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This Question and answers section gives advice on regulatory issues in connection with the Mutual Recognition and Decentralised Procedures. Reference is made, where additional information is available from CMDh guidance documents.
For general regulatory guidance on the interpretation and implementation of the new pharmaceutical legislation, please refer to the Notice to Applicants, where updated guidance will be published by the European Commission.
Index Questions & Answers:
- Eagle Outfitters Leisure Shorts American winter Denim w4vv1Fq [Track version] (January 2018)
- Wordmark Packers T Shirt Men's Nike NFL Essential eSubmissions [Track version] (June 2015)
Nike Wordmark T Shirt NFL Men's Essential Packers Further Q&As covering issues of eCTD dossier submission and handling under the new variations regulation
- amp; Casual winter Barrow Croft Boutique Dress EqwBIfnwA [Track version] (December 2012)
- Paediatric Regulation [Pullover amp;Co Style winter Sweater Boutique EqOtw66x] (January 2015)
Further Q&As have been published on the EMA website
- Post-Authorisation Efficacy Studies (PAES) in MRP/DCP (November 2015)
- Renewals (November 2012)
- Usage Patents (October 2012)