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CELEX 02012R0528 · v20260819

Article 51 / Detailed rules

In order to ensure a harmonised approach to the cancellation and amendment of authorisations, the Commission shall lay down detailed rules for the application of Articles 47 to 50 by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3).

The rules referred to in the first paragraph of this Article shall be based, inter alia, on the following principles:

(a) 

a simplified notification procedure shall be applied for administrative changes;

(b) 

a reduced evaluation period shall be established for minor changes;

(c) 

in the case of major changes, the evaluation period shall be proportionate to the extent of the proposed change.

Source: Content sourced from EUR-Lex and licensed under CC BY 4.0. This is an unofficial presentation; only the official EUR-Lex version is legally authentic.