B2B PHARMA declared its brokerage business on May 2015 to the ANSM.
As a reminder, drug brokerage activity is defined as any activity related to the sale or purchase of drugs that do not include physical handling and that consists of negotiating independently or on behalf of a natural or legal person (Article L. 5124-19 of the CPH).
Natural or legal persons performing brokerage activity must ensure that the brokered medicines benefit from a marketing authorization for centralized marketing or are issued by the competent authority of the country in which they are placed on the market.
They are subject to the provisions relating to the fight against the falsification of medicines (Articles R. 5124-48-2 and R. 5124-60 of the CPH), the batch traceability (Article R. 5124-58 of the CPH) and in compliance with good wholesale distribution practices published by the European Commission.
In a pharmaceutical environment where falsified medicines rate continues to rise, the brokerage business is now highly regulated.
B2B PHARMA by its pharmaceutical activity is aware of the business requirements.
In parallel with the statutes of the Central purchasing agency and wholesale distributor to the export of medicinal products for human use which govern nature of products (OTC or reimbursed by the health insurance) and authorized geographic region (DOM-TOM & COM versus export), the new status allows us to complete our legal and regulatory arsenal thus validating the opportunity to respond to pharmaceutical applications from any order from our customers some of their geographical location area.
B2B PHARMA thus presents a complete profile allowing to pharmaceutical buyers to make us request knowing that we have the right regulatory solution to source pharmaceutical reference, either the market configuration or the proposed commercial operation.