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CHCUK: New "NIS News & Articles" Webpage
 Our newly upgraded website now includes a "News & Articles" section which we update as soon as we're aware of changes to NIS regulations and guidelines. This section covers global updates. Please visit our " News & Articles" section |
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CHCUK: Why Wait for NIS News When You Can Get it Live?!
CHCUK Introduces a new free 'NIS Considerations" app for all platforms
 It seemed mad to wait 2 months for our 'NIS Considerations' newsletter, so we've developed a new FREE app for all smartphone that provides you with live NIS news updates (from our updated website). Just search for "NIS Considerations" on the applicable app store. The 'NIS Considerations' app is live on the Android and iPhone stores and have been submitted to the Windows and Blackberry stores, so should be live for the latter two platforms any time soon. |
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CHCUK: NIS Considerations (Europe - Part 2)
It's here at last!
 2013 proved to be an interesting year. National legislation was uniformly updated to reflect, amongst other things, the new EU pharmacovigilance requirements for safety reporting and mandated non-interventional post-authorisation safety studies (PASS). So we waited for to release revision 3 of the 'NIS Considerations - Europe: Part 2' report. Then the EFPIA HCP Code was updated and required members to update their national codes by December 2013 to include various updates and a new requirement for 'Disclosure of Transfers of Value'. The national codes were revised in December 2013 and became effective on the 1st January 2014. Hence, the delay in the release of the 'NIS Considerations - Europe: Part 2' report. We are using a new file sharing tool called 'ProjectSend". If you have previously purchased a copy of the report you should have received a link to the 'ProjectSend' tool today (20th Feb 2014), where you can download the revised report...all 702 pages! If you have previously purchased a copy of the report and haven't received the ProjcetSend email and link, then please do email me at: stuart.mccully@chcuk.co.uk |
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CHCUK: New NIS Promotional Video
 We've created a short video to promote our non-interventional study services. Have a look and see what you think! Click on the link below: |
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Romania: New ARPIM HCP/HCO Disclosure Code
A new ARPIM Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals (HCP) and Healthcare Organisations (HCO) was published in Dec 2013. The new code is applicable from 1st January 2015.
[read more...]
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Romania: ARPIM HCP Code Revised in Dec 2013
The ARPIM Code of Ethics was last amended in December 2013. The latest version of the ARPIM HCP Code is applicable from 1st April 2014. [ read more...] |
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Romania: New National Ethics Committee
Contributed by: Mirela Tudor, Senior NIS Submissions Specialist, inVentiv Health Clinical
The National Ethics Committee is now the "National Bioethics Committee of Medicines and Medical Devices (CNBMDM)" which has now taken full responsibility for evaluation and approval of clinical studies with human medicines and medical devices in Romania ( press note dated 5th February 2014) [ read more...] |
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Slovenia: Two New Codes of Practice Published in Dec 2013
The Forum of International Research and Development Pharmaceutical Companies (FIRDPC) published the fowling two codes of practice on 11 December 2013:  |
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Croatia: Hundreds Charged with Corruption
The authorities in Croatia have charged a pharmaceutical company and 364 people - most of them reportedly doctors - for allegedly rigging the drugs market.  Senior managers at the drugs firm Farmal bribed a network of doctors and pharmacists to prescribe the company's products, officials said. They have been charged with bribery, abuse of power and corruption. Local media said the indictment was the biggest of its kind in the country's judicial history
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EMA: Draft Guideline on Key Aspects for the Use of Pharmacogenomic Methodologies in the Pharmacovigilance Evaluation of Medicinal Products
 The 'Draft guideline on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products' ( EMA/281371/2013) has been released for public consultation as of 30 January 2014 with a deadline for comments of 30 July 2014. [ read more...] |
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EMA: Revision 2 of the Guideline on Good Pharmacovigilance Practices
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France: Update on the 'French Sunshine Act'
Contributed by: Mark Heinemann, Senior NIS Submissions Specialist, inVentiv Health Clinical
 According to the provisions of article L.1453-1 CSP, pharmaceutical companies must now disclose the existence of agreements that they concluded with: - Healthcare professionals,
- Associations of healthcare professionals,
- Students in medicine and odontology,
- Associations of patients,
- Health establishments,
- Foundations,
- Press organs for health professionals for all media (press, radio, TV or online communication);
- Medical prescription and deliverance software editors;
- Learned societies.
Each company must disclose the information for each agreement concluded. Above a limit of 10 euros all taxes includes, the obligation of disclosure also applies to the advantages in nature or in money granted directly or indirectly by pharmaceutical companies to the above listed recipients. Consequently, all advantages granted to persons listed above that are above 10 euros will have to be disclosed. The said information will be disclosed in French on a unique public website held by an authority to be created by an order of the Ministry of Health.
