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CHAPTER 5 VARIATIONS 1. Introduction In accordance with Directives 65/65/EEC and 81/851/EEC, a marketing authorization for a medicinal product is granted for a period of 5 years, renewable upon application

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Chapter 5 variations refer to changes or modifications made to a specific chapter in a document or agreement.

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Chapter 5 variations can be filled out by detailing the specific changes or modifications needed in the designated chapter of the document or agreement.

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Chapter 5 variations must include details of the specific changes or modifications made to the designated chapter.

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