Commission Regulation (EC) No 1234/2008of 24 November 2008concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products(Text with EEA relevance) (revoked)
CHAPTER IGENERAL PROVISIONS
Article 1Subject matter and scope
Article 2Definitions
Article 3Classification of variations
Article 4Guidelines
Article 5Recommendation on unforeseen variations
Article 6Variations leading to the revision of product information
Article 7Grouping of variations
CHAPTER IIVARIATIONS TO MARKETING AUTHORISATIONS GRANTED IN ACCORDANCE WITH DIRECTIVE 87/22/EEC, CHAPTER 4 OF DIRECTIVE 2001/82/EC OR CHAPTER 4 OF DIRECTIVE 2001/83/EC
Article 8Notification procedure for minor variations of type IA
Article 9Notification procedure for minor variations of type IB
Article 10‘Prior Approval’ procedure for major variations of type II
Article 11Measures to close the procedures of Articles 8 to 10
Article 12Human influenza vaccines
Article 13Coordination group and arbitration
CHAPTER IIaVARIATIONS TO PURELY NATIONAL MARKETING AUTHORISATIONS
Article 13aNotification procedure for minor variations of type IA
Article 13bNotification procedure for minor variations of type IB
Article 13c‘Prior Approval’ procedure for major variations of type II
Article 13dGrouping of variations to purely national marketing authorisations
Article 13eMeasures to close the procedures of Articles 13a to 13c
Article 13fHuman influenza vaccines
CHAPTER IIIVARIATIONS TO CENTRALISED MARKETING AUTHORISATIONS
Article 14Notification procedure for minor variations of type IA
Article 15Notification procedure for minor variations of type IB
Article 16‘Prior Approval’ procedure for major variations of type II
Article 17Measures to close the procedures of Articles 14 to 16
Article 18Human influenza vaccines
CHAPTER IVSECTION 1Special procedures
Article 19Extensions of marketing authorisations
Article 20Worksharing procedure
Article 21Pandemic situation with respect to human influenza
Article 22Urgent safety restrictions
SECTION 2Amendments to the decision granting the marketing authorisation and implementation
Article 23Amendments to the decision granting the marketing authorisation
Article 23aThe statement indicating compliance with the agreed completed paediatric investigation...
Article 24Implementation of variations
Article 24aApplication of national provisions on variations to purely national marketing authorisations
CHAPTER VFINAL PROVISIONS
Article 25Continuous monitoring
Article 26Review
Article 27Repeal and transitional provision
Article 28Entry into force
ANNEX IExtensions of marketing authorisations
1.Changes to the active substance(s): 2.Changes to strength, pharmaceutical form and route of administration: 3.Other changes specific to veterinary medicinal products to be administered...
ANNEX IIClassification of variations
1.The following variations shall be classified as minor variations of...2.The following variations shall be classified as major variations of...
ANNEX IIICases for grouping variations referred to in Article 7(2)(b) and Article 13d(2)(b)
1.One of the variations in the group is an extension...2.One of the variations in the group is a major...3.One of the variations in the group is a minor...4.All variations in the group relate solely to changes of...5.All variations in the group are changes to an Active...6.All variations in the group relate to a project intended...7.All variations in the group are changes affecting the quality...8.All variations in the group are changes to the pharmacovigilance...9.All variations in the group are consequential to a given...10.All variations in the group relate to the implementation of...11.All variations in the group are consequential to the assessment...12.All variations in the group are consequential to a given...13.All variations in the group are consequential to a specific...14.All variations in the group are consequential to a specific...
ANNEX IVElements to be submitted
1.A list of all the marketing authorisations affected by the...2.A description of all the variations submitted, including: 3.All necessary documents as listed in the guidelines referred to...4.Where a variation leads to or is the consequence of...5.In the case of variations to centralised marketing authorisations, the...6.In the case of variations to marketing authorisations granted by...
ANNEX V
PART 1PART 21.Variations concerning a change to or addition of a non-food...2.Variations concerning the replacement or addition of a serotype, strain,...3.Variations concerning the replacement of a strain for a veterinary...
ANNEX VIList of Member States referred in Article 24a

Commission Regulation (EC) No 1234/2008

of 24 November 2008

concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products

(Text with EEA relevance) (revoked)

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Annotations:
Amendments (Textual)