Advicenne’s laboratory is a quality system developed around the following standards:
The Public Health Code
Article R5124-2 of the Public Health Code defines the concept of pharmaceutical distribution business and specifies the activities which are the responsibility of a pharmaceutical distribution business:
- wholesale or gratuitous distribution
- batch monitoring and, if necessary, batch withdrawal and, where appropriate, the corresponding storage operations
Good Manufacturing Practices
The role of good manufacturing practices is to regulate activities related to the development, manufacture, control and monitoring of medicines, with a view to making them available for human use.
Good Pharmacovigilance Practices
Good pharmacovigilance practices aim to ensure the safety of the drug throughout its life cycle.
Good Practices of Wholesale Distribution of Medicines for Human Use
Good distribution practices serve to regulate the distribution, supply, transportation and monitoring of medicines marketed for human use.
Europe, Japan and the US have created the ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use). The role of the ICH is to draw up harmonized technical and regulatory documents. These documents are complementary to good manufacturing practices.
Charter on information for the promotion of medicines via canvassing or soliciting
According to the law dated 13 August 2004[or August 13, 2004] relating to health insurance, pharmaceutical distribution laboratories which market reimbursable medicines with promotional activities, such as canvassing or soliciting, and who are signatories of an agreement with the French Economic Committee for Health Products (CEPS), must undertake to comply with the Information Charter (signed on 15 October 2014) [or October 15, 2014], as well as its current terms of reference (March 2017) when canvassing or soliciting to promote medicines.
This commitment is verified by annual audits carried out by certifying bodies over a three-year period, as follows:
- Year 1: initial audit
- Year 2: surveillance audit (provided that the laboratory has been certified at the end of the initial audit)
- Year 3: surveillance audit
- Year 4: initial audit (then two years of surveillance audits), etc.
The purpose of these audits is to verify that the regulatory obligations of the Charter and its terms of reference are implemented within the laboratory. During these audits, the medical representatives’ activity is reviewed, to ensure their task of providing information about and promoting the drug to the medical profession is fulfilled within the framework of “good practice” for the drug and the current regulations.
The laboratory was initially certified in 2016 in accordance with the 2014 Charter and the 2009 terms of reference for certification for medical detailing.
Following an audit conducted in March 2017, the Laboratory has been certified based on the new terms of reference. As part of this certification, the Laboratory will be subject to two surveillance audits, in 2018 and 2019, before restarting the certification process in 2020.