Introductory Text
Scope and definitions
Article 1.. . . . . . . . . ....
Article 2.. . . . . . . . . ....
Article 3.. . . . . . . . . ....
Notification procedure for minor variations
Article 4.. . . . . . . . . ....
Article 5.. . . . . . . . . ....
Approval procedure for major variations
Article 6.. . . . . . . . . ....
Article 7.. . . . . . . . . ....
Article 7a.. . . . . . . . . ....
Article 7b.. . . . . . . . . ....
Article 8.. . . . . . . . . ....
Signature
ANNEX I
MINOR VARIATIONS (TYPE I) TO A MARKETING AUTHORIZATION AS REFERRED TO IN ARTICLE 3 (1)
Introductory statements
ANNEX II
Changes to a marketing authorization leading to a new application as referred to in Article 2
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