EMEA publishes Questions and answers on the preparation of applications for a PIP and/or waiver

The European Medicines Agency (EMEA) has published a comprehensive Q&A document on the preparation of applications for a PIP and/or waiver, eleven pages long, with answers to the following 21 questions:

  • How and when should I submit a PIP Letter of intent?
  • When should I submit the application for PIP and /or Waiver?
  • To whom should I submit the PIP/waiver application?
  • How many copies should I submit for a PIP/waiver application?
  • What information should be provided in the cover letter accompanying the application?
  • What are the technical requirements for the electronic submission of PIP/waiver applications?
  • How do I use the electronic template for PIP/waiver application (part A)?
  • What information should I include in the electronic template for PIP/waiver applications (Part A)?
  • How should I present the scientific documentation (part B to E; references separate part F)?
  • What shall I submit in case my product is developed for a condition listed in the EMEA decision on class waiver?
  • Should I submit a separate PIP/waiver application in case of multiple marketing authorisations/marketing authorisation applications?
  • How shall I answer the PDCO’s Request for modification of a PIP and/or waiver?
  • What is the procedure to request a re-examination of the PDCO opinion on my PIP/waiver application?
  • How do I apply for a modification of an agreed PIP?
  • When is my product considered “not authorised in the Community”?
  • Does Article 7 or Article 8 of the Paediatric Regulation apply to my application, taking into account the Global Marketing Authorisation concept?
  • What is a new indication in the context of Article 8?
  • Does Article 7 or Article 8 of the Paediatric Regulation apply to my informed consent application?
  • Do the requirements of Article 7 of the Paediatric Regulation apply to fixed-combination products?
  • Is there a procedure to transfer the PIP/waiver decision to another applicant?
  • Does Article 7 of the Paediatric Regulation apply to advanced therapy medicinal products

Summariesed by:
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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