180. Regulation of the Federal Minister of Health on the reporting obligation for non-interventional studies

Pursuant to Section 48 (3) of the German Medicines Act, BGBl. No. 185/1983, as last amended by the Federal Law BGBl. I No 146/2009, shall be ordered:

Scope

§ 1. This Regulation shall apply to all non-interventional studies carried out in Austria.

Requirements

§ 2. Non-interventional studies are to be planned in accordance with the requirements of the medical education (in particular with regard to participation in a non-interventional study) according to the state of science and perform.

Definitions

§ 3. (1) Unless otherwise provided for in the following, the definitions of the Medicines Act shall also apply to the scope of this Regulation.

(2) "Responsible" means any person on whose behalf a non-interventional study is carried out.

Register of non-interventional studies

§ 4. (1) The Federal Office for Health Security has an electronic register on all reported non-interventional studies to be conducted.

(2) The Federal Office for Health Security has the information in the register of non-interventional studies the information in accordance with § 5 (2) (1) to (4) and the summary of the final report (§ 7 (1) and (3)) on the Internet access. The Federal Office for Health and Safety (Bundesamt für Sicherheit im Healthcare) has access to the main association of the Austrian social insurance institutions within the register of non-interventional studies to access the information in accordance with Article 5 (2) (6) (6) on a reasoned request. If the proprietary medicinal product (s) with which the non-interventional study is to be carried out are listed in the refund code in accordance with § 31 (3) (12) of the ASVG.

Reporting obligation

§ 5. (1) Each non-interventional study shall be electronically reported to the Federal Office for Safety in the Public Health Service before being carried out by the person responsible.

(2) The notification referred to in paragraph 1 shall, in any case, contain the following information:

1.		the name and address of the person responsible,
2.		the name of the proprietary medicinal product with which the non-interventional study is to be carried out,
3.		planned period and planned regions (political districts) of the non-interventional study,
4.		expected number of patients,
5.		Description of the non-interventional study (target, method, etc.),
6.		the name and address of the doctors, dentists, hospitals and pharmacies expected to take part,
7.		the pattern of the contract to be concluded between participating doctors, dentists and pharmacists and the person responsible, including the compensation provided for (fees); and
8.		an indication as to whether an Ethics Committee has been referred to in accordance with Section 41b of the Medicines Act and, if so, the opinion thereof.

Procedure for reporting

§ 6. (1) The implementation of the non-interventional study may commenced after the reimbursement of a proper notification, provided that a positive opinion of a Ethics Committee pursuant to Section 41b of the German Medicines Act is submitted.

(2) If no opinion of a Ethics Committee is submitted in accordance with § 41b of the German Medicines Act (Medicines Act) with the notification, it is possible to begin the implementation 21 days after the refund of a proper notification. If the Federal Office for Health Security has doubts as to the admissibility of the planned non-interventional study, it may within this period of time the person responsible to submit an opinion of a pharmaceutical law pursuant to § 41b of the German Medicines Act (Medicines Act) to the Assessment of a clinical trial appointed Ethics Committee. In such a case, the non-interventional study may only be initiated if a corresponding positive opinion has been sent to the Federal Office for Health Security.

(3) In the event of a negative opinion issued by an Ethics Committee in accordance with Section 41b of the German Medicines Act (Medicinal Products Act), or if the Ethics Committee has issued a negative opinion in the proceedings pursuant to Section 2, the Federal Office for Security (Bundesamt für Sicherheit) shall Health care within 60 days of the admissibility of the non-interventional study.

(4) Essential changes to the non-interventional study are to be reported to the Federal Office for Safety in Health.

(5) In so far as the Federal Office for Health Security has reasons to believe that the conditions of the notification are not or no longer exist, it has to suspend or prohibit the non-interventional study in a modest way.

Final Report

§ 7. (1) After the end of the non-interventional study, the Federal Office for Health and Safety in the Public Health Service shall be subject to an electronic final report within six months at the latest and a summary report of the final report , unless other deadlines arise from the regulatory requirements.

(2) The final report also has the notifications made in the framework of the non-interventional study in accordance with § § 75a and § 75a. 75b of the Medicines Act.

(3) The short version of the final report, in any case, has the period of implementation and the number of patients involved, a brief description of the non-interventional study, names and addresses of doctors, dentists, hospitals and Pharmacies who participated in the non-interventional study, as well as a description of the result.

entry into force

§ 8. This Regulation shall apply to all non-interventional studies, which will commenced on 1 September 2010.

Stöger