Article 11 Paragraph 3 on Product Information File reads: “The Responsible Person shall make the product information file readily accessible in electronic or other format at his address indicated on the label to the competent authority of the Member State in which the file is kept. The information contained in the Product Information File shall be available in a language which can be easily understood by the competent authorities of the Member State.”

Format

The Regulation requires the PIF to be kept in electronic format or any other format (e.g. paper), as long as it is readily accessible to the competent authority in the Member State where the PIF is kept.

Language

Provisions regarding the language used for the PIF states that the information should be easily understood by the controlling officer when he/she comes to verify the PIF in the country where it is kept.
Therefore, it is obviously in the interest of the company concerned to make the PIF available in the national language(s) for the country where the PIF is held, unless it has been previously established that the competent authority is equally willing to accept another language. In many Member States, English will be “a language …