Both the elearning module and the detailed country-specific report for the NIS considerations have been updated. So what’s changed?
Updated Pharmacovigilance Legislation
Decree No 2012-1244 of November 8, 2012 relating to the strengthening of the safety provisions of medicinal products for human use subject to market authorization and pharmacovigilance
Transposes Directive 2010/84/EU into national law:
- Serious Adverse Effects (e.g., ADRs) to be notified to the authorities with 15 days (as per current practice)
- Non-serious AEs to be notified to the authorities within 90 days (previously notified only in the PSURs)
- Serious and non-serious AEs to be notified via EudraVigilance by the ANSM and companies by 2015 (at the latest)
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Transparency of Relations Between Life Science Industry/ Manufacturers of Products Intended for Human Use and Health Professionals
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.
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Requirements Regarding the Summary of Product Characteristics (SmPC)
The summary of product characteristics (SmPC) should now (as per Decree No. 2012-1244):
- Feature standard text, expressly asking patients to report suspected adverse reactions to their physician, pharmacist or other healthcare professional or directly to the Regional Pharmacovigilance Centre, and detailing the different modes of communication at their disposal
- Include a statement for drugs on the list referred to in Article 23 of Regulation (EC) No 726/2004 of European Parliament and of the Council of 31 March 2004, the notice must, in addition to the information mentioned above, include the statement that,
- “This medicinal product is subject to additional monitoring”
- This statement is to preceded by a black symbol referred to. Article 23 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 and followed by an explanatory sentence determined by the European Commission.
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LEEM HCP Code Updated in Jan 2014
The LEEM Healthcare Professional (HCP) Code has been updated. The new code is effective from 1 January 2014.
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