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Welcome to PLM Portal

A secure online portal for managing electronic Application Forms, electronic Product Information (ePI) and authorised product data (PMS) in the European Union, in collaboration with the European Medicines Regulatory Network.

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Application Forms Avaliable

Marketing Authorisation Applications

Apply for Initial Marketing Authorisation or an extension of a Marketing Authorisation

  • Human MAA CAP
  • Human MAA NAP
  • Vet MAA CAP
  • Vet MAA NAP

Variations

Apply for a variation

  • Human Variation CAP
  • Human Variation NAP
  • Vet Variation CAP
  • Vet Variation NAP

Renewals

Apply for renewal of Marketing Authorisation

  • Human Renewal CAP
  • Human Renewal NAP
  • Vet Renewal CAP
  • Vet Renewal NAP

PMS Art. 57 Submission

Portal to provide an update of the product data in accordance with the Art. 57 requirement

  • Data Submission Art.57
  • EMA Service Desk
  • eSubmissions

© 2023. European Medicines Agency. All rights reserved.

For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.