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Tag: products

State aid: EU Commission approves €21 million Belgian scheme to support the production of coronavirus-relevant products in the Flemish region

The European Commission has approved a €21 million Belgian scheme to support the production of coronavirus-relevant medical products, equipment, technologies and raw materials in the Flemish region. The scheme was approved under the State aid Temporary Framework adopted by the Commission on 19 March 2020, as amended on 3 April 2020 and 8 May 2020. […]

State aid: EU Commission approves €449 million Polish scheme to support research and development, testing and production of coronavirus relevant products

The European Commission has approved a PLN 2 billion (approximately €449 million) Polish scheme to support research and development (R&D) and production of coronavirus relevant products. The scheme was approved under the State aid Temporary Framework adopted by the Commission on 19 March 2020, as amended on 3 April 2020 and 8 May 2020. The […]

Coronavirus: European Commission backs international initiative to facilitate trade in healthcare products

The ongoing global coronavirus crisis has highlighted the need for a collective response from the international community to reinforce preparedness for this and future crises. Following a first discussion among EU ministers, Commissioner for Trade, Phil Hogan, yesterday afternoon shared the European Commission’s ideas for an international initiative to facilitate trade in healthcare products with […]

State aid: EU Commission approves €5 billion French “umbrella” scheme to support research

… development, testing infrastructures and production of coronavirus relevant products The European Commission has approved a €5 billion French “umbrella” scheme to support research and development, testing and upscaling infrastructures and production of coronavirus relevant products. The scheme was approved under the State aid Temporary Framework adopted by the Commission on 19 March 2020, as […]

Warning against the Off label Use of BCG Products

In Germany, immunostimulatory products on the basis of bacteria preparations derived from the Bacillus Calmette-Guérin (BCG) mycobacterial strain are authorised for the treatment of urinary bladder carcinoma. The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines has issued a warning that the BCG products available in pharmacies are not authorised for the treatment or prevention of […]

State aid:EU Commission approves €11.5 million Maltese scheme to support investments in the production of coronavirus-relevant products

The European Commission has approved a Maltese aid scheme of €11.5 million to support investments in the production of products that are relevant to the coronavirus outbreak, including vaccines, ventilators and personal protective equipment. The scheme was approved under the State aid Temporary Framework adopted by the Commission on 19 March 2020, as amended on […]

3. QUALITY VARIATIONS

QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC 3.1. Can quality requirements be waived/adapted for medicines intended to be used for the treatment of COVID-19 patients? Without prejudice to the flexibilities afforded by the ECMP, the quality requirements foreseen in the marketing authorisation should be complied with […]

2. MANUFACTURING, IMPORTATION OF FINISHED PRODUCTS AND ACTIVE PHARMACEUTICAL INGREDIENTS AND GMP AND GDP ISSUES

QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC 2.1. How can changes in the manufacturing/supply chain be implemented swiftly to ensure continuity of supplies to the EU of crucial medicines for treatment of COVID-19 patients? MAHs may experience supply chain/manufacturing disruptions due to manufacturing, distribution and trade […]

QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC

The current COVID-19 pandemic has a considerable impact on citizens, patients and businesses. It may force marketing authorisation holders of medicinal products and regulatory authorities to operate under business continuity mode, impacting the standard way of working. Moreover, public health needs may require quick actions or re-prioritisation of operations. The ultimate aim of the EU […]

State aid: EU Commission approves €140 million Portuguese scheme to support investment in research, development, testing and production of coronavirus relevant products

The European Commission has approved a €140 million Portuguese aid scheme to support investment in research and development (R&D), testing and production of products that are relevant to the coronavirus outbreak, including vaccines, ventilators and personal protective equipment. The scheme was approved under the State aid Temporary Framework adopted by the Commission on 19 March. […]

State aid: EU Commission approves €140 million Portuguese scheme to support investment in research, development, testing and production of coronavirus relevant products

The European Commission has approved a €140 million Portuguese aid scheme to support investment in research and development (R&D), testing and production of products that are relevant to the coronavirus outbreak, including vaccines, ventilators and personal protective equipment. The scheme was approved under the State aid Temporary Framework adopted by the Commission on 19 March […]

State aid:EU Commission approves Czech scheme of up to €37 million to support investments in the production of coronavirus-relevant products

The European Commission has approved a Czech aid scheme of up to CZK 1 billion (approximately €37 million) to support investments by small and medium-sized enterprises (SMEs) in the production of products that are relevant to the coronavirus outbreak. The scheme was approved under the State aid Temporary Framework adopted by the Commission on 19 […]

State aid: EU Commission approves €30 million Luxembourg scheme to support research and development and investments in the production of coronavirus relevant products

The European Commission has approved a €30 million Luxembourg aid scheme to support coronavirus related research and development (R&D) and investments in the production of products relevant to the coronavirus outbreak. The scheme was approved under the State aid Temporary Framework adopted by the Commission on 19 March 2020, as amended on 3 April 2020. […]

COVID-19: How to protect yourself from falsified medical products?

At a time when the Covid-19 epidemic is posing unprecedented challenges to the health sector, the Council of Europe calls on governments to be extremely vigilant against counterfeit or falsified medicines and medical products. Faced with this threat, states can rely on the MEDICRIME Convention to safeguard public health and target the criminal behaviour of […]