View source for Reference:EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12 Article 107m (1)

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{{:Document:EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12}}

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! colspan="2" class="gplx-infobox-header" | Reference Details
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! Scope
| NIS
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! Document part
| Article 107m
(1)
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! Language
| EN
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! Original entry by
| Florian Adragna
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! Contributors
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! Tags (EN)
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! Tags (original language)
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! Tags (FR)
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! Comment
| Supervision of post-authorisation safety studies (PASS)
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== Content ==
CHAPTER 4
Supervision of post-authorisation safety studies

Article 107m

1.   This Chapter applies to non-interventional post-authorisation safety studies which are initiated, managed or financed by the marketing authorisation holder voluntarily or pursuant to obligations imposed in accordance with Articles 21a or 22a, and which involve the collection of safety data from patients or healthcare professionals.