Ravimiametite juhtide koostöövõrgustikust (HMA)

HMA on koostöövõrgustik, kuhu kuuluvad liikmesriikide pädevate asutuste juhid, kelle juhitud riiklikud asutused reguleerivad humaan- ja veterinaarravimite valdkonda Euroopa majanduspiirkonnas.

HMA juhid teevad koostööd Euroopa ravimiametiga (EMA) ja Euroopa Komisjoniga, et hoida käigus Euroopa ravimiregulaatorite võrgustikku ning see on vabatahtlike ja kohustuslike tegevuste unikaalne koostöö ja jagamise mudel.

HMA tööd koordineerib ja kontrollib juhtgrupp ja seda toetavad mitmete spetsiifiliste valdkondade töörühmad ning alaline sekretariaat.

Peamised tegevused

HMA:

käsitleb kõige tähtsamaid strateegilisi küsimusi võrgustikus, näiteks teabevahetust, infotehnoloogia arengut ja jagab parimaid praktikaid
keskendub Euroopa ravimiregulaatorite võrgustiku arengule, koordineerimisele ja kokkusobivusele
tagab kõige tõhusama ressursside kasutamise koostöövõrgustikus. See tähendab ka tööjaotuse arendamist ja ülevaatust.
koordineerib vastastikuse tunnustamise (MRP) ja detsentraalsete menetluste (DCP) protseduure.

Ravimiametid toetavad võrgustikku võimaldades kõrgekvaliteedilist professionaalset ja teaduslikku ressurssi kõigile ravimiregulatsioonide aladele, kaasa arvatud tsentraalsed, MRP, DCP ja riiklikud protseduurid.

ABOUT HMA | RECENTLY PUBLISHED

CTCG Key documents list
modified 20/12/2024

EU NTC Members and Representatives
modified 19/12/2024

HMA/EMA guidance document on the identification of personal data and…
modified 18/12/2024

HMPWG Reports
modified 05/12/2024

HMPWG Guidance documents on Quality
modified 02/12/2024

JAP Programme
modified 18/11/2024

Pharmaceutical Inspection Co-operation Scheme (PIC/S)
modified 18/11/2024

JAP Contact
modified 18/11/2024

JAP Members and Representatives
modified 18/11/2024

HMA MANAGEMENT GROUP The Heads of Medicines Agencies (HMA) Management Group, as…
modified 14/11/2024

DOWNLOADS

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

History and milestones

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QUICK LINKS

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Medicines Approval System
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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

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2024	Hungary
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.