be the responsibility of the Governor.

(2) In order to fulfil this task, the Landeshauptmann has to serve as supervisory bodies in specially trained bodies. The following are considered to be specially trained:

1.		Doctors who have passed the physics exam and
2.		Persons corresponding to the training requirement in accordance with § 35 para. 6 LMG 1975.

(3) Supervisory bodies shall be entitled, wherever goods are placed on the market, to keep an inspection and to take samples. To this end, they shall be granted access to all the places where goods are located. In addition to the control of means of transport or in the event of a risk of default, the retrospective shall be carried out during normal business hours or operating hours. The disruption of the business operation is to be avoided as far as possible.

(4) The sample taken is, in so far as it is naturally possible, to be divided into two equal parts, which are to be officially closed, and which is not their proper assessment. Part is to be returned as a counter-sample of the party for evidence. If a division is not possible, the Board of Supervisors shall supply the sample without prior division of the investigation. No compensation is due for the samples taken.

(5) On the occasion of sampling, a cover letter shall be completed by the Board of Supervisors and shall be accompanied by any part of the sample containing the findings and perceptions of the institution which are of considerable interest to the verifier. The further development of the sample accompanying letter is to be determined by the Federal Minister for Health and Women.

(6) The sample taken is to be transmitted to the relevant investigative institution. This investigative institution shall examine the sample and draw up findings and opinions on the sample. Findings and opinions shall be transmitted immediately to the sampling point. If the applicant considers that there are grounds for suspecting that there is a breach of legislation, it shall establish this in its opinion and inform the competent authority of the matter without delay.

(7) The Federal Minister for Health and Women's Health and Women's Health and Women's Health and Women's Health and Women's Affairs Committee has adopted a Regulation on the relevant investigative institution or the relevant investigative institutions in accordance with paragraph 6 of this Regulation, provided that it concerns the taking of investigations into substances in the sense of § 5a shall act in agreement with the Federal Chancellor.

§ 76b. (1) Supervisory bodies in accordance with Section 76a (2) shall seize a product if there are reasonable grounds for suspecting that these substances are contained within the meaning of Section 5a.

(2) On the seizure of seizure, the Board of Supervisors shall issue to the person entitled to dispose of the seizure a certificate stating the place of storage and the nature and quantity of the goods seized.

(3) In the event of seizure, the Board of Supervisors shall immediately send a formal request from the Court or the District Administrative Authority, depending on whether there is a suspicion of a criminal offence or of suspected administrative transgressive action. Seizure decision (seizure notice) to be collected.

(4) With regard to the costs of an investigation, § 381 para. 1 Z 3 StPO applies in criminal proceedings. In the administrative criminal proceedings, the penal shall be required to pay the compensation of the costs of the investigation to the relevant investigative institution. "

(62) The following paragraph 5 is added to § 80:

" (5) The Federal Minister for Health and Women is also empowered to enter data within the meaning of Article 11 (1) and (17) (3) of Directive 2001 /20/EC in the European database provided for therein and the information referred to in Article 11 (2) of the Directive 2001 /20/EC shall be sent to the competent authorities of the Member States of the European Union, to the European Agency for the Evaluation of Medicinal Products or to the European Commission. "

63. § 83 Z 3 reads:

" 3.		Substances or preparations of substances within the meaning of Article 1 (3) (9) (9) against § 11c or a regulation pursuant to Section 11c (1) release or for the submission or contrary to a prohibition in accordance with § 11c para. 2 shall be placed on the market, "

64. In § 84 the following Z 6b is inserted after Z 6a:

" 6b.		homeopathic proprietary medicinal products within the meaning of Section 11 (2a) of the homeopathic medicinal product in Germany or for the tax in the country where changes have been made which have not been reported in accordance with Section 24 (9), "

64a. According to § 84 Z 9 the following Z 9a is inserted:

" 9a.		Contrary to § 55 or a regulation adopted on the basis of its provisions, a premium, financial or material benefits may be demanded or accepted, "

64b. § 84 Z 12 reads:

