by In2Pharma | Jul 31, 2025 | News
Belgium A new web-based eAF (electronic Application Form) from the Product Lifecycle Management Portal (PLM Portal) has been established for variation applications for non-centrally authorised products. The use of this new web-based eAF is recommended, yet, the...
by In2Pharma | Jul 1, 2025 | News
Belgium Starting 1 June 2025, the Federal Agency for Medicines and Health Products (FAMHP) will require companies to use a new contact form for inquiries regarding variations and renewals of marketing authorisations for human medicinal products. This form will replace...
by In2Pharma | Jul 6, 2020 | News
Europe The CMDh recently published a revised version of the Q&A paper regarding variations. With the revision of the document a new question 1.9 has been introduced: “How do I notify an update of the contact details of the qualified person for...