Module 6

03/10/2024

Regulatory framework for PV

Binding on Member States as to results to be achieved

Regulations European Law

Directives Directive 2001/20/EC (CT) 2010/84/EC (P-M)

Method of implementation at discretion of national governments

Decisions

Implemented within a stated period

Recommendations and Opinions

Issued by the Council of Ministers

Publiciation in the Official Journal

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7

Status of GVP Modules within EU Legislation

Regulation 726/2004 Regulations EU 1235/2010, 520/2012

Regulations European Law

2001/83/EC 2004/24/EC 2004/27/EC 2001/20/EC

Directives 2010/84/EC Directive

Directives

Decisions

Recommendations and Opinions

Publication in the Official Journal

Volume 9A Guideline Good Vigilance Practices

8

8

4