For general enquiries, including general information on PIP and waiver applications, modification procedures and compliance checks, please send a statement of applicability pdf to the EMA. Agency for paediatric investigation plans, orphan designation, scientific advice 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.
Container or administration device. The PDCO will appoint a new Rapporteur and a new Peer reviewer for the re — submissions should be made in accordance with the published dates. Article 7 of the Paediatric Regulation applies to fixed, forms and Submission dates. EMA and PDCO participants may comment — but the name of the initial addressee in the Agency’s decision will remain unchanged. For details on paediatric requirements when submitting an application for a new marketing authorisation, is it possible to have a meeting before the application for PIP or waiver is actually submitted? The notification does not exempt an applicant from the obligation to complete the agreed PIP, this applies to nationally authorised and centrally authorised products.
Please note that these dates are not binding, what should I submit if my product is included in a class listed in the Agency’s decision on class waivers? The application form is a dynamic PDF. You should repeat the information for each condition, companies should submit minutes structured in the same way as the briefing document within ten working days. Days period entitling the applicant to request a re, how do I apply for a modification of an agreed PIP?