Om The Heads of Medicines Agencies (HMA)

HMA er et netværk, der består af direktørerne for de nationale europæiske lægemiddelmyndigheder, som er ansvarlige for reguleringen af lægemidler til mennesker og dyr inden for det europæiske økonomiske samarbejdsområde (EØS).

HMA samarbejder med det Europæiske Lægemiddelagentur (EMA) og Europa-Kommissionen om at drive det europæiske netværk for medicinregulering, og det er en unik model for samarbejde og arbejdsdeling om lovpligtige og frivillige reguleringsaktiviteter.

HMA koordineres og ledes af en ledelsesgruppe og understøttes af flere arbejdsgrupper, der dækker specifikke ansvarsområder, og af et fast sekretariat.

Hovedaktiviteter

HMA

håndterer vigtige strategiske områder for netværket som udveksling af informationer, it-udvikling og videndeling om best practice
fokuserer på udvikling, koordinering og ensretning af medicinreguleringen i Europa
sikrer, at ressourcerne udnyttes på den mest effektive måde på tværs af netværket. Det omfatter udvikling og overvågning af tiltag inden for arbejdsdeling
koordinerer den gensidige godkendelsesprocedure (MRP) og den decentrale godkendelsesprocedure (DCP).

Medlemmerne understøtter netværket ved at bidrage med faglige og videnskabelige ressourcer af høj kvalitet til alle områder inden for regulering af medicin, herunder de centrale, gensidige, decentrale og nationale procedurer.

ABOUT HMA | RECENTLY PUBLISHED

SAFE CT
modified 23/04/2024

CTCG Key documents list
modified 22/04/2024

HMA Guide to Managing Declarations of Interest
modified 19/04/2024

CTCG News and events
modified 25/03/2024

WGEO Members and Representatives
modified 21/03/2024

WGEO Introduction/Overview/Mandate
modified 13/03/2024

Key documents list
modified 13/03/2024

WGEO Activities and achievements
modified 13/03/2024

Working Groups Joint
modified 07/03/2024

Working Groups Human
modified 07/03/2024

DOWNLOADS

HMA leaflet 'Protecting and Promoting Public and Animal Health in Europe | pdf
Updated July 2019

History and milestones

THIS PAGE IN YOUR LANGUAGE

QUICK LINKS

CMDh
CMDv
Medicines Approval System
Compassionate Use Programmes
Availability of Medicines

COVID-19

As a network of the National Competent Authorities (NCAs) in the EU, the HMA is cooperating together with EMA and the European Commission to fight the outbreak of the novel coronavirus disease (COVID-19).

All the COVID-19 related information, guidelines and other documents relevant to the European Medicines Regulatory Network can be found here.

HMA Calendar

No events

2024	Belguim
2023	Spain
2023	Sweden
2022	Czech Republic
2022	France
2021	Slovenia
2021	Portugal

The United Kingdom submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union. This means that unless a ratified withdrawal agreement establishes another date, all Union primary and secondary law ceases to apply to the United Kingdom from the UK withdrawal date. The United Kingdom will then become a 'third country'.

Preparing for the withdrawal is therefore not just a matter for EU and national authorities, but also for private parties.

For centrally authorised products please find guidance by the European Medicines Agency and European Commission here.
For questions & answers on EU actions to prevent medicine shortages due to Brexit please find the information prepared by the European Medicines Agency here.

For products authorised in decentralised or mutual recognition procedures please find guidance by CMDh here and CMDv here.
For information to sponsors of clinical trials regarding continuous compliance with the EU legislation following Brexit please find the joint technical notice by the European Commission, EMA and HMA here.
For country specific issues please revert to the NCA in that country.
The Heads of Medicines Agencies would like to reiterate the paramount importance for all involved to prepare for withdrawal in the interest European human and animal health.