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EMA Webinar on submissions of parallel distribution notifications for centrally authorised products (CAPs) FDA Addition of the new validation error code 1738. Update to the 4.4 problems for error code 1735. Update the description and effective date for error code...
IRISS IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants (updated) EMA Digital application dataset integration (DADI) and Product Management Service (PMS) webinar - Variations form for human medicinal products - What will happen...
EMA Referrals document: Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products (updated) Regulatory and procedural guideline: European Medicines Agency...
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