Notice Of Non-Interventional Post-Authorisation Safety Studies

Original Language Title: Bekendtgørelse om ikke interventionssikkerhedsundersøgelser

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Completion of not intervention safety examinations 1)

In accordance with § 92 a, § 92 b (b) 2 and 3, section 104 (3). Three, in the law. 1180 of 12. In December 2005 on medicinal products, as amended by law no. 534 of 17. June, 2008, Law No. No. 464 of 18. May 2011 and Law No 605 by 18. June 2012 shall be determined :

Scope of application

§ 1. This notice shall include non-intervention safety surveys, which are a condition for a marketing authorisation for a medicinal product for human beings, cf. Article 9 (4) of the medicinal product. 2, which are covered by the Article 92 (b) of the medicinal product. 1.

Paragraph 2. The placing on the market of a security investigation shall mean any examination of an approved medicinal product which is carried out in order to identify, characterize or quantify a security risk, certifying the medicinal product ; the safety profile or the efficacy of the effectiveness of risk management measures.

Paragraph 3. A non-intervention investigation shall mean a study in which the medicinal product or the medicinal product is prescribed as normal in accordance with the conditions for the marketing authorization. The decision to prescribe the medicinal product concerned is clearly separate from the decision to include the patient in the investigation. The treatment itself does not occur according to a protocol, but will follow standard practice. No additional diagnostic or control procedures are carried out, and epidemiological methods must be used to analyse collected data.

Paragraph 4. Clinical trials with medicinal products are not covered by the notice.

Permit Applications

§ 2. A non-intervention safety survey that is a condition for a marketing authorisation and which has been established after the marketing authorization is issued, cf. Section 9 (1). 2, shall not be implemented until the Board of Health has authorized this, if the survey is to be carried out only in Denmark, cf. Article 92 b (b) of the medicinal product. 1.

Paragraph 2. The application for authorization to launch the investigation shall be submitted to the Board of Health. The application must include a draft protocol containing a detailed description of the purpose and organisation of the investigation.

§ 3. The Board of Health shall take a decision within 60 days of receipt of the application and draft test protocol.

Paragraph 2. The Board of Health may submit a reasoned objection and, if necessary, to discover the application if it is assessed that the examination will promote the use of the medicinal product, or the examination is designed in such a way as to ensure that : the purpose of the investigation cannot be achieved.

Amendments to the protocol ;

§ 4. Prior to the marketing authorization holder, significant amendments to the protocol of a non-intervention safety survey approved by the Health Service shall apply for authorisation by the holder of the marketing authorization ; here.

Paragraph 2. Applications for amendment of the protocol must be submitted to the Health Service, which shall decide whether or not they may be authorised to amend it. The application must contain a draft of the modified test protocol and a reason for the changes.

Penalty provisions

§ 5. The penalty will be penalized by the penalty that violates § 2 or § 4.

Paragraph 2. Companies can be imposed on companies, etc. (legal persons) punishable by the penal code 5. Chapter.

Entry into force

§ 6. The announcement shall enter into force on 3. August 2012.

The Ministry of Health and Prevention, the 1. August 2012

Astrid Krag

-Dorthe Eberhardt Søndergaard

Official notes

1) The commotion contains provisions that implement parts of Directive 2001 /83/EC of the European Parliament and of the Council of 6. November 2001 establishing a Community code of medicinal products for human use, the Official Journal of the European Communities. L 311, s. Last amended by Directive 2010 /84/EU of the European Parliament and Council Directive 2010 /84/EU of 15. December 2010, EU Official Journal, nr. L 348, s. The Directive 74 and the European Parliament and Council Directive 2011 /62/EC of 8. June 2011, EU Official Journal, nr. In 174, s. 74.