For general enquiries, including general information on PIP and waiver applications, modification procedures and compliance checks, please send a question to the EMA. Agency for paediatric investigation plans, orphan designation, scientific marketing multiple choice questions with answers pdf or protocol assistance.
Applicants will receive the UPI number by e-mail. They should quote this number every time they contact the Agency for any matter related to this specific medicine. How and when should I submit a PIP letter of intent? February 2018Please notify the Agency of the intent to submit an application for a PIP or a request for waiver or deferral, using the form for the letter of intent. The letter of intent is expected at least two months before the planned start of procedure. For submission deadlines and start of procedure dates, see Paediatric investigation plans: Templates, forms and submission dates. Please do not send letters of intent or applications to individual email addresses within the Agency.
If you do not have a specific EMA referee contact, please use ‘paediatric’ as the referee. After submitting your letter of intent, you will receive a paediatric product number. When should I submit the application for a PIP or waiver? Applicants are welcome to submit their PIP applications during or even before initial PK studies in adults.
Failing to provide a date of completion of PK studies in adults should be justified. Late submission of the PIP or waiver application should be justified as well in the template for scientific document, parts B-F. Please submit your application for a PIP or waiver according to the published deadlines for submission to the Agency. For submission deadlines, see PIPs: Templates, Forms and Submission dates. To whom and how should I submit the PIP or waiver application? The Agency and the PDCO no longer accept CD and Eudralink submissions.
Please do not resend documents that have not been modified. When you request a confirmation of the applicability of class waiver in the cover letter for a PIP or waiver application, please clearly indicate the proposed therapeutic indication for which the confirmation is sought. What are the technical requirements for the electronic submission of PIP or waiver applications? PDF image files as far as possible. When a document is only available on paper, please ensure that the scanned version is readable both on screen and when printed out. Guidance on paediatric submissions so they can be easily identified, and do not merge application forms into a single PDF file. Please do not start to fill in the template within your web browser as you may not be able to save the content.