1: Home (ALT-H)
2: HMA Joint (ALT-M)
3: Human Medicines (ALT-U)
- 3.1: Heads of Agencies (ALT-E)
- 3.2: CMD(h) (ALT-C)
- 3.3: MRI Product Index (ALT-R)
- 3.4: Directory (ALT-I)
4: Veterinary Medicines (ALT-V)

You are here: Human Medicines > CMD(h) > Templates > AR > Paediatric Data

3.2.1: About CMDh (ALT-O)
3.2.2: Statistics (ALT-S)
3.2.3: Press Releases (ALT-P)
3.2.4: Procedural Guidance (ALT-L)
3.2.5: CMDh-Referrals
3.2.6: Product Information (ALT-T)
3.2.7: Advice from CMDh
3.2.8: Templates
- 3.2.8.1: QRD (ALT-Q)
- 3.2.8.2: AR
  - 3.2.8.2.1: DCP (AR/Comments) (ALT-N)
  - 3.2.8.2.2: MRP
  - 3.2.8.2.3: Renewals (ALT-W)
  - 3.2.8.2.4: Variations
  - 3.2.8.2.5: Art 61.3 Procedure (ALT-6)
  - 3.2.8.2.6: Public AR
  - 3.2.8.2.7: Paediatric Data
- 3.2.8.3: Applications for MA
- 3.2.8.4: Art.29 Referrals (ALT-2)
- 3.2.8.5: Variations
3.2.9: CMD subgroups / working groups (ALT-G)
3.2.10: Paediatric Regulation
3.2.11: Questions & Answers
3.2.12: Contact Form
3.2.13: Contact Points
3.2.14: What's new history (ALT-Y)

Assessment on Paediatric Data

Template for the Paediatric assessment report
.doc / .dot

Paediatric Regulation: Article 45

Template for AR for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No 1901/2006, as amended (Latest update: July 2010)
.doc / .dot

Public AR for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No 1901/2006, as amended
(Latest update: July 2010)
.doc / .dot
Track changes Click here

Paediatric Regulation: Article 46

Template for AR for paediatric studies submitted in accordance with Article 46 of Regulation (EC) No 1901/2006, as amended (Latest update: July 2010)
.doc / .dot

Public AR for paediatric studies submitted in accordance with Article 46 of Regulation (EC) No 1901/2006, as amended (Latest update: July 2010)
.doc / .dot
Track changes Click here

Comments from the Competent authority on the Paediatric work sharing Preliminary assessment report

Comments from the Competent authority on the Paediatric work sharing Preliminary assessment report for Article 45 and / or Article 46 (June 2009)
doc. / dot.