Application for extension of an existing national authorisation (AL) and of recognitions
An application for extension of a national authorisation (AL) – also known as a first authorisation, or a reference authorisation – or Union authorisation should be submitted to the national authority that assessed the first application (reference member state). If the national authorisation (AL) was the subject of mutual recognition, the application for extension must also be submitted concurrently to all member states in which the national authorisation (AL) was recognised (in R4BP as a grouped submission). The application for extension must be submitted via R4BP at least 550 days prior to the expiration of the authorisation.
IMPORTANT:
To ensure recognition can be extended together with the national authorisation (AL), the same terms and conditions of authorisation must apply to both the national authorisation (AL) and the recognition (in accordance with Art. 1 (2) or (3) EU 492/2014).
In other words, deviations of the recognition from the national authorisation (AL) are limited to:
• changes of an administrative nature (in accordance with (EU) no. 354/2013)
• or restrictions ordered by the authorities based on Art. 37 BPR
If the terms and conditions of authorisation for the recognition versus those of the national authorisation (AL) differ from the above, a separate application for extension must be submitted for the recognition. In this case, grouped submission of the extension of the recognition with the national authorisation (AL) is not possible.
After validation of the application dossier, the assessing authority decides within 90 days whether a comprehensive assessment is necessary for extension of the authorisation. If the assessing authority concludes that a comprehensive assessment is required, it has a further 275 days to assess the application for extension. If a comprehensive assessment is not required, the authority has 90 days to assess the application for extension. If the national authorisation (AL) was recognised in another member state and an application for extension was also made for this national authorisation (AL), the comment procedure is the same as for the first authorisation (90 + 30 days). The national authorities then issue an official decision on the extension of the authorisation.
The fees are CHF 500 – 10,000 (without comprehensive assessment) or CHF 11,000 – 45,000 (comprehensive assessment) for assessment of an extension of a first authorisation, or CHF 500 – 1,300 for extension of recognition.
