IPO An application for a paediatric extension of granted certificate SPC/GB/95/010 was filed. The preliminary view of the examiner was that this application did not meet the requirements of Article 8(1)(d)(i) of Regulation (EEC) No. 1768/92 as it did not include a copy of the statement of compliance with an agreed completed paediatric investigation plan as referred to in Article 36(1) of EC Regulation (EC) No. 1901/2006. This view was upheld by the Hearing Officer who considered the relevance of Articles 8, 23, 24, 29 and 36 of Regulation (EC) No. 1901/2006 and IPO decision BL O/035/09 (Merck and Co. Inc). He further found that the application did not fulfil the condition of Article 8(1)(d)(ii) of Regulation (EEC) No. 1768/92 to prove that the product was approved for use in all EU member states. This he found to be an explicit requirement under Article 36(3) when the Mutual Recognition Procedure (MRP), as set out in Articles 32-34 of Directive 2001/83/EC, is used to gain approval for variation of the marketing authorisation. The documents supplied, a commission decision under Article 29 of Regulation (EC) No. 1901/2006, a preliminary variation assessment report from the national competent authority of the reference member state and an opinion from the Paediatric Committee of the European Medicines Agency (EMeA) on compliance with an agreed completed paediatric investigation plan were not sufficient to meet the requirements under Article 36 of Regulation (EC) No. 1901/2006 regarding a statement of compliance with an agreed completed paediatric investigation plan and that the product was approved for use in all EU member states.
Citations:
[2009] UKIntelP o09609
Links:
Jurisdiction:
England and Wales
Intellectual Property
Updated: 21 October 2022; Ref: scu.457321
