S.L. 437.47 · Veterinary Medicinal Products (S.L. 437.47)
S.L. 437.47 Art. 15Necessary arrangements for documents to be drafted by experts.
TITLE III
(1) Applicants shall ensure that the detailed and critical summaries referred to in the second paragraph of regulation 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 Veterinary Services.
(2) Persons with the technical or professional qualifications referred to in subregulation (1) shall justify any use made of the scientific literature referred to in regulation 13A(1) in accordance with the conditions set out in the Schedule.
(3) A brief curriculum vitae of the persons referred to in subregulation (1) shall be appended to the detailed critical summaries.
CHAPTER 2 Particular provisions applicable to homeopathic veterinary medicinal products
Änderungsgeschichte
- Amended by L.N. 82 of 2006