As a part of our regulatory affairs services, Medfiles offers review of promotional materials for medicinal products. Our most popular compliance tasks are writing national abbreviated product information texts and reviewing marketing materials for medicinal products, including both promotional and informative materials.
Don’t forget the national abbreviated product information
Abbreviated PI, abbreviated SmPC, short SmPC – this text has several names, but the meaning is the same: a shortened version of the summary of product characteristics, which is mandatory in all promotional materials for medicinal products addressed to healthcare professionals.
The content requirements for the abbreviated SmPC vary between countries, which is why it is very important that these documents are created and updated by national experts to ensure that all requirements are fulfilled. Medfiles can provide abbreviated SmPCs for your products for all Nordic (FI, SE, DK, NO, IS) and Baltic (EE, LV, LT) countries. Even if you intend to use the same promotional material for several countries, you should remember that you must include in the marketing materials a separate abbreviated SmPC for each target country.
Examples of typical abbreviated SmPC tasks outsourced to Medfiles:
- Consultation regarding country-specific abbreviated SmPC requirements
- Creation or update of a specific abbreviated SmPC document for any of the Nordic or Baltic countries
- Maintenance and review of abbreviated SmPCs directly in the content management platforms for common promotional material (such as Veeva). Medfiles has plenty of experience in using such platforms.
- Maintenance of the abbreviated SmPC for products for which Medfiles already has the regulatory affairs responsibility: the maintenance task can be easily linked to the RA maintenance work. After an updated SmPC has been approved by an authority, we will update the abbreviated SmPC within the agreed time period.
Interested in compliance services for the promotional materials of medicinal products?
For more information, contact Mikko Reinman, Head of Operations, Pharma Regulatory Affairs ().
