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) > Procedural Guidance > USR

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)
- 3.2.4.1: General Info (ALT-G)
- 3.2.4.2: Application for MA (ALT-T)
- 3.2.4.3: eSubmissions (ALT-N)
- 3.2.4.4: Generics
- 3.2.4.5: Applicant´s Responses
- 3.2.4.6: Renewal (ALT-W)
- 3.2.4.7: Variation
- 3.2.4.8: USR
- 3.2.4.9: Art 61.3 Procedure (ALT-6)
- 3.2.4.10: Consultation with target patient groups
- 3.2.4.11: Post Referral Phase
- 3.2.4.12: Pandemic Plan
3.2.5: CMDh-Referrals
3.2.6: Product Information
3.2.7: Advice from CMDh
3.2.8: Templates
3.2.9: CMD subgroups / working groups (ALT-K)
3.2.10: Paediatric Regulation
3.2.11: Questions & Answers (ALT-Q)
3.2.12: Contact Form
3.2.13: Contact Points
3.2.14: What's new history (ALT-Y)

Urgent Safety Restriction

In order to view some of the documents on this website you need Acrobat Reader
(click here to download)

Urgent Safety Restriction Members States' Standard Operating Procedure (Last Update: March 2010)
Click here