" 12.		the persons referred to in § § 68 (1), 76 (1), 76a (2) and 76b (1) shall not enter, inspect, verify or withdraw samples or inspect the records to be carried out under this Federal Act, or to: No orders of these persons shall be complied with, "

65. § 86 (4) Z 6 reads:

" 6.		The Medicinal Products Import Act 2002, "

66. In accordance with § 86 (4) Z 18, the following Z 19 is added:

" 19.		the Biocide Products Act, BGBl. I No 105/2000. '

67. § 94a (2) second sentence reads:

" For these proprietary medicinal products, the Federal Minister for Health and Women may order the submission at any time if it does not appear to be secured that the evidence of quality, efficacy and efficacy contained in the approval documents is not available. Safety to the last state of scientific knowledge. "

(68) The following paragraphs 5 and 6 are added to Section 94a:

" (5) Clinical trials, which are before the entry into force of the Medicines Act in the version of the Federal Law BGBl. I n ° 35/2004, according to the legal situation prior to the entry into force of the Medicines Act, as amended by the Federal Law BGBl (Federal Law Gazette). I n ° 35/2004.

(6) Substances or preparations of substances within the meaning of Article 1 (3) Z 8, provided that they are always manufactured in the same composition in advance and placed on the market under the same name in a form intended for sale in retail sale, which have been reported in accordance with § 11b may be delivered further domestily or held for the purpose of delivery domestiy, unless § 3, which applies analogously to these products, shall be contrary to that. "

69. According to Article 95 (6), the following paragraphs (6a) and (6b) are inserted:

" (6a) (1) § 2a, § 29 para. 1 and 2, § 30, § 32 para. 1 Z 3, 5, 9, 11, 14 and 15, § 32 para. 2 Z 1, § 2 para. 3, § 34 Z 5, § 36 Z 2, 4, 9 and 12, § 37a, § 38, § 39, § 40, § 41, § 41a, § 41b, § 41c, § 41d, § 41 e, § 42, § 43, § 43a, § 45 paragraph 2, § 47 para. 6 and 8, § 49 (1) and (11), § 80 (5) and § 94a (5) shall enter into force on 1 May 2004. Section 29 (4) shall not enter into force at the same time.

(6b) § 41b shall enter into force with the proviso that the notification pursuant to Section 41b (2) shall not take place immediately after the event, the inclusion of the activities of these ethics committees pursuant to § 41b only with 1 May 2004. "

69a. § 96 reads:

§ 96. (1) With the enforcement of this Federal Act, the Federal Minister for Health and Women is entrusted with the responsibility of the Federal Minister for Health and Women, to the extent that it is not otherwise determined in paragraph 2.

1.		with regard to section 59 (3) and section 60 (7) in agreement with the Federal Minister for Economic Affairs and Labour and
2.		as regards Section 79 (1), in agreement with the Federal Minister for Finance.

(2) With the enforcement of

1.		§ 5a and § 68a as well as § 76a (6) and (7)-as far as the investigation into substances within the meaning of § 5a is concerned-is the Federal Chancellor and
2.		§ 76b (3)-insofar as this is a decision on seizure-and § § 84a and 85a of this Federal Law is the Federal Minister for Justice

"

70. The following Z 23 is added to § 97:

" 23.		Directive 2001 /20/EC of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the application of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 327, 22.11.2001, p. No. OJ L 121, 1.5.2001).

Article II

Amendment of the Federal Act on hospitals and health care institutions

Federal law on hospitals and health care institutions, BGBl. No 1/1957, as last amended by BGBl. I n ° 90/2002, shall be amended as follows:

Title 1

(Basic provisions)

1. § 2a (2) reads:

" (2) Hospitals which, in addition to the tasks in accordance with § 1, serve in whole or in part of the research and teaching of a medical university, are in any case central hospitals within the meaning of para. 1 lit. c. "

§ 3a reads as follows:

