Pharma Package" Adopted - Particular Needs Of Non-Prescription Medicines Recognised

Main Category: Pharmacy / Pharmacist
Also Included In: Public Health;  Regulatory Affairs / Drug Approvals
Article Date: 11 Dec 2008 - 0:00 PDT

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The European Commission adopted today the so-called "pharma package", which consists of a Communication covering "a renewed vision for the pharmaceutical sector" and legislative proposals on information to patients, falsified medicines and pharmacovigilance.

"This package well recognises the particularities of non-prescription medicines", stated AESGP (Association of the European Self-Medican Industry) Director General Hubertus Cranz. "The new pharmacovigilance requirements will allow focusing on the main risks and will put scarce resources to better use." The European Commission suggests giving up the principle of periodic safety update reports for well-established substances and centralising literature screening, which will make the entire system more efficient. This is in line with the AESGP considerations published in Smart Regulation 2015.

Mr Cranz further highlighted that "the Commission's proposal on information to patients refers to prescription medicines only and leaves the adequate and well-functioning provisions that have already been in place for non-prescription medicines for many years unchanged."

With regard to falsified medicines, a clear differentiation has been put in place between prescription and non-prescription medicines concerning tracking and tracing requirements. "This shows that the European Commission understands the specific situation of self-care products well and envisages a balanced approach in the fight against counterfeiting, which AESGP strongly supports", explained Cranz.

Finally, AESGP particularly appreciates the recognition in the Commission's Communication of the important role of non-prescription medicines in light of their economic and social benefits, and that particular attention needs to be paid to their access and availability.

Association of the European Self-Medican Industry