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 2
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 71 CELEX: 02019R0006-20220128 Procedure for harmonisation of summaries of product characteristics for generic and hybrid veterinary medicinal products
1. When the procedure referred to in Article 70 has been closed and a harmonised summary of product characteristics for a reference veterinary medicinal product has been agreed, the marketing authorisation holders of generic veterinary medicinal products shall apply, within 60 days of the decision by the competent authorities in each Member State and in accordance with Article 62, for the harmonisation of the following sections of the summary of product characteristics for the generic veterinary medicinal products concerned, as applicable: (a) target species; (b) clinical information referred to in point (c) of Article 35(1); (c) the withdrawal period. 2. By way of derogation from paragraph 1, in the case of a marketing authorisation for a hybrid veterinary medicinal product supported by additional pre-clinical studies or clinical trials, the relevant sections of the summary of product characteristics referred to in paragraph 1 shall not be considered to be subject to harmonisation. |
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 71 CELEX: 02019R0006-20220128 3. The marketing authorisation holders of generic and hybrid veterinary medicinal products shall ensure that the summaries of products characteristics of their products shall be essentially similar to those of the reference veterinary medicinal products. |