SmPC, PIL, and packaging labeling
Any Marketing Authorization Application in the EU requires product information: a Summary of Product Characteristics (SmPC), a Patient Information Leaflet (PIL), and labeling of the packaging. Bronsing authors SmPC, PIL, and labeling texts based on your Company Core Data Sheet or Target Product Profile, and arranges an assessment by the authorities.
How is the product information used?
The SmPC forms the basis for your sales force to introduce the product to prescribers. It is a legal text authored by the company, and it’s reviewed and assessed by the authorities.
The PIL is meant for the patient. This text is inserted in the packaging of the drug product. It is also authored by the company and approved by the Regulatory Authorities.
The labeling is the layout and information on the packaging. Labeling is important, as it is the first thing the patient, pharmacist, and prescriber see. Writing these texts is often an iterative process.
Variation Applications
After your product is approved, you may need to amend the conditions of your Marketing Authorization, for instance, when your manufacturing process changes, or just because you need to keep up with scientific and regulatory developments. Bronsing helps you plan for these amendments, whether you need the application for a single or multiple products.
Bronsing Life Science Consultancy:
- helps you prepare, compile, and plan for the variations
- authors new labels
- applies for the variation with relevant authorities (single variations or for larger procedures involving many MAs, i.e. ‘Work Sharing Procedures’)