An updated guide for pharmaceutical companies
From the European Medicines Agency an updated guide intended for pharmaceutical companies, with indications for the modification of the documentation relating to the product information of medicinal products for human use approved in the European Union, i.e. the package leaflet, summary of product characteristics and labeling of medicines.
The templates of these documents have been updated with the aim of improving the way information on medicines is transferred to patients and healthcare professionals. The review is the result of the work of the EMA and the Working Group on Quality Review of Documents following two years of experience evaluated on the previous models, already reviewed in accordance with the provisions of the new pharmacovigilance legislation, and on suggestions made by national regulatory agencies, industry, patients and consumer groups.
Product information is an integral part of the marketing authorization of all medicines: it provides an objective and updated description of the quality, efficacy and safety of the medicine and constitutes a guide for patients, doctors, pharmacists and other health professionals in prescribing, dispensing and drug administration.
The details of the changes made can be consulted in the guide prepared for pharmaceutical companies. “The most important changes – recalls the Italian Medicines Agency – concern the brochure (for patients it may only contain the address of the local representative of the marketing authorization holder of the Member State where the medicine in question is marketed, instead of the full list of contact details of all local representatives of the Member States of the 'EU)”
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