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  1. 12. März 2023 · The proof of establishment should be included in annex 5.3 of the application form (available in the Notice to Applicants (NTA) Volume 2B – Application Form: Module 1.2). It should be emphasised that while the MAH may delegate certain activities to third parties, the MAH remains responsible for assuring all the obligations imposed ...

  2. 7. Jan. 2009 · This page lists questions that marketing-authorisation holders (MAHs) may have on transfers of marketing authorisations. It provides an overview of the European Medicines Agency's position on issues that are typically addressed in discussions or meetings with MAHs in the post-authorisation phase.

  3. The proof of establishment of the applicant in the EEA must be provided and: • must have the same name and address (if mentioned) as in section 2.4.1 of the eAF; • the address must be in the EEA; • should not be older than 6 months.

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  4. 14. Feb. 2024 · In all other cases, proof of professional experience is not obligatory to submit an application. However submitting certificates, payslips, attestations from employers or other relevant evidence can help reduce the risk that the host country authorities ask you to take an aptitude test or to undergo an adaptation period before they ...

  5. 1. Where applicable, the (G)TOC structure should follow the structure of an application dossier according to Annex II to the Regulation and as detailed in the VNeeS guidance. Examples for GTOC level: p1-toc.pdf p2-toc.pdf. Examples for TOC level: 2f-stab. 2f1-stability-active-subst.pdf.

  6. EU Fact Sheets 09-01-2024. The freedoms of establishment and service provision are pivotal for business and professional mobility within the EU. The complete implementation of the Services Directive is crucial for solidifying the internal market, but obstacles still persist. The COVID-19 pandemic added new challenges.

  7. To furnish proof of continued existence then, the secretary of state must issue a certificate of good standing. This confirms the due and proper formation as well as the continued existence of the corporation as a legal entity as of the certificate’s date of issue.