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Greetings!
A new month brings new opportunities. Or as someone recently told me, "there are no missed opportunities, just opportunities"!
This month we're embarking on making the 'NIS Europe' reports available on line as country-specific documents (i.e., individual reports for each country), that will be free to download. It's time to start releasing the information as a complimentary resource. This is one of the reasons why we've delayed the updated to Part 2 of the report and indeed the countries covered in Part 2 of the report will be the first to be released.
Please be patient with us! This project will take some time to roll out, but we will keep you updated.
Best wishes,
Stuart McCully
CHCUK
Tel: +44 (0) 1997 42 33 11
Mobile: +44 (0) 7909 111 510
email: stuart.mccully@chcuk.co.uk |
Denmark: Who Do I Notify?
Clarification on Notification Requirements The more astute of you will, and have, noticed that the "Summary of the Legal & Regulatory Provisions" for Denmark, which are listed on page 55 of Part 2 of the CHCUK NIS Report indicate that notification to the Danish Medicines Agency (DMA) is required for NIS.
However, according to Lif's Position on the "Use of non-intervention studies":
"Non-intervention studies are not subject to any reporting obligation (except for the general obligation to notify the Danish Data Protection Agency), nor to any supervision by the Danish Medicines Agency, the scientific ethical committees or any other authority."
However, please note that in accordance with Article 88(1) of the Danish Medicines Act, although non-interventional trials may be implemented without the authorisation of the Danish Medicines Agency, trials on humans must be approved by a scientific ethical committee, cf. Act on a Scientific Ethical Committee System and the Processing of Biomedical Research Projects.
Furthermore, according to recently updated "Guidelines about Notification etc. of a Biomedical Research Project to the Committee System on Biomedical Research Ethics" (No 9154, 5 May 2011)
What is to be notified?
"Any biomedical research project shall be notified to the regional committee on biomedical research ethics, cf. section 8 of the Committee Act. It is a precondition, however, that research activity is carried out in Denmark, i.e. that the chief investigator works in this country." (refer to Section 2.0 of Guideline No 9154, 5 May 2011)
Non-Intervention Trials Involving Medicinal Products
"Non-intervention trials involving medicinal products shall not be notified to the committee system as the patient is not exposed to any special harm or risk, and the primary aim of prescribing the medicinal product is treatment. Take care to apply for identical approval periods in the committee system and and in the Danish Medicines Agency. The chief investigator is responsible for securing the required approval from these two agencies throughout the duration of the trial - possibly by applying for prolongation." (refer to Section 2.2.2 of Guideline No 9154, 5 May 2011)
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NIS Considerations: Finland 2011
Newly Updated NIS Considerations Report for Finland  After much deliberation and consideration on how best to manage the 'NIS Considerations' reports for Europe we've decided, based on your guidance and feedback, to split the reports into single country reports that will be available through the website. We've focused on Finland for the first of these reports - see link below: The intention will be to add a drop down menu to the NIS Resources webpage to allow you to select and automatically download the reports. We'll also continue to provide summary country-comparison overviews. Once this section of the website goes live, these reports will all be available as 'open source' documents. That is, they will all be readily available free of charge. Feel free to send me your comments at: stuart.mccully@chcuk.co.uk What's new in Finland? The following changes have been seen since Part 2 of the report was published in 2009: - The National Medicines Agency (NMA) is now the Finnish Medicines Agency (Fimea)
- The Medicines Act (No. 395/1987) was updated in 2010 and as of 1 June 2011 an English translation of the amended is available
- The Medical Research Act (N0. 488/1999) was updated in 2010 to reflect the changes in the Medicines Act
- The Pharma Industry Finland website changed address and can now be found at: http://www.pif.fi/frontpage
- The National Committee on Medical Research Ethics (TUKIJA) was set up on 1 October 2010 in accordance with Government Decree No. 820/2010.
In spite of all of this, the requirements for the conduct of NIS in Finland remain the same, namely: - Ethics approval should be sought from the regional ethics committee
- Fimea approval and/or notification isn't necessary
- NIS should be approved and supervised by the Company's scientific service
- Data protection legislation should be complied with
- Written contracts should be in place
- Study results should be analysed and submitted to the Company's scientific service within a reasonable period of time and the company should send the executive summary of the study results to all healthcare professionals that participated in the study
- lastly, the study must not constitute an incentive for the recommendation or prescription of a specific medicinal product
The following guidance and and tools may be helpful:
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