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Heads of Medicines Agencies: About HMA

The Heads of Medicines Agencies (. Is a network of the heads of the National Competent Authorities (. Whose organisations are responsible for the regulation of medicinal products for human and veterinary use in the European Economic Area. Co-operates with the European Medicines Agency (. And the European Commission. In the operation of the European medicines regulatory network and it is a unique model for cooperation and worksharing on statutory as well as voluntary regulatory activities. Leaflet 'Protec...

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Heads of Medicines Agencies: About HMA | hma.eu Reviews

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The Heads of Medicines Agencies (. Is a network of the heads of the National Competent Authorities (. Whose organisations are responsible for the regulation of medicinal products for human and veterinary use in the European Economic Area. Co-operates with the European Medicines Agency (. And the European Commission. In the operation of the European medicines regulatory network and it is a unique model for cooperation and worksharing on statutory as well as voluntary regulatory activities. Leaflet 'Protec...

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1 human medicines

2 veterinary medicines

3 you are here

4 vision and mission

5 structure

6 working groups

7 national contacts

8 transparency

9 meetings

10 medicines approval system

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human medicines,veterinary medicines,you are here,vision and mission,structure,working groups,national contacts,transparency,meetings,medicines approval system,publications and reports,recently published,main activities,and national procedures,psur,hmpwg

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Heads of Medicines Agencies: About HMA | hma.eu Reviews

https://hma.eu

The Heads of Medicines Agencies (. Is a network of the heads of the National Competent Authorities (. Whose organisations are responsible for the regulation of medicinal products for human and veterinary use in the European Economic Area. Co-operates with the European Medicines Agency (. And the European Commission. In the operation of the European medicines regulatory network and it is a unique model for cooperation and worksharing on statutory as well as voluntary regulatory activities. Leaflet 'Protec...

INTERNAL PAGES

hma.eu

1

Heads of Medicines Agencies: What's new history

http://www.hma.eu/186.html

CMD Working Parties / Working Groups. What's new (last 6 Months). This is the 'What's new' page for the Human Medicines section. Added in August 2016. NEW- Statistics on Member States acting as Rapporteur in Paediatric worksharing procedure - Art.45 and Art.46. UPDATE - Contact Points. UPDATE - Chapters 4 and 5 of the Best Practice Guide on Variations. NEW - June 2016 CMDh Minutes. NEW - Minutes from the CMDh meetings with Interested Parties in May 2016. Added in July 2016. NEW - Addendum to the. NEW - T...

2

Heads of Medicines Agencies: CMDh

http://www.hma.eu/cmdh.html

CMD Working Parties / Working Groups. Meeting with Interested Parties on. Improvements - 23 May 2016 MinutesPr. CMDh meeting with Interested Parties - 24 May 2016 MinutesPresentationsCMDh str. CMDh SOP on the processing of. Single assessment for nationally authorised p. List of documents published on CMDh Website. The CMDh started its activities in November 2005, replacing the informal Mutual Recognition Facilitation Group (. Examination of questions related to variations;. Laying down, yearly, a list of...

3

Heads of Medicines Agencies: Application for MA

http://www.hma.eu/91.html

Consultation with target patient groups. Art 61.3 Procedure. CMD Working Parties / Working Groups. Application for Marketing Authorisation (. In order to view some of the documents on this website you need Acrobat Reader. Click here to download). Best Practice Guide for the Decentralised and Mutual Recognition Procedures. April 2013) [ Track version. Best Practice Guide on the Assessment Report for Mutual Recognition and Decentralised Procedures. July 2011) [ Track version. April 2016) [ Track version.

4

Heads of Medicines Agencies: eSubmissions

http://www.hma.eu/277.html

Consultation with target patient groups. Art 61.3 Procedure. CMD Working Parties / Working Groups. Further guidance on eSubmissions can be found on the. CMDh Best Practice Guide on the use of eCTD in the. June 2015) [ Track version. Any change requests for the document should be handled in accordance with the change request instructions given on the. Release notes to the CMDh Best Practise Guide on the use of eCTD in the. Technical validation of eCTD submissions for new MAAs in. May 2016) [ Track version.

5

Heads of Medicines Agencies: Variation

http://www.hma.eu/96.html

Consultation with target patient groups. Art 61.3 Procedure. CMD Working Parties / Working Groups. In order to view some of the documents on this website you need Acrobat Reader. Click here to download). Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition Procedure. April 2013) [ Track version. Please note: for purely national Marketing Authorisations these Best Practise Guides will apply from 4 August 2013). July 2014) [ Track version. Human medicinal pr...

