1: Home (ALT-H)
2: HMA Joint (ALT-M)
3: Human Medicines (ALT-U)
- 3.1: Heads of Agencies (ALT-E)
- 3.2: CMDh (ALT-C)
- 3.3: MRI Product Index (ALT-R)
- 3.4: Directory (ALT-I)
4: Veterinary Medicines (ALT-V)

You are here: Human Medicines > CMDh > Procedural Guidance > Art 61.3 Procedure

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 Working Parties / Working Groups (ALT-K)
3.2.10: Paediatric Regulation
3.2.11: Pharmacovigilance Legislation
3.2.12: Questions & Answers (ALT-Q)
3.2.13: Contact Form
3.2.14: Contact Points
3.2.15: What's new history (ALT-Y)

Art. 61.3 Procedure

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

CMDh Standard Operating Procedure for Article 61(3) changes to patient information and the notification for product information amendment under Article 61(3) (not accompanying a variation change) (October 2011) [Track version]

Flowchart for the Article 61(3) procedure (July 2007)

Notification Form (July 2011) [PDF]