Article 2 Content of applications
United Kingdom
By way of derogation from Article 20(1) of Regulation (EU) No 528/2012 F1... an application for authorisation of a same product shall contain the following information:
- (a)
the authorisation number or, for not yet approved related reference products, F2the application number of the related reference product provided by the competent authority on submission of that application;
- (b)
an indication of the proposed differences between the same product and the related reference product, and evidence that the products are identical on all other aspects;
- (c)
where required by Article 59(1) of Regulation (EU) No 528/2012, letters of access to all the data supporting the authorisation of the related reference product;
- (d)
a draft summary of the biocidal product characteristics for the same product.
Annotations
Textual amendments
- F1
Words in Art. 2 omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 196(a); 2020 c. 1, Sch. 5 para. 1(1)
- F2
Words in Art. 2(a) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 196(b); 2020 c. 1, Sch. 5 para. 1(1)