Medicines regulatory news
New legislation regarding pharmacovigilance came into effect in August 2012. One of the requirements of this legislation is that the Agency publish on a website the Summary of Product Characteristics (SPC) and the patient information leaflets (or package leaflets).
It has been noted by the Agency that PIL mock-ups submitted as part of a marketing authorisation frequently contain personal information in addition to the PIL text. This may be names of company personnel associated with various aspects of the product or details of printing companies and their staff.
This additional personal information is not required by the Agency. With due regard to the Data Protection Act 1998 (the DPA) and the rights of individuals, the Agency will not publish PILs accompanied by such personal information.
Accordingly, the Agency requires the PIL mock-ups submitted as part of a marketing authorisation, to contain only the text of the PIL and any relevant information such as colours employed, artwork dimensions and font information.
In order to prevent publication of personal information, the Agency will not progress submissions that have personal information incorporated into PIL mock-ups until such time as confidential information-free PILs are provided.
This will come into force for submissions received after 31 January 2013. The Agency thanks you for your cooperation in protecting the personal information of your employees, contractors and suppliers.
If you have any questions or require further advice please contact our Product Information Quality Unit at firstname.lastname@example.org