Everything you care about in one place
Follow feeds: blogs, news, RSS and more. An effortless way to read and digest content of your choice.
Get Feederema.europa.eu
Regulatory and procedural guidelines (human and veterinary)
Get the latest updates from Regulatory and procedural guidelines (human and veterinary) directly as they happen.
Follow now 343 followers
Latest posts
Last updated 4 days ago
Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 1
4 days ago
Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO)...
Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe: Introduction - EU Implementation Guide
4 days ago
Products Management Services - Implementation of International Organization for Standardization (ISO) standards...
Guidance on the anonymisation of protected personal data and assessment of commercially confidential information during the preparation of RMPs (main body and annexes 4 and 6)
22 days ago
Guidance on the anonymisation of protected personal data and assessment of commercially...
Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group
25 days ago
Table of decisions of labelling exemption requests falling under article 63 of...
Union procedure on the preparation, conduct and reporting of EU pharmacovigilance inspections
about 2 months ago
Procedural advice for orphan medicinal product designation: Guidance for sponsors
2 months ago
Procedural advice for orphan medicinal product designation: Guidance for sponsors
Connection template - EMA ESTRI Gateway using an AS2 compatible product
2 months ago
Connection template - EMA ESTRI Gateway using an AS2 compatible product
Deadlines for submission of applications for orphan medicinal product designation to the EMA and corresponding COMP timetable for valid applications - 2024-2025
2 months ago
Deadlines for submission of applications for orphan medicinal product designation to the...