![]() ![]() See all AEMPS services related to pharmaceutical inspection and enforcement. (*) In some of the procedures included in LABOFAR, the use of a digital certificate is optional. ![]() (You must to use one of these special characters in your keyword: #, %, &) Register of brokers of medicinal products for human use Opening of new Labs, inspection activities, foreign trade. PHARMACEUTICAL INSPECTION AND ENFORCEMENT Procedure See all AEMPS services related to veterinary medicines. Pharmacovigilance of veterinary medicinesĪplication Software Veterinary Drugs Commercialisation Submission of a dossier in electronic format (NEES) Marketing authorization and licensing of veterinary medicines, modifications. See all AEMPS services related to human medicines. (*) In case of applications without digital signature, it is necessary to send to the AEMPS Registry the cover letter in paper including a handwritten signature and the token provided by the portal. Management Telematics Technical data sheet and patient information leaflet during the authorization process for a new medicine (provided that it has obtained a favorable report by the CODEM in the national event, or when you launched the translation phase in the case of MRP) and variation of the marketing authorization involving a modification of the texts. Search all your autorizations in pdf format and signed electronically Search all your authorizations in pdf format and signed electronically Pharmacovigilance: Registry of Pharmacovigilance Contact PersonĪpplication for the PhV Contact Person registration Notifications About Marketing Authorizations of Medicines for Human UseĪplication Software Medicines for Human Use Commercialisation Submission of applications for clinical trials in CD/DVD Pharmacovigilance: Electronic submission of suspected adverse reactionsĬlinical Trials: Authorization, protocol modifications. Submission of a dossier in electronic format (eCTD/NEES) RAEFAR: Registry of Human Medicines and Medicinal Plants Marketing authorization and licensing of human medicines, modifications.
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