484. Regulation of the Federal Minister of Health, amending the Regulation on the reporting obligation for non-interventional studies
On the basis of § 48 (3) of the German Medicines Act, BGBl. No. 185/1983, as last amended by the Federal Law BGBl. I No 110/2012, shall be arranged:
The regulation of the Federal Minister of Health on the reporting obligation for non-interventional studies, BGBl. II No 180/2010, shall be amended as follows:
1. Before § 1, together with its headline, the following link arrangement together with the title of the title shall be inserted:
" 1. Section
Scope and General Provisions "
2. § 2 together with the title is:
" General requirements
§ 2. (1) Non-interventional studies shall be carried out in accordance with the state of the sciences, in accordance with the requirements to be met for medical education (including, in particular, participation in a non-interventional study). plan and carry out.
(2) Studies shall be inadmissible if it is intended to promote the prescribtion or delivery of a proprietary medicinal product.
(3) Compensation for members of the health professions for their participation in non-interventional studies shall be limited to adequate compensation for the time taken.
(4) In all non-interventional safety studies carried out by the marketing authorisation holder, the marketing authorisation holder shall analyse the data obtained and the significance of the data for the benefit/risk ratio of the medicinal product in question. evaluate. New information, which could have an impact on the evaluation of the benefit-risk ratio of the proprietary medicinal product, should be reported to the Federal Office for Health and Safety in the Health Care Sector. This obligation shall be without prejudice to the obligation to include information on the results of non-interventional studies in the regularly updated safety report in accordance with § 78k of the Medicines Act. "
3. In § 4 (2), the expression " (§ 7 (1) and (3)) " by the parenthesis " (§ 7 (1) and (3) and (11)) " replaced.
4. Before § 5, together with its headline, the following link arrangement together with the title of the title shall be inserted:
" 2. Section
Non-interventional non-interventional studies "
5. § 5 (2) Z 5 reads:
Description of the non-interventional study (study protocol), "
6. § 7 (1) reads:
" (1) After the end of the non-interventional study, a final report and a final report shall be electronically submitted to the Federal Office for Health Security by the person responsible at the latest within twelve months of the completion of the data collection. To submit a summary of the final report. "
7. Before § 8, the following link arrangement together with the corresponding heading shall be inserted:
" 3. Section
Non-interventional non-interventionist studies ordered by the authorities "
8. § 8 together with headline reads:
" § 8. The provisions of this section shall apply exclusively to non-interventional studies on safety, which are based on an obligation imposed in accordance with § § 18 (3) or 19a (1) and (2) of the Medicines Act or in accordance with Art. 10 or Article 10a of Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing the European Medicines Agency, OJ L 327, 30.11.2004, p. No. 1. as last amended by Regulation (EU) No 1235/2010. '
9. According to § 8, the following § § 9 to 14 shall be added together with the headings:
§ 9. (1) The conduct of a non-interventional study, which is conducted only domestiously pursuant to § 19a (1) and (2) of the German Medicines Act, is the responsibility of the Federal Office for Health and Safety (Bundesamt für Sicherheit im healthcare) in accordance with § 5. (1) and (2).
(2) Within 60 days of notification, the Federal Office for Health Security shall approve the implementation by means of a decision, unless the implementation is to be prevented, because the Federal Office for Safety and Security considers in the opinion of the Federal Office for Security in the Healthcare
the study is intended to promote the prescribtion or delivery of a medicinal product in accordance with § 2 para. 2
the objectives of the study cannot be achieved with the proposed study design, or
the study is a clinical trial.
(3) The draft study protocol of all other non-interventional studies referred to in § 8 shall be submitted to the Pharmacovigilance Risk Assessment Committee (PRAC) prior to implementation by the person responsible for the study. .
(4) The conduct of the non-interventional study may not be carried out until the Committee for Risk Assessment in the area of pharmacovigilance (PRAC) has been approved in writing or in writing. after a modest approval by the Federal Office for Health Security, the Federal Office for Health and Safety will begin.
(5) The person responsible shall, after endorsing the draft protocol by the Pharmacovigilance Risk Assessment Committee (PRAC), have the protocol to the competent authorities of the Member States in which the study is to be carried out. ,
Major change to the study protocol
§ 10. (1) After the start of the non-interventional study, major changes to the study protocol prior to their implementation are the Federal Office for Safety in Health (Studies according to § 9 para. 1) or the Committee for Risk Assessment in the field of Pharmacovigilance (PRAC) (studies in accordance with section 9 (3)). The Federal Office for Health and Safety (Bundesamt für Sicherheit im Healthcare) examines the changes that are displayed and has to decide on its approval or rejection in a modest way.
(2) The person responsible shall inform the competent authorities of the Member States where the study is carried out of the approval of the amendments by the Pharmacovigilance Risk Assessment Committee (PRAC).
§ 11. After the end of the non-interventional study, the person responsible shall be responsible for the Pharmacovigilance Risk Assessment Committee (PRAC), respectively. To submit an electronic final report and a summary report of the final report to the Federal Office for Health Security within twelve months, unless the final report has been waived on this issue.
Dealing with data, implementation notice, transitional provision
How to handle data
§ 12. The study protocol, the documentation, the agreements reached between the responsible and the participating doctors, dentists, hospitals or pharmacies, the final report and all other documents relating to the Non-interventional study has to be kept by the person responsible for a period of 15 years after the end of the non-interventional study.
§ 13. This Regulation repeals Directive 2010 /84/EU of the European Parliament and of the Council of 15 December 2010 amending Directive 2001 /83/EC on the Community code relating to medicinal products for human use in respect of pharmacovigilance, 1. No. OJ L 348 of 31 December 2010, S 74, as amended by the corrigendum OJ L 348, 28.12.2010, p. No. OJ No L 21, 25. Jänner 2011, S 8 implemented.
§ 14. The order of detail, including the headline before § 1, § 4, para. 2, the outline order including the headline before § 5, § 5 paragraph 2 Z 5, § 7 para. 1, the order of detail before § 8, § 8 as well as § § 9 to 14 together with headlines in the version of the regulation BGBl. II No 484/2012 are due to 1. Jänner 2013 in force. "