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4.2.1: About CMD(v), Activities (ALT-O)
4.2.2: CMD(v) guidance (ALT-G)
- 4.2.2.1: General Info on Licensing System (ALT-N)
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4.2.3: Definition of
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4.2.11: What's new Archive (6 months) (ALT-6)

Best Practice Guides - Commission Regulation (EC) No 1234/2008

Type IA Variations

Type IB Variations

Type II Variations

Grouping of variations

Worksharing (version in tracked changes)

Worksharing - Applicant's letter of intent

Unforseen variations, Article 5

Status of implementation of Commission Regulation (EC) No 1234/2008 (the ‘variation regulation’) by Member States to purely national Marketing
Authorisations

Recommendations for classification of unforeseen variations according to article 5 of Commission Regulation (EC) 1234/2008, click below:

Veterinary applications

Human applications

Article 5: Request Form

Art. 5 classification request - Timetable

QUESTIONS AND ANSWERS

CMDh Q&A list for the submission of variations according to Commission Regulation (EC) 1234/2008 (December 2009), click here

Link to the European Commission website on Procedural and Classification guidelines

Guidelines

Variations webpage