OpenLegislation

Division B.0

United Kingdom

Original text. Later amendments are not shown.

Detailed and critical summary

The detailed and critical summary shall be signed and dated. Information about the author's educational background, training and occupational experience shall be attached. The professional relationship of the author with the applicant/requestor shall be declared.

All the important data shall be summarised in an Annex, in tabular or graphic form whenever possible and the relevant bibliographic references shall also be included in the Annexes to the document. The relevance for the studies provided for the establishment of maximum residue limits shall be discussed. The detailed and critical summary and the Annexes shall contain precise cross-references to the information contained in the main documentation. That section shall not introduce new studies that are not included in the main documentation.

Notes on Annex

Textual amendments

F1

Words in Annex para. 2 substituted (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 8(5)(a); 2020 c. 1, Sch. 5 para. 1(1)

Footnotes

f1

Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (OJ L 50, 20.2.2004, p. 44).

f2

Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).