Initial paediatric investigation plan (PIP) According to Article 16 of the Paediatric Regulation (Regulation (EC) No 1901/2006), in the case of the applications for marketing authorisation referred to in Articles 7 and 8, or the applications for waiver referred to in Articles 11 and 12, the paediatric investigation plan or the application for waiver shall be submitted with a request for agreement,. [...] Re-examination of PDCO opinion According to Article 25(2) of the Paediatric Regulation (Regulation (EC) No 1901/2006), within 30 days following receipt of the PDCO opinion, the applicant may submit to the Agency a written request, citing detailed grounds, for the re-examination of the opinion. [...] Annual reports on deferrals According to Article 34(4) of the Paediatric Regulation (Regulation (EC) No 1901/2006), in the case of a deferral, the marketing authorisation holder shall submit an annual report to the Agency providing an update on progress with paediatric studies in accordance with the decision of the Agency agreeing the paediatric investigation plan and granting a deferral. [...] For example, to submit a request for Modification of an Agreed PIP, a Compliance check or an Annual Report on Deferred Measures, the applicant must be the holder of the relevant PIP Regulatory Entitlement, and a transfer may thus be necessary beforehand, if the applicant is not the same organisation as the holder of the PIP RE. [...] In addition, the holder of the PIP or waiver RE can update the data on the RE contact person, or the email and phone for public enquiries, directly in the IRIS portal.
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- Pages
- 17
- Published in
- Spain
Table of Contents
- 1. Legislative background, requirements 3
- 2. Objectives 4
- 3. General principles 4
- 3.1. Glossary related to PIP or waiver applications 5
- 4. Prior to application submission (or re-submission) 6
- 4.1. Timelines and planning 6
- 4.2. Interactions prior to submission or re-submission (during clock-stop) 7
- 4.2.1. General questions 7
- 4.2.2. Pre-submission interactions 7
- 4.2.3. Clarification dialogues before re-submission (during clock-stop) 7
- 5. Applications and documentation to be supplied 8
- 5.1. Initial paediatric investigation plan (PIP) 8
- 5.2. Modification of an agreed paediatric investigation plan (PIP) 9
- 5.3. Waivers 9
- 5.3.1. Product-specific waiver 9
- 5.3.2. Request for confirmation of the applicability of the Agency decision on class waivers 10
- 5.4. Compliance check request 11
- 6. Validation of application and start of procedure 12
- 7. Assessment 12
- 8. Answers to PDCO Request for Modification (RfM) - re-submission following clock-stop 12
- 9. PDCO opinion1F 13
- 9.1. Prior to adoption of opinion 13
- 9.2. Oral explanation meeting 14
- 9.3. Opinion 14
- 10. Re-examination of PDCO opinion 14
- 11. EMA decision 14
- 12. Other paediatric procedures 15
- 12.1. Request for confirmation of the applicability of the Agency decision on class waivers 15
- 12.2. Request for confirmation of condition versus indication 15
- 12.3. Discontinuation of paediatric development 15
- 12.4. Annual reports on deferrals 16
- 12.5. Placing paediatric medicines on the market 16
- 13. Changing contacts or transferring a PIP 16
- 13.1. Changing contacts 16
- 13.2. Transferring a PIP to another company 17