[ read more...] |
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Switzerland: Regulation Law on the Federal Act on Research Involving Human Subjects
 The federal law on human research clarifies the requirements of the Act in relation to the ethical, scientific and legal requirements that must be observed in research on humans. Here, the legal and administrative requirements depend on the extent of the risk to participating in the research person. [ read more...] |
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Norway - LMI Rules for Marketing of Medicinal Products Revised in November 2013
 The LMI Rules for Marketing of Medicinal Products were revised in November 2013. There is no impact on the conduct of non-interventional studies as "clinical trials, including non-intervention trials, do not lie within the scope of the Rules". [ read more...] |
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UK: ABPI Code of Practice for the Pharmaceutical Industry 2014
 The latest version of the ABPI HCP Code became effective on the 1st Jan 2014. As set out in the 2014 Code, in 2015 and 2016 transparency will be extended in relation to fees and sponsorship provided to health professionals and healthcare organisations, including naming the recipients in many instances. Companies must document and publicly disclose certain transfers of value made directly or indirectly to health professionals and healthcare organisations located in Europe (as per Clause 21.1 of the ABPI COP 2014). The transfers of value covered by Clause 21.1 are: joint working in accordance with Clause 18.5 donations, grants and benefits in kind provided to institutions, organisations and associations in accordance with Clause 18.6 contracts between companies and institutions, organisations and associations in accordance with Clause 18.7 sponsorship of attendance by health professionals and appropriate administrative staff at meetings in accordance with Clause 19.5 fees paid to health professionals and appropriate administrative staff, or to their employers on their behalf, in accordance with Clauses 20.2 and 20.3 Contributions towards the costs of meetings paid to healthcare organisations or to third parties managing events on their behalf, which may include sponsorship of health professionals by way of registration fees and accommodation and travel. [read more...] |
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UK: MHRA Good Pharmacovigilance Practice Compliance Report Template Now Available
Marketing authorisation holders are encouraged to complete a Good  Pharmacovigilance Practice (GVP) compliance report every two years. The 2013 compliance report is now available for completion, the deadline for submissions is 30 May 2014. The Compliance Report is in an MS-Excel format and contains the questions that need to be completed. Guidance notes on completing the questionnaire are also available and should be read before completing the questionnaire. [ read more...] |
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Finland: New Code for the Disclosure of Transfers of Value
 In line with Articles 125-130 of the present PIF Code, the company must document and publish the economic benefits targeted at healthcare organisations or professions (persons entitled to prescribe or dispense medicines) who have their principal place of business, work address or registered domicile in Europe.Finland-map-colour Economic benefit refers to all direct or indirect transfers of economic value either in cash, in benefits in kind or other forms of benefit. [ read more...] |
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Estonia: APME Code of Ethics Revised
Amendment to the APME Code of Ethics from 01.01.2014
 The Drug Manufacturers Association(APME), in collaboration with the European Association of Pharmaceutical Industries (EFPIA), have revised Articles 9, 10 and 12 of the existing code of ethics. The changes will take effect from 1 January 2014. Article 9 of the amendment is based on EFPIA and the Pharmaceutical Manufacturers Association's intention to impose limits on healthcare workers with regard to terms of food. Amendment to Article 10 prohibits all kinds of gifts, monetary or non-monetary benefits (such as entertainment tickets, trips, gift cards, stationery, notepaper, etc.) to grant or offer. Article 12 provides for an amendment to the health workers, pharmacists and pharmacists, either directly or indirectly, paid service or consulting fees, and disclosure of fees paid to health care providers for the previous year in accordance with the procedure laid down by law, or by the marketing authorization holder each year. The primary data disclosure is made in the year 2016 based on 2015 data. [ read more...] |
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Bulgaria: ARPharM Adopt Code for Disclosure of Transfers of Value by Pharmaceutical Companies to HCPs and HCOs
 On November 26, 2013 the Association of Research- based Pharmaceutical Manufacturers in Bulgaria (ARPharM) adopted the Code for Disclosure of Transfers of Value by Pharmaceutical Companies to Healthcare Professionals and Health Organizations. The new Code requires from the beginning of 2016 all members of the organization to publicly disclose their financial relationships with healthcare professionals and health organizations. Thereby ARPharM joined the initiative of the European Federation of Pharmaceutical Industries and Associations, which adopted its Disclosure Code in June 2013. [ read more...] |
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Bulgaria - ARPharM Code of Ethics Amended in Nov 2013
The ARPharm Code of Ethics of the Research-Based Pharmaceutical Industry in Bulgaria was amended on the 26th November 2013. The amendments will be in force from 1st January 2014. The amendments include: - Article 9.11. (Deleted as of 01.01.2014)
- Article 10 (New, in force since 01.01.2014)- Information and Educational Materials. Items of Medical Utility
- Article 12a (amended on 26.11.2013, in force since 01.01.2014) - Sponsorship of healthcare professionals
- Article 16b (adopted 26.11.2013, in force since 01.01.2014) - Ban on gifts
[read more...] |
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CHCUK: 2014 version of the Country-Specific NIS Report for Bulgaria Now Available
 The second (2nd) edition of our country-specific report on the regulatory and practical considerations for NIS in Bulgaria was published today (11th Jan 2014). NIS Considerations "Bulgaria" provides a comprehensive overview of the country-specific regulatory and practical considerations when conducting non-interventional studies (NIS) in Bulgaria. [read more...] |
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Germany: Federal Institute for Drugs and Medical Devices (BfArM) Launches New Website
 The Federal Institute for Drugs and Medical Devices launched a restructured website on the 15th November 2013. The aim being to provide easier access to the extensive information offered by the BfArM. For further information refer to the BfArM Press Release (In German) |
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Germany - New BfArM/PEI NIS Guidance Coming Soon
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Germany: NIS Reporting Requirements in Germany - Are You Ready?
