Hma.eu

Heads of Medicines Agencies: About HMA

WebThe Heads of Medicines Agencies (HMA) is a network of the heads of the National Competent Authorities (NCA) whose organisations are responsible for the regulation of …

Actived: 9 days ago

URL: https://www.hma.eu/

Availability of Medicines for Human Use

WebRegarding the transparency of shortages and the information provided within the Member States, the HMA compiled an overview to share publicly the knowledge on availability …

Category: Health Go Health

Medicines Approval system

WebThe mutual recognition procedure (MRP) is a European authorisation route resulting in a mutually recognised product.Mutual recognition must be used when a product is already …

Category: Health Go Health

Product Information

WebProduct Information. In the follwing list you can find NCA Websites with links to their information on Authorised Human Medicines if available (as of October 2012) Member …

Category: Medicine Go Health

Heads of Medicines Agencies: CMDh

WebThe CMDh started its activities in November 2005, replacing the informal Mutual Recognition Facilitation Group (MRFG), which was in operation over 10 years, to coordinate and …

Category: Health Go Health

Heads of Medicines Agencies: Procedural Guidance

WebFor the United Kingdom, as of 1 January 2021, European Union law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland / NI.

Category: Health Go Health

BEST PRACTICE GUIDE for Grouping of Variations

WebBEST PRACTICE GUIDE . for . Grouping of Variations . Edition number : 01 . Edition date: 10/10/2013 . Implementation date : 01/01/2010 . CMDv Secretariat:

Category: Health Go Health

Heads of Medicines Agencies: CMDh Composition

WebMember: Sabina Uzeirbegović. Alternate: Gorana Perina Lakoš. Agency for Medicinal Products and Medical Devices of the Republic of Croatia. Ksaverska cesta 4. 10 000 …

Category: Medical Go Health

Heads of Medicines Agencies: National Contacts

WebHealth Products Regulatory Authority (HPRA) Address. Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace Dublin 2. Country. Ireland. Phone. +353 1 676 4971. Fax. +353 …

Category: Health Go Health

DECENTRALISED PROCEDURE MEMBER STATES’ STANDARD …

WebThis is also an opportunity for MSs to discuss outstanding PL and labelling concerns with the applicant. If further discussion is needed in CMD(h), the RMS will give an oral report of …

Category: Health Go Health

RECOMMENDATIONS ON MULTIPLE/DUPLICATE …

WebRevision 3, June 2007. This document was produced by the CMD(h) in order to facilitate and harmonise the regulatory issues for submission of multiple applications so called …

Category: Health Go Health

Heads of Medicines Agencies: Nitrosamine impurities

WebStep 1: Risk evaluation. Conduct a risk evaluation to identify active substances and finished products at risk of N-nitrosamine formation or (cross-)contamination and report the …

Category: Health Go Health

Section 3 (i) Stakeholders

WebIn summary the reasons for communication with stakeholders are:-. Protection of public health through:-. Rapid communication of appropriate, quality information to a clearly …

Category: Health Go Health

BEST PRACTICE GUIDE FOR MUTUAL RECOGNITION …

WebA reference to previous discussions in CMD(h) or MRFG should be included in the Assessment Report, if applicable. The CMS should also include reference to other …

Category: Health Go Health

GUIDANCE for Administration of the Sunset Clause

WebThe monitoring of the so-called Sunset clause provision will be based on the data related to marketing of the products as reported by the MAH. It should be noted that the application …

Category: Health Go Health

BEST PRACTICE GUIDE For Type II Variations CMDv/BPG/006 …

Web3.9 SOP for disagreement in procedures Referral to CMDv (CMDv/SOP/001). 4. Timescales. 4.1 Type II variations are normally processed according to a 60 day timescale; however, …

Category: Health Go Health

Packaging ‘blue-box’ requirements for products authorised …

WebCMDv-GUI-27. EMA/CMDv/391895/2012. Version 072904/101/2014. Formatted: Swedish (Sweden) Packaging ‘blue-box’ requirements for products authorised via. national, …

Category: Health Go Health