To the attention of interested persons
Starting with 05.09.2016, you are required to also submit the documentation electronically (scanned and copied on a storage device).
– Documents related to any type of inspection (administrative documents for request of inspections, standard dossiers, applications forms for inspections, corrective measure plan, documents supporting various requests for changes of authorisations and annexes to authorisations issued by the PID).
– Documents accompanying other types of requests: approval of waiver from labelling, approval of medicinal product donations, approval of supply of medicinal product samples and any other type of requests requiring submission of supporting documents.
– Electronic documents shall accompany the cover letter, which must be submitted in its original form.
– Documents related to the authorisation of units allowed to perform clinical trials in the field of medicinal products for human use shall be submitted on paper and in electronic format (scanned and copied on a storage device).