Amendment Of The Regulation On The Reporting Obligations For Non - Interventional Studies

Original Language Title: Änderung der Verordnung über die Meldepflicht für Nicht-interventionelle Studien

Read the untranslated law here: https://www.global-regulation.com/law/austria/2996908/nderung-der-verordnung-ber-die-meldepflicht-fr-nicht-interventionelle-studien.html

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484. Ordinance of the Federal Minister for health, modifies the regulation about the reporting requirement for non - interventional studies

On the basis of article 48 par. 3 of the medicines Act, Federal Law Gazette No. 185/1983, as last amended by the Federal Act Federal Law Gazette I no. 110/2012, is prescribed:

Ordinance of the Federal Minister of health about the reporting requirement for non - interventional studies, Federal Law Gazette II No. 180/2010, is amended as follows:

1. before article 1, together with its heading, following outline arrangement together with the associated heading shall be inserted:

"Article 1

Scope of application and general provisions"

2. paragraph 2 together with the heading:

"General requirements

Non - interventional studies are section 2 (1) in accordance with the requirements of the medical education (in particular with regard to the participation of a non - Interventional study) according to the State of science to plan and carry out.

(2) studies are not allowed, if the prescribing or dispensing of a medicinal should be promoted through its implementation.

(3) remuneration for health professionals for their participation in non - interventional studies have to restrict themselves to a reasonable compensation for the time spent.

(4) in the case of all non - interventional studies on the safety, which are carried out by the holder of the authorisation, this one has to analyze the data and to evaluate their relevance for the risk-benefit balance of the medicinal. New information that could affect the evaluation of the risk-benefit balance of medicinal, are to report to the Federal Office for security in healthcare. This obligation without prejudice to the obligation, to include information about the results of non - interventional studies in the regularly updated safety report according to § 78 k of the medicinal products act."

3. in section 4, paragraph 2, of the parenthetical expression (§ 7 para 1 and 3) is replaced by the parenthetical expression (§ 7 para 1 and 3 and § 11).

4. before article 5 together with its heading, following outline arrangement together with the associated heading shall be inserted:

"Part 2

Not officially arranged non - interventional studies"

5. § 5 para 2 Z 5 is: "5. Description of the non - Interventional study (Protocol)," 6 article 7, paragraph 1:

"(1) after termination of non - Interventional study a final report and a summary of the final report shall be the data capture is completed the Federal Office for security in the health service by the person in charge at the latest within twelve months after electronically."

7. before article 8, following outline arrangement together with the associated heading shall be inserted:

"Section 3

Officially arranged non - Interventional safety studies"

8 paragraph 8 together with the heading:

"The scope of application

„§ 8. The provisions of this section will find application, due to one according to the § 18 para 3 or obligation on 19a para 1 and 2 of the medicines Act or to article 10 or Article 10a of Regulation (EC) 726/2004 to laying down Community procedures for the authorisation and monitoring of human and veterinary medicinal products and the establishment of the European Medicines Agency only on non - interventional studies on the safety , OJ No. L 136 of 30.04.2004 p. 1, last amended by Regulation (EC) No. 1235/2010, are carried out."

9. According to § 8 following articles 9 to 14 and headings are added:

"Procedure

§ 9 (1) is conducting a non - Interventional study is performed only in the domestic regulatory arrangement according to article 19a, paragraph 1 and 2 of the medicines Act, to sign the Federal Office for security in the health care sector by the person responsible according to § 5 para 1 and 2.

(2) the Federal Office for security in the health care sector has to approve the implementation by the means of notification, if the implementation is not to prohibit, because the prescription or dispensing of a medicinal product should be promoted according to the Federal Office for security in healthcare 1 by the study violates article 2 par. 2 or 2. the objectives of the study cannot be reached with the appropriate study design or 3. a clinical trial represents the study within 60 days after notification.

(3) the design of the study protocol of all other non - interventional studies listed in § 8 is to submit the Committee for risk assessment in the area of pharmacovigilance (PRAC) for the conduct of the person in charge.

(4) the implementation of the non - Interventional study can be started after written approval of the Committee for risk assessment in the area of pharmacovigilance (PRAC) or after decision moderate approval through the Federal Office for security in healthcare.

(5) the person in charge has the competent authorities of the Member States in which the study should be conducted, after approval of the draft of Protocol by the Committee for risk assessment in the area of pharmacovigilance (PRAC) Protocol to transmit.

Substantial amendment to the study protocol

Essential amendments to the study protocol are section 10 (1) after the start of the non - Interventional study prior to their implementation to provide the Federal Office for security in the healthcare sector (studies according to article 9, para. 1) or the Committee for risk assessment in the area of pharmacovigilance (PRAC) (studies according to article 9, para. 3). The Federal Office for security in healthcare examines the changes and has administrative decision about their approval or rejection to decide.

(2) the person in charge has the competent authorities of the Member States where the study is being conducted, to inform about the approval of the amendments by the Committee on risk assessment in the area of pharmacovigilance (PRAC).

Final report

§ 11. After the non - Interventional study a final report and a summary of the final report are electronically the Committee for risk assessment in the area of pharmacovigilance (PRAC) and the Federal Office for security in healthcare period of twelve months from the person responsible to submit, if not waived was by them.

4 section

Dealing with data, implementation instructions, transitional provision

Dealing with data

§ 12. The study protocol, the documentation, the agreements between responsible and participating doctors, dentists, hospitals, or pharmacies, the final report and all other documents that were created in connection with the non - Interventional study, must be kept by the person responsible for a period of 15 years after the end of the non - Interventional study.

Implementation note

§ 13. This regulation directive is amending the Directive 2001/83/EC establishing a Community code relating to human medicinal products with regard to the pharmacovigilance, OJ 2010/84/EC of the European Parliament and of the Council of December 15, 2010 No. L 348 of December 31, 2010, S 74, as amended by the amending OJ Implemented no. L 21 of 25 January 2011, S 8.

Transitional provision

§ 14. "The outline arrangement together with heading before § 1, § 4 para 2, the outline arrangement together with heading before § 5, § 5 para 2 Z 5, § 7 para 1, the outline arrangement before article 8, section 8, as well as the sections 9 to 14, including titles in the version of regulation BGBl. II Nr 484/2012 with 1 January 2013 into force."

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