Reference:EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12 Article 107n: Difference between revisions
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| | |has_document=Document:EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12 | ||
| | |module=1 | ||
| | |unit=1.5.4 | ||
| | |scope=NIS | ||
| | |doc_part=Article 107n | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
|tags=TAG-00285-Pha-enk ++ TAG-00033-Pro-oto ++ TAG-00276-Mar-inh ++ TAG-00300-Ris-lan | |||
|tags_display=[[Glossary:TAG-00285-Pha-enk|Post-authorisation safety study]], [[Glossary:TAG-00033-Pro-oto|Protocol]], [[Glossary:TAG-00276-Mar-inh|Marketing authorisation holder]], [[Glossary:TAG-00300-Ris-lan|Risk management plan]] | |||
|comment=Protocol submission before conducting a PASS | |||
|content=Article 107n | |||
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Article 107n | |||
1. Before a study is conducted, the marketing authorisation holder shall submit a draft protocol to the Pharmacovigilance Risk Assessment Committee, except for studies to be conducted in only one Member State that requests the study according to Article 22a. For such studies, the marketing authorisation holder shall submit a draft protocol to the national competent authority of the Member State in which the study is conducted. | 1. Before a study is conducted, the marketing authorisation holder shall submit a draft protocol to the Pharmacovigilance Risk Assessment Committee, except for studies to be conducted in only one Member State that requests the study according to Article 22a. For such studies, the marketing authorisation holder shall submit a draft protocol to the national competent authority of the Member State in which the study is conducted. | ||
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3. The study may commence only when the written endorsement from the national competent authority or the Pharmacovigilance Risk Assessment Committee, as appropriate, has been issued. | 3. The study may commence only when the written endorsement from the national competent authority or the Pharmacovigilance Risk Assessment Committee, as appropriate, has been issued. | ||
Where a letter of endorsement as referred to in paragraph 2(a) has been issued, the marketing authorisation holder shall forward the protocol to the competent authorities of the Member States in which the study is to be conducted and may thereafter commence the study according to the endorsed protocol. | Where a letter of endorsement as referred to in paragraph 2(a) has been issued, the marketing authorisation holder shall forward the protocol to the competent authorities of the Member States in which the study is to be conducted and may thereafter commence the study according to the endorsed protocol. | ||
}} | |||
Latest revision as of 13:49, 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 | |
| Reference Details | |
|---|---|
| Module | Module 1 — Unit 1.5.4 |
| Scope | NIS |
| Document part | Article 107n |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Post-authorisation safety study, Protocol, Marketing authorisation holder, Risk management plan |
Content
Article 107n
1. Before a study is conducted, the marketing authorisation holder shall submit a draft protocol to the Pharmacovigilance Risk Assessment Committee, except for studies to be conducted in only one Member State that requests the study according to Article 22a. For such studies, the marketing authorisation holder shall submit a draft protocol to the national competent authority of the Member State in which the study is conducted. 2. Within 60 days of the submission of the draft protocol the national competent authority or the Pharmacovigilance Risk Assessment Committee, as appropriate, shall issue: (a) a letter endorsing the draft protocol;
(b) a letter of objection, which shall set out in detail the grounds for the objection, in any of the following cases:
(i) it considers that the conduct of the study promotes the use of a medicinal product;
(ii) it considers that the design of the study does not fulfil the study objectives; or
(c) a letter notifying the marketing authorisation holder that the study is a clinical trial falling under the scope of Directive 2001/20/EC.
3. The study may commence only when the written endorsement from the national competent authority or the Pharmacovigilance Risk Assessment Committee, as appropriate, has been issued. Where a letter of endorsement as referred to in paragraph 2(a) has been issued, the marketing authorisation holder shall forward the protocol to the competent authorities of the Member States in which the study is to be conducted and may thereafter commence the study according to the endorsed protocol.
