Explore European Union Legislation by Asking a Legal Question
assisted-checkbox
filter-instruction-1
positive-filters
negative-filters
act-filter tabs-all
parameters-title
query
assisted-checkbox: ✅
result-title
total 1
Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance) article 45 CELEX: 02019R0006-20220128 Re-examination of the opinion of the Agency
1. Where the applicant requests a re-examination of the opinion of the Agency in accordance with Article 44(4), that applicant shall forward to the Agency detailed grounds for such request within 60 days of receipt of the opinion. 2. Within 90 days of receipt of the detailed grounds for the request, the Agency shall re-examine its opinion. The conclusions reached and the reasons for those conclusions shall be annexed to its opinion and shall form an integral part thereof. 3. Within 15 days of the re-examination of its opinion, the Agency shall forward its opinion to the Commission and the applicant. 4. Subsequent to the procedure set out in paragraph 3 of this Article, Article 44(6) to (10) shall apply. |