EUCOPE's Position Paper on 'Modernising the EU Centralised Procedure'
BioPharma
Source: biopharmadive.com
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SIFI Announces Positive Topline Results of the Pivotal Phase III Study of Polihexanide for the Treatment of Acanthamoeba Keratitis
/PRNewswire/ -- SIFI, a leading international ophthalmic company, announced today that the pivotal Phase III study on polihexanide 0,08% monotherapy in adults...
Source: prnewswire.com
Application and authorisation information hub explainer
Explainer for the pharmaceutical industry on the ongoing implementation of the Veterinary Medicines Regulation relating to applications and authorisations for veterinary medicines.
Source: gov.uk
Product Literature Standard (PLS) for veterinary medicines
Guidance for the veterinary pharmaceutical industry on the production of mock-ups for assessment.
Source: gov.uk
Important Information for applicants of marketing authorisations: New Applications
7 May 2021 Five months have passed since the end of the transition period and our Exit from the European Union and we are embedding the submission opportunities that are now available to applicants. It is important, however, for the VMD to be able to plan its resources to ensure that we can continue to provide you with the predictability of the authorisation process; and to ensure we have assessor availability during the traditional busy periods. This will include the Summer months and the Christmas period, especially as the pandemic lockdown procedures ease and life begins to return to somet...
Source: gov.uk