Voltar 15 abr 2020
  • Novidades 13 de Abril 2020 0

EC - EUROPEAN COMISSION

 

Medicines for Europe welcomes European Commission decision to enable secure supply of hospital medicines

Medicines for Europe welcomes the temporary framework adopted today by the European Commission to facilitate cooperation initiatives aimed at securing supply of hospital medicines during the COVID-19 pandemic.

 

A statement from the President on COVID-19

As President of Medicines for Europe, and someone who is directly involved in medicine production and supplynI want to be clear on the urgency surrounding Medicines for Europe’s main objective – to ensure supply andnavailability of medicines during this unprecedented public health crisis. Our industry looks at this in a number of different ways.

 

Guidelines on the optimal and rational supply of medicines to avoid shortages during the COVID-19 outbreak

These guidelines aim to protect public health and preserve the integrity of the single market, whilst ensuring that Europe has the supply of affordable medicines it needs during the COVID-19 outbreak. They focus on the rational supply, allocation and use of medicines to treat COVID-19 patients. They also cover any medicine at risk of shortage due to the COVID-19 pandemic.

 

Factsheet - Guidelines to optimise supply and avoid medicines shortages

Guidelines to optimise supply and avoid medicines shortages

 

Statement by Ursula von der Leyen, President of the European Commission - Guidelines to ensure supply and availability of medicines (COVID-19)

Coronavirus: Statement by Ursula von der Leyen, President of the European Commission, on guidelines to ensure supply and availability of medicines

 

 

ECA - EUROPEAN COMPLIANCE ACADEMY

 

COVID-19: Temporary Regulatory Flexibilities for Wholesalers in the UK

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a list of temporary regulatory flexibilities on good distribution practices (GDP) that will be allowed to address the current exceptional circumstances during the coronavirus (COVID-19) outbreak. 

 

 

Home Office: is a remote Release possible?

Due to the current Sars-CoV-2 outbreak, more and more people started working from home; this includes Qualified Persons (QPs). But what do the regulators say when it comes to batch certification?

 

 

 

EDQM 

 

The EDQM’s contributions to the protection of public health in the COVID-19 pandemic: latest information

The EDQM’s core activities include the provision of documentary and physical (reference) standards to ensure the quality of medicines and their ingredients. Availability of and access for patients to quality medicines is more important than ever in the context of the current COVID-19 pandemic.

 

 

EMA - EUROPEAN MEDICINES AGENCY

Compilation of Quality Review of Documents decisions on stylistic matters in product information (updated)

At its monthly meeting, EMA’s safety committee (PRAC) has started a review of medicines containing ifosfamide to examine whether there is a higher risk of encephalopathy (brain disorder) with ifosfamide available as a ready-made solution or concentrate for solution than with the powder form.

 

Frequently asked questions about parallel distribution (updated)

This page lists questions about parallel distribution. The information is available as questions and answers, which the European Medicines Agency (EMA) revises as necessary.

 

 

Coronavirus disease (COVID-19) (updated)

EMA published the PDF icon mandate of its COVID-19 EMA pandemic Task Force (COVID-ETF) . The Task Force is helping EU Member States and the European Commission to take quick and coordinated regulatory action on the development, authorisation and safety monitoring of treatments and vaccines intended for the treatment and prevention of COVID-19. 



Compassionate use (updated)

Compassionate use is a treatment option that allows the use of an unauthorised medicine. Under strict conditions, products in development can be made available to groups of patients who have a disease with no satisfactory authorised therapies and who cannot enter clinical trials.

 

 

Minutes of the COMP meeting 20-22 January 2020 (new)

Some of the information contained in this set of minutes is considered commercially confidential or sensitive and therefore not disclosed.

 

 

CHMP rules of procedure (updated)

Article 55 of Parliament and Council Regulation (EC) No 726/2004 of 30 April 2004 establishes the European Medicines Agency with the responsibility for coordinating the existing scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products.

 

 

Explanatory note on general fees payable to the European Medicines Agency

The fees, fee exemptions and definitions described in this explanatory note are based on Council Regulation (EC) No 297/95 of 10.02.1995 on fees payable to the European Medicines Agency1 and its implementing rules.

 

 

Information package for certificates of medicinal products issued by the European Medicines Agency (updated)

The purpose of a certificate of a medicinal product (CMP) is to confirm the marketing authorisation status of the medicinal product and that the medicinal product is produced in accordance with Good Manufacturing Practice (GMP) standards.

 

 

Referral: Estradiol-containing (0.01% w/w) medicinal products for topical use 

Estradiol, Linoladiol,Linoladiol N,Linoladiol Estradiol,Estradiol Wolff,Montadiol, Article 31 referrals, Position provided by CMDh, 08/04/2020

 

 

PRAC recommendation on signal: PRAC recommendations on signals adopted at the 9-12 March 2020 PRAC meeting (updated)

This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of 9-12 March 2020 (including the signal European Pharmacovigilance Issues Tracking Tool [EPITT]4 reference numbers).

 

 

 

 

FDA

 

FDA Requests Removal of All Ranitidine Products (Zantac) from the Market

The U.S. Food and Drug Administration today announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.

 

 

 

GDP ASSOCIATION

 

COVID-19: Temporary Regulatory Flexibilities for Wholesalers in the UK

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a list of temporary regulatory flexibilities on good distribution practices (GDP) that will be allowed to address the current exceptional circumstances during the coronavirus (COVID-19) outbreak.

 

 

  

HMA

 

(No new developments)

 

 

 

HMA - CMDH

 

NEW - PSUFU summary assessment report for bupropion;

 

NEW - Summary of CMDh Activities 2019;

 

UPDATE - Q&As on generics;

 

UPDATE - Applicant's Response document in Mutual Recognition and Decentralised Procedures for Marketing Authorisation Applications

 

 

UPDATE - Requirements on submissions (number and format) for New MA Applications, Variations and Renewals within MRP, DCP or National procedures;

 

UPDATE - CMS Validation Checklist for human medicinal products in DCP and MRP;

 

UPDATE - CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines

 

 

 

ICH

 

(No new developments)

 

 

 

INFARMED

 

Ciproterona - Restrições de utilização devido ao risco de meningioma

A Agência Europeia do Medicamento (EMA) recomenda que os medicamentos com doses diárias de 10 mg ou superiores de ciproterona apenas devem ser usados em doenças androgeno-dependentes, tais como hirsutismo, alopecia, acne e seborreia, quando outras opções de tratamento, incluindo tratamento com doses mais baixas, falharam.

 

 

EFPIA - EUROPEAN FEDERATION OF PHARMACEUTICAL INDUSTRIES AND ASSOCIATIONS

(No new developments)

 

 

OTHERS

 

European Commission Proposes to Delay MDR by a Year Due to COVID-19

The European Commission on Friday released a proposal that would defer for a year the Medical Devices Regulation (MDR) from taking effect on 26 May. With an eye toward avoiding the disruption of the device market at such a critical time, the year-long delay will not alter the substance of MDR. The delay also will “not impose new obligations on the concerned parties.

 

Portaria n.º 85/2020 - Diário da República n.º 67/2020, Série I de 2020-04-03131058332

Procede à primeira alteração à Portaria n.º 390/2019, de 29 de outubro (Procede à quarta alteração à Portaria n.º 224/2015, de 27 de julho - estabelece o regime jurídico a que obedecem as regras de prescrição e dispensa de medicamentos e produtos de saúde e define as obrigações de informação a prestar aos utentes)

 

 

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