Document:EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12: Difference between revisions
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Latest revision as of 14:15, 16 July 2026
| Document information | |
|---|---|
| Reference | EU Directive 2001/83/EC -
Community code relating to medicinal products for human use 20-Jun-12 |
| Validity area | EU |
| Scope(s) | NIS |
| Document name | Directive 2001/83/EC -
Community code relating to medicinal products for human use |
| Version / Revision | 20-Jun-12 |
| Status | Current |
| Document type | Regulatory requirement |
| Language(s) | EN |
| Description | Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
References
| Scope | Document part | Language | Preview | |
|---|---|---|---|---|
| EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12 Article 107m (1) | NIS | Article 107m (1) | EN | CHAPTER 4
Supervision of post-authorisation safety studies Article 107m 1. This Chapter applies to non-interventional post-authorisation safety st⦠|
| EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12 Article 107n | NIS | Article 107n | EN | Article 107n 1. Before a study is conducted, the marketing authorisation holder shall submit a draft protocol to the Pharmacovigilance Risk Assessm⦠|