Contributed by Mark Heinemann, Senior NIS Submissions Specialist, Late Stage Department, inVentiv Health Clinical
 The 3rd law amending the German Medicinal Products Act came into effect on August 13, 2013.Germany-map-colour The new regulations are mandatory for all non-interventional studies with start dates: - later than 12 Aug. 2013,
- earlier than August 2013 and with an end date later than 31 Dec. 2013
The most important changes aim at the disclosure of the actually paid fees for a physician's participation in an observational study and at the reporting requirements for the fees and any payment updates after study start. The sponsor must also explain the appropriateness of the proposed fees in the contract template between sponsor and physician/site. Article 67 par. 6 set 5 AMG requires the initiator of an observational study to submit all changes pursuant to sentence 4 within four weeks after the end of each quarter. [ read more...] |
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India: New Audio-Visual Consent Guidelines
Audio-Visual Recording of Informed Consent
 There has been much talk over the past 6+ months about the new requirements for the patient consent process to be videoed. These requirements were implemented in late 2013 through the DCGI Administration Order of 19 Nov 2013. The CDSCO has also recently (Jan 2014) published a " Draft Guideline on Audio-Visial Recording of Informed Consent". Although, the regulations and DGCI Administrative Order specifically state applicability to 'clinical trials', it is assumed, until otherwise notified, that these requirements also apply to non-interventional studies. [read more...] |
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Medicines Australia: Transparency Reporting
Transparency of payments and transfers of value
 As part of the current Code of Conduct Review, the Code Review Panel is investigating options developed by the Transparency Working Group for increased transparency about payments and transfers of value to healthcare professionals for potential inclusion into Edition 18 of the Code of Conduct. The Code Review commenced in July 2013 and will conclude in June 2014, with Edition 18 becoming effective in January 2015. [read more...] |
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Medicines Australia: HCP Consultant Reports to be Submitted by 30 April 2014
Healthcare Professional Consultant Reports
 What are Healthcare Consumer Professional Consultants?The Code of Conduct defines a healthcare professional consultant as a healthcare professional who is engaged by a member company to provide services or advice for a fee, and who is not an employee of the company.Medicines-Australia What must be reported?Member companies are required to report all consultancies with healthcare professionals as defined in Section 9.8 of the Code. Set out below are examples of the consultancies which must be reported. This list is not exhaustive. - Developing and/or presenting a submission to PBAC or PBS.
- Developing a continuing education program.
- Writing or reviewing a scientific paper, promotional or educational material.
- Expert opinion provided by one or more healthcare professionals on an ad hoc basis.
- Independent grant review committee.
- Market research where the company has selected the healthcare professionals participating in the research.
Reporting TimelinesThe first annual report of healthcare professional consultants must be submitted to Medicines Australia by 30 April 2014 and cover activities commenced on or after 1 January 2013 or ongoing on that date. Thereafter, the report must be provided to Medicines Australia on an annual basis by 30 April each year covering the previous calendar year. [ read more...] |
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Australia: Privacy Law Reforms Effective from 12 March 2014
 The Privacy Amendment (Enhancing Privacy Protection) Act 2012 (Privacy Amendment Act) was introduced to Parliament on 23 May 2012 and was passed with amendments on 29 November 2012. The Privacy Amendment Act introduces many significant changes to the Privacy Act. While these changes will not commence until 12 March 2014, Australian Government agencies* and businesses should start preparing now. The Privacy Regulation 2013, made under the Privacy Act, and to also commence on 12 March 2014 was registered on 17 December 2013. [ read more...] |
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The 
