Regulation (EU) 2019/6 Section 2 — Marketing authorisations valid in a single Member State (‘national marketing authorisations’)

Article 46–Article 47 · 2 articles

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Scope of national marketing authorisation

Article 46

1. An application for a national marketing authorisation shall be submitted to the competent authority in the Member State for which the authorisation is applied. The competent authority shall grant a national marketing authorisation in accordance with this Section and applicable national provisions. A national marketing authorisation shall be valid only in the Member State of the competent authority which granted it. 2. National marketing authorisations shall not be granted in respect of veterinary medicinal products which fall within the scope of Article 42(2), or for which a national marketing authorisation has been granted, or for which an application for a national marketing authorisation is pending in another Member State at the time of the application.

Procedure for national marketing authorisation

Article 47

1. The procedure for granting or refusing a national marketing authorisation for a veterinary medicinal product shall be completed within a maximum of 210 days of the submission of the valid application. 2. The competent authority shall prepare an assessment report containing the information referred to in Article 33. 3. The competent authority shall make the assessment report publicly available, after deleting any commercially confidential information.

Back to Regulation (EU) 2019/6 — full text

Articles on this page are reproduced verbatim from official open data. See the attribution line.

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

What to look at next

Regulation (EU) 2019/6, full textChapter navigation and full text, so you can read this section in contextEuropean Union legislation EU Legal Acts by type and yearGrouped by instrument type and year of enactment, so you can find others of the same kindBrowse by type and year European Union: what this database coversWhich datasets are here, which official source they come from, and how current they areEuropean Union overview