" § 3a. The requirements of medical research and teaching are to be taken into account in the establishment and operation of hospitals, which serve in whole or in part of the research and teaching of a medical university. The cooperation in the operation of the hospital shall be settled in an agreement between the institution of the sickness institution and the institution of the Medical University. "

Section 5b (4) reads as follows:

" (4) A Commission for quality assurance, which is under the direction of a qualified person, is to be established in each bed-leading hospital. This Commission shall have at least one representative of the medical service, the nursing service, the medical technical service and the administrative service. In hospitals, which serve in whole or in part of the research and teaching of a medical university, the Commission also belongs to the Rectorate or a university professor of the Medical University proposed by the University. "

4. § 6 (4) reads:

" (4) The establishment order for a hospital, which is used in whole or in part to the research and teaching of a medical university, has to take into account the needs of research and teaching. Prior to their approval, the institution of the hospital has to hear the rectorate of the Medical University. "

5. § 6a reads:

" § 6a. (1) The state legislation may enact provisions on the collegial management of hospitals by the medical director (§ 7 para. 1), the administrator (§ 11 para. 1) and the head of the nursing service (§ 11a para. 1). The tasks assigned to these executives in accordance with § § 7 (1), (11) (1) and (11a) (1) may not be affected by this procedure. In particular, it is necessary to ensure that the collegial guidance can fulfil its tasks with regard to the measures of quality assurance in accordance with § 5b (3).

(2) In a hospital which is used in whole or in part to the research and teaching of a medical university and in which a collegial lead is established, the rector or a university professor proposed by the university is the Medical university to join the meetings of the collegial leadership with an advisory vote. "

6. § 7a (2) reads:

" (2) In common institutions of clinics and institutes at medical universities, whose tasks include the provision of medical services, the responsibility for these medical tasks shall be the head of the Joint Institution to. "

7. § 8 (1) Z 6 reads:

" 6.		In hospitals in the form of self-employed physical therapy ambulances in which gyms are not trained, the medical service may, instead of a permanent medical presence, be organised in such a way as to ensure that medical care is provided in such a way as to ensure that the patient's medical service is not available. Assistance can be reached at any time and by regular daily attendance the necessary medical orders for the personnel according to the MTD law, BGBl. No 460/1992, as last amended by BGBl. I n ° 169/2002, and for Heilmasseure, according to the MMHmG, BGBl. I No 169/2002, as last amended by BGBl. I n ° 66/2003, as well as, in addition to medical orders, also the necessary supervision of medical masseurs according to the MMHmG and personnel according to the MTF-SHD-G, BGBl. No 102/1961, as last amended by BGBl. I n ° 169/2002; '

8. § 8c (1) the following sentences are added:

" The institutions shall be obliged to allow the ethics committees to carry out their duties in due time by providing the necessary staff and equipment. The sponsors are entitled to demand from the sponsor a cost contribution in accordance with the cost of an assessment in the context of a clinical trial, which is based on the experience, on average. "

9. § 8c (2) reads:

" (2) The assessment of new medical methods has to be taken into account in particular:

1.		cooperating persons and existing facilities (personnel and structural framework conditions),
2.		the test plan with regard to the objective and scientific significance as well as the assessment of the benefit/risk ratio,
3.		the manner in which the selection of the parishes is carried out and in which information and consent are given for participation,
4.		the arrangements made for the occurrence of a claim in connection with the application of a new medical method. "

10. § 8c (4) Z 2 reads:

" 2.		a specialist in whose special subject the relevant clinical trial or new medical method falls, or, where appropriate, a dentist, and who are not examiners, "

11. § 8c (4) (7) and (8) are:

" 7.		of a person who has biometric expertise,
8.		a representative of a representative disability organisation and "

12. In accordance with § 8c (4) Z 8, the following Z 9 is added:

" 9.		a further person not covered by Z 1 to 8, who is responsible for the exercise of matters of pastoral care in the hospital or who otherwise has the appropriate ethical competence. "

Section 8c (5) reads as follows:

