1. December 23, 2020

    Coronavirus: end of derogations for surgical mouth masks

    Source: FAMHP

    Coronavirus: einde van de uitzonderingsmaatregelen voor chirurgische mondmaskers

    Coronavirus : fin des mesures exceptionnelles pour les masques buccaux chirurgicaux

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  2. December 21, 2020

    Coronavirus: the EMA gives a first positive opinion for COVID-19 vaccine

    Source: FAMHP

    The European Medicines Agency (EMA) issued a positive opinion for Comirnaty, the Pfizer/BioNTech vaccine, making it the first COVID-19 vaccine that could be authorised for marketing in the European Union. 

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  3. December 21, 2020

    Coronavirus: European Commission gives conditional market authorisation for vaccine against COVID-19

    Source: FAMHP

    The European Commission granted a conditional marketing authorisation for Comirnaty, the Pfizer/BioNTech vaccine. The Commission is following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). 

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  4. December 18, 2020

    Save the date: APL webinar on 18 February 2021

    Source: APL

    Camille Saettel, Attorney at Law, Partner, will present her very recent book which deals with the law of medicines in Luxembourg. 

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  5. December 18, 2020

    Marevan (warfarin): packages containing 60 tablets may be placed back on the market

    Source: FAMHP

    On 20 November 2020, the FAMHP recalled Marevan 60 tablets of 5 mg (manufactured by Therabel) at pharmacy level. The quality of the medicinal product can now be guaranteed, meaning that the recalled batches may be placed back on the market. As soon as its price is approved (by the FPS Economy), the medicinal product may be supplied to pharmacies.

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  6. December 17, 2020

    Update on the guidance document to assist clinical trials sponsors as part of the pilot project of the FAMHP

    Source: FAMHP

    Based on the evolution of the pilot project for the new Clinical Trial Regulation, the FAMHP made an update on the guidance document to assist clinical trials sponsors as part of the pilot project for clinical trials.

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  7. December 17, 2020

    Critical antibiotics in veterinary medicine: sampling is mandatory again

    Source: FAMHP

    The FAMHP announces the reintroduction of certain articles in the Royal Decree of 21 July 2016. Sampling is once again mandatory before using critical antibiotics in veterinary medicine. This measure applies to all veterinarians and people responsible for animals.

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  8. December 17, 2020

    End of year message by Healixia President Erik Present

    The first 'Healixia year' has come to an end. A special year, but also a successful year. We are ready for 2021!

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  9. December 17, 2020

    Risk Minimisation Activities (RMA): clarifications for authorisation holders on Circular No. 635

    Source: FAMHP

    Circular No. 635 of 4 May 2018 details the approval procedure for risk minimisation activities (RMA). Certain paragraphs of this circular could be misinterpreted and specific situations were not considered. Therefore, the FAMHP would like to provide details on the RMA material included in the medicine package and on the addition / modification of RMA material  for a medicine that is already available on the market.

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  10. December 12, 2020

    News from Luxembourg

    Semper Luxembourg - November 2020

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