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Association of Veterinary Consultants - AVC

http://www.avc.at/default.asp

AVC - Association of Veterinary Consultants. The Association of Veterinary Consultants, the association of completely independent, self employed veterinary specialists, aims at pushing veterinary support and science in the animal health and food sector by supporting global harmonisation of standards for animal health and animal derived products, assuring animal, user and environmental safety and other ethical principles as defined in the AVC - Code of Practice [PDF]. EMA [www.emea.europa.eu].

raajpharmaelearning.com

Pharma Onsite Offshore Training | AnimalHealth Courses in Mumbai | Pharmaceuticals and Allied sectors Courses in Thane | Biotech BioSimilars Courses in Pune

http://www.raajpharmaelearning.com/Useful-links.php

Rajashrio@gmail.com spectrumraajinfo@gmail.com. Info@rajgprac.com raajgprac@gmail.com. Contact : 9819125208 9821144706. ISO 9001:2008 CERTIFIED INSTITUTE. On-site and Off-Shore Training. Pharmaceuticals and Allied sectors. Medical Devices and Diagnostics. Foods,Herbals and Neutraceuticals. Therapeutic Goods Adminstration (TGA). Bundesministerium für Geshundheit und Frauen. Federal Public Service Health, Food Chain Safety and Environment. Wwwhc-sc.gc.ca/index-eng.php. State Institute for Drug Control.

awafarm.waw.pl

Linki - AWAFARM

http://www.awafarm.waw.pl/linki

Adresy wybranych agencji rejestracyjnych i organizacji międzynarodowych. Zajmujących się problematykę rejestracji leków:. European Commission: Enterprise and Industry. European Directoriate for the Quality of Medicines and HealthCare (EDQM). European Medicines Agency (EMA). Federal Institute for Drugs and Medical Devices (Niemcy). Food and Drug Administration (FDA, USA). French Health Products Safety Agency (AFSSAPS, Francja). Medical Products Agency (MPA, Szwecja). National Institute of Pharmacy (Węgry).

compliancegroup.eu

Useful Links | the compliance group

http://compliancegroup.eu/useful-links

The Health Products Regulatory Authority. The European Medicine Agency. The Heads of Medicines Agencies. The International Council for Harmonisation. The European Directorate for the Quality of Medicines and Healthcare. The Health Service Executive. Website design and support by LeanWeb. This site uses cookies More info.

qrcc.co.uk

Clinical research links

http://www.qrcc.co.uk/UsefulLinks.php

QA and Regulatory Compliance. Links to the sites for UK, European and other international agencies and industry groups. 1 UK agency and industry links:. Http:/ www.mhra.gov.uk. Http:/ www.dh.gov.uk/. Http:/ www.hra.nhs.uk/. Http:/ www.nres.nhs.uk. Http:/ www.crncc.nihr.ac.uk/. Http:/ www.abpi.org.uk. Http:/ www.therqa.com/. Http:/ www.topra.org/. Http:/ www.icr-global.org/. Http:/ www.pipaonline.org/. Http:/ www.ccra.org.uk/. 2 European Agencies - EU and EEA. European Agency Medicines (EMA):. Http:/ www&...

edqm.eu

Pharmaceuticals and Pharmaceutical Care - EDQM

http://www.edqm.eu/en/pharmaceuticals-and-pharmaceutical-care-1271.html

Council for europe portal. Menu top (level 1). Bouton d'ouverture du menu. Quality Management (QM) Documents. Vision, Mission and Values. How to visit the EDQM. The Ph. Eur. work programme. Where to find: the Knowledge database. Alternative to animal testing (3Rs). Looking for info on Ph. Eur. texts (Knowledge Database). Have a question about Ph. Eur. texts? How to order Publications. Ph Eur. 8th Edition Publication Schedule. Ph Eur. 8th Edition online (existing clients). Pharmeuropa Bio and SN online.

pharmabide.gr

Regulatory Affairs | PHARMABIDE

http://www.pharmabide.gr/regulatory-affairs

Our Regulatory Affairs Team has extensive experience in providing regulatory support in the European Union and Abroad. Our Human Medicines services involve Pre-submission and Post-approval procedures, while we also engage, with great success, in Medical Devices, Cosmetics and Food Supplements Regulatory Affairs. Consulting on Regulatory Procedures and Submission Strategy. Evaluation of Product Submission Dossier. Mutual Recognition Procedures (MRP). Including module 1 preparation. Notification of medical...

healthquestfoundation.com

Health-QUEST Foundation | Knowledge Updates

http://www.healthquestfoundation.com/client.php

One Day Symposium on Quality Metrics and Good Automated Manufacturing Practices-5 (GAMP-5) for Pharmaceuticals Industry. A Ceremony to grace Honor to IAF Garud Commando Corporal Shailabh Gaur; One of the Real Heroes of Pathankot Attacks. One day Symposium on Current Regulatory Updates in Pharmaceuticals Industry at Hotel KC Cross, Panchkula. Free Health Checkup cum Medicines Distribution Camp for Hindus migrated from Pakistan at Delhi. Click the following links for access to various regulatory agencies:.

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hma.eu

Heads of Medicines Agencies: About HMA

The Heads of Medicines Agencies (. Is a network of the heads of the National Competent Authorities (. Whose organisations are responsible for the regulation of medicinal products for human and veterinary use in the European Economic Area. Co-operates with the European Medicines Agency (. And the European Commission. In the operation of the European medicines regulatory network and it is a unique model for cooperation and worksharing on statutory as well as voluntary regulatory activities. Leaflet 'Protec...

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