" (5) In the assessment of a medical product, a technical safety officer is to be included. If the Ethics Committee is involved in a multi-centre clinical examination of a medicinal product, you will also have to be a specialist in pharmacology and toxicology. If necessary, other experts are to be included. "

Section 8c (8) reads as follows:

" (8) Ethics committees according to paragraph 1 are not to be established for hospitals which are used in whole or in part to the research and teaching of a medical university, if at the Medical University according to university regulations. of equivalent commissions, which carry out the tasks of the Ethics Committee. "

15. In accordance with § 8d, the following § 8e with headline is inserted:

" Child Protection Groups

§ 8e. (1) The Land legislature shall require the institutions of the hospitals which are eligible for the purpose and the provision of services to set up child protection groups. For hospitals whose size does not require their own child protection group, children's protection groups can also be set up jointly with other hospitals.

(2) In any case, the child protection group, as representative of the medical service, has a specialist for paediatric and juvenile medicine, or a specialist in paediatric surgery, representatives of the nursing service and persons who are responsible for psychological care or psychotherapeutic care in the hospital. The child protection group may, if appropriate in individual cases, decide to join a representative of the responsible youth welfare institution.

(3) The child protection group shall in particular be responsible for the early detection of violence or neglect of children and to raise awareness among children of the occupational groups concerned. "

16. § 19a (3) Z 4 reads:

" 4.		In the case of hospitals, which serve in whole or in part of the research and teaching of a medical university, it is also necessary to ensure that they fully fulfil their tasks in the field of university research and teaching "

16a. § 24 (2) reads:

" (2) In the case of the dismissal of a plea, a doctor's letter must be made immediately, in addition to the dismissal certificate, which shall provide the information and recommendations relevant to any further medical care, as well as any arrangements for the release of the doctor. Members of the health care and health care professions in the responsible area of activity. If medically justifiable, recommendations with regard to further medication are to be found in the refund code issued by the main association of the Austrian social insurance institutions and the directive on the economic prescription. consideration. This doctor's letter is after the decision of the Pfleglings

1.		this, or
2.		the doctor or physician who has been directed or treated, and
3.		, if necessary, to submit to the institution or to the appropriate health care and health care professional the prospect of further care and care. If necessary, the doctor's letter should also be given details of measures in the responsible area of activity. "

16b. § 40 (1) (c) is:

		" (c) § § 16, 19a, except para. 4, 23 (1), 24 (1) second and third sentence, 24 (2), with the proviso that the Code of refund and the Directive on the economic prescription shall only apply to recommendations concerning further medication. shall be taken into account if the Pflegling is to receive the cure at the expense of a sickness insurance institution, 24 (4), (26), (27), (32) and (35) (3). "

Title 2

(federal law directly applicable)

17. The title before § 43 reads:

" Special provisions for medical universities "

18. § 43 (2).

Section 46 (3) reads as follows:

" (3) If, on the occasion of scientific work carried out on behalf of third parties, employees or institutions of installation are used, the legal entity of the hospital or, in the case of such a cost support, may be used in the context of the cost of The clinical additional expenses (§ 55) of the federal government as legal entities of the Medical University claim a remuneration. The principles governing the determination of this remuneration should be laid down by the Federal Minister for Education, Science and Culture. The legal entities of the relevant hospitals must be heard before the setting of these principles. "

20. § 55 Z 1 reads:

" 1.		the additional costs arising from the establishment, design and extension of the public hospitals, which are at the same time serving the teaching of medical universities, from the needs of the teaching staff; "

21. § 56 reads:

§ 56. The Federal Minister of Education, Science and Culture, in agreement with the Federal Minister for Finance, after consultation with the Federal Minister for Finance, the Federal Minister for Education, Science and Culture, shall be responsible for the detailed rules on the costs of the federal government provided for in § 55. Relevant national governments shall be determined by Regulation. "

22. In accordance with Section 60 (3), the following paragraph 4 is added:

"(4) At the request of the Federal Minister for Health and Women, the visit to the Federal Ministry of Health and Women or a expert appointed by the Federal Ministry for Health and Women's Affairs is to be attached to the Federal Ministry of Health and Women's Affairs."

