OpenLegislation

Article 15 F1

United Kingdom

Original text. Later amendments are not shown.

1.

Applicants shall ensure that the detailed and critical summaries referred to in the second subparagraph of Article 12(3) are drafted and signed by persons with the requisite technical or professional qualifications, set out in a brief curriculum vitae, before being submitted to the competent authorities.

2.

Persons with the technical or professional qualifications referred to in paragraph 1 shall justify any use made of the scientific literature referred to in Article 13a(1) in accordance with the conditions set out in Annex I.

3.

A brief curriculum vitae of the persons referred to in paragraph 1 shall be appended to the detailed critical summaries.

Annotations

Textual amendments

F1

Substituted by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products.