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:

• CHCUK NIS Video 

The Forum of International Research and Development Pharmaceutical Companies (FIRDPC) published the fowling two codes of practice on 11 December 2013: 

• FIRDPC Code on Disclosure of Transfers of Value fromPharmaceutical Companies to Healthcare Professionals (Dec 2013)
  • The Disclosure code sets out disclosures of payments and other transfers of value to healthcare professionals, whether directly or indirectly via healthcare organisations [read more...]
• FIRCPC Code on the Informing and Communication of Prescription-Only Medicines to, and Cooperation with, HealthCare Professional (Dec 2013)
  • The HCP code regulates the promotion of prescription-only medicinal products to healthcare professionals [read more...]

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.

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.

• Completed compliance reports should be submitted to the GPvP risk-based inspections mailbox in MS-Excel format.
• MHRA good pharmacovigilance practice RBI questionnaire - December 2013  
• Guidance for completing the MHRA good pharmacovigilance practice RBI questionnaire 2013 

• 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

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).

provides a comprehensive overview of the country-specific regulatory and practical considerations when conducting non-interventional studies (NIS) in Bulgaria.

• later than 12 Aug. 2013,
• earlier than August 2013 and with an end date later than 31 Dec. 2013

• 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.