(23) In § 62a (1), the following sentence shall be inserted after the second sentence:

"A statement shall also be made if it is registered in the opposition register held at the Austrian Federal Institute for Health."

24. In accordance with § 62c the following main piece G is inserted:

" Main piece G

Consumer protection

§ 62d. If a plea has made his contract of contract during his stay in the hospital, this is ineffective if it has been delivered under such circumstances, which is a resignation in accordance with Section 3 of the Consumer Protection Act, BGBl. No 149/1979, as amended. '

25. § 67 (2) (1) (1) reads:

" 1.		§ § 43 and 44 is the Federal Minister for Education, Science and Culture, "

Title 3

(1) § 3a, second sentence, in the version of the Novelle BGBl. I n ° 35/2004 shall enter into force 1. Jänner 2007 in force.

(2) The country legislation has the implementing provisions for the first time. Title to be issued within six months. The Implementing Regulations to Z 8, 9, 10 and 11 of the 1. Titles are to be put into effect on 1 May 2004. Proceedings before ethics committees pending before this date shall be continued in accordance with the legal situation in force until that date.

(3) The exercise of the rights of the Confederation in accordance with Art. 15 (8) B-VG with regard to the 1. Titels is the Federal Minister for Health and Women.

(4) With the enforcement of the 2nd title is

1.		with regard to Z 22 and 23 of the Federal Ministers for Health and Women,
2.		with regard to Z 24 of the Federal Ministers for Social Security, Generations and Consumer Protection,
3.		with regard to Z 19, 20 and 21 of the Federal Ministers for Education, Science and Culture in agreement with the Federal Minister for Finance
.

Article III

Amendment of the Proprietary Medicinal Products Import Act 2002

The Medicinal Products Import Act 2002, BGBl. I n ° 28, shall be amended as follows:

1. § 2 (6) reads:

" (6) For the importation of goods within the meaning of Article 1 (1) (1) (1) (1) to (4), the

1.		are authorised in another Contracting Party to the European Economic Area and are transferred from one of the Contracting Parties to the European Economic Area to Austria,
2.		in another Contracting Party of the European Economic Area and transferred from a Contracting Party to the European Economic Area for the purpose of re-exporting to Austria in the presentation designated for the destination State , or
3.		are intended for clinical or non-clinical testing and have been manufactured in one of the Contracting Parties to the European Economic Area and are transferred from one of the Contracting Parties to the European Economic Area to Austria;
in the cases referred to in paragraph 3, an import authorisation shall not be required. A notification to the Federal Ministry of Health and Women shall be made within six months of the import. The notification shall contain the name and quantity of the proprietary medicinal product to be introduced, details of the specific purpose of the import, and the instructions for use intended for the user. In the case of Z 2, the target State shall be designated, in the case of Z 3, the test centres for which the respective proprietary medicinal products are intended. "

2. § 3 (2) reads:

" (2) Applications for the grant of an import licence, other than § 2 (12), shall be submitted by using the official forms. The application and the attached documents shall contain all the information required for the decision. "

3. § 5 (5) Z 2 lit.a reads:

" (a)			be proven or at least made credible by a Member State of the European Union in the context of a review within the meaning of section 6 (3), or "

4. § 6 (1) reads:

"(1) In the case of a transport of medicinal products in the context of importation in accordance with § 2, a copy of the import authorization or proof of the notification has been carried out in accordance with § 2 para. 7 and shall be presented to the control bodies on request."

Article IV

Amendment of the Federal Law on the Establishment of a Fund

,, Austrian Federal Institute for Health Care "

The Federal Act of 25 Jänner 1973 on the establishment of a fund,, Austrian Federal Institute for Health Care, BGBl. No. 63, last amended by BGBl. I n ° 98/2001, shall be amended as follows:

1. In § 2 lit. d will replace the dot with a dash and the following lit. e is added:

" e)		the management of the opposition register pursuant to Section 62a (1) KAKuG. "

Klestil

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