EU Legislation – Free Handbook
NaviReg was created with the aim of improving the clarity and accessibility of EU legislation and related rules (from official sources, unchanged). The platform does not use any AI systems or automated translations. It is a platform created by people for people.
We’re busy behind the scenes – adding more content every day.
Here you can see up-to-date lists of regulations we plan to add/have added in the fields of Pharmaceuticals, Medical Devices, Foods for special medical purposes and Cosmetics.
We are aware it’s not winning any design awards just yet. But we’re focused on filling NaviReg with meaningful content first. The makeover will come in due time – it’s a promise!
Please send your ideas and suggestions for improvement to: compliance@qmfocus.com.
List of regulations
| Legal act | Detail | Official source |
|---|---|---|
| DIRECTIVE 2001/83/EC | Regulation detail | Eur-Lex |
| REGULATION (EC) No 726/2004 | Regulation detail | Eur-Lex |
| REGULATION (EC) No 1234/2008 | Regulation detail | Eur-Lex |
| REGULATION (EU) No 520/2012 | Regulation detail | Eur-Lex |
| GVP – Annex I: Definitions | Regulation detail | EMA |
| GVP – Module I: Pharmacovigilance systems and their quality systems | Regulation detail | EMA |
| GVP – Module II: Pharmacovigilance system master file | Regulation detail | EMA |
| GVP – Module III: Pharmacovigilance inspections | Regulation detail | EMA |
| GVP – Module IV: Pharmacovigilance audits | Regulation detail | EMA |
| GVP – Module V: Risk management systems | Regulation detail | EMA |
| GVP – Module VI: Collection, management and submission of reports of suspected adverse reactions to medicinal products | Regulation detail | EMA |
| GVP – Module VI Addendum I: Duplicate management of suspected adverse reaction reports | Regulation detail | EMA |
| GVP – Module VII: Periodic safety update report | Regulation detail | EMA |
| GVP – Module VIII: Post-authorisation safety studies | Regulation detail | EMA |
| GVP – Module IX: Signal management | Regulation detail | EMA |
| GVP – Module IX Addendum I: Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions | Regulation detail | EMA |
| GVP – Module X: Additional monitoring | Regulation detail | EMA |
| GVP – Module XV: Safety communication | Regulation detail | EMA |
| GVP – Module XVI: Risk minimisation measures | Regulation detail | EMA |
| GVP – Module XVI: update of revision no. 3 and Annex I | Regulation detail | EMA |
| GVP – Module XVI Addendum I: Educational Materials | Regulation detail | EMA |
| GVP – Module XVI Addendum II: Methods for evaluating effectiveness of risk minimisation measures | Regulation detail | EMA |
| GVP – Module XVI Addendum III: Pregnancy prevention programme and other 5 pregnancy-specific risk minimisation measures | Regulation detail | EMA |
| PHV-3 | Regulation detail | Czech Rep.: SÚKL |
| PHV-4 | Regulation detail | Czech Rep.: SÚKL |
| PHV-6 | Regulation detail | Czech Rep.: SÚKL |
| PHV-7 | Regulation detail | Czech Rep.: SÚKL |
| REGULATION (EU) 2017/745 | Regulation detail | Eur-Lex |
| PHV-8 | Regulation detail | Czech Rep.: SÚKL (CS only) |
| UST-45 | Regulation detail | Czech Rep.: SÚKL |
| UST-47 | Regulation detail | Czech Rep.: SUKL (CS only) |
| UST-46 | Regulation detail | Czech Rep.: SÚKL |
| DIS-13 | Regulation detail | Czech Rep.: SÚKL |
Most important news
NaviReg – content
Current and planned situation & suggest your ideas and priorities